The products under FDA censure are largely marketed as weight-loss supplements.
FDA issued warning letters to seven companies marketing products containing methylsynephrine as dietary supplements. According to FDA, methylsynephrine is not a legal dietary supplement ingredient. On March 31, the agency told the companies they must cease selling their misbranded products.
Methylsynephrine is also known as oxilofrine or p-hydroxyephedrine. The products under FDA censure containing methylsynephrine are largely marketed as weight-loss supplements.
The seven companies sent warning letters are: Nutraclipse Inc., Swagger Supps, Total Body Nutrition LLC, Xcel Sports Nutrition, M4 Nutrition Companies LLC, Line One Nutrition Inc., and Chaotic Labz. FDA's letters to Nutraclipse Inc. and M4 Nutrition Companies also warned the companies about the presence of 1,3-dimethylbutylamine (DMBA) and picamilon, respectively, in their products. In the past two years, both of these ingredients have come under fire for unauthorized use in dietary supplements.
Of methylsynephrine, the agency wrote: “While methylsynephrine was listed as a dietary ingredient on product labeling, the substance does not meet the statutory definition of a dietary ingredient. The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Methylsynephrine does not fit under any of these categories, rendering misbranded any dietary supplements that declare methylsynephrine as a dietary ingredient.”
The companies have 15 days from receipt of the letter to tell FDA how they will rectify the problem.
Steve Mister, president and CEO of dietary supplement association the Council for Responsible Nutrition (CRN; Washington, DC), supported FDA’s move to act against companies using methylsynephrine in dietary supplements. “We applaud FDA for taking action against companies breaking the law and potentially putting consumers at risk. Selling products that list methylsynephrine as a dietary ingredient is illegal because the ingredient, also known as oxilofrine, has not been subjected to the New Dietary Ingredient (NDI) notification process, a requirement under the law. Responsible marketers and manufacturers of supplements who compose the mainstream dietary supplement industry are in lockstep with FDA when it comes to enforcing the law and protecting the safety of their consumers, and we strongly urge the companies that received these warning letters-and any others that may be selling this illegal ingredient-to heed the agency’s warning immediately. For any companies that do not take these warnings seriously, we expect FDA to move quickly and aggressively to the next steps available to it under the law to get these products off the market. We urge consumers to follow FDA’s advice and not to use products containing methylsynephrine, oxilofrine, or p-hydroxyephedrine.”
Nutritional Outlook magazine