Warning Letters Sent by FDA to Companies Using Methylsynephrine in Products

Warning Letters Sent by FDA to Companies Using Methylsynephrine in Products

April 5, 2016

The U.S. Food and Drug Administration (FDA) has issued warning letters to several companies that are selling questionable products.

The agency is taking issue with eight products, sold by seven companies, that list methylsynephrine as a dietary ingredient.

Methylsynephrine does not meet the statutory definition of a dietary ingredient, meaning that the products are in violation of the Dietary Supplement Health and Education Act passed by Congress in 1994. This legislation grants the FDA the power to remove products from the market if it can prove that the items are adulterated or misbranded.

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, meaning that the products containing the substance qualify as "misbranded."

The companies that received the FDA warning letters are Nutraclipse, Swagger Supps, Total Body Nutrition, Xcel Sports Nutrition, M4 Nutrition Companies, Line One Nutrition, and Chaotic Labz.

The companies have 15 business days to communicate to the agency the specific steps they will take to bring their products into compliance with the law.