Lawyers: FDA has adequate authority under DSHEA but must act swiftly to enforce
Some industry lawyers conceded FDA should take swifter action to protect consumers from dangerous ingredients in products marketed as dietary supplements and leverage its full breadth of enforcement tools, including criminal prosecution.
FDA has sufficient authority under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to protect consumers when dangerous ingredients end up in products marketed as dietary supplements, four veteran lawyers said in interviews.
Some of them, however, conceded FDA should take swifter action to protect consumers and leverage its full breadth of enforcement tools, including criminal prosecution.
Although FDA has adequate tools to protect consumers, the agency “appears reluctant to enforce” the law, said Steven Shapiro, of counsel to New York-based Rivkin Radler LLP, who has more than 30 years of experience in food and drug regulatory matters.
For example, he questioned the value of FDA writing a warning letter to a company that has already been put on notice through previous warning letters that a controversial ingredient like DMAA (1,3-dimethylamylamine) does not belong in dietary supplements.
Instead, Shapiro suggested FDA initiate a serious enforcement action—such as a seizure of products or criminal prosecution—against a company putting unsafe ingredients in their products and clearly violating the law.