On April 27, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to manufacturers and distributors marketing products containing dimethylamylamine (DMAA) without having first submitted ingredient information to the organization explaining its safety.
According to the FDA, this ingredient has been labeled "natural" by said companies, but without first submitting it to the FDA as a New Dietary Ingredient (NDI). Manufacturers and distributors are required to provide evidence an ingredient is safe, as outlined in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The DSHEA defines a dietary ingredient as " . . . a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances."
"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., director of the FDA’s Dietary Supplement Program, in a press release.
So what does this mean for you?
What DMAA Is
Also known as 1, 3-dimethylamylamine, methylhexanamine, or geranium extract, DMAA is a popular stimulant found in pre-workout supplements. DMAA is a compound found within the oil of the plant's flowers. Synthetic versions are also used. Because it's a stimulant, this ingredient can help increase your endurance during your workout, keeping you more focused and allowing you to work out harder with less recovery time. It's more powerful than caffeine but doesn't produce a "crash" later on. Instead, DMAA helps your body slow down gradually, so you feel calm at the end of your workout.
According to the FDA, DMAA can narrow both the blood vessels and the arteries. These effects can lead to high blood pressure, shortness of breath, tightness in the chest and even heart attack. They have received 42 reports of adverse events concerning products that contain DMAA. The FDA stated these reports don't establish DMAA as the direct cause of these issues, but instances of cardiovascular, psychiatric and central nervous system disorders and death were included in the reports, warranting further investigation.
Current regulations prohibit professional athletes from using these supplements because they can cause a false positive on a drug test and are considered performance enhancers. Amateur athletes who are "not in competition" are permitted to use them as of 2011, according to the World Anti-Doping Agency (WADA) and the U.S. Anti-Doping Agency (USADA).
So what's next?
These manufacturers and distributors now have 15 days to reply to the FDA's letters outlining their planned course of action to address the safety concerns of these products. If the ban goes through, these products could become unavailable for purchase.
If you're currently taking a product containing this ingredient, please be sure to follow dosing instructions carefully. Also, pay attention to how you feel on the supplement and speak with your doctor if you're experiencing any of the symptoms previously mentioned or if you've been diagnosed with a medical condition (especially anything related to the heart) and are currently being treated with medication. Taking other stimulants or consuming alcohol while using them is not recommended.
These supplements can take your workout to the next level, but safety always trumps results, so make informed decisions about the supplements you're taking. Check back here for more updates about the status of these products as the investigation continues.
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