FDA Sends Warning Letter to Regeneca
9/13/2012
Irvine, CA -- The FDA sent Regeneca, Inc. a letter informing it that supplements containing DMAA (1,3-dimethylamylamine), such as the company's product RegeneSlim, cannot be legally marketed in the United States without the submission of a new dietary ingredient (NDI) notification to FDA.
According to the Dietary Supplement Health and Education Act of 1995, an NDI must show that ingredient has a history of use and evidence that establishes that the ingredient is reasonably expected to be safe when used as recommended. The letter also stated that even if the required NDI notification had been submitted, the agency has no evidence that establishes DMAA as reasonably expected to be safe, saying that "to the best of FDA's knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine [DMAA] will reasonably be expected to be safe as a dietary ingredient. In fact, dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack)."
The letter closed with a warning that if Regeneca didn't immediately cease distribution of RegeneSlim, the agency could seize the product and file an injunction against the company.