September 13, 2012 — The U.S. Food and Drug Administration (FDA) has sent a warning letter to Regeneca, Inc., the company that sells “RegeneSlim.” The product contains DMAA, a stimulant drug that may have deadly side effects. This is the eleventh warning letter the FDA has sent to American manufacturers of DMAA supplements.
DMAA is also sometimes known as 1,3-dimethylamylamine, methylhexanamine, or geranium oil/extract. The substance has a moderate stimulant effect, and it is primarily used in supplements for weight-loss or pre-workout energy enhancement.
RegeneSlim is advertised as an “Appetite Control and Weight Loss Management” supplement. DMAA is named on the ingredient label as “methylhexanamine.”
Although DMAA is not officially banned, the FDA warns that products containing this ingredient cannot be sold in the United States for two reasons: First, synthetically-produced DMAA is not a “natural” dietary ingredient. Second, the FDA has never received a New Dietary Ingredient (NDI) notification, as is required under the Dietary Supplement Health and Education Act of 1994.
In the warning letter, the FDA said:
“To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine 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).”
Furthermore, the FDA warned: “Synthetically produced dimethylamylamine is not a dietary ingredient.”
Regeneca must immediately cease distribution of RegeneSlim, or face enforcement action without further notice that may include forcible seizure of the products or injunction against the company. The FDA has also asked Regeneca to provide a response within 15 days, detailing steps the company has taken to correct the violations.
The FDA has already sent warning letters to ten other manufacturers. One company, Nutrex, responded to the FDA with scientific evidence supporting the safety and botanical source of DMAA. The FDA has already received dozens of adverse event reports linked to DMAA, including several deaths. Many experts agree that DMAA is unlikely to be naturally derived from the geranium plant.
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