The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

FDAU.S. Food and Drug AdministrationProtecting and Promoting Your Health

Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

Ingredients, Packaging & LabelingInformation about ingredients, additives, contact substances, GRAS, allergens, and nutrition labeling.Guidance & RegulationGuidance documents, FSMA, CGMPs, HACCP, facility registration, retail food protection, and import/export.Compliance & EnforcementReportable Food Registry, warning and untitled letters, and inspection and compliance programs.International & Interagency CoordinationInternational outreach, trade and interagency agreements, and the International Visitor's Program.

Ingredients, Packaging & LabelingFDA regulates the safety of substances added to food. We also regulate how most food is processed, packaged, and labeled.This section includes information on allergens, ingredients, food and color additives, food contact substances, and labeling requirements.

IngredientsFDA maintains multiple databases and listings related to ingredients, food additives, and colors. The following pages also include overview and educational information.

Ingredients & Packaging Definitions Food Allergens Food Additives & Ingredients Consumer information about additives and ingredients  including: 

o Caffeinated Alcoholic Beverageso Sweeteners

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

o Sodiumo Color Additives

Generally Recognized as Safe (GRAS) Treatment & Packaging

Access program information, inventories, and databases related to food packaging and other substances that come in contact with food.

Packaging & Food Contact Substances (FCS) Irradiated Food & Packaging Environmental Decisions

Labeling & NutritionLearn about how FDA regulates food labeling, what claims can and cannot be made on a food label, and how to use the nutrition label.

Guidance & RegulationThis section contains FDA guidance and regulatory information with links to Federal Register documents. You can also access information about food safety programs, manufacturing processes, industry systems, and import/export activities.

Guidance Documents & Regulatory Information by Topic Guidance Documents: Guidance documents represent FDA's current thinking on a topic.

They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Regulatory Information: FDA issues regulations to implement its statutory authority. The regulations can create binding obligations and have the force of law. Links to Federal Register documents (advance notices of proposed rulemaking, proposed rules, interim final rules, and final rules) are posted in this section. 

FDA Food Safety Modernization Act (FSMA)FSMA is the most sweeping reform of FDA's food safety authority in more than 70 years. This act gives FDA new and enhanced mandates and authorities to protect consumers and promote public health. Food Facility RegistrationInformation on the requirement that owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA. Current Good Manufacturing Practices (CGMPs)Descriptions of the methods, equipment, facilities, and controls for producing processed food and dietary supplements. Following CGMPs ensures the quality of processed foods and dietary supplements. It also ensures that processed food or dietary supplements are packaged and labeled as specified in the master manufacturing record. Final Rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human FoodDocket Number: FDA-2011-N-0920

2018/09

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

Hazard Analysis & Critical Control Points (HACCP)HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards. This includes raw material production, procurement and handling, manufacturing, distribution, and consumption of the finished product.

Dairy Grade A Voluntary HACCP Juice HACCP Retail & Food Service HACCP Seafood HACCP  

Retail Food ProtectionMore than 3,000 state, local, and tribal agencies have primary responsibility to regulate the retail food and foodservice industries in the United States. FDA assists regulatory agencies and the industries they regulate by providing a model Food Code, guidance, training, program evaluation, and technical assistance. Imports & Exports (Food) Information on:

Importing food products into the United States , including Prior Notice of Imported Food Exporting food products from the United States , including export certificates 

DetentionInformation about FDA's authority to order the administrative detention of human or animal food. RecordkeepingInformation on the requirements for establishment, maintenance, and availability of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food into the United States. Federal/State Food ProgramsInformation about milk and seafood safety cooperative programs with FDA and state and local health and regulatory agencies.

Interstate Milk Shippers List Interstate Shellfish Shippers List

Food Protection Plan 2007FDA developed the Food Protection Plan to address the changes in food sources, production, and consumption. The plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. 

Importing Food Products into the United StatesUnder provisions of the U.S. law contained in the U.S. Federal Food, Drug and Cosmetic Act, importers of food products intended for introduction into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. (All imported food is considered to be interstate commerce.)

FDA is not authorized under the law to approve, certify, license, or otherwise sanction individual food importers, products, labels, or shipments. Importers can import foods into the United States

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

without prior sanction by FDA, as long as the facilities that produce, store, or otherwise handle the products are registered with FDA, and prior notice of incoming shipments is provided to FDA.

Imported food products are subject to FDA inspection when offered for import at U.S. ports of entry. FDA may detain shipments of products offered for import if the shipments are found not to be in compliance with U.S. requirements. Both imported and domestically-produced foods must meet the same legal requirements in the United States.

For an overview of the U.S. Import Program, please visit the links provided below.

Procedures and Requirements for Importing Food ProductsIn addition to meeting the requirements of U.S. food regulations including food facility registration, importers must follow U.S. import procedures as well as the requirements of Prior Notice.

Import Program

Prior Notice of Imported Foods

Chapter 5 - Food, Colors, and Cosmetics

Food Safety Importing Food Gifts for Personal Use Sending Gifts to Your Friends and Family: Prior Notice Policy

Importing Gift Packs and Prior Notice

Sending Food through International Mail - Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets

Importing Seafood The Imported Seafood Safety Program

Import ProgramWith the exception of most meat and poultry, all food, drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation, as defined in the FD&C and related Acts, are subject to examination by FDA when they are being imported or offered for import into the United States

Affirmation Of Compliance CodeOne of the functions of the FDA - ACS Interface is the automated screening of FDA regulated import entries to determine which entries to "MAY PROCEED" without FDA examination and which entries require further "FDA REVIEW.” An Affirmation of Compliance (AofC) code, transmitted at the FDA line level, is one data element used in this screening process. By using an AofC code, the filer affirms the firm or product identified in a FDA line meets requirements specific to each code. While submission of this information is voluntary, transmission of the data may expedite initial screening and further review of an entry. The following documents provide the most current AofCs available for use with FDA regulated products. The "FDA Affirmation of Compliance (AofC) Code Reference Guide" provides a detailed

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

explanation of each code and the proper qualifier syntax. The "FDA Affirmation of Compliance (AofC) Code Quick Reference" is a one page document designed to be a quick reference to determine which AofCs are applicable by commodity type and if a qualifier is required.

OverviewAll FDA-regulated products are expected to be in compliance at the time of entry. To help expedite FDA’s review of product compliance, the entry filer can submit additional information at the time of entry, such as registration, listing, and approval numbers. This information can be submitted by using Affirmation of Compliance codes (A of C codes).By using an A of C code, the entry filer affirms that the firm and/or product identified in an FDA line meets the requirements specific to each code. Depending on the product you are importing, submission of certain A of C codes might be mandatory.  The submission of voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and further review of an entry.The responsible party, such as the manufacturer or importer, should be able to indicate when these affirmations should be used and supply the qualifier when required.What is an A of C qualifier?Qualifiers provide product and manufacturer specific information. FDA uses this information to verify that the product is in compliance. Some affirmations require a product manufacturer’s registration number, unique to the facility, or a product’s approval number, specific to the product.Where can I find a list of affirmation of compliance codes and qualifiers?

The affirmation of compliance code quick reference guide provides an overview of A of C codes and will help you determine which code(s) to use with your product type.

The ACE affirmations of compliance is a detailed document with each code, code description, qualifier description, and qualifier example.

ITACSImport Trade Auxiliary Communication System (ITACS)

 

FDA has deployed the Import Trade Auxiliary Communication System (ITACS) for use by the import trade community.  This system   was implemented in order to improve communication between FDA and the import trade community. ITACS provides the import trade community with three functions:  the ability to check on the status of an entry, the ability to submit entry documentation electronically, and the ability to submit goods availability information for targeted shipments electronically. Benefits to the trade include the ability to receive more detailed entry statuses than what is currently transmitted to filers via Customs’ Automated Broker Interface (ABI), reducing the need for phone calls inquiring about the status of entries, and eliminating the need to mail or fax entry documentation and goods availability to FDA and no problems with lost documents. Filers and importers can check the status of their FDA release in the ITACS and it may be accessed at https://itacs.fda.gov. 

Filer Evaluation Importers, or third parties working on behalf of importers, file information about products offered for import into the United States.  FDA conducts evaluations of those filers who submit information electronically to help ensure that they are submitting accurate data.  

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

FDA is posting filer evaluation outcomes on-line, prospectively, starting from the beginning of FY2012, to help increase the accuracy of the information submitted to FDA and the accountability among the actors in the supply chain.  This list will be updated monthly, and it will post the most recent outcome for each filer.    

Because this list is prospective, and updated monthly, interested parties should not make any inferences with regard to the status of filers that do not have filer evaluation outcomes posted on this site.

FDA recognizes that the filer evaluation process currently does not distinguish between serious mistakes or omissions and typographical errors, and FDA is working to improve this process.  In general, FDA attempts to re-evaluate filers with excessive error rates within nine months, as volume and resource constraints permit.  FDA is exploring procedures that would speed up this re-evaluation, which would provide an incentive for filers to improve their outcomes quickly.  

The following files list filers alphabetically, and it discloses one of five different outcomes for each filer:

•    Paperless – Satisfactory evaluation result; FDA has determined that electronic filing is appropriate.

•    Corrective Action Plan – Based on the filer’s error rate, FDA has determined that continued electronic filing is appropriate, but FDA has requested a corrective action plan.

•    Dual-Mode Filer – The filer has been returned to Dual Mode (electronic and paper submissions) after FDA found repeated failures to successfully execute a Corrective Action Plan for improving the quality of the data being submitted. 

•    New Filer – FDA has insufficient information to determine whether electronic filing, alone, is sufficient; FDA requires both electronic and paper submissions.

•    Inactive – The most recent evaluation determined that the firm is either out of business or inactive in FDA commodities. 

FDA Filer Evaluation Outcome

PREDICTFDA's new PREDICT, a risk-based screening tool for imports has been fully deployed. It has replaced the admissibility screening function of OASIS, FDA's legacy system. PREDICT assist entry reviewers in targeting higher-risk shipments for examination. It also expedites the clearance of lower-risk cargo, but only if accurate and complete data are provided by importers and entry filers.   presentation will issue at a later date.

FDA Commissioner Margaret Hamburg on "FDA and the American Public: The Safety of Foods and Medical Products in the Global Age, February 4, 2010."

Watch a video explaining how PREDICT works. Briefing slides for Importers and Entry Filers are included on this page below.

 -

PREDICT Presentation   (PDF - 796KB)

PREDICT FACT Sheet Presentation   (PDF - 138KB)

Import BasicsAll products offered for entry into the United States, including items for personal use, must be declared to U.S. Customs and Border Protection (CBP). CBP refers all FDA-regulated products to the FDA for review. CBP's regulations and requirements are at its website.

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

Most importers choose to hire licensed representatives when offering the products for entry. These representatives are known as customs brokers or entry filers. The entry filers can assist the importer by submitting necessary entry information and appropriate payments to CBP on behalf of the importer. CBP’s website has a clickable US map that will provide a list of specific ports, and under each port, you will find a list of brokers.

FDA ReviewAll imported shipments of FDA-regulated products are reviewed by the FDA and must comply with the same standards as domestic products. The FDA determines whether products are admissible into U.S. commerce and may refuse entry to any that violate or appear to violate any provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Be sure to review:FDA Entry TypesRegulated ProductsEntry Review Process Specifics

Medical Devices Devices must meet FDA regulations prior to the importation of medical devices into the United States. FDA does not recognize regulatory approvals from foreign countries/areas.

If your device is a type that requires a premarket notification (or 510(k)) submission, you are required to submit a 510(k) when the following occurs: (a) a foreign manufacturer intends to export a medical device to the U.S. that the firm has never before shipped to the U.S.; (b) either the foreign manufacturer or initial distributor changes the intended uses of devices that are legally being marketed in the U.S.; or (c) changes or modifications to a legally marketed device that could significantly affect its safety or effectiveness. Information on how to submit a 510(k) is available. 

All foreign firms are required to both register their establishments, identify a U.S. Agent, and individually list their devices before they may import them into the United States. Complete information on registration and listing requirements and processes can be obtained from the Registration & Listing website, or by contacting DICE as described below.

Form FDA 2877 (Declaration for Radiation Standard) is required for radiation-emitting electronic products entering the United States.

Information concerning premarket notification, radiation control standards, or device listing and establishment registration, is available at Device Advice: Device Regulation and Guidance.  You may also contact the Center for Devices and Radiological Health, Division of Industry and Consumer Education (DICE), 10903 New Hampshire Avenue, WO66-4613, Silver Spring, MD 20993-0002, (800) 638-2041. Manufacturers outside the U.S. should call: (301) 796-7100. Email dice@fda.hhs.gov

Import Alerts

COUNTRY/AREA INDUSTRY IMPORT ALERTS BY NUMBER IMPORT ALERTS BY LAST PUBLISHED DATE

 

The Food and Drug Administration (FDA) mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws which are designed to protect consumers' health, safety, and pocketbook. These laws apply equally to domestic and imported products.

With the exception of most meat and poultry, all food, drugs, biologics, cosmetics, medical devices, and electronic products that emit radiation, as defined in the FD&C and related Acts, are subject to examination by FDA when they are being imported or offered for import into the United States. Most meat and poultry products are regulated by the U.S. Department of Agriculture.

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

All imported products are required to meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; radiation-emitting devices must meet established standards; and all products must contain informative and truthful labeling in English.

As defined in the FD&C Act the term adulteration has to do with the content of a product (such as the addition of a substance which makes a product inferior, impure, not genuine, etc.) while misbranding includes statements on labels or labeling that are false or misleading.

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Prior Notice of Imported Foods

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Is just that – prior to arrival.For purposes of Prior Notice, “food” is defined as:

• Articles used for food or drink for man or other animals • Chewing gum • Articles used for components of items listed in the 1st and 2nd

bulletsNote:  "Food" does not include food contact substances or pesticides.

The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

When to Give Prior Notice of a Shipment

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MULLINS INTERNATIONAL SOLUTIONS

The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

Importing Drugs into the United States Drugs Guidance, Compliance & Regulatory Information

Guidance, Compliance & Regulatory InformationGood Review Practices (GRPs)Laws, Acts, and RulesGuidances (Drugs)Enforcement Activities by FDADrug Registration and ListingImports and Exports ComplianceSurveillancePostmarket Requirements and CommitmentsCompoundingResources For You

Compliance Policy Guide, Chapter 4 - Human Drugs Manual of Policies & Procedures (CDER) Sunscreen Innovation Act (SIA)

Related Information Rules & Regulations Legislation

Guidance, Compliance, & Regulatory Information Affordable Care Act (ACA 6004) Bioequivalence Recommendations for Specific Products Drug Compliance Programs Guidances (Drugs) Newly Added Guidance Documents Nicotine-Containing Products Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials Office of Compliance The Office of Prescription Drug Promotion (OPDP) PLR Requirements for Prescribing Information Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have

Required FDA Approval Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Import Operations BranchOur mission is to promote and protect the public health by ensuring human drug importation and exportation adhere to FDA's standards of compliance. More specifically to: Serve as FDA focal point at CDER for all human drug import and export compliance issues.

Promote goodwill and cooperation between the United States and foreign governments through the Export Certificate Program.

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

Assure the integrity of imported and exported drugs by monitoring investigational and unapproved new drugs.  

Importing Medical Devices into the United States

Medical Devices International Programs

International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP)

Pilot US/Canada Regulatory Collaboration US/Japan Regulatory Collaboration Asia-Pacific Economic

Cooperation (APEC) Information Exchange with Other Regulators

FDA Office of International Programs

International Programs - Center for Devices and Radiological Health (CDRH)

CDRH’s commitment to assuring patients and providers have timely and continued access to safe, effective, and high-quality medical devices involves engaging with international regulatory agencies to promote alignment in regulations.

Safety standards and regulations for medical devices vary from country to country. By engaging with regulatory authorities from other countries, CDRH works to implement policies and programs that align these standards and regulations.

CDRH meets with manufacturers and regulatory authorities such as Health Canada (HC), Japan’s Ministry of Health, Labour, and Welfare (MHLW), and the Asia-Pacific Economic Cooperation (APEC) to exchange regulatory information. CDRH exchanges information through web-based training, scientific and policy discussions, and confidentiality commitments.

CDRH’s international efforts are an important step in reducing barriers to medical devices with the potential for important public health impact reaching U.S. patients.

Center for Devices and Radiological Health Section 201(h) of the Food, Drug and Cosmetic Act defines a medical device as any

healthcare product that does not achieve its principal intended purposes by chemical action or by being metabolized.

A medical device can be as simple as a tongue depressor or a thermometer

And can also be as complex as robotic surgery devices

Or anything in between

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

CFR Title 21 CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND

HUMAN SERVICES SUBCHAPTER H—MEDICAL DEVICES - Parts 800 - 1299 800.10 to 800.55 GENERAL 801.1 to 801.437 LABELING 803.1 to 803.58 MEDICAL DEVICE REPORTING 806.1 to 806.40 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807.3 to 807.100 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR

MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808.1 to 808.101 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL

MEDICAL DEVICE REQUIREMENTS 809.3 to 809.40 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810.1 to 810.18 MEDICAL DEVICE RECALL AUTHORITY 812.1 to 812.150 INVESTIGATIONAL DEVICE EXEMPTIONS 813 [Reserved] 814.1 to 814.126 PREMARKET APPROVAL OF MEDICAL DEVICES 820.1 to 820.250 QUALITY SYSTEM REGULATION 821.1 to 821.60 MEDICAL DEVICE TRACKING REQUIREMENTS 822.1 to 822.38 POSTMARKET SURVEILLANCE 830 UNIQUE DEVICE IDENTIFICATION 860.1 to 860.136 MEDICAL DEVICE CLASSIFICATION PROCEDURES 861.1 to 861.38 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT 862.1 to 862.3950 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 864.1 to 864.9900 HEMATOLOGY AND PATHOLOGY DEVICES 866.1 to 866.6050 IMMUNOLOGY AND MICROBIOLOGY DEVICES 868.1 to 868.6885 ANESTHESIOLOGY DEVICES 870.1 to 870.5925 CARDIOVASCULAR DEVICES 872.1 to 872.6890 DENTAL DEVICES 874.1 to 874.5840 EAR, NOSE, AND THROAT DEVICES 876.1 to 876.5990 GASTROENTEROLOGY-UROLOGY DEVICES 878.1 to 878.5910 GENERAL AND PLASTIC SURGERY DEVICES 880.1 to 880.6992 GENERAL HOSPITAL AND PERSONAL USE DEVICES 882.1 to 882.5975 NEUROLOGICAL DEVICES 884.1 to 884.6200 OBSTETRICAL AND GYNECOLOGICAL DEVICES 886.1 to 886.5933 OPHTHALMIC DEVICES 888.1 to 888.5980 ORTHOPEDIC DEVICES 890.1 to 890.5975 PHYSICAL MEDICINE DEVICES 892.1 to 892.6500 RADIOLOGY DEVICES 895.1 to 895.101 BANNED DEVICES 898.11 to 898.14 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND

PATIENT CABLES

Definitions 510(k): premarket notification; the type of medical device application used to obtain market

clearance for Class I and II medical devices (that are not exempt) predicate device: a legally marketed device that is used for comparison to a new device for the

purpose of determining substantial equivalence

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The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

substantial equivalence: demonstration that a new device, as compared to a predicate device, has the same intended use, same technological characteristics or differences that don’t raise different questions

reference device: a legally marketed device that is not a “predicate device” but is otherwise used to address certain performance characteristics of a new device

intended use: the general purpose of a device, or what the device does indications for use: describes the disease/condition the device will diagnose, treat, prevent, cure,

or mitigate, including a description of the target patient population AofC: Affirmation of Compliance Code

Device Classification Classification determines extent of regulatory control (Risk Based) 1700 generic groups of devices Classified within 16 medical specialties

– 21 CFR 862-892862 = Chemistry/Toxicology 878 = General Plastic Surgery864 = Hematology/Pathology 880 = General Hospital866 = Immunology/Microbiology 882 = Neurological 868 = Anesthesiology 884 = Obstetrical/Gynecological870 = Cardiovascular 886 = Ophthalmic872 = Dental 888 = Orthopedic874 = Ear, Nose and Throat 890 = Physical Medicine876 = Gastro/Urology 892 = Radiology

Product Code or Product Code? 73 Anesthesiology Part 868 74 Cardiovascular Part 870 75 Chemistry Part 862 76 Dental Part 872 77 Ear, Nose, and Throat Part 874 78 Gastroenterology and Urology Part 876 79 General and Plastic Surgery Part 878 80 General Hospital Part 880 81 Hematology Part 864 82 Immunology Part 866 83 Microbiology Part 866 84 Neurology Part 882 85 Obstetrics and Gynecology Part 884 86 Ophthalmic Part 886 87 Orthopedics Part 888 88 Pathology Part 864 89 Physical Medicine Part 890 90 Radiology Part 892 91 Toxicology Part 862

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510(k) Number (PMN): K962903

FDA Product Code: 80 F - - LE

Steam Sterilizer:

The terms product code and product classification are different depending on the use of the word(s)

The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

Medical Device “Product Codes” CODE - QUALIFIER EXAMPLES Note: Should always be the DEV associated with the foreign manufacturer and not the US

Specifications Developer. DEV - 3003999999 or 9610123

DII - 3003999999 or 1021365 PMA - P001234 IDE - G01232 DFE - 3003999999 or 9710123LST - E100100PMN - K011234 {this is the 510(k)}MDL - 650 -182

Let’s look at a tongue depressor:

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Tongue Depressor

The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

Product Codes and Product Code BuilderThe Product Code Builder Application will guide you through an easy and user friendly selection process that will assist you in locating and building a product code. By building upon the code portions you select, the application will provide you with valid choices for each of the five components of the product code (Industry, Class, Subclass, PIC, and Product).

Product Code Builder

Importing Radiation-Emitting Products into the United StatesFDA is responsible for regulating radiation-emitting electronic products. The agency's goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products.

The Radiation Control provisions apply to any "electronic product" which is defined as any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation(i) contains or acts as part of an electronic circuit and

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And…Tongue Depressor

MULLINS INTERNATIONAL SOLUTIONS

The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

(ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.Products Subject to Performance StandardsTelevision receivers (21 CFR 1020.10)

Televisions and Video Display Monitors Diagnostic x-ray systems and their major components (21 CFR 1020.30)

Medical X-Rays Fluoroscopy

Cabinet x-ray systems (21 CFR 1020.40) Cabinet X-Ray Products

Microwave ovens (21 CFR 1030) Microwave Ovens

Laser products (21 CFR 1040.10) Medical Lasers Laser Products and Instruments (including Pointers, Light Shows and

Displays, CD Players, CD-ROMs, DVDs, and Printers)Sunlamp products and ultraviolet lamps intended for use in sunlamp products (21 CFR 1040.20)

Sunlamps and Sunlamp Products (Tanning Beds/Booths) High-intensity mercury vapor discharge lamps (21 CFR 1040.30)

Mercury Vapor Lamps Ultrasonic therapy products (21 CFR 1050.10)

Ultrasound Therapy

Another example of Product Code vs Product Code

ProductCode

Product Name

RadiationType

PerformanceStandard(s)

RHZ 3d Laser Scanning System Optical Laser products. [1040.10]

EBZActivator, Ultraviolet, For Polymerization

Optical

No standard applicable. General Radiological Health requirements apply. [1000-1005]

HPIAid, Vision, Optical, Ac-Powered

Optical

No standard applicable. General Radiological Health requirements apply. [1000-1005]

HPE Aid, Vision, Optical, Battery-Powered

Optical No standard applicable. General Radiological Health requirements apply.

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[1000-1005]

Laws and Regulations (Radiation-Emitting Products)The Radiation Control provisions (originally enacted as the Radiation Control for Health and Safety Act of 1968) are located in Sections 531 through 542 of the Act. They apply to any "electronic product" which is defined as: any manufactured or assembled product (or component, part, or accessory of such product) which, when in operation,

(i) contains or acts as part of an electronic circuit and

(ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation.

"Electronic product radiation" is defined as:

(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or

(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.

Examples of electronic products: Medical: diagnostic x-ray or ultrasound imaging devices, microwave or ultrasound diathermy devices, microwave blood warmers or sterilizers, laser coagulators, ultrasound phacoemulsifiers, x-ray or electron accelerators, sunlamps, ultraviolet dental curing devices; Non-medical: microwave ovens, televisions receivers and monitors (video displays), entertainment lasers, industrial x-ray systems, cordless and cellular telephones, industrial RF sealers of plastics and laminates, laser CD players.

Radiation Control Law (Federal FD&C Act)

Overview of Laws and Regulations

Summary of Electronic Product Radiation Control Provisions

Code of Federal Regulations Title 21, Subchapter J (Radiological Health)

General Requirements for All Electronic Products which Emit Radiation (21 CFR § 1000 - 1005)

Overlap of FDA Enforcement Authorities for Radiation Emitting Products [PDF] CFR Title 21 – Food & Drugs

SUBCHAPTER J—RADIOLOGICAL HEALTH

1000 1000.1 to 1000.60

GENERAL

1002 1002.1 to 1002.51

RECORDS AND REPORTS

1003 1003.1 to 1003.31

NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY

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1004 1004.1 to 1004.6

REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS

1005 1005.1 to 1005.25

IMPORTATION OF ELECTRONIC PRODUCTS

1010 1010.1 to 1010.20

PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

1020 1020.10 to 1020.40

PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

1030 1030.10 PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS

1040 1040.10 to 1040.30

PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

1050 1050.10 PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS

Importing Animal & Veterinary Products into the United StatesSection 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA) sets out the requirements for imports and exports of FDA regulated products.

FDA's import program is designed to enforce the Federal Food, Drug, and Cosmetic Act and other related Acts (Federal laws) to protect consumers' health and safety, and from economic fraud.  All imported products are required to meet the same standards as domestic goods.

Sections 801 and 802 of the Federal Food, Drug, & Cosmetic Act (FD&C Act) govern when it is permissible to export an unapproved, adulterated or misbranded product.

For questions about importing veterinary products, contactCVMImportRequests@fda.hhs.gov.

Import TolerancesThe Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug Availability Act of 1996(ADAA), provides a basis for legally marketing food of animal origin that is imported into the United States and contains residues of animal drugs that are not approved or conditionally approved in the United States (unapproved new animal drugs). The ADAA granted the Food and Drug Administration the authority to establish or revoke tolerances for residues of such unapproved new animal drugs present in imported, animal-derived food products. It is unlawful to import animal-derived food that bears or contains residues of an

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unapproved new animal drug unless an import tolerance has been established for residues of that drug and any residues do not exceed that tolerance.

To obtain additional information on how to request establishment of an import tolerance, please contact: Dr. Vernon Toelle, Division of Compliance (HFV-230), Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2733; phone: 240-276-9238; email: vernon.toelle@fda.hhs.gov.

The following tolerances have been established for imported food containing residues of unapproved new animal drugs:

Drug Species TissueImport Tolerance

Year Established

Public Documents

teflubenzuron Atlantic salmon

muscle with adhering skin

0.5 ppm 2014 FOI Summary 1

EA/FONSI 2

Persons using assistive technology may not be able to fully access information in these documents. For assistance, please call 240-276-9300.

1Under the provisions of the Freedom of Information Act (FOIA) and 21 CFR part 20, a summary of the basis of approval (FOI Summary) has been prepared.

2Based on its review of an environmental assessment (EA) submitted by the sponsor, the Agency has concluded that this action will not have a significant impact on the human environment and that an environmental impact statement is not required. A finding of no significant impact (FONSI) has been prepared.

Importing - Animal FeedSection 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA) sets out the requirements for imports and exports of FDA regulated products.

The adulteration and misbranding standards for feed and feed ingredients of foreign origin are the same as for those of domestic origin. A notable difference is the burden of proof that FDA must meet to refuse the entry of products of foreign origin. Under Section 801(a), the agency must only establish that the product “appears” to be violative under the FFDCA. This is a lesser standard than that to establish a domestic product as violative.

The U.S. Customs and Border Protection informs FDA when regulated products are offered for entry into the United States. FDA has the option of releasing the product, requesting the owner to hold the merchandise intact pending FDA examination, or detention if the product has a violative history. Ordinarily these decisions are made at the District level but, at times, District personnel may consult with headquarters to determine the admissibility of a product. To assist field personnel in making these decisions, they have access to resources, which alert them to potential problems, or items that should be sampled. Some of these resources and other

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information on imports are available on the Internet from the FDA’s Office of Regulatory Affairs (ORA), Office of Regional Operations.

The legal requirements that must be met are the same for imported and domestic products, including feed mill licensing and new animal drug approval requirements. However, the enforcement procedures are different. Imported products regulated by FDA are subject to inspection at the time of entry. Shipments found not to comply with our laws and regulations are subject to detention. They must be brought into compliance, otherwise, they are subject to refusal. Refused articles must be either destroyed, or re-exported.

Generally, an USDA permit is required for imported materials derived from animals and plants. Animal products, which require permits, include dairy products and meat products (e.g., meat meal and bone meal) from countries with livestock diseases exotic to the United States. Import permit applications for animal products may be obtained through the Automated Document Retrieval by calling (301) 734-4952, or writing to the USDA-APHIS-VS at:

USDA, APHIS, VS, NCIEProducts Program4700 River Road, Unit 40Riverdale, MD 20737-1231

Import permit applications for plant products may be obtained by calling (877) 770-5990, fax (301) 734-5786, or writing to the USDA-APHIS-PPQ at:

USDA, APHIS, PPQPermit Unit4700 River Road, Unit 136Riverdale, MD 20737-1236

Additional Information Importing Food Products into the United States USDA-APHIS-VS USDA-APHIS-PPQ About the Office of Regulatory Affairs Supplementary Information Certificate to Foreign Government Requests (PDF) (PDF -

506KB) FDA Export Certificates

Importing - Veterinary DrugsNew animal drug substances for which there are no approved New Animal Drug Applications (NADAs) or Investigational New Animal Drug (INAD) exemptions, consigned to veterinarians for use in their private practices, or to manufacturers, or distributors, may not be legally imported into the United States. These drugs will be considered adulterated under section 501(a)(5) of the Act, or misbranded under section 502(f)(1).

Bulk drug substances labeled for further manufacturing or processing and bearing some indication for veterinary use, are adulterated within the meaning of 501(a)(5) unless the recipient or distributor holds an approved NADA, ANADA, conditional NADA, or an INAD exemption for

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preparation of a finished dosage form drug or medicated feed premix from that particular bulk drug source, or an approval is not required at this time either by regulation or policy.

Bulk drug substances labeled for further manufacturing or processing, which do not bear any indications for veterinary use, may be misbranded under Section 502(f)(1) if they are intended for veterinary use. Such drugs are in violation of Section 502(f)(1) because they do not bear adequate directions for veterinary drug use and they are not exempt from adequate directions for use.

New animal drug substances may be imported only if the consignee is:

1. the holder of an approved NADA, ANADA, or a conditional NADA for the imported new animal drug substance; or,

2. the sponsor or investigator named in an INAD exemption for the imported drug substance; or,

3. the investigator conducting tests in vitro and in laboratory research animals with drugs which comply with pertinent Federal regulations (21 CFR 511.1(a)); or,

4. a distributor holding the requisite approvals or having an order from a consignee holding the appropriate approved NADA or INAD exemption.

FDA will take appropriate action to prevent importation of new animal drug substances if the importer does not meet one of these criteria. Field compliance officers will prevent illegal importation by detaining the drug substances at the port of entry. Veterinarians and others should be aware of these requirements when planning to import bulk drugs.

Importing Cosmetics into the United StatesRegistration ProgramReporting system for use by manufacturers, packers, and distributors of cosmetic productsGuidance & RegulationResources on legal, regulatory, and policy issues related to cosmeticsCompliance & EnforcementInformation on compliance with and enforcement of laws and related FDA regulations for cosmeticsInternational ActivitiesFDA's involvement in international activities related to cosmetics, including imports and exportsLabelingRequired labeling information, ingredient names, claims, and moreProducts & IngredientsInformation on selected cosmetics products, ingredients, and potential contaminantsScience & ResearchInformation on research related to cosmetic products, ingredients, and testing

Voluntary Cosmetic Registration Program

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FDA’s Voluntary Cosmetic Registration Program (VCRP) is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

About VCRP

Benefits of VCRP Participation

Some Important Things to Know  

How to Participate 

o Registering cosmetic manufacturing and/or packaging establishments

o Filing Cosmetic Product Ingredient Statements (CPIS)

o Amending or Discontinuing a Product Formulation

More Resources Participate Online

Participate Using Paper Forms

VCRP Help

Cosmetics Guidance and Regulation

About VCRPThere are two parts to the VCRP, described in detail in the sections below. You may participate in both parts of the program or only one part. No fees are required to participate in this voluntary program.

The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to products that are not for sale (Title 21, Code of Federal Regulations (CFR),   part 710.9 ), such as hotel samples, free gifts, or cosmetic products you make in your home to give to your friends.

Benefits of VCRP ParticipationThe VCRP assists FDA in carrying out its responsibility to regulate cosmetics. FDA uses the information to evaluate cosmetic products on the market. Because product filings and establishment registrations are not mandatory, voluntary submissions provide FDA with the best information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution (Federal Register, vol. 73, p. 76360, and vol. 69, p. 9339).

 Information from the VCRP database also has been used by the Cosmetic Ingredient Review (CIR), an independent, industry-funded panel of scientific experts, to assist the CIR Expert Panel in assessing ingredient safety and determining priorities for ingredient safety review

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(Federal Register, vol. 73, p. 76360). FDA representatives attend CIR meetings in a non-voting capacity. By participating in the VCRP you are supporting these safety review processes.

Cosmetic companies gain one additional benefit from VCRP participation. Filers can use the database as back-up storage for product information because the FDA server is secured and off-site.

Some Important Things to Know There are legal differences between cosmetics and drugs. The VCRP applies to products

that are cosmetics as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 201(i). Drugs are subject to different requirements, including those for registering establishments and listing products with FDA (FD&C Act, sec. 510; 21 CFR 207). Some cosmetic products may also be drugs. Additional information on these types of products is available elsewhere on FDA's website. For example, you may wish to refer to “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).” If your products are drugs, or both cosmetics and drugs, see “Drug Registration and Listing System (DRLS & eDRLS)” and “Electronic Drug Registration and Listing Instructions.” 

The VCRP is not a cosmetic approval program or a promotional tool. Cosmetics are not subject to FDA premarket approval. It is the firm's responsibility to ensure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. Registration of a cosmetic establishment, assignment of an establishment registration number, filing a cosmetic product, or assignment of a CPIS number does not mean that FDA has approved the firm or its products (21 CFR 710.8 and 720.9) or that a product is a cosmetic as defined in the FD&C Act. Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number is considered misleading (21 CFR 710.8 and 720.9). Misleading labeling makes a cosmetic misbranded (FD&C Act, 602(a)), and marketing a misbranded cosmetic is against the law (FD&C Act, 301(a)).

The VCRP is not part of an import notification system. Firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into the United States.

Certain information from the VCRP database is available through the Freedom of Information Act (FOIA). For example, FDA sometimes receives such requests from consumers or healthcare providers who wish to identify products that do or do not contain certain ingredients. Proprietary business information, however, is not releasable under FOIA. Firms may submit written requests for confidentiality of a cosmetic ingredient in accordance with 21 CFR 720.8, which also states how FDA handles such requests.

The regulations authorizing this program are found in 21 CFR, parts 710 and 720.

How to Participate1) Registering cosmetic manufacturing and/or packaging establishments. Cosmetic establishments are facilities where cosmetics are manufactured and/or packaged, not locations that house only business operations. Only owners or operators of cosmetic manufacturing or packing facilities can register their establishments, using a separate Form FDA 2511 for each facility location. Distributors cannot register an establishment (21 CFR 710.1). Firms can

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register their establishments before or after their products are entered into commercial distribution and for sale to U.S. consumers. FDA assigns a registration number to each establishment location and returns a copy of your Form FDA 2511 to you, listing the number assigned to the location as a receipt.

2) Filing Cosmetic Product Ingredient Statements (CPIS). A cosmetic manufacturer, packer, or distributor can file a statement for each product the firm has entered into commercial distribution in the United States. Use a separate Form FDA 2512 for each formulation. (If you are using printed forms, you will need both Form FDA 2512 and 2512a.) You also may file a CPIS to amend an earlier submission if you change the formulation. FDA assigns a Cosmetic Product Ingredient Statement Number (CPIS NO.) to each formulation filed in the VCRP and returns an OFFICIAL RECEIPT to you marked COMPLETE, listing the CPIS NO. assigned to the submission.

3) Amending or Discontinuing a Product Formulation. CPIS numbers do not have expiration dates, so it is important for you to follow the procedures in 21 CFR 720.6 to amend a filed formulation or to discontinue a filed product that is no longer in commercial distribution. If you are filing via Internet, use Form FDA 2512 to amend or discontinue a CPIS. If you are using paper forms, use Form FDA 2512 to amend a formulation and Form FDA 2514 to discontinue a formulation.

Guidance & Regulation

Laws & RegulationsFDA enforces laws enacted by Congress and issues regulations as authorized by Congress to implement its statutory authority. The regulations can create binding obligations and have the force of law. Links to laws and regulations that FDA enforces, as well as related overviews and reference materials are posted in this section.

Guidance DocumentsGuidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. Manufacturers can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Links to Federal Register documents, including notices and final rules, are also posted in this section.

Industry: Manufacturers, Packagers, Distributors and Emerging BusinessesLinks to information and resources for the cosmetics industry Cosmetics Registration Program (VCRP)

Cosmetics Labeling Guide

Fact Sheet for Small and Home-Based Businesses

Fact Sheet for Importers & Exporters

View More Resources for Industry

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Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

Whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

How does the law define a cosmetic?

How does the law define a drug?

How can a product be both a cosmetic and a drug?

What about "cosmeceuticals"?

How is a product's intended use established?

How are the laws and regulations different for cosmetics and drugs?

And what if it's soap?

More resources

How are the laws and regulations different for cosmetics and drugs?

The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. Questions regarding laws and regulations for drugs should be directed to FDA's Center for Drug Evaluation and Research (CDER). 

How approval requirements are different

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA [FD&C Act, sec. 505(a) and (b)], or comply with the appropriate monograph for an OTC drug. (A note on the term "new drug": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, it must comply with the requirements outlined above.) 

What do these terms mean?

An NDA is the vehicle through which drug sponsors formally propose that FDA approve a pharmaceutical for sale and marketing in the United States. FDA only approves an NDA after determining, for example, that the data is adequate to show the drug's safety and

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effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients and for new indications entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system, and their "switch" to OTC status is then approved, also through the NDA system.

FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of nonprescription drugs, such as what ingredients may be used and for what intended use. Among the many nonprescription drug categories covered by OTC monographs areo acne medications

o treatments for dandruff, seborrheic dermatitis, and psoriasis

o sunscreens

How good manufacturing practice requirements are different

Good manufacturing practice (GMP) is an important factor in helping to assure that your cosmetic products are neither adulterated nor misbranded. However, while FDA has provided guidelines for cosmetic GMP (see "Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist"), no regulations set forth specific GMP requirements for cosmetics. In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].

How registration requirements are different

FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. The FD&C Act does not require cosmetic firms to register their establishments or list their product formulations with FDA. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510;21 CFR 207]. See Drug Listing and Registration System (DRLS and eDRLS).

How labeling requirements are different

A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling and links to the regulations related to cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.66Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in descending order of predominance as "Inactive Ingredients."

And what if it's "soap"?

Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because—even though

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Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic—Section 201(i)(2) excludes soap from the definition of a cosmetic. 

How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when

the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and

the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

Products that meet this definition of soap are regulated by the Consumer Product Safety Commission  (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC. 

If a cleanser does not meet all of these criteria...

If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also for other cosmetic uses,it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin. If a product consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the

structure or any function of the human body,it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers and cleansers that are also intended to treat acne. If a product is intended solely for cleansing the human body, has the characteristics consumers generally associate with soap, and does not consist primarily of alkali salts of fatty acids,it may be identified in labeling as soap, but it is regulated as a cosmetic. Import SurveillanceThe following are resources on FDA's surveillance and enforcement activities related to imported cosmetics: Import Alerts Related to Cosmetics

An Import Alert allows FDA to detain, without physically examining, products that either have or potentially could violate the Federal Food, Drug, and Cosmetic Act.

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Import Refusals Related to Cosmetics Cosmetics offered for import that do not appear to comply with U.S. law may be refused entry into this country. The list of Import Refusals is updated monthly. 

Cosmetics Compliance Program:   Import and Domestic (PDF 310 KB)  March 15, 2010  For information on some ongoing FDA compliance priorities related to cosmetics

Importing T obacco Products into the United StatesGuidance: To support the public health goals of the Tobacco Control Act, FDA provides guidance to help industry understand and comply with all regulations and the law.

Regulations:FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users and nonusers. Similarly, when developing certain regulations, the law requires FDA to apply a public health approach that considers the effect of the regulatory action on the population as a whole, not just on individual users, with respect to initiation and cessation of tobacco use.FDA regulations are based on the laws set forth in the Tobacco Control Act and the Food, Drug, and Cosmetic Act (FD&C Act). FDA regulations are also federal laws.

***Tobacco products are more regulated by ATF***41 41.1 to

41.273IMPORTATION OF TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO

ELECTRONIC CODE OF FEDERAL REGULATIONS

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Title Volume Chapter Browse Parts Regulatory Entity

Title 21Food and Drugs

1 I 1-99 FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

2 100-169

3 170-199

4 200-299

5 300-499

6 500-599

7 600-799

8 800-1299

9 II 1300-1399 DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE

III 1400-1499 OFFICE OF NATIONAL DRUG CONTROL POLICY

***REMINDER - - - AoC reporting in some cases is a must and in other cases will help to expedite the release/may proceed process.

Affirmation Of Compliance Code One of the functions of the FDA - ACS Interface is the automated screening of FDA

regulated import entries to determine which entries to "MAY PROCEED" without FDA examination and which entries require further "FDA REVIEW.”  An Affirmation of Compliance (AofC) code, transmitted at the FDA line level, is one data element used in this screening process.

By using an AofC code, the filer affirms the firm or product identified in a FDA line meets requirements specific to each code.  Transmission of the data may expedite initial screening and further review of an entry. 

The USFDA has developed AofC codes appropriate for use when transmitting entries of imported medical devices. In the following appendix you will find AofC codes with their associated descriptions and qualifiers for medical devices. Each entry line should contain an AofC code for:

Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE) Device Listing (LST) Device Initial Importer (DII)

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Premarket Application (PMA) (Can be a PMA, a Humanitarian Device Exemption (HDE), or a Product Development Protocol (PDP) number) OR a Premarket Notification Number (PMN) OR an Investigational Device Exemption (IDE)

Additional AofC codes can be provided

(PREDICT) Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting

Purpose: Improve import screening and targeting to Prevent the entry of adulterated, misbranded, or otherwise violative goods Expedite the entry of non-violative goods Use automated data mining and pattern discovery Scoring each entry line on the basis of risk factors View accuracy of product and facility coding by entry filers and importers

Accurate, Consistent, & Complete Data To expedite entry screening by PREDICT, importers and entry filers must provide:

Consistent, accurate identifiers for firms Accurate product codes All relevant affirmations of compliance

Data anomalies and poor data quality are used to adjust the risk scores … and they are posted on the FDA website for everyone to see.

With PREDICT: Affirmations of compliance With accurate and complete affirmations of compliance, PREDICT will validate

information against internal databases. If an automated lookup fails, the entry line will be forwarded to an entry reviewer for

manual processing. That equals delays for your customer.The quality of the data submitted to the FDA will count more than ever. Importers need to work closely with filers to ensure data quality. Poor data quality or missing data will increase the targeting scores for your subsequent entry lines (importers and filers). Higher risk scores increase the likelihood of physical examination by the FDA.

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Reporting Quantities - FDA

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The first pair of fields is used to describe the product in terms of largest container

The next pair is used to describe the contents of one of the containers described in pair

The remaining pairs are used in a similar manner to describe the contents of container in the pair immediately preceding the pair being entered.

The last pair entered must describe the actual amount of product in the smallest container (the container of the immediately preceding pair). This quantity is entered in terms of Quantity Units, which are base units of measure which represent an actual recognized physical quantity

FDA : BASE UNIT CODES

M2 - Square Meters DOZ - Dozen NO - Number PCS - Pieces KM - Kilometers

FDA : CONTAINER CODES

BA - Barrel (Container) BG - Bag CT - Carton CB - Crate, Beer FC - Crate, Fruit

A sequence of quantity fields must contain one and only one of these codes and it must be in the last quantity set (the BASE UNIT set) transmitted for the line.

A sequence of quantity fields may contain one or more of these codes. They may notbe in the last quantity set transmitted for the line.

The ABC’s of Customs Brokerage Week SixFood and Drug Administration – FDA (6.3)

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FDA Reporting Quantity Example

MULLINS INTERNATIONAL SOLUTIONS

75 bundles of 2 cartons each 468.75 pounds net each carton with 4 boxes of 25 packages 2 ounce Dried Egg PlantUnits 1-Quantity 75Units 1-Measure BEUnits 2-Quantity 2Units 2-Measure CTUnits 3-Quantity 4Units 3-Measure BXUnits 4-Quantity 25Units 4-Measure PKUnits 5-Quantity 2Units 5-Measure OZ

In this example, 2 ounce packages of dried eggplant are packed 25 to a box. Each carton contains 4 boxes and the cartons are tied in groups of 2. This amount of detail will usually not be present on the invoice….you have to ask your customer to report correctly