(RxWiki News) Nubreed Nutrition, Inc., has issued a voluntary recall for its pre-workout product called Undisputed.
This recall occurred after the US Food and Drug Administration (FDA) informed the company that one of Undisputed's ingredients, Acacia rigidula, does not meet the definition of a dietary ingredient.
Around this same time last year, the FDA issued warning letters to five companies about their products containing BMPEA as a dietary ingredient.
What is the connection between BMPEA and Acacia rigidula? Two of the five companies last year said the source of BMPEA was Acacia rigidula. However, research conducted by the FDA confirmed BMPEA is not an extract of Acacia rigidula.
Whether BMPEA or Acacia rigidula is listed as a dietary ingredient, the FDA states these ingredients do not meet the definition of a dietary ingredient. Therefore, these products are in violation of provisions of the Federal Food, Drug and Cosmetic Act.
BMPEA is similar to the stimulant ephedrine and can be harmful, especially if consumers are unaware it is in the product they are taking.
The five companies that were issued warning letters last year are the following:
- Hi-Tech Pharmaceuticals, Inc.
- Products: Fastin-XR, Fastin-RR, Lipodrene (Ephedra Free)
- Tribravus Enterprises, LLC d/b/a iForce Nutrition
- Products: Conquer (Fruit Punch Slam and Raspberry Lemonade flavors)
- Train Naked Labs, LLC
- Products: Critical FX and Sudden Impact
- Better Body Sports, LLC
- Product: Phoenix Extreme
- Human Evolution Supplements, Inc.
- Product: Core Burner
The FDA recommends that consumers who have these products in their possession stop taking them. Consumers who have medical concerns about the products they are taking should speak to their doctor.