Supplement company ordered to cease production and marketing after repeat violations.

• FDA has the authority to regulate dietary supplements.  The Agency enforces legal and regulatory provisions applicable to supplements in various ways, including through facility inspections and Warning Letters.  Violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may have criminal consequences; FDA may work through the Department of Justice (DOJ) to seek judicial remedies (seizure, injunction) against companies that violate the law.
• On August 17, 2015, a federal district court in Iowa imposed a consent decree on a dietary supplement company in the state, effectively shutting down operations unless and until a host of legal violations have been remedied.  According to the complaint, the company was aware that FDA alleged numerous violations of the FD&C Act over the past two years.  FDA alleged that the company was distributing unapproved new drugs and misbranded drugs, as well as adulterated and misbranded dietary supplements.  More specifically, the Agency found evidence of:
  • failure to comply with current good manufacturing practices (GMPs) in 21 CFR Part 111;
  • promotional statements indicating that dietary supplement products could be used to cure, mitigate, or prevent diseases such as cancer, malaria, and heart disease
  • product labeling violations
• The company will cease all production and distribution of adulterated, unapproved, and misbranded products.  Further, the company has agreed that it will not resume operations without FDA approval.  Although FDA enforcement in the dietary supplement area is relatively infrequent, this consent decree serves as a reminder of FDA’s authority and the potentially serious consequences of repeat violations related to the production and marketing of supplements.