Warning Letter Again - FDA vs. DSHEA (again)

FDA Sends Another DMAA Warning Letter

September 12, 2012
http://www.naturalproductsinsider.com/news/2012/09/fda-sends-another-dmaa-warning-letter.aspx

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....(read more at above web link)