F D \CONSUMER

Donna E. Shalala, Ph.D.Secretary of Health andHuman Services

David A. Kessler, M.D.Commissioner of Food and Drugs

James A. O 'Hara I I IAssociate Commissioner forPubl ic Affairs

Judith Levine Wil l is / Editor

Patricia N. Edwards / Art Director

Michael L. Herndon / Production Manager

Carol L. Ballentine / Copy Editor

Cover Design: Jack Pardue

FDA Co/i.swnie/-(ISSN 00362-1332) is publishedby the Food and Drug Administration (HFl-40),5600 Fishers Lane, Rockviiie, MD 20857. U.S.Public Health Service, Department of Health andHuman Services. It is published monthly, exceptfor combined issues for July-August andJanuary-February. Use of funds for printing FDAConsumer has been approved by the Office ofManagement and Budget.

E d i t o r i a l M a t t e r s

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THE MAGAZINE OE THE U.S. EOOD AND DRUG ADMINISTRATION

V O L . 2 8 N O . 8 O C T O B E R 1 9 9 4

Avoiding Problems: Liquid Medication and Dosing DevicesUsing household spoons to give liquid medication can cause problems, but so can some devices specifically designed to give medicines. Here's how to take advantage of the devices' benefits whileavoiding the hazards.

Understanding Pet Food LabelsMuch as reading human food labels helps in planning good humanmeals, knowing what to look for on a pet food label can help ownerspick appropriate food for their pets.

Calming Fears, Easing Pain: Children's Anesthesia TrickyTo a child, pain and fear are inseparable. How to safely relieve bothis a subject of growing debate and research. Only recently has a narcotic drug been approved specifically for children, and its use is cont rove rs i a l .

Stalking the Wild MushroomPoisonous mushrooms can cause stomach upset, dizziness, hallucinations, liver and kidney failure, coma—even death. And in NorthAmerica, they are even harder to distinguish from nontoxic mushrooms than in most other parts of the world.

OTC Options: Controlling DandruffFDA banned 27 dandruff shampoo ingredients in 1990. But productscontaining any of the five ingredients FDA okayed for nonprescription use give those with flaky scalps plenty of treatment choice.

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1 6

2 0

2 5

Updates

C o n s u m e r F o r u m

N o t e b o o k

2

5

2 8

I n v e s t i g a t o r s ' R e p o r t s 2 9

S u m m a r i e s o f C o u r t A c t i o n s 3 3

Inside Front Cover Photo: Correct use of the measuring devices that come with liquid medicines is not always as easyas it looks. See page 6.

©

FDA ConsideringNew Food Safety Plan

A new plan under consideration byFDA would help prevent food-home illnesses rather than just react to them. "Thissystem—though it is simple and based oncommon sense—signals one of the broadest food safety policy shifts in the last 50years," said FDA Commissioner David A.Kessler, M.D.

In an advanced notice of proposed rulemaking published in the Aug. 4, 1994,Federal Register, the agency announced itsintent to use Hazard Analysis and CriticalControl Points (HACCF) for part or all ofthe U.S. food supply. FDA also asked forpublic comment on various HACCF issues, including whether such a systemshould be mandatory for all foods.

Earlier this year, FDA propo.sedHACCF for seafood. The agency expectsto issue a final rule on that proposal in1 9 9 5 .

In a HACCF system, companies analyzetheir food production processes and determine "critical control points" at whichfood safety problems are most likely to

occur and thus where risk-reduction measures should be focused. Companies thenmonitor these critical control points andkeep records to give government inspectors a clear, systematic view of how wellfirms are complying with food safety laws.

Written comments should be sent byDec. 2, 1994, to Dockets ManagementBranch (HFA-305), Food and Drug Administration, Room 1-23,12420 FarklawnDrive, Rockville, MD 20857.

Shiley Agrees to PayG o v e r n m e n t M i l l i o n s

Shiley, Inc., a subsidiary of Ffizer, Inc.,will pay the United States as much as$20 million as a result of making falsestatements to FDA. Shiley made the statements to get a mechanical heart valve thecompany knew was subject to life-threatening fracture approved by FDA and tokeep it on the market. The Department ofJustice and FDA announced the settlementlast June 30. The valve is the Bjork-Shiley60-degree Convexo-Concave (C-C) heartvalve.

The firm agreed to pay $ 10.75 millionin fines and reimbursement to the government for payments made for Shiley heartvalves. Shiley will also pay possibly millions more for medical costs the government has incurred since January 1992, asstated in the agreement, or would otherwise incur in the future through Medicare,Medicaid, CHAMFUS, federal hospitals,or other government programs due to fracture or elective replacement of the valve.The agreement, made under the FalseClaims Act, settles the govemment'sclaims against Shiley. (Shiley earlieragreed in a class-action lawsuit to reimburse patients not covered by govemment

programs for surgical replacement anddamages. Other patients filed separateactions.)

The settlement should not affect deci

sions about whether individual patientsshould have their valves replaced. Fatientsshould consult their doctors to decide theirbest course of action.

Shiley first marketed the C-C valve in1979, but withdrew it from the market in1985 and 1986 after FDA took steps towithdraw the approval. Of an estimated31,368 implanted in the United States, 196have fractured. On average, two of everythree fractures are fatal.

The govemment says that Shiley:• falsely asserted the C-C valve causedfewer blood-clotting complications thanother models• falsely asserted a series of manufacturing changes had corrected a serious designd e f e c t• did not provide FDA with all the data ithad concerning fractures during laboratorytesting• argued—to keep marketing the valve after the fracture problem became evident—that the fracture risk was outweighed bytbe purported blood-clotting advantage,which did not prove to be as significant asrepresented to FDA• rebuilt scrap valves• rewelded valves an excessive number of

t i m e s

• polished, rather than rewelded, crackedv a l v e s t r u t s• falsified employee identification numbers on cards attached to bags of reworkedvalves, including more than 3,000 "baggiecards" with inaccurate identification numb e r s .

(See "Shiley Saga Leads to ImprovedCommunication" in the January-February1994 FDA Consumer.)

2 / October 1994/ FDA Consumer

'Mexican Vanilla' Hazardous

Vanilla purchased in Mexico is differentfrom vanilla sold in the United States, andconsumers purchasing it in Mexicoshould be aware that, even though it costsless, it may present hazards.

Mexican-made vanilla is frequentlyadulterated with extract from beans of thetonka tree, in addition to containing vanilla extract. Vanilla sold in the UnitedStates contains only extract from vanillabeans.

In addition, tonka beans don't meet the

food safety requirements of the Food,Drug, and Cosmetic Act. Although tonkabean extract smells like vanilla, it containscoLimarin, which is known to damage theliver and other organs in test animals.FDA has prohibited the use of coumarinin food or as a food additive since 1954.

FDA's standard of identity for vanillaproducts specifies that only vanilla beansbe used to make vanilla extract, concentrates and powders for use in food. Anyproduct labeled as vanilla flavoring or extract and sold in the United States mustmeet the government standard. Flavorsthat don't meet the standard must be labeled as "imitation" vanilla and must still

be made from safe and suitable substances. Tonka bean extract would not beallowed even in "imitation" vanilla due to

i t s hazards .

Pa t ien ts Wi thdrawnF r o m F e l b a t o l

A "Dear Doctor" letter last July recommended the immediate withdrawal of patients from the anti-epilepsy drugFelbatol. As of Aug. 18, the drug had beenlinked to 21 cases, including three deaths,of aplastic anemia—a rare, frequently fa

tal disease in which the bone marrow stopsmaking blood cells. The drug manufacturer, Carter-Wallace, Inc., sent the letterto 240,000 physicians on FDA's recommendat ion .

"We strongly recommend that patientsconsult their physicians as soon as possible, but it is critical that they not discontinue the drug on their own, due to the riskof .seizures," said FDA CommissionerDavid A. Ke.ssler, M.D.

Felbatol was approved in August 1993for partial seizures in adults and forLennox-Gastaut syndrome, a serious formof childhood epilepsy. (See the November1993 FDA C«/),s7//ncrUpdates section.)

The rate of aplastic anemia cases reported with Felbatol appears to be about100 or more times higher than expected.No cases were observed in pre-markettesting involving 1,000 patients. All reports of aplastic anemia associated withFelbatol were from patients taking thedrug for at least five weeks.

In rare cases when Felbatol is contin

ued, FDA suggests careful monitoring.However, there is no evidence that evenclose monitoring can protect against theoccuiTence of aplastic anemia.

Committees Reject OTC StatusFor Tagamet, Rogaine

FDA advisory committees voted lastJuly against a switch from prescription toover-the-counter (OTC) status for theheartburn drug Tagamet (cimetidine) andbaldness treatment Rogaine (minoxidil 2percent topical solution).

Meeting jointly, the agency's Nonprescription Drugs Advisory Committee andGastrointestinal Drugs Advisory Committee rejected OTC use for Tagamet becauseof potential interactions with other prescribed drugs.

The nonprescription committee rejectedan earlier try in 1993 by marketerSmithKline Beecham to switch Tagametto OTC status on the basis of insufficientdata.

In the case of Rogaine, the nonprescription committee recommended againstgranting OTC status based on theproduct's limited effectiveness and thepanel's concern for safety of patients whomay mismse the product or misdiagnosethe reason for their hair loss. Rogaine ismarketed by Upjohn Co.

FDA advisory committees are composed of experts from outside the agency.Committee recommendations play a majorrole in FDA decisions, although theagency is not bound to follow these recommenda t i ons .

More Monitoring forWomen in Cancer Drug Trial

In keeping with the recommendation ofan FDA advisory committee, healthywomen taking Nolvadex (tamoxifen) in astudy of breast cancer prevention will receive additional monitoring for endometrial changes.

The study, sponsored by the NationalCancer Institute, is designed to determinewhether Nolvadex can reduce the inci-

h 'DA Consumer /Oc tobe r 1994 /3

Updates (continued)

dence of breast cancer in healthy womenwho are at increased risk for the disease,and to evaluate the risks and benefits oft h e t r e a t m e n t .

Patients who take Nolvadex have an increased risk of uterine cancer. The drug'slabeling was revised in April 1994 to reflect the most recent information on this

risk, based on Swedish and Americanstudies of patients taking Nolvadex. Theinformed consent document for thetamoxifen breast cancer prevention studywas also updated In early 1994.

FDA's Oncologic Drugs Advisory Committee, upon request from the agency,made recommendations in June regardingthe future course of the study. It recommended that the study should continuewith no changes in design, but that theusefulness of various screening procedures should be "vigorously evaluated."

Women who are not enrolled in a clini

cal trial of Nolvadex for breast cancer prevention should not take the drug for thatp u r p o s e .

O l d e r A m e r i c a n s Ta k e

Inappropriate Drugs

At least 1 In 4 older Americans not

living in nursing homes may take a prescription drug considered inappropriate, anational study concludes.

The study's authors defined an inappropriate drug as 1 of 20 identified by an expert pane! as drugs that older Americansshould avoid because of adverse effects,such as daytime sedation or cognitive impairment. resulting in an increased risk offalls.

The study's authors said their findingsprobably underestimate the incidence ofinappropriate prescribing because thestudy did not consider other prescribing

practices, such as excessive drug dosageor duration, and medication interactions.

The study report appeared In the July27, 1994. issue of the Journal of theAmerican Medical Associat ion, with information from 6.171 people In the 1987National Medical Expenditure Survey by .the Agency for Health Care Policy andResearch, a part of the U.S. Departmentof Health and Human Services.

According to the study, 24 percent ofpeople 65 and older who do not live innursing homes received at least one of the20 Inappropriate drugs In 1987. Of thosereceiving the inappropriate drugs, nearly80 percent received only one drug, while20 percent received two or more.

The authors recommend "more vigorous" doctor education and increased drugregulation to improve the safety of pre-.scrlbing medicines.

IB S t i l l a P rob lem

Tuberculosis from recent person-to-person transmission is three to four timesmore common than had been previouslythought, according to two studies reportedin the June 16 New England Journal ofMedicine. The studies were supported bythe National Institute of Allergy and Infectious Diseases, the National Cancer In

stitute, and Howard Hughes Medical Instit u t e .

Research teams in New York City andSan Francisco used DNA fmgeiprintingand conventional contact-tracing techniques to document the transmission pattern of theTB bacterium. Mycobacteriumtuberculosis. Both teams found that atleast 30 to 40 percent of new TB cases resulted from recent transmission of TB bacteria from a person with active TB. Previously, scientists had thought that onlyabout 10 percent of new TB cases in theUnited States resulted from recent trans

mission, with the rest presumably due toreactivation of latent infections.

In both studies, nearly two-thirds of patients with newly acquired TB were alsoinfected with the human immunodefi

ciency virus (the AIDS virus), whichweakens the body's immune defenses.

In San Francisco, researchers found 44

infection clusters of two to 30 individuals,each of whom carried the same TB strain.

These clusters occuired disproportionatelyin young African American and U.S.-bornHispanic men with AIDS. In the largestcluster, one man with active TB who wasnot successfully treated Infected 29people.

"Current TB control strategies have important limitations in contemporary urbanenvironments," says Peter Small. M.D., ofStanford University School of Medicine,head of the San Francisco study. "Even the95 percent success rate in treating TB patients in San Francisco in recent years isnot good enough."

In the New York study, investigatorsfound that of 104 TB patients, 39 carried astrain of bacteria found in at least oneother patient. The Investigators identified12 clusters of cases and found that patients

4 / O c t o b e r 1 9 9 4 / F D A C o n s u m e r

in these clusters were likely to be young,HIV-infected and Hispanic. They werealso more likely to be born in the UnitedStates and to live in lower-income areaswith more crowded housing than other TBpatients. Almost half of these patientswere resistant to one or more anti-TB

drugs."In our community, most drug-resistant

cases are due to bacteria transmitted from

person to person, and do not develop in anindividual because of poor treatment compliance or treatment failures," said the

head of the study, David Alland, M.D., ofAlbert Einstein College of Medicine/Montefiore Medical Center. "We can anticipate a continuing rise in the incidenceof drug-resistant TB cases if new approaches to interrupting TB transmissionare not developed."

(See "Tuberculosis: Still Striking AfterAll These Years" in the March 1991 FDA

Consumer.)

New Mammography Pub

A free FDA Consumer reprint aboutquality standards for mammography isn o w a v a i l a b l e .

To order single copies of"Mammography Facilities Must MeetQuality Standards" (FDA 94-8284), writeto FDA, HFF-88,5600 Fishers Lane,

Rockville, MD 20857. To order 2 to 100

copies, write to FDA, HFI-40, at the sameaddress, or fax your order to (301) 443-9057. Include the publication number.

Consumer Forum

fl i

M e n u I t e m

It was with great interest that we readthe art icle .. . "New Food Guide: AMenu of Modern Safety Standards," ...in FDA Consumer, Volume 28, No. 3, ...1994. However, we were surprised thearticle made no mention of chemicalsanitizers, the use of which is described inthe 1993 Food Code for the sanitization offood contact surfaces and hands of food

handling employees. Sanitizers have specific FDA approval for safety and efficacy.We believe that only the conscientious application of all the overlapping safeguardsdescribed in the Food Code prevent food-borne illness in the home or in our institu

tions. Thus, the meticulous washing ofhands, appropriate cleansing of all foodcontact surfaces as well as all other areas,and the judicious application of sanitizersas described in the Food Code combine toensure protection of public health.Arno Driedger. Ph.D.Director, Product Safety & ComplianceStepan CompanyNorthfield, IL 60093

Editor's note: The correct title of theFDA Consumer story is "New FoodCode: A Menu of Modern Safety Standards." The Food Code does not address

safety .standards in the home.

New Food Code

A Menu ofM o d e r nSafetyS t a n d a r d s

F D A C o n s u m e r w e l c o m e s c o m m e n t sfrom readers. Send letters to: Editor,FDA Consumer. HFI-40, 5600 FishersLane, Rockville, MD 20857.

F D A C o n s u m e r / O c l o h e r 1 9 9 4 / 5

Avoiding Problems

Liquid MedicationAnd Dosing Devices

by Paula Kitrtzweil

"Just a spoonful of sugar helps themedicine go down, the medicine godown, the medicine go down ... in themost delightful way."—from "Mary Poppins."

In the Walt Disney movie, MaryPoppins suggests a "spoonful" as thecorrect dose of sugar to ease the not-so-pleasant things in life, like taking bad-tasting medicine. But when giving ortaking medicine, FDA warns consumersto put away their spoons and use a moreexact measure—the proper dosing dev ice .

Sugar aside, consumers also shouldtake steps to make sure parts of the dosing device don't go down with the medication. FDA has received reports ofswallowing or choking on the caps ofsyringes used to administer liquid medicines, although no deaths have occurred.

While FDA's warnings apply to everyone, they especially target parents andothers who care for infants, young children, and ailing older people who takeliquid medicines.

The advice applies whether the medicine is prescription or over-the-counterand refers to measuring devices packaged with the medicine or distributed bypharmacists, physicians, or other healthcare professionals.

E x t e n t o f M i s u s eSince 1988, FDA's Center for Devices

and Radiological Health has receivedfour reports of children swallowing orchoking on plastic caps of hypodermic

syringes used to give liquid medication.One other case, reported in a scientificjournal, involved a 6-month-old girl whorequired cardiopulmonary resuscitation.

Health professionals believe that insome or all of the cases, the hypodermicsyringe cap was not removed before giv-

It's important to measure an exactdose of liquid medicine, preferably intoa device provided with the product.Tableware spoons should be avoidedbecause they're not exact.

6/ October 1994 / FDA Consumer

How to Use Dosing Instrumentsing the medicine. As the medicine was being given, the cap came off and entered thechild's mouth. Or, these children may havepicked up the caps and put them in theirmouths .

Another problem associated with liquidmedication is misuse or misdosing. FDAhas received reports about people misreading the markings on do.se cups, using thewrong size dose cup from a different bottleof medicine, and misreading the directions. These have sometimes resulted in

giving several times the recommendeddosage.

Dosing Made AccurateConsumers can get various types of dos

ing instruments for liquid medicines: hypodermic and oral syringes, oral droppers,cylindrical dosing spoons, and plasticmedicine cups. They measure in one ormore units of ounces, teaspoons, tablespoons, cubic centimeters, or milliliters.These devices are more accurate thantableware teaspoons, dessertspoons (aspoon between a teaspoon and tablespoonin size), and tablespoons commonly usedto measure doses.

Common tableware teaspoons come inmany sizes. They may be as small as 2.5milliliters (mL) or larger than 9.5 mL,according to a 1981 article in U.S. Pharmacist. The measuring teaspoon holds 5mL, so on oral syringes and droppers, theteaspoon mark is at the same place as the5-mL mark.

Syringes offer additional benefits:They're easy to irse, especially with infants, young children, and ailing olderadults; relatively inexpensive; and available in various sizes. There are two types:an oral syringe designed especially for administering liquid medicines and the standard hypodermic syringe without theneedle.

According to Susan Bounds, a consumersafety officer in FDA's Center for Devicesand Radiological Health, parents and othercare-givers often receive the standard hypodermic syringe when a doctor handsthem a written prescription, or a pharmacist or other health-care professional handsthem medicine. Health professionals frequently give patients hypodermic syringesrather than oral syringes because they cost

• Remove caps from hypodermic and oral syringes before drawing medicine and giving it to yourself or another person. Keep the caps out of reach of infants and toddlers.

• For oral dosing .syringes, unless the .syringe is filled with medicine for later use, donot recap. Throw out caps immediately.

• For hypodermic .syringes, do not recap: throw out caps immediately.

• Follow label directions for dosage amounts and time intervals. If you have any questions, call your pharmacist.

• Use the plastic dosing cup that comes with the medicine; don't substitute a cup fromanother drug product.

• Verify that dosing instrument measurements are compatible with the product label.

• Use a standard measuring spoon or proper dosing device to measure medicines—nottableware spoons.

• Follow package directions for the proper cleaning and handling of dosing devices. ■

— P . K .

In this photo, the tableware spoon holds 1 mL more than the measuring spoon,which could result in getting 20 percent more medicine than called for.

FDA Consumer /October 1994 /7

How to Use Syringes

Standard hypodermic syringe with protective cop on (left)and off (right) the device

The illustration shows a standard hypodermic syringe withplastic cap in place to protect the nozzle end of the container(left) and with the plastic cap off the device (right).

NOTE: When in place, the protective plastic cap appearsto be an integral, yet inconspicuous, port of the device.

Syringe con be loaded with cap in placeThe plastic cap is simply intended to be a protective bar

rier to the syringe's nozzle.Figure A shows how a liquid medication can be drawn up

into a hypodermic syringe without removal of the protectivecop. Liquid can easily enter the syringe nozzle through clearance around the cap.

Figure B shows the loading of liquid medication into thebarrel of the syringe after removal of the plunger, with theprotective nozzle cap still in place. In either case, the potentialexists for administering liquid medication to a child orelderly person without first removing the protective plasticc a p .

Potential hazard of using capped syringe when administering liquid medication

If left on a loaded hypodermic syringe, the protective plasticcap can be ejected inadvertently into the throat during administration of the contents.

(Adapted by FDA from material prepared by tfie AmericanPharmaceutical Association)

less. In some cases, she said, the healthcare professional draws the medicine intothe syringe for the customer to demonstrate how it is done.

Po ten t i a l P rob lemsBoth types of syringes often come with

caps. According to the American Pharmaceutical Association, manufacturers "cap"their syringes to protect the syringe'snozzle. The cap also may keep medicinefrom leaking out of the syringe. This isuseful in health-care facilities, so the syringe can be capped between the time thenurse or pharmacist measures the medicine and it is given to a patient. Parentswhose children are in day care may alsofill syringes and recap them for later administration by a day-care worker.

The caps are supposed to be removedbefore the medicine is drawn up into anysyringe and administered. But because thecaps sometimes are not distinct from therest of the syringe, the care-giver may beunaware that a cap is there. And, with hypodermic syringes, the medicine can bedrawn up and given with the cap in place.This creates a potentially life-threateningsituation if the cap gets into the child'swindpipe or esophagus.

Also, if the caps are not properly thrownaway, infants and toddlers may pick themup and put them in their mouths. If theyswallow, they are likely to choke.

In May 1994, FDA wrote to makers ofsyringes and other dosing instruments toask their cooperation in addressing the potential hazards of syringe caps. Specifically, FDA sought input on:• approaches for reducing hazards—forexample, through device design, labelchanges, or education initiatives• the feasibility of packaging oral dosingsyringes without caps.

According to Tom McGinnis, a registered pharmacist in FDA's Office ofHealth Affairs, the latter idea is possible

• Use child-resistant caps, and donot leave medicine uncapped.

• Store medicine as directed and in a

safe place out of reach of children.

• Don 7 give medicine to children unless it is recommended for them onthe label or by a doctor.

• Don 7 take drugs prescribed forsomeone else or give yours to someone else.

• Don 7 use medicine for purposesnot mentioned on the container or in

package directions, unless so directed by a doctor.

• Don 7 try^ to remember the doseused during previous illnesses; readthe label each time.

• Keep liquid medicines in theiroriginal bottles; don 7 transfer themto other conta iners.

• Use a prescribed medicine for aslong as the doctor recommends to ensure complete recovery.

• Check with your doctor or pharmacist if you have any problems with orquestions about your medicine. ■

— P . K .

because syringes intended for oral use donot have to be sterilized, and, therefore, acap is not necessary. Only syringes used toinject a substance into the body need to beabsolutely free of contaminants and therefore must have a cap.

Within two weeks of requesting input.

FDA heard from six firms interested in

working with FDA to address the problemand suggesting ways to correct it.

Inappropriately marked plastic dosingcups also have posed some problems. In1992, FDA received a report of a childwho had been given three times the safedose of a liquid acetaminophen product, 2teaspoons. The dosing cup packaged withthe drug gave measurements in tablespoons rather than teaspoons. The parentsmeasured to the 2-tablespoon levelmarked on the cup, and the child got triplethe recommended dose.

F D A A c t i o n

Soon after FDA received the report ofthe acetaminophen dosing cup error, theagency learned of similar incidents withother acetaminophen drug products andpediatric cough/cold preparations. As a result, FDA undertook a survey of over-the-counter liquid medication makers to ensure that the labeling of these products iscompatible with their dose cups and thatthe cups are easily readable. FDA's actionprompted eight drug firms to recall nationwide over 980,000 bottles of oral medications and their accompanying dosage delivery devices because the devices werenot consistent with the products' labeleddi rec t ions.

Some solutions to dosing device problems may be a few years away. FDA hasbegun a public education campaign to increase health professional and consumerawareness of misdosing hazards and potential syringe cap problems with liquidm e d i c i n e s .

The agency hopes this campaign willalert consumers to the potential dangersand avert any further problems while FDAand the manufacturers work on appropriate changes. ■

Paula Kurtzweil is a member of FDA 7public affairs staff.

FDA Consumer / Oc tober 1994/9

UndepsfandinqP I 1e\ rDod L(□ DG

by David A. Dzanis, D.V.M., Pli.D

As Americans become more health conscious, they are reading food labels andchoosing products more carefully. Manypeople are extending this scrutiny to foodfor their pets as well. Pet food labels areregulated by different rules than foods forhuman consumption, but reading and understanding a pet food label can help consumers make proper food choices for theirpets, too.

Pet food labeling is regulated at twolevels. The federal regulations, enforcedby the Food and Drug Administration'sCenter for Veterinary Medicine, establish standards for all animal feeds:

proper identification of the product, netquantity statement, manufacturer's address, and proper listing of ingredients.Some states also enforce their own la

beling regulations. Many of these followthe model pet food regulations of the Assoc ia t ion o f Amer ican Feed Cont ro l Officials (AAFCO). a nongovernment advisory body with representatives fromall states. These model regulations aremore specific, covering aspects of labeling such as product name, guaranteedanalysis, nutritional adequacy statement,feeding directions, and calorie statem e n t s .

P r o d u c t N a m eThe product name is the first part of

the label a consumer notices, and can bea key factor in the decision to buy aproduct. For that reason, manufacturersoften use fanciful names or other tech

niques to emphasize a particular aspect.Many product names incorporate thename of an ingredient to highlight itspresence in the product. Consumers areoften confused, however, as to howmuch of a named ingredient is actually in

the product. The percentages of named ingredients in the total product are dictatedby four AAFCO model rules.

The first of these is the "95 percent"rule. It applies to products consisting primarily of meat, poultry or fish, such assome of the canned products. They havesimple names, such as "Dave's Beef forDogs." In this example, at least 95 percentof the named ingredient must be beef, exclusive of water for processing. Countingthe added water, it still must comprise 70percent of the product.

Since ingredient lists must be in theproper order of predominance by weight,"beef should be the first ingredient listed,followed often by water, and then othercomponents such as vitamins and minerals. If the name includes a combination of

ingredients, such as "Dave's Chicken 'n'Fish Cat Food," the two together mustcomprise 95 percent of the total weight,and there must be more chicken than fish.

The second rule, the "25 percent" or"dinner" rule, applies to many canned anddry products. If the named ingredient(s)comprise at least 25 percent of the productexclusive of water for processing, but lessthan 95 percent, the name must include aqualifying descriptive term, such as"Dave's Beef Dinner for Dogs." Many descriptors other than "dinner" are used,however. "Platter," "entree," "nuggets,"and "formula" are just a few examples.Because, in this example, only one-quarterof the product must be beef, it would mostlikely be found third or fourth on the ingredient list.

Since the primary ingredient is not thenamed ingredient, and may in fact be anundesired ingredient, the list should always be checked before purchase. For example, a cat owner may complain that her

PHOTO BY LAWRENCE RUGGERI F D A C o n s u m e r / O c t o b e r 1 9 9 4 / J I

If there is scientific evidence showingan ingredient or additive presents a healthrisk to animals, FDA's Center for Veterinary Medicine can prohibit or requiremanufacturers to modify its use in petfood. For example, propylene glycol isused as a humectant in semi-moist petfoods, giving these products their uniquetexture and taste. It was affirmed GRAS

(generally recognized as safe) for use inhuman and animal food before the advent

of semi-moist foods.

It was known for some time that propylene glycol caused a red blood cell disorder in cats called Heinz body formation,but it could not be shown to cause overt

anemia or other clinical effects. However,recent reports of scientifically sound studies show that propylene reduces red bloodcell survival time, renders red blood cellsmore susceptible to oxidative damage, andhas other adverse effects in cats consum

ing the substance at levels found in semi-moist food. Therefore, the center is work

ing to amend the regulations to expresslyprohibit the use of propylene glycol in catf o o d s .

Another somewhat controversial petfood additive is ethoxyquin. Ethoxyquinwas approved as a food additive more than30 years ago as an antioxidant chemicalpreservative in animal feeds. A few yearsago, the center began receiving reportsfrom dog owners attributing myriad adverse effects to the presence of ethoxyquinin dog food. The reported effects includeallergic reactions, skin problems, majororgan failure, behavior problems, and cancer. However, there is little available scientific data to support these contentions, orto show other adverse effects in dogs atlevels approved for use in dog food. Assuch, there is no sound scientific basis towarrant a change in the regulatory statusof ethoxyquin at this time. ■

— D A . D .

added. If the burst reads "with bacon andcheese," it must contain at least 3 percentbacon and 3 percent cheese.

Some manufacturers have been usingthe "with" designation as part of the product name, which may give the impressionthat more of an ingredient is present thanreally is. For example, one may not expecta "Dave's Dog Food with Beef to contain as much as "Dave's Beef Dinner," butnot as little as 3 percent. The A AFCO PetFood Committee is considering newmodel regulations to address this issue.

Under the fourth rule or "flavor" rule, a

specific percentage is not required, but aproduct must contain an amount sufficientto be able to be detected. In the exampleof "Dave's Beef Flavor Dog Food," theword "flavor" must appear on the label inthe same size, style and color as the word"beef." The corresponding ingredient maybe beef, but more often it is another substance that will give the characterizing flavor, such as beef meal or beef byproducts.Pet foods often contain "digests," whichare materials treated with heat, enzymesand acids to form concentrated natural flavors. Stocks or broths are also occasion

ally added. Whey is often used to add amilk flavor. Often, labels will bear a claimof "no artificial flavors." Actually, artificial flavors are rarely used in pet foods.The major exception to that would be artificial smoke or bacon flavors, which areadded to some treats.

Net Quantity StatementIt's important to check the net quantity

statement when comparing products. Today, many canned products are sold innonstandardized sizes, so even though theproducts look the same, one may be a better buy. Also, dry products may differgreatly in density, especially some of the"lite" products. Thus, a bag that may typically hold 40 pounds of food may onlyhold 35 pounds of a food that is "puffedup" with air.

When new federal regulations go intoeffect requiring ''dual declarations" on petfood labels, not only will the customary

cat s chicken dinner" smells like fish.She avoids buying fish, since her catdoesn't like it, but she is more concernedthat the food might be spoiled. In readingthe ingredient list, however, she discoversthat the primary ingredient is indeed fish.

If more than one ingredient is includedin a "dinner" name, they must total 25percent and be listed in the same order asfound on the ingredient list. Each namedingredient must be at least 3 percent of thetotal, too. Therefore, "Dave's Chicken 'n'Fish Dinner Cat Food" must have 25 percent chicken and fish, and at least 3 percent fish.

The third rule is the "3 percent" or"with" rule. It is intended to apply to ingredients highlighted on the label butwhich appear outside the product name.This allows manufacturers to point outthe presence of minor ingredients that arenot or cannot be added in sufficient quantity to merit a "dinner" claim. For example, a "Bacon Dinner," with 25 percentbacon, would not be feasible, nor wouldit most likely be palatable or nutritionallysound. However, both "Dave's Beef Dinner for Dogs" and "Dave's Chicken Dinner for Dogs" could include a side burst"with bacon" if at least 3 percent bacon is

1 2 / O c t o b e r 1 9 9 4 / F D A C o n s u m e r

"pound" or "ounce" declaration be made,but a unit of metric measurement, such as

"kilogram" or "gram" ("kg" or "g") willalso appear on the label. Many pet foodlabels already bear both measurements.

M a n u f a c t u r e r ' s N a m e a n d A d d r e s sThe "manufactured by ..." statement

identifies the party responsible for thequality and safety of the product and itslocation. A consumer who has a questionor complaint about a product should nothesitate to contact the manufacturer. Manymanufacturers also include an "800" tele

phone number on the label for consumerinquiries.

Ingredient ListAs mentioned, ingredients are required

to be listed in their proper order of predominance by weight. The weights of ingredients are determined as they are addedin the formulation, with their inherent water content. This is important when evaluating relative quantity claims, especiallywhen ingredients of different moisturecontents are compared.

For example, one pet food may list

Labels on dog food (left) and cat

food (right) can give pet owners avariety of information, including:the ingredients, in order of

predominance by weight; proportions of protein, fats, fiber, and

moisture; and daily feeding guide.

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 1 3

"chicken" as its first ingredient, and"corn" as i ts second. The manufacturer

doesn't hesitate to point out that itscompetitor lists "corn" first (chickenmeal is second). However, chicken is

very high in moisture (approximately 75percent water). On the other hand, waterand fat are removed from chicken meal,so it is only 10 percent moisture. Comparing both products on a dry matter basis, the second product has morechicken meal than the first product hasch icken .

That is not to say that the second product has more chicken, or in fact, anychicken at all. Chicken meal is notchicken per se, since all the fat and waterhave been removed by rendering.

Ingredients must be listed by their"common or usual" name. Most ingredients on pet food labels have a corresponding common definition in the AAFCO official publication. For example, "meat" isdefined as the "clean flesh of slaughteredmammals and is limited to ... the striatemuscle ... with or without the accompanying and overlying fat and the portionsof the skin, sinew, nerve and blood vesselswhich normally accompany the flesh." Onthe other hand, "meat meal" is "the rendered product from mammal tissues, exclusive of any added blood, hair, horn,

hide trimmings, manure, stomach andrumen contents . "

Meat meal may notbe very pleasing tothink about eating,even though it'sprobably more nutritious, but the dist inct ion must be

made in the ingredient list.

Fur ther down the

ingredient list, the"common o r usua l "

names become lesscommon or usual to

m o s t c o n s u m e r s .

The majority of ingredients with chemical-sounding namesare, in fact, vitamins, minerals, or othernutrients. Other possible ingredients include artificial colors, stabilizers, and

preservatives. All must be either "Generally Recognized as Safe" (GRAS) or approved food additives for their intendeduses. When there are health risks with an

ingredient, FDA takes appropriate action. (See "When There Are HealthRisks.")

Guaranteed AnalysisAt minimum, a pet food label must state

guarantees for minimum percentages ofcrude protein and crude fat, and maximumpercentages of crude fiber and moisture.The "crude" term refers to the specificmethod of testing the product, not to thequality of the nutrient itself.

Some manufacturers include guaranteesfor other nutrients as well. Maximum ashis often guaranteed, especially on catfoods. Cat foods commonly bear guarantees for taurine and magnesium as well.For dog foods, minimum levels of calcium, phosphorus, sodium, and linoleicacid are found on some products. If theguarantees don't include information on aparticular nutrient that you're interested in,ask the company or don't buy the product.

The levels of crude protein and most

Other nutrients are much lower for thecanned product than for a comparabledry product due to differences in moisture contents. Canned foods typicallycontain 75 to 78 percent moisture,while dry foods contain only 10 to 12percent water. A rough approximationof comparable nutrient levels of acanned and dry product can be made bymultiplying the guarantees for thecanned product by four.

When buying a canned food, look atthe moisture guarantee. The maximummoisture content for a pet food is 78 percent, except for products labeled as a"stew," "in sauce," "in gravy," or similarterms. The extra water gives the productthe qualities necessary for appropriatetexture and fluidity, but you are payingfor it.

Nutritional Adequacy StatementManufacturers must substantiate the

nutritional adequacy of a "complete andbalanced" pet food by one of two means.By the first method, the pet food mustcontain ingredients formulated to providenutrient levels established by the AAFCOdog or cat nutrient profile. (The recommendations of the National Research

Council [NRC] are no longer used as thebasis for nutritional adequacy. If a petfood label claims "meets or exceeds

NRC," it means the product is old or themanufacturer has yet to comply with thenew model regulations.)

The alternative means of substantiatingnutritional adequacy is for the product tobe tested following the AAFCO FeedingTrial Protocols. These products shouldbear a nutritional adequacy statement thatbegins, "Animal feeding tests ...." However, not all products that bear the claimare the ones actually tested. Some may bemembers of a "family" formulated to benutritionally similar or superior to theproduct tested. Because of some concemsregarding the application of the familyconcept by manufacturers, AAFCO isconsidering new model regulations.

The nutritional adequacy statement also

14/ October 1994 / FDA Consumer

Premium? Natural? Light?Many pet foods are labeled as

"premium," and some now are labeledas "superpremium"^—and even"ultrapremium." Other products are toutedas "gourmet" or "natural." None of theseterms have any official FDA or state regulatory standing. Products labeled as premium or gourmet are not required to contain any different or higher qualityingredients, nor are they held up to anyhigher nutritional standards than are anyother complete and balanced products.Products labeled "natural" do not approximate the natural diet of the animal, as the

products do not contain whole bodies ofbirds or small mammals. Nor do they exclude artificial ingredients, since all complete and balanced products must contain

some chemically synthesized ingredients,such as vitamin supplements. (Some products will include the disclaimer "natural

ingredients with added vitamins andminerals.")

For the most part, "natural" can be construed to mean the product contains no artificial flavors, colors or preservatives. Artificial flavors are rarely employedanyway, and artificial colors are not reallynecessary, except to please the pet owner'seye. If used, they must be from approvedsources, the same as for human foods. Especially for high-fat dry products, someform of preservative must be used to prevent rancidity. Natural-source preservatives, such as mixed tocopherols (a sourceof vitamin E), can be used in place of artificial preservatives. However, they are notas effective. If a product smells bad, or the

pet doesn't eat it or gets sick, take theproduct back to the store or contact themanufac tu rer.

Following trends in human foods, manypet food labels carry the claim to be "lite"or "light." However, unlike human foods,there are presently no standards for "light"pet foods. A manufacturer's light productis only light relative to another of thecompany's products. In some cases, onecompany's light product may containmore calories than another's regular product. AAFCO is considering new modelregulations to address this problem. ■

— D . A . D .

tional needs for growth and reproduction.A maintenance ration will meet the needsof an adult, non-reproducing dog or cat ofnormal activity, but may not be sufficientfor a growing, reproducing, or hard-working animal. On the other hand, an "all lifestages" ration can be fed for maintenance.Although higher levels of nutrients are notharmful to the healthy adult animal, theyare not really necessary.

Feeding DirectionsFeeding directions tell how much of the

product should be offered the animal. Atminimum, they should include verbiagesuch as "feed cups per pounds ofbody weight daily." On some small cans,this may be all the information that can fit.However, feeding directions for other petfoods are much more elaborate, especiallyon dry product labels.

The feeding directions should be takenas rough guidelines. They tend to overestimate an animal's needs, possibly to makesure that highest calorie requirements(such as those of working dogs, pregnantand lactating dogs, and certain activebreeds) are met. So don't be afraid to adjust portions to your pet's needs, especially if you feel it's gaining too muchweight.

C a l o r i e S t a t e m e n tUntil recently, calorie statements were

not allowed on pet food labels. NewAAFCO model regulations allow manufacturers to substantiate calorie contentand include a voluntary statement.

If a calorie statement is made on the label, it must be expressed on a "kilocaloriesper kilogram" basis. Kilocalories are thesame as the "Calories" consumers are used

to seeing on food labels. A "kilogram" isequal to 2.2 pounds. Manufacturers mayalso express the calories in familiar household measurements (cup, pound) alongwith the required statement.

Other label statements are not requiredbut sometimes appear on the label nonetheless (see "Premium? Natural? Light?").

Pet owners have a right to know whatthey are feeding their animals. The petfood label contains a wealth of information, if you know how to read it. Don't beswayed by marketing gimmicks or eyecatching claims. If you have a questionabout the product, contact the manufacturer, your state regulatory agency, orF D A . B

David A. Dzanis is a veterinary nutritionist with FDA's Center for VeterinaryMed ic ine .

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 1 5

by Rebecca D. Williams

Calming Fears,P a i n

Children's Anesthesia Tricky

L t the age of 2, Russ Irvin of

Woodbridge, Va., knew what scrub masks

and surgical bonnets meant—pain. Diag

nosed with a brain tumor as an infant, the

child had already endured four surgeries

and numerous tests. When he needed a

neural shunt removed in the spring of

1989, a nurse and doctor, both wearing

scrubs, came to carry him to the operating

r o o m .

16 /Oc tobe r 1994 /FDA Consumer

(Companies have been hesitant to test pain medications on chiidrenfor fear of causing harm.

"He was fine on my lap until he sawthem coming," says his mother, Liz Irvin."He started crying and clinging to me.That was the time I lucked out and got asensitive anesthesiologist. They gave hima shot, and they let me hold Russ until hewas groggy. Other times, they had takenhim off crying."

To a small child, pain and fear are inseparable. Relieving both safely withmedication can be very tricky. Childrenoften need to be sedated not just to relievepain, but to hold them still for tedious procedures like drilling cavities or collectingblood samples.

Too much of a drug can harm a child.Too little doesn't work. Too often, there'snot much room in between. Pediatric se

dation is the subject of growing debateand research in the medical community.

Until recently, there were no anestheticsor sedatives specifically approved by theFood and Drug Administration for use inchildren. Physicians commonly use adultdrugs "off label," a practice that is legaland often necessary in pediatrics. Butsince doses for children aren't listed onthe labels, anesthesiologists rely on theirown knowledge and experience to mixdrugs for young patients.

"There's a whole host of cocktails outthere with no FDA approval for childrenand no testing in children," says EdwardD. Miller Jr., M.D., an anesthesiologist atColumbia University and chairman ofFDA's advisory committee on anestheticand life-support drugs.

In an ongoing effort to stimulate research for pediatric drugs, last March thecommittee met to discuss the issue of pediatric sedation. Miller and other expertsmet in Rockville, Md., to hear from parents pleading for better and safer pain

medications, and from physicians knowledgeable about pediatric sedation.

During the meeting, the committeediscussed the drug Oralet (fentanyl). Approved in October 1993 but not yet on themarket at press time, Oralet is the first narcotic ever tested in and approved specifically for children.

It is approved for calming children before surgery. Because Oralet is administered by mouth in a hardened candy-likemass on top of a stick, it has acquired thenickname "narcotic lollipop." But it is afar cry from candy.

Oralet contains the powerful narcoticfentanyl, a drug commonly marketed as askin patch called Duragesic and in severalinjectable brands. What kids like bestabout Oralet is that it doesn't require ashot—the most dreaded part of any hospital visit.

But opponents of Oralet fear it will beabused or misused by physicians and doctors, possibly leading to accidental death.Advocates say Oralet will be very usefulin easing children's anxiety withoutneedles.

"There is no reason to hurt children anymore than we need to," says Charles Cote,M.D., a proponent of Oralet and an anesthesiologist at Children's Memorial Hospital in Chicago and Northwestern University Medical School.

Lack o f ResearchResearch in children's pain relief lags

behind that for adults. Side effects fromeach drug aren't consistently reported, andno one can say for certain what a child'srisks are from most painkillers and anest h e t i c s .

As recently as the mid-1980s, somephysicians thought infants couldn't feel

pain as well as adults because their nervous systems were underdeveloped. Eventoday some doctors use little or no painmedication because they fear it is unsafefor young children, or that older childrenmight become addicted to it. Plus, theyreason, children heal quickly anyway.

Liz Irvin remembers how her son's

doctor removed a central venous tube (fordelivering chemotherapy to a main veinnear his heart) without anesthesia whenhe was an infant. She recalls, "the surgeonsaid a baby couldn't feel pain." WhenRuss was 4 years old, the same surgeonplanned to remove a stomach tube without medication, so his mother mixedTylenol and Valium for him at home.

"I cleared it with his oncologist first,"she says. "It seemed to help." Few parentsfeel compelled to go to such extremes.But it's difficult to watch a child undergoa painful procedure without any relief.

Research has shown that children areoften undermedicated. A study in 1968showed that only 15 percent of children ina hospital's intensive care unit receivedany type of narcotics for pain, and only 3percent received pain medicine after surgery. A 1992 study reported that infantsreceived less than half the number ofdoses of pain medication that adults didafter open heart surgery.

One problem is that children can't describe their pain in words that nurses anddoctors understand. Instead, they expressit through crying, facial expression, andbody movements. Heart rate and breathing also increase when a child is in pain.

Another reason children may beundermedicated is the fear that strongdrugs will suppress their breathing. Indeed, FDA has received reports—thoughrare—of deaths in otherwise healthy

FDA Consumer / October 1994/17

j r .oa small child, pain and fear are inseparable.

Oralet, the sedative

fentanyl in a dosage

form resembling a

lollipop, is the only

narcotic ever tested in

and approved specifi

cally for children. Its

use is controversial.

(Photo courtesy

Abbott Laboratories)

children from doses of anesthesia and

painkillers."Nobody really knows the absolute risk.

It's just something you have to be waryof," says Robert Bedford, M.D., an anesthesiologist and medical officer on FDA'spilot drug evaluation staff. The overall riskof a child's dying from anesthesia is estimated to be 1 in 10,000, he says. Doctorsrecognize the risk to be greater for youngchildren, and much greater for newbornand premature babies, but there are nodefinite statistics on those risks.

According to FDA's Spontaneous Reporting System (SRS), which collects information on serious reactions to drugs,from 1968 to 1993. there were 133 casesof serious reactions among children whowere sedated before undergoing medicalprocedures or receiving anesthesia.

The reports included a 4-year-old girlwho died from drugs given to calm her fora dental procedure, and a 2-year-old boywho died from sedatives given to calmhim for a CAT (computed axialtomography) scan.

Because the SRS is voluntai-y, the datacollected cannot be used to determine the

absolute risks of any drug. What the SRScan do is signal potential problems.

Calining HelpsThe most dangerous time during anes

thesia administration isjust as the patientis going to sleep. If a frightened toddler iscrying hysterically and gagging on a runnynose, it makes anesthesia more risky,Bedford says.

"If you can sedate kids in advance, thenthey don't seem to care as much what'sgoing on," he says. That's the advantage ofOralet. "Kids doze off, then the doctor canwhisk them away for a nice smooth anesthet ic induct ion."

One alternative to Oralet is an oral sedative called Versed (midazolam). Althoughnot approved for use in children. Versed is

commonly used to calm them before surgery. Physicians dilute the drug withTylenol syrup, which is cherry-flavoredand a favorite among youngsters.

But some doctors argue that anxiety relief should first be tried without drugs.

"Perioperative stress is a psychologicalthing, not a painful thing," says Allen J.Hinkle, M.D., an anesthesiologist at

Dartmouth Medical School and opponentof Oralet.

He urges taking extra time with a child,explaining the procedure if possible, andhaving a parent come into the operatingroom, holding the child on his or her lap ifnecessary. Only when those attemptsdon't work does he advocate a sedativebefore anesthesia.

"My experience is that parents like [thedrug-free approach] and will do it again,"says Hinkle.

Promoting ResearchNevertheless, pediatric drugs are often

necessary, and FDA is actively encouraging drug companies to do more researchon their products for use in children. Theagency has held symposiums, publishedguidelines on pain relief, and urged drugmanufacturers to test new drugs, including those for anesthesia and sedation, inch i ld ren.

Companies have been hesitant to testpain medications on children for fear ofcausing harm, says Miller, and parents often dislike entering their children in drugtrials. Plus, he says, there's little economicincentive for drug manufacturers to conduct extra tests on drugs if a product isalready on the market.

Even so. Miller predicts there willlikely be more testing in children in thefu tu re .

As for Oralet, few other drugs havebeen subjected to as stringent a regulatedintroduction to the market, according toCurtis Wright, M.D., acting director ofFDA's pilot drug evaluation staff.

For one year after the drug enters themarket, Oralet will only be available inchildren's hospitals and university teaching hospitals, where the manufacturer cantrack any side effects. Any child suckingan Oralet will be watched carefully by ahealth-care professional and monitoredelectronically with a pulse oximeter, a device that measures pulse and oxygen levels through the fingertip. After a yeai;FDA will reevaluate the drug's distribution plan and decide whether it can beused safely in general hospitals.

FDA has-been very cautious with the

18 /Oc tobe r 1994 /FDA Consumer

c?esearch has shown that children are often undermedicated

Where's the 600-600?

Very young children usually cannot

verbalize their pain. Even those old

enough to talk have difficulty explain

ing where it hurts, and whether it's a

sharp pain or a dull ache. Infants, espe

cially premature ones, may not always

cry when in pain, instead lying quietly

as they suffer.

Much research has been done on as

sessing pain in children, and a few use

ful methods have evolved. One method

drug, Wright says, holding extra meetingswith pediatric anesthesiology experts, andsupervising the drug's labeling, advertising and introduction plan.

"The concern with Oralet is that physicians would not identify it as an anesthetic. but as a way to manage pain beforea well-baby exam," says Wright.

Fentanyl, the narcotic in Oralet, cancause death if misused. For example, a 17-year-old boy died after having his wisdomteeth out because his dentist gave him ahigh dose of fentanyl in a Duragesic skinpatch to use at home.

is showing the child a scale of faces,

progressing from a crying face (severe

pain) to a smiling face (no pain). Chil

dren as young as 3 can point to the one

that shows how much they hurt.

Other studies have used drawing,

number scales, and dolls to help chil

dren describe their pain and its location

in ways that adults can understand.

No matter the method, children al

most always rate their pain higher than

doctors or nurses do. And studies have

shown that parents almost always assess

their child's pain more accurately than

do medical personnel. ■

— R . D . W .

Duragesic is approved only for long-term chronic pain, and is not recommendedfor pain after surgery. The boy's mothertesti filed before FDA that she feared Oralet,too, would be misused with tragic results.

Still another concern about Oralet is itsso-called "lollipop" dosage and raspberryfi a v o r .

"By associating a child's popular itemlike the lollipop with the euphoria of narcotics, we are indeed sending a confusingmessage to our children," Hinkle warned ina l e t t e r t o F D A .

"That's something you worry about,"

says Wright, "but we've made medicinetaste like candy for years." Considerchen-y-flavored cough drops and Tylenol,or sweet orange-flavored baby aspirin, forexample. Even Mary Poppins used a spoonful of sugar to help the medicine go down,

"We all realize the dangers of this drug,"says Miller. "But we know about the dangers of many drugs, and we do all we canto make them safe.

"We have prepared as many safeguardsfor Oralet as any drug ever put out. If physicians will follow those safeguards anduse common sense, this will be a very safednig."

Facing AnesthesiaWhen a child is facing surgery or a

medical procedure requiring sedation,there are a few things parents can do beforehand to help it go smoothly.

First, try to find a doctor, nurse or technician who is patient and understandingwith chi ldren.

"It really boils down to the patience ofthe technician," says Jim Kitterman ofDamascus, Md., whose 7-year-old son,Ben, was treated for cancer as apreschooler.

"It makes a world of difference if

they're patient and understanding withkids," Kitterman says, "even in somethingas simple as drawing blood."

Parents can also educate themselves

about their child's treatment. Liz Irvin discovered, and now demands, newer stomach tubes for her son that aren't painful toreplace.

Physicians say it's best to find a hospitalwhere the staff is thoroughly knowledgeable about pediatrics, such as a children'shospital. Then, talk with the anesthesiologist about any procedure that requires. s e d a t i o n .

'Amesthesia is very safe today, andproblems are rare," says Miller. "Therehave been major improvements in monitoring drugs, training doctors, and in thedrugs themselves," he adds. "Parentsshould not woiry." ■

Rebecca D. Williams is a writer in OakRidge, Tenn.

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 1 9

Stalking The WildSACUSWROOSM.

by Marian Segal

Lishrooms can kill you. the Frenchman

told author Peter Mayle, newly trans

planted to Provence front England.

"That I could believe," Mayle wrote in A Year in

Provence, but it didn't explain the thigh-high rubber

boot the Provencal wore on his right leg. or the

man's nervous thrusting of a stick around the roots

of an old .send? oak tree "in the manner of a fettcer

expecting a sudden and violent riposte."

€ 2 1

/ / AMs a novice, you'd better not go out and pickmushrooms, eat them, and expect to live very long/'— John Gecon, FDA biologist

"This was a new and woirying aspect of the Luberon," Mayle wrote. "It was, as I alreadyknew, a region full of strange things and even stranger people. But surely mushrooms,even wild mushrooms, didn't attack fully grown men."

Perhaps not with an epee. but, indeed, poisonous mushrooms can wreak havoc on men,women and children. It ingested, their toxins can cause stomach upset, dizziness, hallucinations, and other neurological symptoms. The more lethal species can cause liver andkidney failure, coma, and even death.

As it happens, the Provengal's immediate concern was not poison: "He slapped therubber [boot] with his wooden sword and swaggered down toward me. D'Artagnan with ashopping basket... 'Les serpents' He said it with just the trace of a hiss. 'They are preparing for winter. If you disturb them—ssst!—they attack. It can be very grave.'"

Here in the United States, Food and Drug Administration biologist John Gecan worries less about "/e.s serpents'" than about ignorance when it comes to harvesting wildmushrooms. Many edible mushrooms have toxic "look-alike" species, Gecan says, anduntrained pickers often are woefully incompetent to distinguish the bad from the good.

T h e U n s k i l l e d

"People go out and harvest wild mushrooms without the foggiest notion of whatthey're picking. They may know what mushrooms they're looking for, but they may alsomistakenly pick up toxic look-alikes found in the .same place," he says.

Gecan, a mushroom expert with the agency's Center for Food Safety and AppliedNutrition, says quite simply: "As a novice, you'd better not go out and pick mushrooms,eat them, and expect to live very long."

FDA regulates commercially grown and harvested mushrooms, which are cultivatedin concrete buildings or caves, but there are no systematic controls on individual gatherers harvesting wild species.

Some of the most deadly mushrooms produce toxic amanitins. Among them is thegenus Amanita, whose members have telltale common names such as death angel, fool'smushroom, and destroying angel. These, and less deadly species, may end up in gourmet shops, co-ops, supermarkets, and restaurants, mistaken for their nontoxic, ediblelook-a l ikes .

Armed with illustrated books and a big jar of dried mixed forest mushrooms importedfrom France, Gecan demonstrates how difficult it can be to distinguish similar looking

species. He emphasizes that even experts can't know all there is to know to identifyevery kind of wild mushroom, because of their great diversity.

There are two general groups of fleshy fungi—ascomycetes and basidiomycetes—which are differentiated by their spore-bearing reproductive structures. Ascomycetesbear spores enclosed in a sac-like cell called an ascus. They include the cup fungi, falsemorels, and true morels. Basidiomycetes bear spores on one end of a specialized cellcalled a basidium. This group is further broken down into subgroups based on theirspore-beainng structures and include, among others, the chanterelles, gilled fungi(including the "button" mushrooms commonly seen in supermarkets), and puffballs.

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 2 !

e d i b l e

half-free morelMorche l la semi l ibe ra

To the untra ined mushroom har

vester, the poisonous early false

morel fVerpa bohemica, left) can

be easily mistaken for the edible

half-free morel (Morchella

semilibera, right). Their ridged,

striated caps look very similar, but

the cap of the edible morel is at

tached halfway down, while the

cap of the poisonous species at

taches at the top. Microscopic dif

ferences also distinguish the two.

Gecan, whose primary expertise is identifying morels and their look-alikes, illustrates the complexity of the task. He notes,for example, that the edible bell morelVerpa conica and half-free morelMorchella semilibera, and the poisonousearly "false morel" Verpa bohemica allhave caps that look like a partially closedparasol with vertical ridges and striations.The three can easily be confused by an inexperienced harvester, as their distinguishing features are not conspicuous.

The edible half-free and bell morels

both have eight spores per a.scus, but thestem on the half-free attaches halfway upinside the cap, while the stem of the bellmorel attaches at the very top of the cap.The stem of the poisonous early false morel also attaches at the very top of the cap,but it has only two to four large spores pera s c u s .

Tbe UnscrupulousUnskilled harvesters are not the only

problem of the wild mushroom trade; thelucrative market has generated its share of

unsavory characters."There's such an economic gain to be

had here that people are going out knowingly including the toxic Verpa bohemicain their harvest of edible morels. This wasa serious contamination problem in morelscoming from India in the late 1980s,"Gecan says. He tells of an importer whoadmitted that some harvesters will pick upanything that looks like a morel, addingthat some pickers even stuff them withstones to increase the weight.

The wild mushroom business has also

spawned violence. Some wild mushroomssell for $ 1 GO or more a pound, Gecan says,and armed robberies are occurring in thePacific Northwest, where the combinationof heavy-covered forests and moist environment yields a plentiful crop.

T h e E v i d e n c e

FDA first became involved with analyzing wild mushrooms when agency field inspectors sent samples to headquarterslaboratories following a poisoning outbreak in 1977. Four people suffered abdominal pains, dizziness, vomiting, andfainting after eating "veal morel" at a NewYork City restaurant. The morels, imported from France and Switzerland, included Gyromitra esculenta mushrooms,which produce the methylhydrazine derivative gyromitrin, a toxin that can sometimes cause death. "It's basically one ofthe components of rocket fuel," Gecans a y s .

He explains that "Gyromitra is pickedand canned and eaten in France and elsewhere in Europe with no ill effects, because the chefs over there know how to

prepare them."In July 1978, FDA issued an import

alert directing sampling of morel shipments from the French and Swiss firms

implicated in the 1977 outbreak, fn 1980,analysis of samples of French morels collected by FDA's Denver district showedthey contained Gyromitra.

In 1987, a food poisoning investigationby FDA's Detroit district led to a shipmentof dried "morels" packed by two firms inIndia. The mushrooms contained

22/ October 1994 / FDA Consumer

Gyromitra as well as another toxic species,Verpa bohemica.

In December 1990, the agency identified Verpa bohemica in samples of twolots of dried "morels" from a third French

fi r m .The agency's current import alert in

structs the districts to sample morelsshipped from all the firms implicated inprevious poisoning outbreaks and sendthem to Gecan for identification. Also,morel shipments from other firms—particularly in France, Switzerland and India—must be examined for proper labeling and packaging and, if necessary,sampled. When toxic species are identified, the shipment is refused entry.

The SurveyTo determine the extent of the problem

of toxic wild mushrooms in the U.S. mar

ket, Gecan and his FDA colleague, biologist Stanley Cichowicz, directed a two-year survey of wild mushrooms incommercial distribution. They publi,shedtheir results in the August 1993 Journal ofFood Protection.

For the survey, 10 FDA districts weredirected to collect samples of specific species of canned, dried and fresh importedand domestic mushrooms. About two

dozen species were collected at ports ofenti7 and from gourmet shops, supermarkets, health food stores, and other commercial establishments. They includedmorels, false morels, shiitakes, strawmushrooms, chanterelles, hiratakes, andothers, as well as mixed mushrooms.

Of the 344 samples collected, toxicmushrooms were found only in the morelsand the mixed mushrooms. Of the 42 morel samples collected, nine contained toxicspecies. Seven of the nine were fromFrance, the other two from India. Of 13mixed mushroom samples collected,two—both from France—contained toxicspecies.

Although all the toxic mushrooms identified in the survey originated overseas,potential problems exist with wild mushrooms harvested here at home as well. Except for Michigan, where wild mushroom

growers and harvesters must be licensed,and Illinois, which prohibits the sale ofwild-picked mushrooms through wholesale, retail or food service establishments,the states do not regulate the sale of wildmushrooms. And FDA has no regulatoryauthority for products not sold in interstatec o m m e r c e .

During the survey, Gecan received aquart canning jar of mushrooms an FDAinvestigator bought in a Chicago bar. Theinvestigator learned from the bar owner

U.S. growers now produce a variety of

specialty mushrooms in addition to white

button mushrooms, includingportobella,

shiitake, oyster, and enoki mushrooms.

(Photo courtesy of the American

Mushroom Institute)

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 2 3

In July 1978, FDAissued an import

alert directing

sampling of morel

shipments from theFrench and Swiss

firms implicated inthe 977[poison-

ing] outbreak.

lands have particular problems when theyc o n t i n u e t h a t t r a d i t i o n h e r e . T h e m u s h

rooms in this country may look like theones they or their parents and grandparents picked in the old country. But appearances can be deceiving.

Cichowicz explains that North Americahas perhaps four times as many mushroomspecies as Europe, so European immigrants think they're picking the samemushrooms as back home, when actuallythey're harvesting toxic look-alikes.

Immigrants from other parts of theworld have similar problems. Gecan tellsof a group of Koreans in the Pacific Northwest who, looking for straw mushrooms,picked death caps instead. "They cleanedthem, cooked them, and ate them, and allneeded liver transplants," he says.

It gets still more complex, Cichowiczsays, because even within different partsof this country, a particular mushroomgrown under certain conditions—a certaintype of soil or nutrient source—will lookone way, whereas the same species grownunder different conditions will have aslightly different appearance. He says aspecies grown east of the Rockies mightbe edible, whereas west of the Rockies itmight not.

that some local women who had immigrated from Poland had been hired to pickthe mushrooms in a Wisconsin woods.The mushrooms were packed in brine inmason jars and sold at local bars.

The mushrooms turned out to be okay,Gecan says, but both the possibility oftoxic mushrooms and the brine levels werecause for worry. Improper processingcould have caused botulism toxicity.

New World, New SpeciesGecan says that immigrants who com

monly pick mushrooms in their native

T h e C l u b sNot all wild mushroom harvesters ai'e

unskilled or un.scrupulous. There aremycology (mushroom) clubs in the UnitedStates with extremely knowledgeablemembers that organize forays and gaincontinuing experience from their fieldwork. Gecan recommends that interestedamateurs contact a club through the NorthAmerican Mycological Association.

He says, "Experienced collectors shouldgo out in the field, know every mushroomthey pick, and if there's a question in theirmind, should chuck it away."

The common button mushroom

24/Oc tobe r 1994 /FDA Consumer

Agaricus bisporus sold in retail markets iscommercially grown under controlled conditions and presents no hazard of contamination with toxic mushroom species. Butbecause there are no absolute guaranteesthat toxic mushrooms won't reach the

market, Gecan endorses the maxim "buyerbeware." Because of increased demand,retail food stores are offering more andmore varieties of wild mushrooms, whiletheir harvesting remains largely unregulated.

That is not to say that Americans needforever forgo the taste delights of wildmushrooms. Gecan says that althoughtoxic morel look-alikes are occasionallyfound in commercial mushrooms, they arerarely fatal. In addition, individuals havedifferent thresholds for the toxins, so thatsome people might display only mildsymptoms or none at all. Someone whogets sick from eating wild mushroomsshould go to a hospital emergency roomfor treatment.

These considerations are reminiscent ofPeter Mayle's mind-set as he pondered agift from his friend:

"He had been in the forest since sixo'clock, and he had a present for us. Frombehind his back he produced his oldchecked cap, bulging with wild mushrooms. He gave us his favorite recipe—oil,butter, garlic, and chopped pai'sley—andtold us a dreadful story about three menwho had died after an ill-chosen mu.sh-room supper. A neighbor had found themstill at the table with wide, staring eyes—Monsieur Sanchez gave us a demonstration, rolling his eyes back in his head—completely paralyzed by malignantfungus. But we were not to worry, he said.He would stake his life on the mushroomsin his cap. Bon appetit!" ■

Marian Segal is a member of FDA'spublic affairs, staff.

OTC Optionsby Audrey T. Hingley

If you're troubled by dandruff, thatsnowy, dust-like stuff that falls from scalpto shoulders, you're not alone: Nearly everyone has dandruff to some degree.

Dandruff is treatable with over-the-

counter (OTC) products and causes nogeneral health problems or permanentdamage. But care must be taken not toconfuse simple dandruff with other conditions that also cause flaking ofthe scalp, such as sebomheicdermatitis or psoriasis.

Dandruff occurs when the

scalp sheds dead epidermal(skin) cells in large clumps.Dandruff scales appear dry,white or grayish, appearing assmall, unsightly patches, especially on top of the head.

Scalp cells replenish themselves in a pattern similar tothat of hair, but more rapidly:The skin of the head renews itself about once a month. Dead

scalp cells are constantly beingpushed from the deepest layerof the epidermis to the skin'ssurface, where they graduallydie. Usually the scalp shedsthem in a nearly invisible way.But for reasons that are still un

clear. cell turnover sometimesbecomes unusually rapid, anddead cells are shed as the visible flakes called dandruff".

In 1990, FDA banned 27 ingredients in dandruff shampoosbecause they were not provensafe and effective. Today dandruff can be treated with OTC drug products containing five ingredients FDA hasverified as safe and effective: salicylicacid, pyrithione zinc, sulfur, selenium sulfide, and coal tar. FDA allows drug products to be sold without a prescription ifthey are safe for consumer use without a

Controlling Dandrnfdoctor's supervision and provide adequatedetailed information for use on theirlabels.

Approved OTC ingredients for dandruffti eatment are available in shampoos,rinses, or in products that users apply andleave on the scalp. Each works in differentways to control dandruff .symptoms like.scaling or itching.

OTC drug products are available in anestimated 750,000 outlets nationwide,including pharmacies and supermarkets,according to the Nonprescription DrugManufacturers Association (NDMA).NDMA also reports that dandruff isamong the top 10 problems consumers are

FDA Consumer/October 1994 /25

Dandruff occurs when

the scalp sheds deadskin cells in large

clumps.

most likely to treat with OTC drug products: 59 percent of the time dandruff sufferers use OTC drug products.

Coal-tar preparations and salicylic acidare approved for treating dandruff,seborrheic dermatitis, and psoriasis;pyrithione zinc and selenium sulfide fordandruff and seborrheic dermatitis; sulfurfor dandruff; and salicylic acid and sulfurin combination for dandruff treatment. OnJan. 28,1994, FDA published a final ruleamending the monograph published in theDec. 4,1991, Federal Register allowingmicronized selenium sulfide in a concentration of 0.6 percent to be included as anactive ingredient to control dandruff.

According to Ida I. Yoder, a chemist inFDA's Office of OTC Drug Evaluation anda member of its dnig policy staff, micronized selenium sulfide is a very finelyground form of selenium sulfide, with aparticle size of approximately 5 micrometers. Because the selenium sulfide is morefinely ground, it can be used at lower concentration levels.

"A drug is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affectthe structure or function of the body," saysYoder. Shampoos classified as cosmeticscannot make such medical claims. Theyare marketed for cleansing, beautifying, orpromoting attractiveness.

2 6 / O c t o b e r 1 9 9 4 / F D A C o n s u m e r

If a product only claims to wash off Lexington, Ky. "A large preponderance ofdandruff flakes, it could be considered a males have dandruff, which may suggestcosmetic, Yoder says. But if it claims to some role of androgen hormones in dan-prevent or treat the condition, it's consid- druff."ered a drug. Children under 10 rai-ely have dandruff,

but it is common in adolescents. WhileWhat Makes the Flake? some experts say it tends to decrease in

Although most people assume dandruff middle and old age. Bark disputes this,comes from a dry scalp, the opposite is "It really is a postpubescent disease, buttrue: People with oily scalps tend to suffer I don't believe it diminishes in old age.most from dandruff. We see a lot of dandruff and seborrheic

This may be due to an oily scalp sup- dermatitis in stroke patients and in olderporting the growth of yeast in the scalp, people," he explains,which is thought to be instrumental in the Bark says that dandruff has its brightdevelopment of scaling and .scalp irrita- side: If the scalp doesn't shed its dea d skintion, says Joseph P. Bark, M.D., chairman cells, the human scalp would be tremen-of dermatology at St. Joseph's Hospital in dously thick.

Dandruff is amongthe top 10 problemsconsumers are most

likely to treat withOTC drug products.

seborrheic dermatitis, or some other disorder."

A form of seborrheic dermatitis thatsometimes alarms new parents is knownas "cradle cap." The scaly scalp inflammation is common in newborn babies, although it can occur anytime in infancy.Rubbing warm olive or mineral oil into thebaby's scalp and leaving it on overnightcan loosen and soften scales, which can bewashed off the next day with a mild shampoo. It usually clears up quickly and does

"But when the cell turnover goes too farand increases, then you get not only visible excess scaling, but redness and itching," he says. "Redness and itching is actually seborrheic dermatitis, and it frequentlyoccurs around the folds of the nose and the

eyebrow areas, not just the scalp."Although seborrheic dermatitis mimics

dandruff with its flaky scales, the inflammation and itching that accompanies itsets it apart from simple dandruff. OTCpreparations are available to help mildcases, but seborrheic dermatitis often isbest treated by prescription medications.

"All the evidence points strongly to thisyeast, known as Pityrosponim ovale, as acausation of seborrheic dermatitis, in that

when you treat it with anti-fungal shampoos [such as Nizoral (ketaconazole) aprescription shampoo], you destroy the organism and the condition stops," Barksays.

What do you do if you have dandruffbut suspect your problem may be a moresevere disorder like seborrheic dermatitis?

"If you have mild scaling, you can usually take care of it with an OTC dandruffshampoo containing salicylic acid," Barkadvises. "Use it for several weeks, and ifyou don't see a clear-cut improvement inthe scaling, consult a dermatologist. Adermatologist can diagnose whether youhave a fungus infection of the scalp.

Pso r i as i sPsoriasis is an inflammatory skin dis

ease in which skin cells replicate at a rapidrate. Although the symptoms of psoriasis—silvery scales covering reddenedareas of the scalp—seem similar to dandruff, psoriasis is very different. New skincells are produced about 10 times fasterthan normal, but the rate at which old cellsare shed is unchanged. Live cells then accumulate and form the thick patches covered with flaking skin.

The scales are heaped-up, and the disorder may involve other areas of the bodybesides the scalp, most commonly theknees, elbows, back, or buttocks. It canalso affect legs, arms, and just about anyother part of the body. Psoriasis can bechronic or it may have periods of flare-upsand remission periods.

Psoriasis is annoying mainly because ofits tendency to return again and again, andbecause of its unsightly, blotchy appearance. It is more common in whites than inblacks and Asians.

If you think you may have psoriasis,consult a doctor about treatment.

C o a l Ta rCoal tar, one ingredient in OTC dan

druff products, is a byproduct of treatedbituminous coal. In constant exposure toconcentrated solutions in industrial set

tings over long periods (20 to 25 years).

coal tar has been associated with skin cancer. But coal-tar products are consideredsafe for topical use in shampoos becausecontact with the scalp is only for a shortdura t ion .

For body seborrheic dermatitis andpsoriasis, however, products containingcoal tar remain on the skin for longer periods. There are no well-defined, long-termstudies that demonstrate how long coal-tarproducts can be used safely. FDA hasnoted that prolonged use of such productsmay not be completely risk free due topossible cancer-causing effects.

Coal tar also produces photosensitivityreactions (reactions that occur with exposure to sunlight). Residual amounts of coaltar may remain on the scalp, hair, or surrounding areas after using. So if you'regoing out in the sun after shampooingwith these products, you may want to takeextra precautions.

FDA requires OTC dandruff productsthat contain coal tar to state on their labels,"Do not use for prolonged periods withoutconsulting a doctor. Use caution in exposing skin to sunlight after applying thisproduct. It may increase your tendency tosunburn for up to 24 hours after applicat i o n . "

Coal-tar shampoos also tend to give anorange tinge to light-colored hair.

Dave Bostwick, a reviewer in FDA'sdivision of anti-infective drugs. Office ofDrug Evaluation II, says one alternative tousing OTC products to control dandruff ismechan ica l .

"Washing your hair more often meansyou remove dandruff flakes that otherwisewould remain on the head," he says.

Other than washing your hair more frequently, there is really no way to controldandruff without treatment. So if you findyou're flakier than you'd like to be, OTCdrug products may solve your problem. ■

Audrey T Hingley is a writer inMechanicsvi l le , Va.

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 2

N o t e b o o k

The Notebook: a potpourri of items ofinterest gathered from FDA news releases, other news sources, and the Federal Register (designated ¥R, with dateof publication). The Federal Register isavailable in many public libraries.

■ Over-the-counter asthma drugs willbe discussed when FDA's Nonprescription Drugs and Pulmonary-AllergyDrugs advisory committees meet Nov.14. Issues include possible marketing

changes for OTC bronchodilators, and apossible switch of some anti-asthmadrugs from prescription to OTC. Formore information, contact Lee L.Zwanziger. FDA, Center for DrugEvaluation and Research (HFD-9), 5600Fishers Lane. Rockville, MD 20857;telephone (301) 443-4695. (FR July 7)

■ Anesthesia apparatus proceduresare described in the FDA document

"Anesthesia Apparatus Checkout Recommendations, 1993." Included is ageneral checkout and inspection procedure that should be conducted before

administering anesthesia to ensure the anesthesia machine, patient breathing system, and monitors are correctly connected,adjusted and functioning. For a free copy,request Docket No. 86B-0058 and sendtwo self-addressed labels to Office of

Training and Assistance (HFZ-240), Center for Devices and Radiological Health,FDA, 5600 Fishers Lane, Rockville, MD20857. (FR July 11)

■ S a l m o n e l l a c o n t a m i n a t i o n i n a n imal feed is covered in a guide availablefrom FDA. The guide, "Symposium on

Feed Quality Assurance, a System-wideApproach." calls for hazard analysis critical control point (HACCP) programs infeed manufacturing. The new guide replaces two previous FDA policy guides onthe subject. For a free copy of the newguide, request (FDA) 91 -6050 fromLinda Grassie, Center for VeterinaryMedicine (HFV-222), 7500 StandishPlace, Rockville, MD 20855; telephone(301) 594-1728. (FR July 1)

■ N e w r e c o m b i n a n t D N A r e s e a r c h

guidelines from the National Institutes ofHealth took effect last June 24. The guidelines specify constructing and handlingpractices for recombinant deoxyribonucleic acid (DNA) molecules and organisms and viruses containing recombinantDNA molecules. (FR July 5)

■ The chance of stroke increases in proportion to the heart's left ventricular mass,according to a recent study. MaheshBikkina, M.D., M.P.H., Daniel Levy.M.D., and colleagues from theFramingham, Mass., Heart Study, foundthe greater the heart's left ventricularmass, the greater the likelihood for strokeor transient ischemic attack (obstruction ofthe blood supply). (Journal of the American Medical Association, July 5)

■ High homicide death rates amongyoung African Americans and Latinos inNew York City may be due to increasedinvolvement with both cocaine use andfirearms, according to a recent study. Kenneth Tardiff. M.D., M.P.H.. and colleaguesfound that the homicide rates there for African American and Latino males aged 15to 34 years were roughly twice the nationalrates forthis age group. (JAMA July 5)

2 8 / O c t o b e r 1 9 9 4 / F D A C o n s u m e r

Investigators' Reports

»

Puritan-Bennett Closes Two Plantsby Paula Kiirlzweil

A major U.S. manufacturer of ventilators and other medical deviceswas forced to shut two of its U.S.

plants earlier this year, after agreeing to acorporate-wide injunction.

In a consent decree filed Jan. 13, 1994,Puritan-Bennett Corp. of Overland Park,Kan., agreed to a permanent injunctionagainst itself and two of its principals,Burton A. Dole Jr., president and chief executive officer, and John H. Morrow III,vice president and chief operating officer.The injunction was filed in the U.S. District Court in Kansas. (See S.J. No. 21 inthis issue's Summaries of Court Actions.)

The injunction forced Puritan-Bennettto shut plants in Boulder, Colo., and inCarlsbad, Calif. Its other U.S. manufacturing facilities are subject to closure ifthey do not comply with FDA regulations.

The action was the first corporate-wide injunction against a medical devicemanufacturer for violating good manufacturing practice (GMP) and MedicalDevice Reporting regulations. It followed 34 product recalls and two safetyalerts undertaken by the company between 1985 and 1993. Many of the violations involved inadequate manufacturing specifications and processes.

"We bel ieved that the violat ions were

corporate-wide," said Bill Defibaugh, aconsumer safety officer in FDA's Centerfor Devices and Radiological Health."So we looked at the corporation as awhole, not the individual plants separately."

The corporate-wide regulatory approach toward noncomplying medicaldevice firms that operate multiple facilities has since been used in similar actions

against two other device manufacturers.

National Medical Care Inc., Waltham,Mass., and Siemens Medical Systems,headquartered in Iselin. N.J. (See"Siemens Agrees to Correct Manufacturing Problems" in the September 1994FDA Consumer.)

Pur i tan-Bennet t makes resusc i ta tors .

ventilators for hospital and home use.and other respiratory therapy devices, aswell as a blood gas monitoring system.

Resuscitators provide emergency respiratory support through a face mask.Venti lators control or assist the breath

ing of patients unable to breathe on theirown, either permanently or for long periods. FDA considers the uni ts "cr i t ica ldevices" because they support or sustainl i f e .

In addition to the closed plants inBou lder and Car fsbad, Pur i tan-Bennet t

operates plants in Lenexa, Kan.;Wilmington and Marlborough, Mass.;and another in Carlsbad. Calif. The com

pany also has plants in Mexico and Ireland. both of which ship finished devices to the company's U.S. plants. Distribution of these devices also is bound bythe terms of the injunction. Defibaugh.said.

Between 1985 and 1993. FDA conducted about 36 inspections of variousPuritan-Bennett plants. Many of thoseinspections resulted in recalls of ventilators, airway delivery systems, and humidifiers. At least two of the recalls hadto be repeated because the original recallfailed to correct the problem.

Recalls resulted from such problemsas defective circuits, fluid leaks, andsoftware problems.

The company also issued two safetyalerts. One followed the discovery of apotential bum problem with a pulseoximetry monitoring option used with thecompany's hospital ventilators. The otherstemmed from a potential fire hazard due

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 2 9

to possible development of high oxygenconcentrations for various models of portable home-use ventilators.

According to Defibaugh, the companyalways responded to FDA's warningsand notices of adverse findings with awillingness to correct the problems. "Theywould correct some things and makepromises to correct others." he said, "butthen, upon reinspection. we would findsome of the same GMP problems."

FDA sought the permanent injunctionafter a series of inspections between September and November 1993 revealed con

tinuing significant GMP violations at theColorado plant, which made portablehome ventilators, and the Carlsbad facilitythat produced a blood gas monitoring syst e m .

For example, FDA found tbat Puritan-Bennett failed to:• ensure that a critical device did not

leave the manufacturer for distribution until the appropriate employee checked allacceptance records and test results• validate software programs by adequateand documented testing, when computerswere used as part of an automated production or quality assurance system• maintain a device history record to showthat a device was made according to thedevice master record• receive, store and handle componentsused in manufacturing in a way that wouldprevent damage, mix-up, contamination,and other adverse effects and keep not-yet-accepted components separate from accepted components

• validate changes in the manufacturingprocess of a device• provide complete information as required by FDA's Medical Device Reporting system.

Under the consent decree, the companymay not reopen its two closed plants untilthe GMP violations are coiTected. as deter

mined by FDA. As of June 1994, theCarlsbad, Calif, plant had not reopened,and the firm has permanently discontinuedmanufacturing at the Colorado facility.

FDA continues to monitor the company.

Paula Kurtzweil is a member of FDA'spublic affairs staff.

Georgia Man ArrestedI n G H B S e i z u r e

Charcoal dust covered the teenager'sface when she awoke in the hospital intensive care unit. Fler throat felt like it was on

fire. She had lost consciousness severalhours earlier after an overdose of an unapproved drug called gammahydroxybutyrate (GHB). The charcoal onher face came from the mixture used to

pump her stomach, and her throat painfrom emergency workers' efforts to helph e r b r e a t h e .

This is one of many serious reactions toGHB that FDA discovered during a yearlong investigation in 1993 that eventuallyled to a 21 -month prison sentence and a$30,000 fine for the man who sold the unapproved drug to the teenager and manyo t h e r s .

On April 14, Joseph Saffar, Morrow,Ga., was sentenced in the U.S. DistrictCourt for the Northern District of Georgia.

Saffar. 55, pleaded guilty last Dec. 9 toone felony count of introducing a mis-branded drug into interstate commerce.

GHB is promoted illegally for strengthtraining, muscle building, weight loss, andas a replacement for L-tryptophan, a foodsupplement that FDA ordered removedfrom the market in 1989 after reports associated its use with a rare blood disorder.

GHB is also sold and used as a hallucino

gen and a sleep inducer. FDA has not approved the drug for marketing in thiscountry for any use. However, clinicaltrials cun-ently are testing its safety and effectiveness as a treatment for narcolepsy, arare disorder characterized by uncontrollable periods of sleep.

Although Saffar was sentenced based onhis activities in 1993, his involvement withGHB first came to FDA's attention in

January 1991, when his name appeared ona customer list belonging to Amino Discounters Ltd.. a Tucson, Ariz., firm theagency was investigating for manufactur

ing and distributing GHB.On Jan. 2, 1991, Atlanta district FDA

investigator Eric Weilage visited Saffar athis Morrow, Ga.. health food store. Natu

rally Good. Weilage warned him that itwas illegal to sell GHB. Saffar replied thathe no longer .sold it, but that he believedGHB was a legitimate product and feltFDA was harassing Amino Discountersfor no reason.

At some time during the next two years,Saffar began selling GHB again, and inNovember 1992, the Morrow Police De

partment relayed to FDA's Atlanta office acitizen's complaint about the sale of GHBat Naturally Good. In January, a memberof the Fayette County, Ga., Narcotics TaskForce reported to FDA an overdose associated with the use of GHB purchased fromNaturally Good.

On Jan. 14, FDA investigator MarieMathews interviewed the woman who had

complained to the police. The woman'sdaughter told Mathews that fellow high

SO/Ocroher 1994/FDA Coi i .s i imer

school students were buying GHB atNaturally Good.

That same day. Mathews went to Naturally Good undercover and purchased abottle of GHB. A week later, she boughtfive more bottles. Saffar told her GHBcould be used to "bulk up" and to "gethigh."

On April 8, an Atlanta Constitution reporter told FDA the Fayette County Department of Emergency Services had responded to 11 cases of GHB overdosessince December 1992. In addition, a member of the Fayette County Narcotics TaskForce told FDA's Mathews that GHB wasthe nutnber one drug problem in FayetteCounty schools and that Naturally Goodwas the source for most of the GHB.

At that time. FDA and the U.S.

Attorney's Oifice in Atlanta began thework on a search and seizure warrant for

Saffar's Naturally Good store, while theagency continued to gather evidenceagainst Saffar.

FDA investigator Cheryl Dyer, who iswith FDA's Greenville, S.C., resident post,visited Saffar's store twice in late May.She told Saffar she was a friend of "Patn,"Mathews' alias, and he sold her severalbottles of GHB. On June 15. she phonedSaffar and ordered 12 bottles of GHB tobe shipped to Starr. S.C.. a suburb ofGreenvi l le.

The GHB airived June 22, and on July1. Dyer called to order four or five morecases. Saffar said it would take at least amonth before he would be able to send herthat much.

The next day FDA investigators fromthe Atlanta office. FDA agents from theagency's Office of Criminal Investigations(OCl), and local police, armed with asearch warrant, searched Saffar's store andseized 22 bottles of GHB.

With Saffar's consent. OCI agents alsosearched a nearby storage shed Saffarleased and his home, where they found 75bottles and $60,000.

On July 12. Dyer received a letter fromSaffar saying that FDA was investigatinghim, and if the government contacted her,she should tell them he had sold her shark

cartilage.On Aug. 26. Dyer received a letter

from Saffar stating. "There's plenty ofstuff in stock now." but that the GHB was

in liquid form instead of the powder hehad been selling.

This was the evidence Dyer and theother investigators had been .seeking, because several of the overdose victims saidthe GHB they bought from Saffar was inliquid form.

On Sept. 8. Dyer went to Morrow andbought a case of liquid GHB from Salfar.and the next afternoon, called to say shewanted to buy five more cases. Saffaragreed and told her to come by the storein about 30 minutes. Instead of Dyer,other FDA investigators and agents andlocal police showed up with a warrantissued earlier in the day. OCl agents arrested Saffar and charged him with knowingly delivering for introduction into interstate commerce a misbranded drug.They seized five cases of liquid GHB athis Moitow store and storage shed. Fourteen more cases were .seized at a storeSaffar owned in Marietta. Ga.

U.S. Attorney Gerrilyn Brill chargedSaffar on Dec. 9. 1993. Saffar is currentlyserving his prison sentence. At press

time, the seized GHB was still in FDA'spossession.

Personnel from FDA's Atlanta officeand Office of Criminal Investigations provided Georgia narcotics authorities and theGeorgia General Assembly backgroundinformation on the dangers and extent ofGHB drug abuse. On March 4. 1994,Georgia became the first state to makeGHB a controlled substance subject tostate and local law enforcement.— D o r i S t e h i i n

Cyanamid Fouls Fowl Data

American Cyanamid Co.. a major animal drug maker, received $400,000 inpenalties after pleading guilty last Feb. 28to not maintaining required records in aneffectiveness study of the poultry drugCygro (maduramicine ammonium).

Cyanamid's monitor for the study.David L. Sharkey. Ph.D., also pleadedguilty last March 8 to not maintaining required records. He was sentenced June 24to a $5,000 fine, two years' probation. 100hours of community service, and substance-abuse counseling.

The Wayne, N.J.-based company wastesting Cygro to support an FDA new animal drug application. The drug was designed to be mixed with feed to protectpoultry from the parasitic diseasecoccidiosis and to be combined with other

F D A C o n s u m e r / O c t o b e r 1 9 9 4 / 3 1

drugs to increase bird weight and feed efficiency.

The study protocol FDA had reviewedcalled for independent clinical investigators to conduct feeding studies underactual-use conditions at several test sites.From those studies, Cyanamid was to collect and analyze detailed data from whichFDA would determine the drug's effectiveness for all intended uses. But, according to the government's statement filed inthe U.S. District Court for the District of

Maryland, the company violated food anddrug laws related to record keeping whileconducting the tests between October1987 and March 1990.

The company failed to:• record correct results of drug assays• record that investigators had intentionally exposed test animals to a diseaseagent that may have enhanced the apparent effect of the test drug• keep accurate study records of feed consumption totals, bird numbers, bird mortality, and bird weight• record observations of adverse condi

tions under which the birds were raised.

Sharkey's misdeeds first came to FDA'sattention in January 1990, after agencyofficials received a tip about possible manipulation of the study at one of its sites.An FDA inspection at the site revealedenough evidence of possible fraud to warrant investigating the rest of the study'sfield sites.

In August 1990. FDA officials inspectedCyanamid's New Jersey headquarters andthe study's field-trial sites in Maryland,California, Colorado, and Missouri. The

agency collected considerable evidence,including a statement from a clinical investigator who claimed he had altered datain several studies. FDA refeired the case tothe Justice Department for further investigation. That probe confirmed what had already become apparent: "At least half of[the clinical investigators] admitted they

had changed data," says Gerald Miller,investigator in FDA's Baltimore districto f fi c e .

In a statement to the court, the prosecutor listed examples of study fraud:• In a test of Cygro's effectiveness incombination with two other drugs, conducted at a Maryland field site betweenJanuary and March 1989, Sharkey addedorganisms that cause coccidiosis to po.ultrydrinking water. The intent, FDA officialssay, was to make the drug combination appear more effective. The-Cygro study protocol did not allow for intentionally infecting test animals, and Cyanamid's finalstudy report did not reveal the companyhad done so.• In a test of Cygro and the drug

virginiamycin at the Maryland site between March and May 1989. Sharkey instructed a clinical investigator to changedata concerning bird weights and the number of birds under study that died or were

removed. The study originally had notshown that the two drugs produce a statistically significant weight gain. But afterthe investigator made the changes Sharkeyrequested, data appeared to indicate an increase, "One of the clinical investigatorstold us it was common practice to falsifydata this way," says Mike Bruckheimer,compliance officer in FDA's Newark distr ict office.• In a December 1989 Virginia field

study, Sharkey had specific birds removedfrom the study. For example, investigatorswithdrew large birds from some pens andsmall ones from other pens. This, say FDAofficials, had the effect of improving theapparent performance of test groups relative to the control group.

Court documents chronicled severalother violations over a 2'/2-year period,such as altering data entries originally recorded in pencil and failing to record accurate drug assays. Cyanamid withdrewall Cygro combination drugs shortly afterFDA began its investigation in 1990.

FDA notes that the Cygro tests were forefficacy, not safety. And Cyanamid officials say that throughout the study,Cygro's safety was never in question. ButFDA reviewer Vernon Toelle, Ph.D., saysthere's another issue to consider if an ineffective poultry drug is approved: Needlessdrug residue can accumulate in the bird."Animal drugs can affect millions ofpeople because they eat chicken and turkey," Toelle says. "There's no benefit toexposing humans to unnecessary drugresidue. Luckily, there doesn't appear tobe a safety problem in the Cygro case."

In the wake of the court action,Cyanamid has created a regulatory andscientific affairs department, and the company says it has "instituted new controlsrelated to the accuracy of scientific data toprevent a recurrence of the Cygro situat i o n . "

—John Henke l

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Summaries of Court Actions

%S E I Z U R E A C T I O N S

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Cereals, and other grocery stocks, at Mauldin. Dist.S.C.; Civil No, 6-93-1818-20.CHARGED 7-23-93: While held by Bi-Lo Inc., Mauldin, S.C.,the articles had been held under insanitary conditions—402(a)(4).DISPOSITION: Consent—authorized release to the dealer forsalvaging. (F.D.C. No. 66761; S. No. 93-654-026; S.J. No. 1)

PRODUCT: Chickpeas, basmati rice, and tamarind concentrate, at Niles, N. Dist. 111.; Civil No. 93-C-6465.CHARGED 10-22-93; While held by International GoldenFoods, Inc., Niles, 111., the chickpeas and rice had been held under insanitary conditions—402(a)(4); and the tamarind concentrate contained insect and bird filth—402(a)(3).DISPOSITION; Default—ordered destroyed. (F.D.C. No. 66795;S. No. 93-709-874; S.J. No. 2)

PRODUCT; Elephant fish fillets, at Chicago, N. Dist. 111.; CivilNo. 93-C-4228.CHARGED 7-14-93: Whi le he ld for sa le , the ar t ic le conta ined

decomposed seafood—402(a)(3).DISPOSITION: Default—ordered destroyed. (FD.C. No. 66743;S.J. Nos. 93-661-755/6; S.J. No. 3)

PRODUCT: King fish, frozen, at Frederiksted, St. Croix, Dist.Virgin Islands; Civil No. 1993/0204.CHARGED 8-10-93; While held for sale, the article containeddecomposed king fish—402(a)(3).DISPOSITION; Default—destruction. (F.D.C. No. 66765; S. No.93-724-041; S.J. No. 4)

PRODUCT; Rice vermicelli, at Alhambra, C. Dist. Calif.; CivilNo. 93-3639 WJR{JGX).CHARGED 6-22-93; When imported, the article, labeled "GuilinRice Vermicelli ... Product of China ... Distributed By; KoonLun Hong ... Flat A ... Hong Kong," contained rodent, bird andinsect filth and human hair—402(a)(3).DISPOSITION: Consent decree—authorized release to SoonHing Trading Co., Alhambra, Calif., for export to the foreignsupplier. (F.D.C. No. 66737; S. No. 93-713-483; S.J. No. 5)

PRODUCT: Shengu herb leaves, peppermint leaves, pearlbarley, and other food stocks, at San Francisco, N. Dist. Calif.;C i v i l No . C -90 -3368 -DLJ .CHARGED 11-28-90; While held by Kwok Shing Import-Export, Inc., San Francisco, N. Dist. Calif., the barley and peppermint leaves contained insect and rodent filth—402(a)(3); theShengu herb leaves contained insect filth and mold—402(a)(3);and all of the articles had been held under insanitary conditions—402(a) (4) .DISPOSITION: Consent decree—authorized release to the dealer

for salvaging. (F.D.C. No. 65965; S. No. 90-592-498 et al.; S.J.No. 6)

PRODUCT: Tomatoes, peeled, canned, at Miami, S. Dist. Fla.;C iv i l No . 93 -1308 .CHARGED 7-8-93: When shipped from Canada, the article labeled "Hellas ... Distributed by Aliments Hellas Inc., Montreal,Canada ... Product of Spain ... Plum Style Tomatoes" containedmoldy tomatoes—402(a)(3).DISPOSITION: Default—ordered destroyed. (F.D.C. No. 66726;S. No. 92-594-928; S.J. No. 7)

Food/Economic and Labeling Violations

PRODUCT; "Orange juice" from concentrate, frozen, atGracewood, S. Dist. Ga.; Civil No. 193-193.C H A R G E D 11 - 3 0 - 9 3 ; W h i l e h e l d f o r s a l e , t h e a r t i c l e , w h i c hwas labeled "100% Pure Orange Juice From Concentrate," hadhad pineapple juice substituted for orange Juice—402(b)(2); thearticle's label falsely and misleadingly claimed that the articlewas 100 percent pure orange juice—403(a)(1); and the articlefailed to conform to the definition and standard for orange juicefrom concentrate because the article contained pineapple juicesolids—403(g)( 1)DISPOSITION; Default—ordered de.stroyed. (F.D.C. No. 66910;S. No. 94-719-884; S.J. No. 8)

Drugs/Human Use

PRODUCT; Accupatch kits containing an appetite controlsolution and adhesive bandages and components, at Las Vegas, Dist. Nev.; Civil No. S-88-681-RDF (LRU).CHARGED 8-18-88; When shipped by BECO Chemical Co.,of Lynwood, Calif., the article (labeled "Vital Life AccupatchAppetite Control Program ... Vital Life Products, Inc. ... LasVegas, Nevada ... to assist weight reduction) was a new drugwithout an effective approved New Drug Application—505(a);the labeling of the article contained false and misleading claimsfor appetite control—502(a); and adeciuate directions for thearticle's intended use could not be written—502(f)(1).DISPOSITION: After the complaint for forfeiture had beenserved, the article had been seized, and no response or claim hadbeen made, the government moved for the entry of a defaultjudgment. Some time later, Carolyn Keene and Vital Life Products, Inc.. Las Vegas, Nev., claimed the articles and filed answers to the complaint. The government moved to strike suchclaims and answers as being untimely tiled. The claimants opposed such motion, arguing that the delay was due to bungledcommunications between themselves, out-of-state counsel, andin-state counsel. The court denied the government's motions aslong as the claimants performed the condition the court placedupon them. The court was concerned that the claimants presentedno good cause for their dilatory behavior and conditioned thedenial of default judgment upon payment by the claimants of

FDA Consumer /October 1994 /33

the government's attorneys' fees and costs.Subsequently, the government served written interrogatories,

requests for admissions, and requests for the production of documents upon the claimants. After a number of months, the instate council moved to withdraw as attorney of record for theclaimants. The application to withdraw was continued. Approximately three years after the article had been seized, the government renewed its motion for a default judgment and for an orderauthorizing destruction of the article, asserting that thegovernment's costs and fees had not been paid and that the sterility and safety of the article had been compromised by the passage of time. The claimant's counsel filed an affidavit in responseto the government's renewed motion for a default judgment.Subsequently, the court granted the government's motion andordered the article destroyed. Ultimately, the article was destroyed. (F.D.C. No. 65515; S. No. 88-541-132; S.J. No. 9)

PRODUCT: Cata'Vite capsules, at Roslyn, E. Dist. N.Y.; CivilN o . 9 3 - 2 8 3 1 .

CHARGED 6-25-93: While held by Vision Research Technologies, Inc., Roslyn. N.Y., who promoted the article for cataractsand other eye disorders, the article was accompanied by leafletssuch as "Exciting News About Cataracts ... CataVite ... Nutritional Supplement for the Eye," and the article was a new drugwithout an effective approved New Drug Application—505(a);and the article's labeling lacked adequate directions for use andwas not exempt due to its new drug status—502(f)(1).DISPOSITION: Default—ordered destroyed. (F.D.C. No. 66661:S. No. 92-647-182; S.J. No. 10)

PRODUCT: Oxygen, U.S.?., at Philadelphia. E. Dist. Pa.; CivilN o . 9 3 - C V- 3 2 1 6 .CHARGED 6-16-93: While held by United Health Care Services, Inc., Philadelphia, Pa., the circumstances used for the processing, packing and holding of the article failed to conformwith current good manufacturing practice—501(a)(2)(B).DISPOSITION: Consent—authorized release to the dealer forattempting to bring into compliance. The claimant also agreedto not manufacture, pack or process medical oxygen unless anduntil a government inspector records and notifies the claimantthat its operations appeared to be in compliance. The decree alsoprovided that the claimant should immediately discontinue allmanufacturing, processing and packing of gases for medical uses,if within five years the claimant was officially advised that anyof its medical gas was adulterated as charged above. Ultimately,the claimant came into compliance and was authorized to resume operations. (F.D.C. No. 66703; S. Nos. 93-634-955/56;S.J. No. 11)

PRODUCT: Oxygen, U.S.?., at Springfield. S. Dist. Ohio; CivilN o . C - 3 - 9 3 - 3 2 0 .CHARGED 8-30-93: While held by Dasco Home Health CareCorp., Springfield. Ohio, the circumstances used for the manufacture, processing, packing, and holding of the article failed to

conform with current good manufacturing practice—501(a)(2)(B).DISPOSITION: A consent decree of condemnation authorizedrelease of the article to the dealer for bringing into compliance.The consent decree also included a permanent injunction againstthe dealer and its president that, among other things, permanentlyenjoined such defendants from processing any drug in high-pressure cylinders unless and until specified conditions were met.including the institution of current good manufacturing practice(CGMP) and a report by the claimant as to what actions hadbeen taken to ensure conformity with CGMP regulations. (F.D.C.No. 66750; S. No. 93-671-682 et ah; S.J. No. 12)

PRODUCT: Pectin, citr ic acid, and dextrose combinationpowder in unlabeled packets, and berbal tea in tea bags, atTulsa, N. Dist. Okla.; Civil No. 93-C-683E.CHARGED 7-30-93: While held by Zydot Unlimited. Inc.. Tulsa.Okla.. the articles (which were accompanied by various of thedealers' labeling, such as "ZYDOT Special Blend [or "NaturalBlend Herbal Tea"] ... Cleanse Your Urine of Unwanted Toxins... Manufactured for Zydot Unlimited. Inc.") were new drugswithout effective approved New Drug Applications—505(a): andthe articles failed to bear adequate directions for their intendeduse and were not exempt due to their new drug status—502(f)( I).DISPOSITION: The articles were claimed by the dealer, whodenied the charges. Subsequently, a consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66692: S. No.93-617-103; S.J. No. 13)

M e d i c a l D e v i c e s

PRODUCTS: Curettes, dilators, and other obstetrical and gynecological devices, at Glens Falls. N. Dist. N.Y.; Civil No. 93-CV-1012(CGC/RS).CHARGED 1-30-93: The articles (which were manufactured byInternational Medical Technologies Group. Inc., Glens Falls.N.Y., had been manufactured, packed and stored under circumstances not in conformity with current good manufacturing practice—501(h); a number of the articles (c. g., UterVac RigidVacuum Curettes, UterVac Tissue Collection sets, and UterCyteEndometrial Sampling sets) were class 111 devices and no approved pre-market approval applications were in effect—50i(f)(l )(B); and the labeling of all of the articles faksely andmisleadingly represented or suggested that the devices were sterile—502(a); the devices' labeling failed to bear adequate directions for use, since such directions cannot be written for deviceslabeled as .sterile but which have not been sterilized—502(f)( I);the articles were dangerous to health when used as directed intheir labeling—502(j); the articles were manufactured in an unregistered establishment, and required information regardingspecified UterVac and other devices had not been provided toFDA—502(o) .DISPOSITION: Default—destruction. (F.D.C. No. 66736: S. No93-544-578; s.J. No. 14)

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PRODUCT: Ear cones, unlabeled, at Columbus, S. Dist. Ohio;Civil No. 2-93-750.CHARGED 7-28-93: The article (which was accompanied byan instruction leaflet reading "Ear Cones (Ear Candles) ... aidto ear care ... Questions and Answers") was a class 111 deviceand there was no approved pre-market approval application ineffect—501(f)(l )(B); the article's labeling contained false claimsfor treating hearing and sinus problems, headaches, and ear in-fection.s—502(a); the article's labeling lacked adequate directions for use; the article was dangerous to health when used asrecommended and suggested in its labeling—502(j) and the article was prepared in an unregistered establishment and requiredinformation had not been filed—502(o).DISPOSITION: Default—ordered destroyed. (F.D.C. No. 66746;S.No. 93-670-000; S.J. No. 15)

PRODUCT: Gloves, la tex, for medical examinat ions, atDoraville, N. Dist. Ga.; Civil No. 1:92-CV-1961-ODE.CHARGED 8-18-92: The articles, which were labeled "Ampro... Latex Exam Gloves ... Manufactured in U.S. By AmericanPro Latex ... Monmouth, II.," had been manufactured, packedand stored under circumstances lacking current good manufacturing practice—501(h).DISPOSITION: A settlement agreement was entered into between the possessor, Dillard Paper Co., Doraville, Ga., and thegovernment stating that, before filing the complaint for forfeiture, most of the articles had been returned to the manufacturer,and that the possessor agreed to destroy the remaining seizedarticles. Pursuant to the settlement agreement, the remainingarticles were destroyed; and the action was dismissed. (F.D.C.No. 66466; S. No. 92-618-639; S.J. No. 16)

PRODUCT: Perfluorodecaline intraocular fluid, at Chicago,N. Dist. 111.; Civil No. 93-C-7490.CHARGED 12-13-93: The article (which had been imported,was labeled "Perfluorodecaline ... sterile single use bottle ...for investigational use in the laboratory animals," and was being offered for sale to ophthalmologists) was a class 111 deviceand it did not have an approved pre-market approval applicationin effect—501 (f)( 1 )(B); and required information respecting thearticle had not been provided—5()2(o).DISPOSITION: Default—ordered destroyed. (F.D.C. No. 66916;S.No. 94-661-732; S.J. No. 17)

C R I M I N A L A C T I O N S

DEFENDANTS: Apple'Valley International, Inc., Spiuta, W. Dist.Mich.; Criminal Nos. l:93-CR-49.CHARGED on or about 4-1-93: When shipped to firms outsideof Michigan, foods represented (with the intent to defraud) to beunsweetened orange juice concentrate had had invert beet sugarsubstituted in part for orange juice concentrate—402(b)(2).DISPOSITION: Guilty plea; $480,000 fine. (F.D.C. No. 65991;S.J. No. 18)

DEFENDANTS: Daniel Busick, Ted Busick, and Harry Sanders.(t/a Die Biloxi Oyster & Fish Co.), Biloxi, S. Di.st. Miss.;C r i m i n a l N o . l : 9 3 c r 4 8 B r R .CHARGED 10-19-93 by the grandjury: Conspiracy by the threedefendants to traffic in oysters valued in excess of $350 thatwere in violation of federal and Mississippi laws and regulations—16 U.S.C. 3372(a)(2)(A), 3373(d)( 1 )(B). The comspiracyinvolved the concealment of their activities from the agenciesresponsible for enforcing maritime species laws and regulations,as well as the purchase of untagged oysters from Louisiana. Inaddition. Ted Busick and Harry Sanders, with intent to defraudand mislead, knowingly caused interstate oysters to be labeledwith falsified tags bearing a false growing area and a false nameand number for the harvester and shipper—403(a)( 1).DISPOSITION: Guilty pleas; each defendant sentenced to $3,000fine, probation for two years, and 100 hours of community service. (F.D.C. No. 66814; S. No. 93-652-174; S.J. No. 19)

DEFENDANT: Mark Saur, owner and officer of a fruit juiceprocessing firm, Sparta, W. Dist. Mich.; Criminal No. 1:93-M-3 7 3 .

CHARGED 4-1-93: When shipped to firms outside the state ofMichigan, foods represented to be unsweetened orange juiceconcentrate had had invert beet sugar substituted in part for orange juice concentrate—402(b)(2).DISPOSITION: Guilty plea; $100,000 fine. (F.D.C. No. 65991;S.J. No. 20)

I N J U N C T I O N A C T I O N S

DEFENDANTS: Puritan-Bennett Corp., and Burton A. DoleJr., president, and John H. Morrow III, executive vice president, Overland Park, Dist. Kan.: Civil No. 94-2014-JWL.CHARGED 1-11-94 in a complaint for injunction: That at thecorporation's various plants, the defendants manufactured, processed, packed, labeled, stored, and held for sale after interstateshipment of components, and distributed in interstate commerce,various adulterated and/or misbranded devices {i.e., respiratorytherapy devices manufactured at a plant in Lenexa, Kan.; home-use volume ventilator devices manufactured at a plant in Boulder,Colo.; intra-arterial blood gas monitoring devices and hospitalvolume ventilator system devices manufactured at plants inCarlsbad, Calif.; the distribution and specification developmentof Irish manufactured pulmonary function testing devices(spirometers) from Wilmington, Mass.; and various medicaldiagnostic specialty gas mixture.s—used to perform pulmonaryfunction testing—that were manufactured at a plant inMarlborough, Mass.)

Although no manufacturing occurred at Overland Park, Kan.,the defendants' corporate office there set corporate policies regarding legal compliance, handling complaints, and determining which complaints and service reports were to be submittedto FDA as medical device reports. FDA inspections of three of

FDA Consumer /October 1994 /35

Summaries of Court Actions (continued)

the defendants' manufacturing plants showed that the circumstances used for the devices manufactured at those plants failedto conform with current good manufacturing practice—501(h).FDA inspections at two of the defendants' plants revealed thatthe defendants had failed to furnish required material or information with respect to various devices—502(t)(2). The defendants' responses to the latest FDA inspection had been evaluated and determined to be inadequate. Previous inspectionsrevealed that a number of the same or substantially similar deviations from current good manufacturing practice had occurred.The government believed that, unless restrained by the court,the defendants would continue to violate the law.DISPOSITION: A consent decree of permanent injunction enjoined the complained-of violations. Detailed provisions withrespect to various of the plants enjoined specified operationsunless and until specified conditions had been met. In addition,following a resumption of any operations as authorized by thedecree, FDA was authorized to notify Puritan-Bennett to immediately halt further shipment and distribution of devices if (as aresult of an inspection, sample analyses, or other information)FDA concluded the firm's devices were adulterated and/or mis-branded as charged. (Inj. No. 1347; S. No. 94-486-463 et ah;S.J. No. 21)

M I S C E L L A N E O U S A C T I O N S

SUBJECT: Cell replication inhibiting drugs, FDA drug approval, and injury to a patient, Columbus, S. Dist. Ohio; CivilNo . 2 -93 -512 .CHARGED 5-21-93 by Reginald Nichols, a Columbus, Ohio,patient treated with AZT, against the U.S. Food and Drug Administration in a suit for damages and injunction: The plaintiffhad accepted the standard medical treatment (AZT) for his disease; and AZT had weakened the plaintiff's immune system.FDA had knowingly approved a drug that couldn't prolong lifebecause it inhibited cell replication that was an essential part ofall life and necessary to sustain life; and the plaintiff asked thatall drugs that inhibit normal cell replication be removed fromthe U.S. market.DISPOSITION: The government moved to dismiss on thegrounds that the plaintiff had not filed a tort claim against FDAand had failed to exhaust administrative remedies. The courtgranted the government's motion and dismissed the action. Thecourt determined that it was without jurisdiction over the claimfor money damages because of failure to exhaust the administrative remedies provided by the Federal Tort Claims Act. Similarly, the court dismissed the claim for an injunction. In theplaintiff's broad request for the removal from the market of anentire class of drugs, the plaintiff was asking the court to interfere in an area that Congress clearly intended to be left to FDA'sspecial expertise. The court found that the policy underlying theexhaustion of administrative remedies was quite applicable tothis case. Accordingly, the matter was dismissed in its entirety(Misc. No. 999; S.J. No. 22)

SUBJECT: Denial of use of Dermatron and interference withdesired medical treatment, Reno, Dist. Nev.; Civil No. N-91-0 4 1 - H D M .PETITIONED 1-28-91 by Century Clinic, Reno, Nev., YiwenY. Tang, M.D., H.M.D., clinic medical director, Katrina C. Tang,H.M.D., clinic staff member, six named patients of the clinic,and an association of clinic patients, against HHS Secretary LouisW. Sull ivan and FDA Commissioner David A. Kessler in a com

plaint for declaratory judgment and injunction: That theDermatron was a galvanic skin response measurement deviceemployed by thousands of physicians and that the Dermatronhad been in commercial distribution prior to the enactment ofthe Medical Device Amendments on May 28, 1976, and accordingly had a "grandfather" status; that the Century Clinic and theother plaintiffs had their property seized with attendant threatened criminal prosecution and violations of their civil rights,and the patients had been unlawfully denied access to theDermatron and o ther modal i t ies .

The asserted unlawful course of action of the defendants included,among other actions, the following: On Sept. 9,1990, FDA agents,purportedly acting pursuant to a search warrant, seized medicalrecords of 49 patients as well as medications, Dermatrons, and othermedical equipment, private files, and other items; and on Oct. 25,1990. FDA agents, purportedly acting pursuant to a search warrant,seized the medical records of 22 or more active clinic patients, aswell as medications, Dermatrons, and other medical equipment,private files, and other items.

In addition, the plaintiffs asserted that no statute authorizedthe defendants to interfere with free choice as to the Dermatron,and that, by virtue of the above actions, the patient plaintiffs hadbeen denied lawful access to the Dermatron. The plaintiffs accordingly prayed for a declaratory judgment that the Dermatronwas a lawful and proper medical device, and for a declaratoryjudgment that the defendants' actions were null and void. Theplaintiffs also prayed for a preliminary and permanent injunction against such actions.DISPOSITION: The government generally denied the charges,except for admitting the execution of search warrants and theseizure of Dermatrons, other medical devices, and other objects.The government moved for a stay of the proceedings pendingcompletion of a criminal investigation and potential criminalproceedings. The plaintiffs moved for a preliminary injunctionto enjoin the government from harassing and interfering withthe doctor-patient relationship between the patients of Dr. Tangand seeking to destroy the homeopathic medical practice of theplaintiffs Tang.

The court denied the plaintiffs' motion for a preliminary injunction and granted a stay of the proceedings pending outcomeof criminal proceedings. Ultimately, pursuant to a consent decree of permanent injunction against Century Clinic, Inc., andKatrina Tang, this action was dismissed. (Misc. 941; S J No23)

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TlieAbvFood Label

j h

Have you seen the new food label? It's appearing in grocery storeseverywhere! The new food label makes it easier to find out what's In thefood you eat. It helps you compare products quickly. Look for the boxcalled "Nutrition Facts" on the side or back of the package-that's howyou know It's the new food label.