Food and Drug

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.