Cambridge, MA…The U.S. Food and Drug Administration (FDA) recently issued warning letters to 10 supplement companies for selling the amphetamine-like drug dimethylamylamine (DMAA). According to a new report by a Harvard Medical School researcher, there is no scientific evidence that DMAA is safe or effective to support its sale as a supplement. The report, published online today by the Archives of Internal Medicine, comes as companies have less than 10 days to provide the FDA with evidence of DMAA’s safety as a supplement ingredient.
DMAA is found in over 200 brands of dietary supplements, including OxyELITE Pro and Jack3d, which are sold at mainstream retail chains. Over a half billion dosages of DMAA supplements have been sold over the past five years. Recent reports of serious adverse health effects and deaths potentially related to use of DMAA supplements spurred the FDA to act.
“This drug should never have been in supplements in the first place,” said report author Dr. Pieter Cohen, an internist at Cambridge Health Alliance and an assistant professor of medicine at Harvard Medical School.
Developed by the pharmaceutical firm Eli Lilly & Co., DMAA was introduced in 1948 but withdrawn for lack of evidence of efficacy and safety in the early 1970s. Over 30 years later, DMAA was reintroduced in over-the-counter supplements. Manufacturers have argued that DMAA is a safe ingredient because it is found in rose-scented geranium which is used to add flavor to baked goods.
The new report questions the scientific validity of that claim. Dr. Cohen found that only one study in a Chinese-language journal detected DMAA in geranium, while a half-dozen independent scientific teams have been unable to confirm those findings. Dr. Cohen also highlighted the potential risks of DMAA, which is more potent than the banned substance ephedra and has been linked to seizures, strokes, heart failure, and deaths. The U.S. Department of Defense recently withdrew all DMAA from military exchanges because of concern that it may have contributed to the death of two soldiers.
“DMAA poses potentially serious health risks to consumers and should be immediately removed from store shelves,” said Dr. Cohen. He cautioned that the FDA will be unable to remove DMAA from U.S. markets unless it acts decisively in the coming weeks.
“DMAA as a Dietary Supplement Ingredient.” Pieter A. Cohen, MD. Archives of Internal Medicine, online publication ahead of print.
Cambridge Health Alliance is an integrated, award-winning health system that provides high quality care in Cambridge, Somerville, and Boston’s metro-north communities. It includes three hospital campuses, a network of primary care and specialty practices, and the Cambridge Public Health Dept. CHA is a Harvard Medical School teaching affiliate and is also affiliated with Harvard School of Public Health, Harvard School of Dental Medicine, and Tufts University School of Medicine. Visit us online at www.challiance.org.