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:
- 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."
- 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.
- 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?