DMAA Supplements Illegal in U.S., FDA Says

After being declared illegal in Ireland, Canada, and England, DMAA-containing supplements have been declared illegal in the United States, as well. DMAA—1,3-dimethlamylamine—is a popular stimulant product that has also prompted bans or warnings in a number of other countries, including Australia, New Zealand, Finland, Denmark, Spain, Sweden, The Netherlands, France, Italy, and Malta.

The U.S. Food and Drug Administration (FDA) now says that workout-enhancing and fat-burning products containing DMAA and sold by popular stores such as GNC and Vitamin Shoppe, are illegal and may present serious health hazards to consumers, wrote The New York Times. DMAA does not qualify as a “legal dietary ingredient” and “could raise blood pressure, potentially causing heart attacks and other health problems,” The Times said.

DMAA is an ingredient used in popular weight loss and body building supplements and has been linked to high blood pressure, headaches, vomiting, stroke, and death. Originally developed as a nasal decongestant, DMAA has been used as an ingredient in “workout boosters” sold under brand names like Lean Efx, Napalm, Nitric Blast, and Jack3D. Some supplement makers claim DMAA is a so-called “natural stimulant” derived from geranium extract, but a number of recent studies have failed to show that this is true. The American Herbal Products Association (AHPA), the only national trade association focused on herbs and herbal products, recently informed its members that DMAA should not be labeled as a product of geranium oil.

A study published in the journal Drug Testing and Analysis that examined eight different geranium extracts of different geographical origins concluded that the DMAA used in dietary supplements could not have originated from the geranium plant. DMAA is also known as Methylhexanamine, Geranamine, Geranium oil, and Cranesbill. According to a prior report by the Daily Mail, DMAA is included on the list of prohibited list of banned substances by the World Anti-Doping Agency and has been responsible for 137 doping violations worldwide.

The U.S. Army also pulled DMAA supplements from its commissaries after the sudden deaths of several soldiers were tied to the product. Last April, the FDA issued warning letters to 10 DMAA supplement makers, alleging sale of the chemical to be illegal, as there was no evidence that DMAA deserved to be classified as a dietary supplement.

At least five fatalities and 81 other adverse health reactions have been reported since 2008 to the FDA in consumers using DMAA-containing products, said The Times. “We are very concerned,” Daniel Fabricant, the director of agency’s division of dietary supplements programs, said in a telephone interview with The Times. “We think consumers should stay away from products containing DMAA.”

Steve Mister, president of the trade group, the Council for Responsible Nutrition said, “The FDA has spoken…. We are urging the industry not to manufacture products with DMAA. Retailers should heed the advisory as well,” The Times reported. An attorney for USPlabs, the marketer of Jack3d and OxyElite Pro, said his client disagrees. “USPlabs continues to believe that DMAA is legal, or otherwise they would not be selling it,” said the lawyer.

The FDA made its announcement on Friday and, as of Friday afternoon, GNC was still selling Jack3d on its website as a “hot buy.” A company spokesman did not return The Times’ requests for comment. Vitamin Shoppe was not stocking the product and was offering a similarly named formulation that does not contain DMAA.

This entry was posted in Defective Products, Health Concerns, Toxic Substances. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.