3 ways supplement makers land behind bars

Dietary supplements are a focus of the Department of Justice, and three categories of cases stand out most, according to the director of the DOJ's Consumer Protection branch.

Ivan Wasserman, Partner

December 9, 2014

2 Min Read
3 ways supplement makers land behind bars

On Dec. 8, I attended the Food and Drug Law Institute's Enforcement, Litigation and Compliance Conference in Washington, D.C.,  which included a panel titled, "Criminal Enforcement in Foods, Cosmetics, and Dietary Supplements." During that session, Michael Blume, director  of the Consumer Protection branch of the U.S. Department of Justice, discussed the government's focus on prosecution of individuals.

When asked to comment about criminal prosecutions related to dietary supplements, Blume responded that dietary supplements are a focus of DOJ. While there are others, he noted that three categories of cases stood out as most often being of interest to DOJ:

  1. Spiked supplements. This is, in Blume's words: "When a product claims to have an organic ingredient from some type of tree, but in reality the product contains generic Viagra causing it to be effective."

  2. Receiving multiple FDA warning letters. While a warning letter has never been something that should be ignored, with the threat of criminal prosecution increasing, it is more important than ever to take them very seriously and to adequately address any problems they identify.

  3. Consumer injury. Blume explained that when there are a lot of consumer injuries traced to a product, whether it be a supplement, food, drug or consumer product, DOJ will spend a lot of resources investigating to determine if there should be prosecutions.

Blume also stressed that once an investigation starts, it will not be limited to violations of the Food, Drug and Cosmetic Act, and often prosecutions are based on fraud and other criminal acts.

While none of this should be surprising, it is important to remember that product recalls, warning letters and even injunctions are not necessarily the end of the story for distributing adulterated, misbranded or otherwise dangerous supplements. In fact, in certain circumstances, individuals may end up in jail.  

Will botanicals make a difference?
How has the DOJ's direction in 2014 affected your supplement business or retail sales?

About the Author(s)

Ivan Wasserman

Partner, Amin Talati Upadhye

Ivan Wasserman is one of the nation’s premier attorneys for health, wellness, beauty and other consumer products. Companies of all sizes making, marketing and selling food, dietary supplements, cosmetics, over-the-counter drugs and medical devices praise the depth of his knowledge and experience, his humor and his ability to maintain the human perspective while leading them through this heavily regulated landscape. Frequently cited by the media as a legal authority, Ivan helps his clients launch products and create and execute advertising campaigns that match the clinical evidence they have for their products, paying close attention to the changing rules governing internet marketing, consumer testimonials and social media.

Ivan advocates for clients subject to the often overlapping jurisdictions of the U.S. Food and Drug Administration, the Federal Trade Commission,  and the U.S. Consumer Product Safety Commission.   When advertising disputes arise, he regularly represents companies before the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP). He has been included in Best Lawyers in America from 2007 – 2017.

Subscribe and receive the latest updates on trends, data, events and more.
Join 57,000+ members of the natural products community.

You May Also Like