On November 17, the Department of Justice (DOJ) issued a press release announcing that it and other federal agencies have slapped more than 100 makers and marketers of dietary supplements with civil and criminal cases over the last year. The press release highlighted a criminal indictment that was recently unsealed in which the DOJ accused a supplement manufacturer and many of its officers of violating the Food, Drug, and Cosmetic Act (FDCA) as well as committing federal wire fraud, obstruction, and conspiracy. According to the indictment, the defendants allegedly made false statements to the public and the FDA about certain imported ingredients, used falsified certificates of analysis for phony “plant-based” ingredients manufactured by Chinese chemical suppliers, and surreptitiously continued distributing a dietary supplement, even after learning that it could lead to serious liver damage.
Although the criminal indictment represents an extreme set of alleged facts, the DOJ’s press release sends a strong message that the agency intends to sweep far and wide. In addition to featuring a criminal prosecution, the press release also highlights civil actions brought by the DOJ and Federal Trade Commission (FTC) involving the FDA, the Department of Defense, the Internal Revenue Service, the US Postal Inspection Service, and the US Anti-Doping Agency. Many civil cases filed by the DOJ and FTC (some of which date back to November 2014) target less extreme conduct, including alleged misbranding due to claims about products’ intended uses and alleged Current Good Manufacturing Practice issues. The DOJ’s press release signals proactive and coordinated enforcement in the area of dietary supplements and an intent to investigate and prosecute manufacturers and retailers alike.
Read the full press release.