Dietary supplement compliance is a complex matter, requiring broad vetting of not only packaging but also all advertising and marketing materials. Unfortunately, many manufacturers and distributors still leave themselves open to legal risk. All too often, they focus on Food and Drug Administration (FDA) requirements and miss a crucial step in dietary supplement compliance, namely adhering to Federal Trade Commission (FTC) requirements.
FDA vs FTC. While both the FDA and FTC have authority over marketing dietary supplements, they have distinctly different legal responsibilities. The two agencies work together to determine which one or both would pursue government investigation of a dietary supplement that makes dubious or not fully supported claims. The FDA primarily looks at packaging, labeling, content, purity, and safety. Many manufacturers of dietary supplements focus primarily on the required disclaimers for labeling pursuant to the Dietary Supplement Health and Education Act of 1994. One of the well-known disclaimers is: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
The FTC, however, has authority to go beyond the package and examine the truth and accuracy of all dietary supplements’ advertising and marketing material. Thus, all radio, tv, print, Internet, and social media campaigns must comply with Section 5 of the FTC Act. All claims must be truthful, not misleading, and substantiated. The FTC offers detailed guidance in its document, “Dietary Supplements: An Advertising Guide for Industry.”
Examples of Enforcement Actions. Using unsubstantiated claims can have dramatic and costly results. In 2014, the FTC ordered Sensa’s marketers to pay more than $26 Million in redress to consumers who bought the supplement. The marketers, according to the FTC, had deceptively advertised that consumers could “sprinkle, eat, and lose weight” simply by using Sensa. In 2016, the FTC settled with the sellers of Supple, a glucosamine and chondroitin liquid settlement. The FTC alleged that the Supple sellers had falsely advertised the products’ ability to provide complete relief from arthritis and fibromyalgia joint pain. Part of the settlement included a $150 Million judgment.
The FTC is not the only player in town. The Council for Responsible Nutrition works collaboratively with the National Advertising Division of the Better Business Bureau (NAD) to ensure dietary supplement compliance with Section 5 standards. The NAD has investigated supplements over and over, recommending that sellers revise their advertising claims if they do not have sufficient clinical evidence. If a dietary supplement marketer does not comply with the NAD’s guidance, the NAD is likely to turn the matter over to the FTC.
Legal Vetting Best Practices. Health marketers should be aware of the following dietary supplement compliance considerations:
* When creating marketing and advertising for a dietary supplement, let qualified legal counsel vet your materials for FTC and FDA compliance.
* Remember that both implied and express claims must meet the legal standards for commercial speech.
* Your clinical evidence requires careful legal analysis based on the advertising claims. It may not be sufficient to support your marketing claims if it does not match typical consumer experience or does not follow certain scientific standards.
* The FTC also often finds problems with consumer testimonials and expert or celebrity endorsements. Your marketers should ensure they fully understand the FTC’s requirements in these areas.
If you are a manufacturer, distributor, or marketer of dietary supplements and want to know more about legal requirements for advertising and selling these products, please contact Kyle-Beth Hilfer, Esq.