Companies marketing functional foods or dietary supplements should be aware of the Federal Trade Commission’s new regime for using health-related advertising claims and the Food and Drug Administration’s heightened scrutiny of health-related front-of-package (FOP) labeling claims.

In two game-changing settlement orders, issued in July of this year, the FTC, for the first time, required that the companies under order (1) possess two clinical trials for weight loss claims and certain disease claims, (2) have FDA approval for most other disease claims, and (3) follow a new standard for relying on ingredient testing as claim substantiation. The FTC has indicated that it intends to include similar requirements in its future food and supplement orders, suggesting that these new standards soon could set the bar for all companies, regardless of whether they are under order or not.

Similarly, FDA has issued a series of warning letters challenging the use of nutrient content claims, health claims, and other health benefit claims in food and beverage product labeling. Recent FDA warning letters challenge a number of claims appearing on the principal display panel of food and beverage product labels, underscoring the agency’s enforcement and policy development priorities concerning the standards governing FOP labeling systems.

Kelley Drye's Advertising and Marketing practice group has prepared several articles to help companies navigate the new terrain successfully:

With increasing enforcement and litigation activity, food and supplement companies should stay informed about government scrutiny of health-related claims and the standards for competent and reliable scientific evidence.