FDA has announced warning letters to 11 companies for products which allegedly included unapproved new dietary ingredients and/or unsafe food additives. The agency also asserted that some of the companies had made drug claims for their products by presenting them as intended for use in the cure, mitigation, treatment, or prevention of disease. In the warning letters, FDA advised all of the companies to take prompt corrective action, and that failure to correct the alleged violations could result in legal action without further notice, including, without limitation, seizure and/or injunction.
All of the warning letters in the announcement involved ingredients which FDA had removed from the Dietary Supplement Advisory List, including two, octopamine and 5-alpha-hydroxy-laxogenin, which had been removed from the list in a nearly simultaneous action. The Advisory List contains substances the agency tentatively asserts “do not appear to be lawfully included in products marketed as dietary supplements”. The removal of ingredients from the list frequently reflects a conclusion by the agency that the ingredients are unlawful. In individual warning letters, the agency stated its belief that octopamine is an unapproved new dietary ingredient, and that 5-alpha-hydroxy-laxogenin does not qualify as a valid dietary ingredient under the provisions of the FD&C Act.
Read the full warning letter announcement here. The Dietary Supplement Ingredient Advisory List is available here.
