FDA WARNING_LETTER - Top Secret

The FDA issued a Warning Letter to Top Secret Nutrition, LLC concerning their product, Pump Igniter, marketed as a dietary supplement. The letter states that the product's labeling lists Picamilon (also known as pikatropin, nicotinyl-gamma-aminobutyric acid, or nicotinoyl-GABA) 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 (the Act), as it is a unique chemical entity synthesized from niacin and gamma-aminobutyric acid, not fitting any specified categories. Consequently, declaring Picamilon as a dietary ingredient causes the product to be misbranded under section 403(a)(1) of the Act, as its labeling is false or misleading. Furthermore, Picamilon is not approved as a food additive or prior sanctioned for use in dietary supplements, and the FDA has no basis to conclude it is Generally Recognized As Safe (GRAS) for food use. Top Secret Nutrition, LLC is required to take prompt action to correct this violation, cease distribution of products containing Picamilon, and provide a written response within 15 days detailing corrective steps, including those for products currently in the marketplace and measures to prevent recurrence. Failure to comply could result in enforcement actions, including product seizure and injunctions.