Home Home About Us Practice Areas Our Attorneys Press & Publications Events Diversity Pro-Bono Careers
FOLLOW US:

Advertising, Marketing & Promotions:
5th Edition: Trends in Marketing Communications Law

FDA: Food & Dietary Supplements >> Regulatory and Class Action Claims Against "Healthy" and "Natural" Food and Dietary Supplement Products on the Rise

May 24, 2018

The U.S. Food and Drug Administration (FDA) and class action bar are continuing to pursue enforcement and litigation against food and dietary supplement manufacturers who make drug claims, and in 2017, paid particular attention to products purported to have "anti-inflammatory" effects or to "treat" or “cure” cancer. Class action attorneys have been keeping a steady eye on and drawing from the FDA’s warning letters when deciding to bring class action claims, and as a result, FDA enforcement actions and consumer class action claims have seemingly followed the other.

The Federal Trade Commission (FTC) also continues to actively pursue cases against dietary supplement manufacturers that make unsubstantiated claims about their products. In 2017, the FTC imposed a $6.57 million judgment against a dietary supplement company and its advertising agency, in part for making unsubstantiated claims that the dietary supplement would reverse mental decline and reduce joint and back pain, inflammation and stiffness in as little as two hours. As part of the settlement, the dietary supplement company and its advertising agency are barred from making false or unsubstantiated health claims and are required to have competent and reliable scientific evidence to support their claims.

In 2018, FDA Commissioner Scott Gottlieb indicated that the FDA is expected to issue long-awaited guidance on the definition of "natural" and revise the definition of the term "healthy." The FDA requested public comment on the use of both terms, and the comment periods ended in 2016 and 2017, respectively. While the FDA has yet to take action on the comments, class action cases against products advertised as "natural" and "healthy" continue to be brought against companies with mixed results. Certain courts have stayed consumer class action cases against “natural” products on primary jurisdiction grounds while awaiting a decision from FDA on the definition, while other courts have allowed such cases to proceed.

Key Takeaways:

  • "Natural" and "healthy" claims should be reviewed carefully in light of a lack of guidance from the FDA and continued oversight from the class action bar.
  • Manufacturers and marketers of food and dietary supplements should review product claims on their packaging, websites and other advertising to ensure compliance with FDA regulations and review claims through a conservative lens.
  • Manufacturers and marketers of food and dietary supplements should ensure they have competent and reliable scientific evidence to support their product claims.