FDA WARNING_LETTER - Regeneca, Inc - August 28, 2012

The FDA issued a Warning Letter to Regeneca, Inc. regarding their product "RegeneSlim," labeled as a dietary supplement. The product contains 1,3-dimethylpentylamine HCL, also known as dimethylamylamine (DMAA).

The FDA states that DMAA is a "new dietary ingredient" for which a notification is required under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. To the FDA's knowledge, there is no information demonstrating DMAA was lawfully marketed as a dietary ingredient before October 15, 1994, or present in the food supply in an unaltered form. Since the required notification was not submitted, "RegeneSlim" is deemed adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

Furthermore, the FDA asserts there is no evidence establishing DMAA's safety, noting it narrows blood vessels, increases cardiovascular resistance, and can elevate blood pressure, potentially leading to cardiovascular events. Therefore, the product is adulterated under 21 U.S.C. 342(f).

The letter also highlights that synthetically produced DMAA is not considered a "dietary ingredient" as defined in section 201(ff)(1) of the Act (21 U.S.C