FDA WARNING_LETTER - ICF International, LLC

The FDA issued a Warning Letter to ICF International, LLC, regarding their product Myokem Nitramine, marketed as a dietary supplement. The letter identifies a violation under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)], stating the product is misbranded because its labeling is false or misleading.

The core issue is the inclusion of Picamilon (also known as pikatropin, nicotinyl-gamma-aminobutyric acid, or nicotinoyl-GABA) as a dietary ingredient. The FDA asserts that Picamilon does not meet the definition of a dietary ingredient under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Picamilon is a synthesized chemical entity from niacin and gamma-aminobutyric acid, not fitting into categories such as vitamins, minerals, herbs, amino acids, or other specified dietary substances.

The FDA requires prompt action to correct this violation for Myokem Nitramine and any other products marketed by the firm that list Picamilon as a dietary ingredient. Failure to cease distribution could lead to enforcement actions, including product seizure and injunctions under sections 302 and 304 of the Act [21 U.S.C. §§ 332