Food

Methylsynephrine in Dietary Supplements

Methylsynephrine is a substance that 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 supplement products that declare methylsynephrine as a dietary ingredient.

Methylsynephrine is also known as:

  •   oxilofrine
  •   p-hydroxyephedrine

Recent FDA Action on Dietary Supplements for Which the Product Labeling Lists Methylsynephrine as a Dietary Ingredient

April 2016

On March 31, 2016, the FDA issued warning letters to 7 companies regarding a total of 8 products marketed as dietary supplements for which the product labeling lists methylsynephrine as a dietary ingredient.

Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).

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 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.

The agency will continue to update this page in the event additional actions are taken related to methylsynephrine.

Warning Letters

 

Page Last Updated: 04/04/2016
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