FDA WARNING_LETTER - SDC Nutrition Inc

The FDA issued a Warning Letter to SDC Nutrition, Inc. d/b/a NVIE Nutrition concerning its product NVIE Edge Pro, marketed as a dietary supplement. The core violation identified was that the product's labeling falsely declared Picamilon as a dietary ingredient. The FDA determined that Picamilon does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(ff)(1)], as it is a unique synthesized chemical entity and not a vitamin, mineral, herb, amino acid, or other specified dietary substance or derivative. This renders products listing Picamilon misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] due to false or misleading labeling. The FDA also noted that Picamilon is not approved as a food additive, prior sanctioned, or generally recognized as safe (GRAS) for use in food. SDC Nutrition was instructed to take prompt action to correct this violation, immediately cease distribution of NVIE Edge Pro and any other products containing Picamilon, and respond in writing within 15 days detailing corrective actions, including those for products in the marketplace, and steps to prevent recurrence. Failure to comply could result in enforcement actions such as product seizure and injunctions.