fda dietary supplement update
DESCRIPTION
FDA Dietary Supplement Update. Daniel Fabricant, Ph.D. Director, Division of Dietary Supplement Programs, ONLDS, CFSAN [email protected] Natural Marketplace June 15, 2012. 1. Update . Overall NDI SAER cGMP Other. General. General Regulatory Paradigm - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/1.jpg)
1
FDA Dietary Supplement Update
Daniel Fabricant, Ph.D.Director, Division of Dietary Supplement Programs,
ONLDS, [email protected]
Natural MarketplaceJune 15, 2012
![Page 2: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/2.jpg)
Update • Overall• NDI• SAER• cGMP• Other
![Page 3: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/3.jpg)
General• General Regulatory Paradigm
– Limited premarket review – No Premarket approval– No formulation standards– No product registration– No approval of s/f claims– Manufacturer responsible for ensuring safety and compliance
• Where to find Information– Statutes (15, 21 & 42 U.S.C)– Code of Federal Regulations (Title 21)– Guidances
![Page 4: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/4.jpg)
Statutory Authority• Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et. seq.)
– Dietary Supplement Health and Education Act of 1994 (Pub. L. 103-417, 108 Stat. 4325)
– Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469)
– Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171, 116 Stat. 135-527)
– Food Allergen Labeling and Consumer Protection Act of 2004 (Pub. L. 108-282, 118 Stat. 905)
– Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188, 116 Stat. 594)
– FDA Food Safety Modernization Act (Pub. L. 111-353, 124 Stat. 3885
![Page 5: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/5.jpg)
From FVM strategic plan
![Page 6: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/6.jpg)
![Page 7: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/7.jpg)
Dietary Supplements
• over 400 recalls of spiked products since 2008 • OAI on GMPs (+ VAI) = more non-compliance
(varying degrees) than compliance with cGMPs• only ~50 NDINs annually• Indication and Growing Evidence of
underreporting of AERs• Increase in Claim WLs in 2011 (2012 tracking)
![Page 8: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/8.jpg)
NDI
![Page 9: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/9.jpg)
Salt Lake Tribune• “I think most people in the industry would
say we have been under-filing in the last few years,” http://www.sltrib.com/csp/cms/sites/sltrib/pages/printerfriendly.csp?id=52397201
![Page 10: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/10.jpg)
10
NDI FDA Response Options• Acknowledgement• Objections can be categorized as follows:
• The notification contained unresolved safety concerns (identity or toxicology issues);
• The notification was incomplete; or• The notification was objected to for other reasons,
e.g., the substance that was the subject of the notification was an approved drug or did not meet the definition of a dietary ingredient.
• ToxSci paper- http://toxsci.oxfordjournals.org/content/123/2/333.full
![Page 11: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/11.jpg)
11
Unresolved Safety:Germanium;Pyrrolizidine-containing seed oil
(Echium plantagineum);Phytolacca americana lectins;Oleander extract (Nerium oleander) ;Gammabutyrolactone (GBL); E.coli; “Milkweed seed oil”
Non-Dietary Ingredients:Cotinine; trans-resveratrol; Hyaluronic acid
A few examples of notable “objections”
![Page 12: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/12.jpg)
2004 FR notice• Federal Register / Vol. 69, No. 202 /
Wednesday, October 20, 2004• Public Meeting Held on Nov. 15, 2004• Cited McGuffin/Young FDLI paper
12
![Page 13: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/13.jpg)
Background of draft guidance• Sharfstein speech to 2009 CRN Annual meeting: “One such tool is the agency’s ability
to review new dietary ingredients, or NDIs. An NDI is a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.Although DSHEA excludes from premarket notification “grandfathered” dietary ingredients that were marketed before DSHEA became law, dietary supplements that contain new dietary ingredients must submit a 75-day pre-market notification to FDA. This provides FDA a chance to review the safety of the supplement that contains the new dietary ingredient before consumers can use the product. Dietary supplements containing new dietary ingredients for which this notification is not provided are illegally marketed. So far, we have been hampered by the fact that no verified list of grandfathered ingredients exists. But here’s what we can do. We can set out guidance explaining how to demonstrate that a product is in fact grandfathered in. Then, when we see concerning products we do not believe were marketed prior to October 15, 1994 on the market, we can ask companies to provide evidence of prior marketing … or to voluntarily pull the product until an NDI premarket notification is filed. For this approach to work as well as possible, we must also provide clear standards and prompt review for new ingredients. This will allow us to support legitimate products … while acting to remove risky ingredients quickly from the market.”
• http://www.fda.gov/NewsEvents/Speeches/ucm187640.htm 13
![Page 14: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/14.jpg)
Background of draft guidance• Senate Judiciary Senate Aging hearing (5/2010):
http://aging.senate.gov/events/hr221sm.pdf -“What is needed, though, to increase success in filing NDI notifications, is a formal guidance from FDA that explains clearly the agency’s views on what constitutes a new dietary ingredient versus a grandfathered one and provides instruction on how firms can establish the reasonable expectation of safety from the evidence they provide. Industry has been asking for this guidance for years and FDA has been promising it, but to date, it has not been issued.”
![Page 15: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/15.jpg)
History of NDI draft guidance
• 111th Congress- S. 3002 & Full Implementation of DSHEA
• 111th Congress - Some elements folded into S. 510 became FSMA
![Page 16: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/16.jpg)
NDI Draft Guidance Background• The FDA Food Safety and Modernization Act
(FSMA) required FDA to publish NDI guidance not later than 180 days after the date of enactment.
• “Guidance represents the FDA's current thinking on this topic. It does NOT create or confer any rights for or on any person and does not operate to bind FDA or the public.”
![Page 17: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/17.jpg)
Comment Period closed Dec. 2nd • From FDMS over 7,000 comments as of
12/8/2011• Some paper docs still being uploaded• Thanks to all of those who commented
17
![Page 18: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/18.jpg)
Guidance v. Statute v. Regs• What is the difference between the
Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA guidance?
• http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm
18
![Page 19: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/19.jpg)
• Good Guidance Practice (21 CFR 10.115): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115 – “Guidance documents do not establish legally
enforceable rights or responsibilities. They do not legally bind the public or FDA.”
– “One may choose to use an approach other than the one set forth in a guidance document. However, your alternative approach must comply with the relevant statutes and regulations. FDA is willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations.”
19
![Page 20: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/20.jpg)
Next steps • We continue to review comments• Timeline unknown for any decisions at
present
20
![Page 21: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/21.jpg)
• To look at previous NDI notifications and FDA responses at regulations.gov docket FDA-1995-S-0039
• Questions about a notification: NDI Consumer Safety Officer: [email protected]
![Page 22: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/22.jpg)
Non-guide NDI matters
![Page 23: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/23.jpg)
1,3 –Dimethylamylamine (DMAA)
• Open case • 15-days to respond, we have received
responsed from all firms• Failed to file NDI per the statute was the
cite in the WLs• New article in Arch. Int. Med. – DMAA as a
DS ingredient – Pieter Cohen• High level of consumer/commercial press
interest
![Page 24: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/24.jpg)
402(f)(1)(B)A food shall be deemed to be adulterated—
(f) Dietary supplement or ingredient: safety.
• (1) If it is a dietary supplement or contains a dietary ingredient that—
• (B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
![Page 25: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/25.jpg)
SAERs
![Page 26: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/26.jpg)
Authority & Responsibility in Non-Rx & DS Consumer Protection Act
• 15-day mandatory submission requirement – submission by rule of construction does not establish causality
• 1 year mandatory follow-up with any new & relevant information
• Access to records• Record maintenance• Domestic address or phone required on the
label
![Page 27: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/27.jpg)
Dietary supplement adverse event reports, FDA-Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2008 – 2011.
Counts were obtained using FDA Received Date and year of first report for a case if there were multiple reports for a case (e.g., both a voluntary report and a mandatory report; follow-up reports); CAERS was searched on March 2012 for these counts;
Submission will not be construed by FDA as an admission that the dietary supplement caused the Adverse Event
Year Mandatory Voluntary Both voluntary and
mandatory
Total cases per year
Deaths per year
2008 677 430 12 1119 12
2009 705 581 20 1306 24
2010 985 391 19 1395 23
2011 2019 430 24 2473 32
Total cases by report type 4386 1832 75 6293 91
![Page 28: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/28.jpg)
GAO on AERs
![Page 29: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/29.jpg)
Post-Market Surveillance - AERs and Product Complaints
• Reasonable Corporate Systems are likely Integrated
• PC are receiving, documenting and tabulating; AERs are the same + reporting requirement
• If trending and benchmarking are absent and/or deficient in cGMP regarding product complaints, what might this mean for other requirements?
• Assessment of a firm’s capabilities
![Page 30: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/30.jpg)
What’s wrong with this picture?Medwatch 800 number
• (c) MISBRANDING.—Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:
• "(y) If it is a dietary supplement that is marketed in the United States, unless the label of such dietary supplement includes a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.".
![Page 31: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/31.jpg)
• FDA has taken action for firms that have failed to notify FDA of serious adverse event reports (AERs).
• The most significant example to date was the filing of a complaint for permanent injunction against the firm ATF/Made (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm281017.htm). The complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania, charged that in addition to “adulterating” and “misbranding” their final products, the manufacturer and its owner failed to report serious adverse events associated with their products, including one case where an individual who consumed one of the products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack..
![Page 32: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/32.jpg)
• Other examples of recent FDA action on adverse events:– Nordimex Warning Letter - 403(y) citation "failure to
furnish an address or phone number for adverse event reporting" (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm275369.htm);
– BioSan warning letter - 403(y) citation "the label fails to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement." (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm262443.htm).
![Page 33: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/33.jpg)
SAERs – take home• Submitting an AE does not establish a causal
relationship to indicate the AE is unsafe; not submitting or failing to submit an AE does not indicate the product is safe, though it is a violation of the Act
• Clear indications of underreporting are increasing – resource intensive to ensure compliance
• Reasonable systems take a “holistic” approach to compliance/corporate responsibility
![Page 34: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/34.jpg)
cGMPs – 21 CFR Part 111
![Page 35: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/35.jpg)
cGMPs -21 CFR Part 111• For FY’11 – 175 inspections • First Injunction citing 21 CFR Part 111• First Seizure citing 21 CFR Part 111• For FY’12 (PAC Code 21008A - 5/1/12):
38(NAI); 48 (VAI); 51 (OAI)• Subpart (E)
![Page 36: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/36.jpg)
What investigators are finding during their inspections.
• Failure to prepare a master manufacturing record.– Specifications for each step in the
manufacturing process– Unique formulation for each batch– Identity and weight– Theoretical yield
36
![Page 37: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/37.jpg)
What investigators are finding during their inspections
• Failure to prepare a batch record– Unique identifier– Actual yield– Documentation at time of performance
![Page 38: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/38.jpg)
What investigators are finding during their inspections
• Failure to establish specifications– Identity– Purity, strength and composition– Limits on contaminants
![Page 39: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/39.jpg)
What investigators are finding during their inspections
• Failure to determine if specifications are met– Tests to meet specifications– Qualifying the supplier– Documentation of how supplier was qualified
![Page 40: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/40.jpg)
What investigators are finding during their inspections
• Failure of adequate quality control– Lack of review– Lack of material review and disposition
decision– Lack of quality control procedures
![Page 41: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/41.jpg)
cGMP Enforcement Options• WLs• Seizure• Injunction• Criminal Penalties
![Page 42: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/42.jpg)
Other matters• Tainted DS• OIG on FDA – Str/Fn Statements and
Registration under BT• Nanotech Guidance
![Page 43: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/43.jpg)
Tainted products• 060112-Reumofan Plus (methocarbamol &
diclofenac sodium) - http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm306348.htm
• 052612-Recall - V maxx (sulfoaildenafil) - http://www.fda.gov/Safety/Recalls/ucm305795.htm
• 051812 – Recall – Firminite et al., (Tadalafil) - http://www.fda.gov/Safety/Recalls/ucm304719.htm
• 041912 – Recall - Xrock
![Page 44: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/44.jpg)
Tainted Weight Loss Supplements JFK Int. Mail Facility
![Page 45: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/45.jpg)
45
Importation Through Mail FacilityRaw ingredient and finished product are often misdeclared and include false return addresses
![Page 46: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/46.jpg)
Red Flags• ED, weight loss, bodybuilding• Mass solicitations (spam email, etc)• Directions for use, such as
• Take 15 min to1 hr before sexual activity (ED)• Take 1 in morning before breakfast (weight loss)
• “Works like” or “better than” Rx drug• Labels in foreign language or “broken” English• Label contraindications or
warnings: pregnancy, cardiovascular disease, seizures
![Page 47: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/47.jpg)
Guilty Plea01/17/2012
Anabolic Resources (AR) & Nutrition Distribution (ND) dba Anabolic Xtreme
Distributed “supplements” containing: • Superdrol (methasterone, a synthetic steroid)• Hyperdrol (6-bromodione and androstenedione)• Slim Xtreme (designer stimulant)
![Page 48: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/48.jpg)
Guilty Plea• AR fined $500,000• ND forfeited $100,000• Must pay for
independent monitoring and testing of all products for 5 years
![Page 49: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/49.jpg)
Indicted Novocare, SLC, UT • Ex-official indicted for selling “100% natural and safe” ED
products tainted with sildenafil analogs: – “Stiff Nights”, “Natural Wow”, “Size Matters”, “OMG” – “Not a drug” and “Better than Viagra”
• 1 count conspiracy, 12 counts wire and 9 counts mail fraud, 4 counts money laundering
![Page 50: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/50.jpg)
Criminal Sentencing
• June 3, 2011: Chinese national sentenced to over 7 yrs in federal prison for trafficking counterfeit “Alli” and tainted supplements. – Texas ER doc suffered mild stroke– Pay ½ million in restitution
![Page 51: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/51.jpg)
![Page 52: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/52.jpg)
Enforcement Challenges• Foreign manufacturers of finished product or ingredients• Sold on 1000s of websites, domestic and foreign• One product may be sold on 100s of websites AND e-
commerce sites (e.g. eBay, Amazon)• Domestic sites often operated from residences, fictitious
address, P.O. boxes • Dealers may order directly from foreign sources using
email, Skye, etc., or from e-commerce sites like Alibaba.com
• Suppliers solicit US dealers (email, “work at home schemes”)
• Often imported using international mail rather than legal declared imports
![Page 53: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/53.jpg)
Tainted Products Links• Tainted Products Widget
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm242603.htm
• RSS feed: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml
• Tainted Products listhttp://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder
• Reporting: [email protected]
![Page 54: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/54.jpg)
In closing• over 400 recalls of spiked products since 2008 • OAI on GMPs (+ VAI) = more non-compliance
than compliance with cGMPs• only ~50 NDINs annually• Indication and Growing Evidence of
Underreporting of AERs• Increase in Claim WLs in 2011 (2012 tracking
upwards)• Evident of Systemic Issues
![Page 55: FDA Dietary Supplement Update](https://reader035.vdocument.in/reader035/viewer/2022062302/5681662a550346895dd98a5c/html5/thumbnails/55.jpg)
Questions?