Food and Drug Regulation
Food and Drug Regulation
Kelley Drye provides food and drug industry clients with legal strategies that ensure compliance and mitigate liability risk throughout a product’s life cycle, building and preserving the value of the brand.

From premarket clearance requirements through manufacturing and marketing, our team brings a unique, wide-angled legal perspective to help clients achieve their business objectives for foods, functional foods, medical foods, dietary supplements, foods/feeds for pets and livestock, cosmetics, nonprescription drugs and devices, and other health products.

Kelley Drye’s food and drug team is experienced in the full spectrum of regulatory and legal risk management issues that food and drug companies must navigate to comply with Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Federal Trade Commission (FTC) requirements, and be successful in the U.S. marketplace.  We represent companies throughout product development and marketing, including all premarket clearance requirements for product safety, labeling, advertising and other marketing promotions.  We also represent companies in food and drug law matters concerning product manufacturing, distribution, supply chain management and import/export requirements.  In addition, our food and drug team represents companies in matters concerning defective products in the U.S. marketplace, including post-market adverse-event reporting obligations, recalls, investigations, warning letters and adverse publicity.  We defend companies when the safety, labeling or marketing of their products is challenged in cases brought by the government, competitors, or on behalf of consumers.

Our attorneys counsel throughout the full product life cycle, including at the following stages:

  • Launching New Products, Labeling and Marketing Claims–We provide strategic legal counsel to clients engaged in the development, introduction/import and marketing of products that are new to the U.S. market, including a wide range of food and beverage products (e.g., conventional and functional foods, medical foods, dietary supplements, foods/feeds for pets and livestock); cosmetics and other skincare products; consumer health products (e.g., nonprescription drugs and devices); and a wide range of medical and healthcare products, and other health products.  The Food and Drug Law team counsels manufacturers and importers on premarket clearance requirements and helps clients comply with federal and state product safety, consumer protection and import/export laws before products enter the marketplace, and ensures that product benefit claims are adequately substantiated by scientific research and other evidence.

  • Ensuring Regulatory Compliance and Managing Liability Risk–We provide strategic legal counsel to clients concerning regulatory requirements and enforcement policies of FDA, USDA, FTC and related state laws, equipping our clients to ensure that their products, labeling and marketing practices meet regulatory requirements and reflect sound liability risk management practices. We also develop and submit comments, propose regulatory policies and model legislation to federal agencies, on behalf of clients.

  • Defending and Challenging Product Safety, Labeling and Marketing Claims–We defend companies when product safety, quality, labeling or marketing claims are challenged by the FDA, USDA or FTC, by state governments in enforcement proceedings, or in Congressional investigations.  We also defend companies when the safety, quality, labeling or marketing claims for their products are challenged in private lawsuits, including those brought by competitors and on behalf of consumers.  We have substantial experience defending clients in cases presenting significant First Amendment and Federal Preemption issues.  Additionally, we help clients defend their product brands and markets by challenging the unlawful products and deceptive marketing products of their competitors, including both domestic and international competitors.  We initiate competitor challenges on behalf of our clients through litigation, regulatory and legislative initiatives.

  • Recalling Unlawful Products, Postmarket Reporting and Crisis Management–We advise clients on regulatory compliance and liability risk management matters arising after products have entered the U.S. market, including recalls of unsafe or mislabeled products, and post-market adverse-event reporting obligations (e.g., the Reportable Food Registry, Medwatch Reports, etc.).  We counsel clients concerning the development of effective regulatory compliance, product recall, post-market reporting, and crisis prevention and management plans. We mobilize the range of legal, scientific and technical resources that clients need to respond effectively when products in the marketplace are unsafe, mislabeled or may be otherwise defective.


Kelley Drye’s Food and Drug team coordinates with lawyers specializing in complementary areas of the firm’s practice, including Advertising and Marketing Law, Litigation, Product Liability, International Trade, Government Relations and Public Policy, Insurance Recovery, Environmental, Intellectual Property and White Collar Crime and Investigations.

Launching New Products, Labeling and Marketing Claims

  • Advised manufacturers and marketers of cosmetics, nonprescription drugs and medical device products concerning FDA, FTC and state law standards governing product labeling and health-related claims.

  • Advised food and dietary supplement manufacturers concerning standards and procedures governing product safety under federal and state food and drug laws, including with respect to GRAS substances, food additives, food contact substances, color additives, new dietary ingredients, cGMP and HACCP programs.

  • Advised manufacturers, importers and marketers of medical device products with respect to FDA premarket clearance requirements, including 510(k) notifications.

  • Developed “best practices” guidance concerning the premarket review of product benefit claims and substantiation.

  • Advised importers of food, dietary supplements and consumer health products concerning FDA requirements and enforcement policies concerning imported products.

  • Advised manufacturers concerning FDA requirements governing exports of food and drug products that do not comply with U.S. product safety and labeling requirements.

  • Developed successful health claim petition resulting in FDA approval of claims concerning walnut consumption and the reduced risk of heart disease.

  • Developed successful Food and Drug Administration Modernization Act (FDAMA) notification to the FDA authorizing a health claim concerning fluoridated bottled water and the reduced risk of dental cavities.

  • Developed proposed marketing claim strategies and claim language based on weight of the evidence, substantiation analyses concerning diet/health benefit relationships relating to particular food and beverage products, nutrients and U.S. dietary consumption patterns.

  • Advised food and dietary supplement manufacturers concerning the design of “cyber-libraries” and other websites providing scientific research and health information relating to products, dietary ingredients and other components.

  • Advised food and beverage companies concerning the communications with health professionals concerning emerging scientific evidence supporting diet/health benefits and distribution of product samples.

  • Coordinated evaluations of the premarket approval, labeling and recall requirements of several countries in Europe and Asia, and advised food and dietary supplement ingredient manufacturers on product launch and recall matters.

Ensuring Regulatory Compliance and Managing Liability Risk

  • Advised companies that manufacture, import and market food, beverage, dietary supplement, cosmetic, nonprescription drug and other consumer health products concerning the FDA and FTC requirements and related state law requirements.

  • Conducted regulatory compliance due diligence assessments and prepared reports making findings and recommendations.

  • Developed and coordinated multidisciplinary regulatory and legislative strategy on behalf of a food company to support FDA and USDA enforcement of food ingredient safety and labeling standards applicable to meat products.

  • Advised an association of the world’s leading food, beverage and consumer products companies on a variety of food and beverage marketing matters, including industry self-regulation and advertising practices directed toward children in the United States and around the world.

  • Counseled a producer of weight-control products on all aspects of their food product advertising and marketing programs, including with respect to celebrity endorsements, testimonials, weight loss claims, and requirements of FDA, FTC and state consumer protection laws.

  • Conducted regulatory due diligence evaluations establishing that a leading U.S. bakery products manufacturer's compliance program satisfied FDA’s Bioterrorism Act requirements.

  • Developed model FDA regulations, guidance and enforcement policies on behalf of companies and industry trade organizations.

  • Proposed model regulations and enforcement policies in submissions made to the FDA, USDA and Congress on behalf of companies and industry trade organizations.

  • Developed model amendments to the Federal Food, Drug and Cosmetic Act and model Appropriations and Farm Bill provisions concerning food products on behalf of client companies and industry trade organizations.

  • Developed submissions to the Institute of Medicine (IOM) documenting food marketing practices concerning children and youth on behalf of an industry organization in conjunction with an IOM study evaluating food marketing practices in the context of U.S. obesity prevention objectives.

  • Developed submissions to the FTC, documenting food marketing practices concerning children and youth on behalf of a food manufacturer in conjunction with an FTC study investigating industry marketing practices and expenditures.

Defending and Challenging Product Safety, Labeling and Marketing Claims

  • Successfully defended food manufacturers in lawsuits brought by competitors alleging that product marketing claims violate federal and state laws.

  • Successfully defended product labeling on statutory and First Amendment grounds in submissions made to the FDA on behalf of product manufacturers in enforcement proceedings.

  • Submitted a successful complaint to the FDA on behalf of a food manufacturer challenging the unlawful marketing practices of a competitor.

  • Successfully defended substantiation supporting nutrition and health-related benefit claims for various food products in response to inquiries from the FTC and USDA on behalf of product manufacturers.

  • Prepared responses to FDA warning letters and inspection reports.

  • Prepared responses to advertising substantiation challenges on behalf of major pharmaceutical and personal care products brands.

  • Represented pharmaceutical companies in cases alleging consumer fraud, unfair trade practices and fraudulent price reporting and marketing in the pharmaceutical industry.

  • Successfully defended a beverage marketer in an FTC investigation concerning substantiation support for advertising claims promoting beverage consumption benefits in promoting cardiovascular health and wellness.

  • Successfully defended a leading quick service restaurant’s launch of its new food product in a false advertising lawsuit brought by a competitor challenging the company’s ingredient claim.

  • Defended allegations brought by a quick service restaurant regarding our client’s advertisements before the NAD.

  • Successfully challenged ads before the NAD implying that a quick service restaurant’s hamburgers contained substantially more meat than our client's.

  • Successfully defended a dietary supplement manufacturer against a number of consecutive claim substantiation challenges initiated by competitors before the NAD regarding advertising for weight loss, dietary and other nutritional supplement products.

  • Successfully represented a nutritional supplement manufacturer in false advertising litigation challenging a former U.S. distributor.

  • Represented a national marketer of nutritional supplements in litigation filed by the Department of Justice alleging violations of a prior FTC order.

  • Advised OTC unit of major pharmaceutical company in response to challenge to company’s “natural” claim for a key product initiated by competitor.

  • Assisted in-house counsel of major OTC drug company in negotiating successful resolution of advertising dispute with major competitor in antacid market.

  • Successfully represented an OTC drug company in a packaging and false advertising case involving laxatives.

  • Represented two drug companies in litigation involving product safety claims that a pharmaceutical product caused bodily injury.

  • Defended allegations brought by a pharmaceutical company regarding advertising for our client’s smoking cessation product.

  • Conducted an internal investigation for a Fortune 500 pharmaceutical company in an FDA/Customs case of illegal importation of misbranded antibiotics into the United States.  Represented the client in a grand jury investigation.

Recalling Unlawful Products, Post-market Reporting and Crisis Management

  • Advised food, dietary supplement, pet food, cosmetic and medical product companies concerning legal standards governing product recalls and related liability risk mitigation considerations.

  • Advised food, dietary supplement and health/medical products companies concerning FDA postmarket reporting requirements (e.g., Reportable Food Registry, Medwatch, etc.).

  • Conducted presentations and training programs for client companies concerning FDA, USDA and FTC regulations, enforcement matters and related liability/risk management issues, including programs designed for legal, marketing and science/regulatory executives.
 
 

Overview

Kelley Drye provides food and drug industry clients with legal strategies that ensure compliance and mitigate liability risk throughout a product’s life cycle, building and preserving the value of the brand.

From premarket clearance requirements through manufacturing and marketing, our team brings a unique, wide-angled legal perspective to help clients achieve their business objectives for foods, functional foods, medical foods, dietary supplements, foods/feeds for pets and livestock, cosmetics, nonprescription drugs and devices, and other health products.

Kelley Drye’s food and drug team is experienced in the full spectrum of regulatory and legal risk management issues that food and drug companies must navigate to comply with Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Federal Trade Commission (FTC) requirements, and be successful in the U.S. marketplace.  We represent companies throughout product development and marketing, including all premarket clearance requirements for product safety, labeling, advertising and other marketing promotions.  We also represent companies in food and drug law matters concerning product manufacturing, distribution, supply chain management and import/export requirements.  In addition, our food and drug team represents companies in matters concerning defective products in the U.S. marketplace, including post-market adverse-event reporting obligations, recalls, investigations, warning letters and adverse publicity.  We defend companies when the safety, labeling or marketing of their products is challenged in cases brought by the government, competitors, or on behalf of consumers.

Our attorneys counsel throughout the full product life cycle, including at the following stages:

  • Launching New Products, Labeling and Marketing Claims–We provide strategic legal counsel to clients engaged in the development, introduction/import and marketing of products that are new to the U.S. market, including a wide range of food and beverage products (e.g., conventional and functional foods, medical foods, dietary supplements, foods/feeds for pets and livestock); cosmetics and other skincare products; consumer health products (e.g., nonprescription drugs and devices); and a wide range of medical and healthcare products, and other health products.  The Food and Drug Law team counsels manufacturers and importers on premarket clearance requirements and helps clients comply with federal and state product safety, consumer protection and import/export laws before products enter the marketplace, and ensures that product benefit claims are adequately substantiated by scientific research and other evidence.

  • Ensuring Regulatory Compliance and Managing Liability Risk–We provide strategic legal counsel to clients concerning regulatory requirements and enforcement policies of FDA, USDA, FTC and related state laws, equipping our clients to ensure that their products, labeling and marketing practices meet regulatory requirements and reflect sound liability risk management practices. We also develop and submit comments, propose regulatory policies and model legislation to federal agencies, on behalf of clients.

  • Defending and Challenging Product Safety, Labeling and Marketing Claims–We defend companies when product safety, quality, labeling or marketing claims are challenged by the FDA, USDA or FTC, by state governments in enforcement proceedings, or in Congressional investigations.  We also defend companies when the safety, quality, labeling or marketing claims for their products are challenged in private lawsuits, including those brought by competitors and on behalf of consumers.  We have substantial experience defending clients in cases presenting significant First Amendment and Federal Preemption issues.  Additionally, we help clients defend their product brands and markets by challenging the unlawful products and deceptive marketing products of their competitors, including both domestic and international competitors.  We initiate competitor challenges on behalf of our clients through litigation, regulatory and legislative initiatives.

  • Recalling Unlawful Products, Postmarket Reporting and Crisis Management–We advise clients on regulatory compliance and liability risk management matters arising after products have entered the U.S. market, including recalls of unsafe or mislabeled products, and post-market adverse-event reporting obligations (e.g., the Reportable Food Registry, Medwatch Reports, etc.).  We counsel clients concerning the development of effective regulatory compliance, product recall, post-market reporting, and crisis prevention and management plans. We mobilize the range of legal, scientific and technical resources that clients need to respond effectively when products in the marketplace are unsafe, mislabeled or may be otherwise defective.


Kelley Drye’s Food and Drug team coordinates with lawyers specializing in complementary areas of the firm’s practice, including Advertising and Marketing Law, Litigation, Product Liability, International Trade, Government Relations and Public Policy, Insurance Recovery, Environmental, Intellectual Property and White Collar Crime and Investigations.

Experience

Launching New Products, Labeling and Marketing Claims

  • Advised manufacturers and marketers of cosmetics, nonprescription drugs and medical device products concerning FDA, FTC and state law standards governing product labeling and health-related claims.

  • Advised food and dietary supplement manufacturers concerning standards and procedures governing product safety under federal and state food and drug laws, including with respect to GRAS substances, food additives, food contact substances, color additives, new dietary ingredients, cGMP and HACCP programs.

  • Advised manufacturers, importers and marketers of medical device products with respect to FDA premarket clearance requirements, including 510(k) notifications.

  • Developed “best practices” guidance concerning the premarket review of product benefit claims and substantiation.

  • Advised importers of food, dietary supplements and consumer health products concerning FDA requirements and enforcement policies concerning imported products.

  • Advised manufacturers concerning FDA requirements governing exports of food and drug products that do not comply with U.S. product safety and labeling requirements.

  • Developed successful health claim petition resulting in FDA approval of claims concerning walnut consumption and the reduced risk of heart disease.

  • Developed successful Food and Drug Administration Modernization Act (FDAMA) notification to the FDA authorizing a health claim concerning fluoridated bottled water and the reduced risk of dental cavities.

  • Developed proposed marketing claim strategies and claim language based on weight of the evidence, substantiation analyses concerning diet/health benefit relationships relating to particular food and beverage products, nutrients and U.S. dietary consumption patterns.

  • Advised food and dietary supplement manufacturers concerning the design of “cyber-libraries” and other websites providing scientific research and health information relating to products, dietary ingredients and other components.

  • Advised food and beverage companies concerning the communications with health professionals concerning emerging scientific evidence supporting diet/health benefits and distribution of product samples.

  • Coordinated evaluations of the premarket approval, labeling and recall requirements of several countries in Europe and Asia, and advised food and dietary supplement ingredient manufacturers on product launch and recall matters.

Ensuring Regulatory Compliance and Managing Liability Risk

  • Advised companies that manufacture, import and market food, beverage, dietary supplement, cosmetic, nonprescription drug and other consumer health products concerning the FDA and FTC requirements and related state law requirements.

  • Conducted regulatory compliance due diligence assessments and prepared reports making findings and recommendations.

  • Developed and coordinated multidisciplinary regulatory and legislative strategy on behalf of a food company to support FDA and USDA enforcement of food ingredient safety and labeling standards applicable to meat products.

  • Advised an association of the world’s leading food, beverage and consumer products companies on a variety of food and beverage marketing matters, including industry self-regulation and advertising practices directed toward children in the United States and around the world.

  • Counseled a producer of weight-control products on all aspects of their food product advertising and marketing programs, including with respect to celebrity endorsements, testimonials, weight loss claims, and requirements of FDA, FTC and state consumer protection laws.

  • Conducted regulatory due diligence evaluations establishing that a leading U.S. bakery products manufacturer's compliance program satisfied FDA’s Bioterrorism Act requirements.

  • Developed model FDA regulations, guidance and enforcement policies on behalf of companies and industry trade organizations.

  • Proposed model regulations and enforcement policies in submissions made to the FDA, USDA and Congress on behalf of companies and industry trade organizations.

  • Developed model amendments to the Federal Food, Drug and Cosmetic Act and model Appropriations and Farm Bill provisions concerning food products on behalf of client companies and industry trade organizations.

  • Developed submissions to the Institute of Medicine (IOM) documenting food marketing practices concerning children and youth on behalf of an industry organization in conjunction with an IOM study evaluating food marketing practices in the context of U.S. obesity prevention objectives.

  • Developed submissions to the FTC, documenting food marketing practices concerning children and youth on behalf of a food manufacturer in conjunction with an FTC study investigating industry marketing practices and expenditures.

Defending and Challenging Product Safety, Labeling and Marketing Claims

  • Successfully defended food manufacturers in lawsuits brought by competitors alleging that product marketing claims violate federal and state laws.

  • Successfully defended product labeling on statutory and First Amendment grounds in submissions made to the FDA on behalf of product manufacturers in enforcement proceedings.

  • Submitted a successful complaint to the FDA on behalf of a food manufacturer challenging the unlawful marketing practices of a competitor.

  • Successfully defended substantiation supporting nutrition and health-related benefit claims for various food products in response to inquiries from the FTC and USDA on behalf of product manufacturers.

  • Prepared responses to FDA warning letters and inspection reports.

  • Prepared responses to advertising substantiation challenges on behalf of major pharmaceutical and personal care products brands.

  • Represented pharmaceutical companies in cases alleging consumer fraud, unfair trade practices and fraudulent price reporting and marketing in the pharmaceutical industry.

  • Successfully defended a beverage marketer in an FTC investigation concerning substantiation support for advertising claims promoting beverage consumption benefits in promoting cardiovascular health and wellness.

  • Successfully defended a leading quick service restaurant’s launch of its new food product in a false advertising lawsuit brought by a competitor challenging the company’s ingredient claim.

  • Defended allegations brought by a quick service restaurant regarding our client’s advertisements before the NAD.

  • Successfully challenged ads before the NAD implying that a quick service restaurant’s hamburgers contained substantially more meat than our client's.

  • Successfully defended a dietary supplement manufacturer against a number of consecutive claim substantiation challenges initiated by competitors before the NAD regarding advertising for weight loss, dietary and other nutritional supplement products.

  • Successfully represented a nutritional supplement manufacturer in false advertising litigation challenging a former U.S. distributor.

  • Represented a national marketer of nutritional supplements in litigation filed by the Department of Justice alleging violations of a prior FTC order.

  • Advised OTC unit of major pharmaceutical company in response to challenge to company’s “natural” claim for a key product initiated by competitor.

  • Assisted in-house counsel of major OTC drug company in negotiating successful resolution of advertising dispute with major competitor in antacid market.

  • Successfully represented an OTC drug company in a packaging and false advertising case involving laxatives.

  • Represented two drug companies in litigation involving product safety claims that a pharmaceutical product caused bodily injury.

  • Defended allegations brought by a pharmaceutical company regarding advertising for our client’s smoking cessation product.

  • Conducted an internal investigation for a Fortune 500 pharmaceutical company in an FDA/Customs case of illegal importation of misbranded antibiotics into the United States.  Represented the client in a grand jury investigation.

Recalling Unlawful Products, Post-market Reporting and Crisis Management

  • Advised food, dietary supplement, pet food, cosmetic and medical product companies concerning legal standards governing product recalls and related liability risk mitigation considerations.

  • Advised food, dietary supplement and health/medical products companies concerning FDA postmarket reporting requirements (e.g., Reportable Food Registry, Medwatch, etc.).

  • Conducted presentations and training programs for client companies concerning FDA, USDA and FTC regulations, enforcement matters and related liability/risk management issues, including programs designed for legal, marketing and science/regulatory executives.
Partner
Email (202) 342-8582(202) 342-8582
Sarah Roller, J.D., R.D., M.P.H., is a partner in the firm’s Washington, D.C. office and chair of the Food and Drug Law practice.  She focuses her practice on the representation of U.S....
Partner
Email (202) 342-8456(202) 342-8456
Mike maintains a 30-year track record of obtaining relief for his clients from unfair foreign trade practices that threaten their existence. Mike has handled many U.S. antidumping (AD) and (C...
Partner
Email (202) 342-8811(202) 342-8811
Bill MacLeod chairs the firm’s Antitrust and Competition practice group.  The Immediate Past Chair of the Antitrust Section of the American Bar Association, Bill is a former bureau...
Partner
Email (202) 342-8821(202) 342-8821
Lew Rose serves as managing partner of Kelley Drye, and is a member of the firm’s Executive Committee. Lew also served as managing partner of the Washington, D.C. office and past chair ...
Partner
Email (202) 342-8588(202) 342-8588
Dana Rosenfeld chairs the firm’s Privacy and Information Security practice.  A former assistant director of the Federal Trade Commission (FTC) Bureau of Consumer Protection and attorney...
Partner
Email (202) 342-8485(202) 342-8485
Paul Rosenthal co-chairs the firm’s Government Relations and Public Policy practice.  Paul is a member of the firm’s executive committee, and previously served as managing partner ...
Partner
Email (202) 342-8423(202) 342-8423
A member of the firm’s Executive Committee, John Villafranco provides litigation and counseling services, with a focus on advertising law matters and consumer protection. John is highly resp...
Partner
Email (202) 342-8805(202) 342-8805
Kristi Wolff’s practice focuses on food, drugs, dietary supplements, medical devices, personal care and consumer health products, as well as wearable technology and health privacy issues.&nb...
Of Counsel
Email (202) 342-8646 (202) 342-8646
Jodie Bernstein is of counsel in the firm’s Washington, D.C. office. She is widely respected among consumer groups, industry organizations and the private bar as one the country’s leadi...
Of Counsel
Email (202) 342-8514(202) 342-8514
John Wittenborn focuses his practice on environmental and energy regulatory and litigation matters at the federal and state levels, and throughout the United States.  John has more than three...
Director of Government Relations
Email (202) 342-8608(202) 342-8608
Dana Wood co-chairs the firm’s Government Relations and Public Policy group.  Dana has been a public policy advocate for more than three decades, representing client interests before Co...
Special Counsel
Email (202) 342-8537(202) 342-8537
Katie Bond provides regulatory counseling and litigation support in matters involving a variety of consumer products, including dietary supplements, foods, OTC drug products, cosmetics and sports e...
Senior Associate
Email (202) 342-8461(202) 342-8461
Elisa Nemiroff is a senior associate in the firm's Washington, D.C. office. Her practice focuses on counseling clients regarding all elements of advertising and promoting their brands, product...
Senior Associate
Email (202) 342-8455(202) 342-8455
Katie Rogers advises on general advertising and consumer protection matters, with an emphasis on food marketing and environmental marketing issues.  She reviews product labeling and advertisin...
Associate
Email (202) 342-8645(202) 342-8645
Donnelly McDowell is an associate in the firm’s Washington, D.C. office. Donnelly’s practice focuses on advertising and marketing, food and drug law, consumer financial protection matt...

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