The Food and Drug Administration and the Federal Trade Commission have jointly requested that consumers report dietary supplements that “didn’t work as promised” or that are marketed with “unbelievable” claims. Consumers may call either FDA or FTC, and then the agencies will determine whether FDA or FTC should investigate. The agencies’ joint request follows the Government Accountability Office’s May 2017 report calling on FDA and FTC to inform consumers about their oversight of dietary supplements to curb marketing abuses.
FDA regulates claims on dietary supplement labeling and packaging, and monitors adverse reactions and content purity. FDA also takes enforcement action against manufacturers that make prescription drugs claims (i.e., claims that a product may diagnose, cure, mitigate, treat or prevent a disease). FDA’s enforcement options include warning letters, recalls, seizures, injunctions and civil penalties.
FTC oversees supplement claims in advertising, including print and broadcast advertisements. Product claims, even ones as basic as “natural” or “organic,” must have adequate substantiation. Several dietary supplement manufacturers have settled suits brought by FTC for more than $1 million for insufficient claim substantiation and have agreed to cease certain marketing claims.
But FDA and FTC are not the only ones watching marketing claims closely. State attorneys general may regulate dietary supplement marketing under their consumer protection laws and may impose civil penalties for statements that are deceptive, unfair or unlawful. Consumers are also scrutinizing marketing claims and have filed false advertising class actions. Both state attorneys general and consumers will look to FDA and FTC guidance and actions to bolster their claims that dietary supplement advertising does not have sufficient support.
Manufacturers should be aware that FDA, FTC, state attorneys general and consumers may view marketing claims differently and manufacturers may face different standards of proof if litigation is filed. It is, therefore, important to consider these various standards when developing potential marketing claims.
Barry Boise is a partner in Pepper Hamilton’s Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum. Jessica Rickabaugh is of counsel in the Health Sciences Department.
The material in this publication was created as of the date set forth above and is based on laws, court decisions, administrative rulings and congressional materials that existed at that time, and should not be construed as legal advice or legal opinions on specific facts. The information in this publication is not intended to create, and the transmission and receipt of it does not constitute, a lawyer-client relationship.