Food, Drug, Cosmetic, and Dietary Supplements

The most significant challenges facing advertisers in health, beauty, weight loss, and dietary supplement advertising is substantiation of health and performance claims. The attorneys at The Lustigman Firm represent companies facing regulatory investigations and litigation, competitor challenges or advertising litigation for food products, pharmaceuticals, cosmeceuticals, cosmetic and dietary supplements, "health" foods, and diet products.

Look for someone with experience. The Lustigman Firm focuses its legal practice on serving the needs of the advertising and promotions community. Contact The Lustigman Firm to talk directly to an advertising law attorney about your pharmaceutical, cosmetic, cosmeceutical, or dietary supplement advertising challenge.

Food and Drug Claims and the FDA

The First Amendment to the Constitution protects truthful advertising for lawful conduct. But the FDA has historically had almost unlimited discretion to make decisions on what it deemed to be the truth. In the past, the FDA would forbid marketers from including disease or health condition claims on products that did not have FDA approval.

After the Nutritional Labeling and Education Act of 1990, a marketer could include a disease or health claim on its label if it had pre-approval. But this led to legal challenges and, ultimately, to changes in the scope of FDA actions. U.S. courts have decided that the government cannot place an absolute ban on potentially misleading information if it can be presented in a way that is not deceptive. The court ruled that it is better to have more disclosure—disclaimers on packaging—than to suppress free speech.

Moreover, the Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted as a result of public debate concerning the importance of dietary supplements in promoting health, the need for consumers to have access to current and accurate information about supplements, and controversy over the FDA regulatory approach to dietary supplement products. While marketers are still limited to the types of claims that can be made for supplement products, and are required to possess adequate substantiation, DSHEA revolutionized the marketing and sale of dietary supplement products.

Changes on the Horizon for Advertisers of Health Products

Testimonials have long been a powerful advertising messages and inspirational motivator. The FTC has sought public comment on the use of testimonials and endorsements and the reporting of results obtained by the use of products. The proposed revisions to the FTC endorsement and testimonial guides, if implemented, will greatly impact advertising that uses testimonials to advertise health and diet products. (Learn more at our advertising law blog.)

At The Lustigman Firm, our lawyers are prepared to help clients strike the right balance in advertising and labeling and, when affected by excessive government regulation, to fight for the client's First Amendment rights. Lawyers from The Lustigman Firm provide:

• Legal counsel on relevant advertising and labeling regulations for drug, pharmaceutical, food, cosmetic, or dietary supplement products
• Review of labeling and packaging to help ensure compliance with relevant laws
• Legal representation before the FDA, U.S. Customs Service, and U.S. Postal Service in regulatory investigations and regulatory litigation
• Legal representation to resolve issues around product recalls or product seizures

Contact The Lustigman Firm at (212) 683-9180 to talk directly to an advertising law attorney. We represent clients in New York, New Jersey, throughout the United States and in Canada.

To learn more about claims substantiation

Publications

Marketing Law Basics

[PDF] Regulation of Dietary Supplement Advertising: Current Claims of Interest to the Federal Trade Commission, Food and Drug Administration and National Advertising Division, Food and Drug Law Journal, Co-authored by Andrew B. Lustigman, The Lustigman Firm, New York, NY