Kelley Drye

Practices 

Contact Information

John E. Villafranco
Partner

Email
Washington, D.C.
Phone: (202) 342-8423
Fax: (202) 342-8451

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Dietary Supplements and Functional Foods

Dietary Supplement Industry Self-Regulation

How the National Advertising Division is helping discontinue claims that don’t meet truthfulness standards.

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With the increasing collaboration between Federal Drug Administration (FDA) and the Federal Trade Commission (FTC), there is a notable shift in the regulatory and enforcement policies that underscores the importance of the overlapping jurisdiction of the two agencies. Kelley Drye provides strategic legal counsel to companies engaged in the development, launch, and marketing of new dietary supplement and functional food products, equipping our clients to ensure that their products, labeling, and marketing practices satisfy FDA, FTC, and related state law requirements.

Our attorneys help clients develop dietary supplements and functional foods through the full product life cycle, navigating product safety obligations set forth under the Federal Food, Drug, and Cosmetic Act (FDCA) and laws prohibiting "unfair or deceptive acts or practices" under the FTC Act.  We conduct reviews and provide counsel to ensure that supplement advertisements and marketing materials are truthful, not misleading, and substantiated, and that companies have the competent and reliable scientific evidence required for health-related efficacy and safety claims.  In the event of an adverse event, government investigation, competitor challenge, or consumer class action, the Kelley Drye team designs legal strategies that achieve the best possible outcomes for our clients and preserves the value of their brands.

Representative Experience

  • Defended a dietary supplement manufacturer and retailer in several matters involving the advertising and labeling of weight loss dietary and other nutritional supplement products. Defended allegations of false advertising brought by competitors and regulators, including several investigations from District Attorneys in California and other states.

  • Served as counsel for a dietary supplement manufacturer in more than 20 consumer class action lawsuits alleging false advertising, product liability, and breach of express and implied warranties concerning the packaging, promotion, and marketing of the client's weight loss product.

  • Defeated motion for a preliminary injunction in a purported class action challenging a dietary supplement's advertising claims. Plaintiffs sought to enjoin the company's allegedly false advertising for the product throughout California, arguing that the advertising representations were false and deceptive, and violated the State's "baby FTC Act."

  • Defended the maker of dietary supplement products in a false advertising lawsuit brought in the U.S. Eastern District Court of New York. The jury unanimously found that our client's statement used on wholesalers' and retailers' store brand packaging for joint care products, which invites consumers to compare the products to a competitor's products, is not false and misleading and does not violate Section 43 of the Lanham Act.

  • Represented a subsidiary of the world's largest food and nutrition company in the FTC's first case challenging advertising for probiotics. Successfully negotiated a settlement for the case, which alleged deceptive advertising claims about the health benefits of a children's nutrition drink.

  • Represented a national pharmacy chain in a settlement with the FTC regarding advertisements for a line of cold-and-flu treatment dietary supplements. The FTC's allegations related to alleged unsubstantiated health claims involving cold and flu prevention and immune boosting.

  • On behalf of a national pharmacy chain, review current product advertising for food, over-the-counter drugs, and dietary supplements for compliance with FTC and FDA requirements.

  • Advise a supermarket chain regarding permissible private label functional food claims.

  • Advise a subsidiary of a global food company about functional claims for baby foods.

  • Conduct due diligence on potential acquisitions of nutritional supplement companies.

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

  • 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.

  • Defended a maker of dietary supplements in an NAD challenge regarding substantiation of performance, exclusivity, establishment and expert endorsement claims made in advertising a sleep formula. The NAD's Electronic Retailing Self-Regulation Program (ERSP) determined that our client had substantiated claims and recommended one minor modification.

  • Defended the maker of dietary supplements in a challenge brought by a competitor regarding substantiation of establishment, performance and comparative claims. The ERSP determined that our client provided reasonable basis for performance claims.

  • Challenged the maker of a dietary supplement on the substantiation of product performance, exclusivity and testimonial claims in advertising. The ERSP recommended that they modify diet/beauty pill advertising claims.

  • Challenged a competitor, initiated by our client, the maker of dietary supplement products. The basis of inquiry was substantiation of establishment, performance, comparative and testimonial claims in advertising. The competitor voluntarily discontinued advertising and was advised about future efforts.

  • Challenged the truth and accuracy of a dietary supplement manufacturer's comparative pricing claims related to a vitamin supplement. The NAD recommended that the competitor discontinue these claims and modify pricing structure to comply with FTC regulations.

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

  • Advised dietary supplement manufacturers concerning standards and procedures governing product safety under federal and state food and drug laws, including with respect to New Dietary Ingredients, "old" dietary ingredients, and cGMPs.

  • Counseled a producer of weight-control products on all aspects of their 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.

  • Developed "best practices" guidance concerning the premarket review of dietary supplement product benefit claims and substantiation.

  • Advised importers of dietary supplements concerning FDA import requirements and enforcement procedures.

  • Coordinated evaluations of the premarket approval, labeling and recall requirements of several countries in Europe and Asia for dietary supplement ingredient manufacturers.

  • Advised dietary supplement manufacturers and distributors concerning FDA standards governing product recalls and related communications with FDA and the public.

  • Advised dietary supplement companies concerning FDA postmarket reporting requirements (e.g., Medwatch, etc.).

  • Conducted educational programs for dietary supplement companies concerning FDA and FTC requirements, enforcement trends and related liability risk management issues, including programs designed for legal, marketing and science/regulatory executives.

  • Conducted regulatory due diligence to evaluate compliance of dietary supplement and functional food products with FDA, FTC, and related state law requirements.
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December 2013

Food and Consumer Health Product Claims Substantiation: A Comprehensive Guide

Food and Drug Law Institute Resources

Additional Resources