Has FDA effectively slammed the door shut on DMAA?
Most likely you’ve heard recent rumblings about DMAA. DMAA, or 1,3-dimethylamylamine, is an ingredient said to elevate mood, improve cognition, and produce a relaxed but alert state. Controversy stems from the nature of the ingredient’s origins, with some questioning whether DMAA is in fact a constituent of geranium oil (Pelargonium spp.), as others claim.
DMAA is also synthetically produced, most notably by pharmaceutical firm Eli Lilly, which filed for a patent in 1944 for the drug DMAA as a nasal decongestant, which was ultimately trademarked in 1971 as Forthane. While the Forthane trademark has expired, dietary supplement forms of DMAA said to be derived from geranium oil became popular for weight loss and bodybuilding.
After being reintroduced as a supplement in 2005 by the now-infamous BALCO Labs sports-doping operation, DMAA afterwards appeared as a legitimate ingredient in dozens of weight-loss and bodybuilding formulations from different manufacturers, including Jack3d and OxyElite Pro marketed by sports supplement firm USPlabs (Dallas, TX).
Following publicity and outcry surrounding the death of two U.S. soldiers in 2011 after reportedly consuming a DMAA-containing product, in late 2011 the U.S. Defense Department removed DMAA-containing products from all stores on U.S. military bases, including approximately 100 GNC stores.
In April 2012, FDA sent warning letters to 10 companies informing them that DMAA is not an approved supplement ingredient and that the continued use of it would have to be supported by new dietary ingredient (NDI) notifications and relevant safety dossiers. All companies agreed to reformulate without DMAA, except for USPlabs, initially, which questioned FDA’s position by submitting to the agency its own safety and analytical data, some of which was conducted by the regulatory firm Intertek Cantox (Bridgewater, NJ).
On April 11, 2013, FDA issued a consumer advisory against DMAA-containing products, saying that the ingredient “can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath, and tightening of the chest.” After reviewing the studies provided by USPlabs, FDA wrote that the agency “found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”
In response to the consumer advisory issued by FDA on DMAA, Steve Mister, CEO of the Council for Responsible Nutrition (CRN; Washington, DC), issued this statement: “For over a year, DMAA has been an ingredient under question. CRN has looked to FDA to determine whether this ingredient is safe or not safe, as well as whether this product could be considered a legal dietary ingredient for use in supplements.”
Industry organizations have been backing away from DMAA for some time now. In July 2011, the board of the American Herbal Products Association (AHPA; Silver Spring, MD) passed a trade requirement stipulating that, starting in 2012, none of its members should label DMAA as “geranium oil” or as an extract from any part of the geranium plant. (Members are still allowed to use geranium labeling for ingredients that are, in fact, proven derived from the geranium plant, however.)
“It is clear from FDA’s Consumer Advisory that, having evaluated the evidence, FDA views DMAA as unsafe and warns that it presents unreasonable health risks to consumers,” added Mister. “FDA also stated that, in its view, products containing DMAA are illegal and should not be sold as dietary supplements. With this conclusion, CRN now calls on dietary supplement manufacturers to stop manufacturing these products and further advises consumers to stop using them.”
He added, “Given the agency’s serious warnings about DMAA, we expect the agency will use the full range of its regulatory authority under the Dietary Supplement Health and Education Act (DSHEA) and take further action beyond the Consumer Advisory. DSHEA provides the agency with a variety of tools, many of which FDA mentions in its Advisory (e.g., detentions, seizures, voluntary and mandatory recalls, injunctions, criminal prosecution, etc.), to protect consumers.”
On April 16, 2013, USPlabs, the company that received a DMAA warning letter from FDA a year ago, agreed to remove DMAA from its top-selling Jack3d pre-workout products and its OxyElite Pro weight-loss supplements.
The company made this statement: “USPlabs stands by the safety and legality of its products containing the dietary ingredient 1,3-DMAA. We disagree with FDA’s position. The company has nevertheless concluded for business reasons to phase out products containing 1,3-DMAA.”
And that apparently is the DMAA route many industry companies and retailers have also decided to take-regardless of DMAA’s relatively safe track record, according to some. Retailer GNC-which as of May 2012 had reportedly sold 440 million servings of DMAA since 2007-said it had only experienced one formally reported DMAA-related adverse event.
While some praise the removal of DMAA from the marketplace, some industry reporting has framed what has transpired over DMAA as an example of FDA using its enforcement power to take a product off the market. Some we spoke to wondered whether or not the agency will try to eliminate use of other botanical extracts in a similar way, declaring them also to be effectively off limits to manufacturers and dangerous to consumers.