FDA Sends Another DMAA Warning Letter

IRVINE, Calif.Supplements that contain DMAA (1,3-dimethylamylamine ) can not be legally marketed in the United States if product owners don't submit a new dietary ingredient (NDI) notification to FDA, according to a warning letter the agency send Regeneca Inc., a company that sells the DMAA product RegeneSlim. Further, FDA questioned the legal status of DMAA regardless if the company submits an NDI notification.

FDA said DMAA requires an NDI notification because it was not marketed in the United States before Oct. 15, 1994. Supplements sold after the passage of  Dietary Supplement Health and Education Act of 1995 (DSHEA) must submit notifications to FDA at least 75 days before introducing the product to the market.

Per DSHEA, an NDI notification must show the ingredients have a history of use or safety evidence, such as citation to published safety articles, that establishes, when the ingredients are used under recommended conditions, they are reasonably expected to be safe.

In this warning letter, FDA said no information demonstrates that DMAA was lawfully marketed in the United States before Oct. 15, 1994. Also, FDA said no information shows it is present in the food supply.

Further, FDA said even if the required NDI notification had been submitted, the agency said no evidence establishes DMAA as  reasonably expected to be safe. Therefore, FDA said  RegeneSlim is likely adulterated.

"To the best of FDAs 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," FDA said in the letter. "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)."

FDA also noted some DMAA used in supplements may be produced synthetically; it is the agency's stance that synthetically produced botanicals are not legal dietary ingredients and therefore, cannot be used in dietary supplements. FDA outlined its thinking on NDIs and how they relate to synthetic botanicals in its NDI draft guidance, released in July 2011. The agency has since agreed to reissue its draft guidance, according to industry trade organizations, after the industry took issue with many of FDA's views, including that of synthetic ingredients.

FDA closed the letter by telling Regeneca that if it didn't immediately cease distribution of RegeneSlim, FDA could respond with product seizure and  injunction against the company.

INSIDER's Take:

This warning letter was a bit of a cut-and-paste job of the 10 warning letters FDA sent to DMAA marketers in April. This letter shows FDA still believes DMAA is at best a NDI and at worst, not even a dietary ingredient at all.

Manufactures that still market DMAA need to be ready to counter FDA, as it's likely the agency will be sending more warning letters. However, a warning letter is not legally binding; it only shows FDA's thinking on the matter. Here, FDA says DMAA products are illegal because they are either on the market without an NDI notification or they are illegal because synthetic DMAA is not a dietary ingredient.

Companies can fight back, as Nutrex did in its response letter to FDA. Nutrex was one of the 10 companies that received a warning letter in April. DMAA companies can choose to stand their ground and argue that their products are legal, backing it with science showing DMAA is safe, and is derived from geranium oil (and therefore not synthetic).

However, FDA shows that it indeed will not rest on this issue. If a company is selling DMAA, it better be able to back up its stance that it's legal. After all, FDA only gives 15 working days to respond to warning letters. After that, FDA may take further regulatory action.