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FDA issues warning letters to companies for selling adulterated, misbranded products
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On April 16, the FDA issued 11 warning letters to as many companies for alleged violations of federal law regarding some of their ingredients, the agency said in a statement.
Eight of those letters went to companies whose products are marketed as dietary supplements and labeled to contain DMHA, a substance intended to improve sports performance and weight loss, the FDA said.
The agency said DMHA is either a “new dietary ingredient” for which the FDA has not received the necessary New Dietary Ingredient notification or that DMHA is an unsafe food additive. Thus, products containing DMHA are adulterated, the agency added.
The FDA also said DMHA is also known as: 1,5-Dimethylhexylamine; 1,5-DMHA; 2-amino-5-methylheptane; 2-amino-6-methylheptane; 2-aminoisoheptane; 2-Heptylamine, 6-methyl-, 2-Isooctyl amine, 2-Metil-6-amino-eptano, 6-Amino-2-methylheptane, Amidrine, Octodrine and Vaporpac.
The eight companies receiving letters regarding DMHA are: Line One Nutrition; Iron Brothers Supplements; Eflow Nutrition LLC; Hi-Tech Pharmaceuticals Inc.; IQ Formulations LLC / DBA Metabolic Nutrition Inc.; Down To Earth Solutions LLC; Forbidden Labz and Total Body Nutrition Labs LLC.
The other three warning letters the FDA issued on April 16 went to companies whose products are marketed as dietary supplements and labeled to contain phenibut, a product found in items labeled as dietary supplements and sometimes marketed as a sleep aid.
According to the FDA, phenibut is not considered a dietary ingredient under the Federal Food, Drug, and Cosmetic Act. Thus, products with phenibut are misbranded.
The FDA also said phenibut is also known as: fenibut, phenigam, PhGaba, Phenigamma, Phenygam, 4-Amino-3-phenylbutanoic acid, -(aminomethyl)benzenepropanoic acid, beta-(Aminomethyl)hydrocinnamic acid and -phenyl--aminobutyric acid.
The three companies receiving warning letters regarding phenibut are Atomixx; Evol Nutrition Associates, Inc. and NeusoScience.
All 11 companies have 15 business days from the letter’s receipt to inform the FDA what they specifically intend to do to ensure their products are in compliance with the law, according to the FDA. The agency also said it may take additional enforcement action without further notice if companies do not immediately stop distributing their respective products.