Insurance companies are pulling their product liability coverage for controversial supplement, DMAA. DMAA, or 1,3-dimethylamylamine or methylhexaneamine, received its patent decades ago as a nasal decongestant and is similar in composition to ephedrine and amphetamine. Today, DMAA can be found in over 200 products.
Recently, DMAA-containing supplements have been implicated in the recent deaths of two U.S. soldiers who had traces of the chemical in their systems following their post-workout deaths on military bases. DMAA supplements have also been linked to other, less serious complications that were sufficiently significant to warrant a warning letter from the U.S. Food & Drug Administration (FDA). Complications cited included panic attacks, dizziness, and seizures.
Now, two insurers that offer product liability coverage to the dietary supplement industry will be including DMAA to their so-called “ingredient exclusion” lists, said Natural Products Insider, citing Greg Doherty, practice leader of the dietary supplement insurance division of Poms & Associates Insurance Brokers Inc. “I predicted this over a year ago, and now it’s happening” Doherty told Natural Products Insider. “There has been too much negative press lately on DMAA, and eventually it was bound to catch the eye of some of the insurance company underwriters. Two carriers will now exclude it, although one has hinted that they may offer coverage for products containing DMAA on a ‘carveback’ basis, which means that based on the type of products being sold, the dosage of DMAA and the volume of DMAA sales as a percentage of overall sales, this carrier might offer DMAA coverage for an additional premium. The key word is ‘might.’”
Doherty pointed out that when ephedra alkoloids were receiving negative press, the so-called “carvebacks” enabled coverage, but as the press worsened, coverage was excluded, with insurers paying millions over ephedra claims, wrote Natural News Insider. To date, the FDA has only ever banned one supplement ingredient: ephedrine alkaloids.
“As of right now, coverage is still available for DMAA products from other insurers, but my opinion is that the window is closing. It’s really the ephedra insurance coverage story all over again,” Doherty said, wrote Natural News Insider. “Companies currently selling DMAA and want it to be covered in the future face a real dilemma.”
We recently wrote that a new comprehensive study is likely derailing any hopes the makers of dietary and workout supplements containing the additive DMAA had of keeping their products on the market. The findings, published in the Journal of Analytical Toxicology, reveal that natural geranium oils as well as the “young and mature, fresh and dried leaves and stems” of these plants had absolutely no levels of DMAA. This conclusion will make it difficult for the manufacturers of DMAA-based supplements to continue to claim their products are naturally derived, geranium-based, and, therefore, exempt from the rules enforced by the FDA for products making medical claims.
The World Anti-Doping Agency (WADA) classifies DMAA as a prohibited substance and says DMAA was the cause of 123 doping bans in 2010, the most of any banned substance. Meanwhile, Australia just issued a DMAA supplement warning and is considering a ban of the controversial supplement; New Zealand classified DMAA as a narcotic; and the FDA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued warning letters to DMMA-containing supplement makers over a number of DMAA-containing products.