“Methylsynephrine is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, according to our research, methylsynephrine is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, methylsynephrine is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake,” state the warning letters, dated March 31, 2016.
“Accordingly, methylsynephrine is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act. Declaring methylsynephrine in your product labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.”
The warning letters dated March 31 2016 were sent to Nutraclipse, Inc.; Swagger Supps; Total Body Nutrition, LLC; Xcel Sports Nutrition, LLC; M4 Nutrition Companies, LLC; Line One Nutrition, Inc; and Chaotic Labz.
According to the Dietary Supplement Label Database (DSLD), there are 25 products from seven brands containing “methylsynephrine” anywhere on the label. Only one of the companies listed on the DSLD received a warning letter from the FDA (Chaotic Labz).
Commenting on this discrepancy, Marianna Naum, PhD, strategic communications and public engagement staff in the Office of Foods and Veterinary Medicine at the FDA, told us: “FDA’s action provides regulated industry with a clear message regarding the status of methyl synephrine: no firm can now remain under the illusion that methyl synephrine is a dietary ingredient. Preparing a Warning Letter takes time and resources, and products frequently come on and off the market, so the agency works hard to strike the right balance. If FDA waited to act until we were certain we had addressed every marketed product, we wouldn’t ever be able to issue these warning letters.”
The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law.
"We expect FDA to move quickly and aggressively," says CRN's Mister
The actions were welcomed by Steve Mister, president and CEO, of the Council for Responsible Nutrition. "We applaud FDA for taking action against companies breaking the law and potentially putting consumers at risk," he said in a statement. "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."
Not to be confused with p-synephrine
Methylsynephrine should not be confused with p-synephrine, which is a legal dietary ingredient, said the FDA’s Dr Naum.
“P-synephrine is a constituent of Citrus aurantium (bitter orange), which is a dietary ingredient,” she said. “The fact that p-synephrine is a dietary ingredient, however, does not necessarily mean that it can always be legally marketed in dietary supplements.”
P-synephrine is claimed to increase energy expenditure, facilitate the breakdown of fat and increase glucose uptake by muscles. It is widely used in weight management and sports nutrition supplement.