FDA WARNING_LETTER - Iron Forged Nutrition

On April 24, 2015, the FDA issued a Warning Letter to Iron Forged Nutrition d/b/a TGB Supplements regarding their product, Contraband, labeled as a dietary supplement. The product's Supplement Facts panel declares AMP Citrate, also known as DMBA, as a dietary ingredient.

The FDA states that DMBA is a "new dietary ingredient" for which a notification is required under section 413(a)(2) of the Act and 21 CFR 190.6. To the best of FDA's knowledge, DMBA was not lawfully marketed as a dietary ingredient in the U.S. before October 15, 1994, nor has it been present in the food supply as a chemically unaltered food article. Since the required notification was not submitted, Contraband is deemed adulterated under sections 402(f)(1)(B) and 413(a) of the Act.

Furthermore, the FDA states there is no evidence establishing DMBA's safety when used as a dietary ingredient, leading to further adulteration under the same sections due to inadequate safety information. The letter also notes that synthetically produced DMBA is not considered a "dietary ingredient" as defined in section 201(ff)(1) of the Act.

The FDA requested prompt action to correct these violations, including ceasing distribution of Contraband