In response to a firm warning letter sent to them by the U.S. Food & Drug Administration (FDA), a number of companies whose dietary supplements include the controversial ingredient DMAA are attempting to make a future without it. According to the FDA, there is no credible scientific evidence that shows DMAA deserves to be classified as a dietary supplement. To date, the administration has received at least 42 adverse event reports associated with DMAA-containing dietary supplements including cases of cardiac disorders, psychiatric problems, strokes, and death.
If you or a loved one has been injured by DMAA, you should contact our DMAA lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
According to a recent CNBC report, a company called MuscleMeds that makes the best-selling pre-workout supplement Code Red, has deleted the product from its website and is currently in the process of reformulating it. Farenheit Nutrition, another one of the companies that received the FDA’s warning letter, stated on its web page that its Lean EFX supplement no longer contains DMAA. However, it remains unclear as to what changes the company made to phase the ingredient out of its product.
Following CNBC’s report, Amazon.com announced that it had halted the direct sale of DMAA-containing dietary supplements, but that it would continue to allow third party venders to do so. A spokesman for GNC stated that the company is satisfied with its safety finding, and that it will continue to sell products like OxyElite Pro and Jack3d for the foreseeable future.
But for GNC and the other vendors that continue to sell DMAA supplements, the fundamental issue raised by the FDA’s warning letters is that of whether the ingredient can be classified as a dietary supplement or not. These companies are now scrambling to come with data to support the idea that it is. USP Labs, maker of both Jack3d and OxyElite Pro, has defended its products by saying that DMAA is a dietary supplement because the substance is derived from geranium root. Mounting research and numerous case studies have disputed this assertion.
If it is ultimately determined that DMAA is, in fact, not a derivative of geranium, the FDA can freeze sales and seize any products containing the ingredient. Since DMAA continues to occupy an ambiguous regulatory status, companies can either file paperwork with the administration to get approval for DMAA as a dietary supplement, or if the ingredient is found to be synthetic, the companies can file to get it approved as a drug, which is a much more stringent process.
DMAA was banned in Canada last July after federal health regulators in that country found that it was not a dietary supplement, and was instead a drug that requires further testing and approval.
Do I Have a DMAA Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in DMAA lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by DMAA, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.