FDA Compliance Law

We promote, protect, and defend products made by industries regulated by the U.S. Food and Drug Administration (FDA). The products we help get to market include foods, pharmaceuticals, medical devices, dietary supplements, and cosmetics. In addition, we have a very comprehensive practice in the regulation of packaging materials for food and cosmetics and other food-contact articles. We represent clients in addressing all issues relating to these products, including the suitability of their composition, inspection of manufacturing facilities, labeling and advertising, recall procedures, quality assurance programs, and appropriate responses to consumer complaints and tampering incidents. We also have substantial experience conducting “due diligence” audits of marketed products, labeling, advertising claims, and manufacturing operations, both for the clients’ internal control purposes and as part of product line or corporate acquisitions.

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Food Law

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Our food and drug lawyers regularly assist our clients in the following areas:

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• Providing opinion letters on the compliance status of food ingredients and additives, functional foods, and substances used in food packaging and processing equipment;

• Preparing and submitting to the relevant authorities food additive petitions, food-contact notifications, technical dossiers, and other filings, and obtaining regulatory clearance for the use of new food additives, novel foods, novel food ingredients, and substances used in packaging materials and processing equipment;

• Assisting in establishing “Generally Recognized as Safe” status for food ingredients and food packaging materials used in the United States;

• Advising on food labeling, allergen labeling, and advertising issues, including criteria for making “nutrition,” “health,” and “structure/function” claims;

• Assisting on compliance issues, including good manufacturing practice requirements, product recalls, U.S. FDA inspection practices and warning letters, and record keeping and traceability requirements;

• Advising on production, formulation and labeling issues for “organic” products; and

• Advising on requirements pertaining to the contained use, experimental release, marketing, and labeling of genetically modified organisms (GMOs) and products derived from GMOs;

In the dietary supplement, nutraceutical, and functional food area, we counsel clients on all aspects of dietary supplement requirements, including the following:

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• Advising on the U.S. Dietary Supplement Health and Education Act’s (DSHEA) adulteration, current good manufacturing practices, new dietary ingredient, and misbranding provisions;

• Reviewing labels, labeling, and advertising for compliance issues;

• Providing advice to dietary supplement manufacturers and distributors regarding the types of claims (and the substantiation needed to support them) that may appear in advertising, labels, labeling, and promotional materials for these products, including the claims used to market dietary supplements via the Internet;

• Advising on the classification of a product as a dietary supplement, conventional food or a drug based on the product claims;

• Counseling on potential product liability issues; and

• Providing guidance on the safety testing of dietary ingredients, including toxicology, carcinogenicity, and sensitivity testing on volunteers.

Medical Device Law

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In the area of medical devices, we assist clients with regulatory and compliance needs, including the following:

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• Advising on the need to submit and, if necessary, helping to prepare premarket notifications (510(k)s), applications for premarket approval (PMAs) in the U.S.; and related international applications;

• Assisting in establishing compliance with the essential requirements of the Medical Devices Directive and with similar international requirements;

• Advising on the proper classification of devices;

• Counseling on product liability issues for finished device manufacturers and component suppliers and defending related court cases; and

• Assisting with other compliance issues, including good manufacturing practice/quality system (QS) regulation matters; establishment registration and device listing; product recalls or market withdrawals; Medical Device Reports (MDRs) (Part 803) and Reports of Corrections and Removals (Part 806); U.S. FDA inspection practices; responding to Warning Letters and other actual or threatened enforcement actions; and advising on device promotion and advertising boundaries.

Cosmetic Law

With regard to cosmetics, our food and drug attorneys advise and assist clients with the full range of regulatory compliance issues, including the following:

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• Reviewing labeling and advertising for compliance;

• Advising on the classification of a product as a cosmetic or a drug based on the product claims;

• Counseling on potential product liability issues and defending related court cases;

• Providing guidance on the safety testing of cosmetic ingredients, including toxicology, carcinogenicity, and sensitivity testing on volunteers; and

• Assisting in compliance issues, including good manufacturing practices, recordkeeping, product recalls, and governmental inspection practices.