The FDA is disputing the efficacy of Nubreed Nutrition's dietary supplement called Undisputed.
The FDA is disputing the efficacy of Nubreed Nutrition’s dietary supplement called Undisputed.
FDA representatives told the manufacturer that one of the ingredients, Acacia rigidula, does not meet the definition of a dietary ingredient, therefore the product is in violation of the Federal Food, Drug, and Cosmetic Act.
The recall affects all lots of the company’s product, which was marketed as a pre-workout “powerhouse.”
Undisputed was sold to distributors, wholesalers, retail stores, and consumers, but Nubreed Nutrition stopped its production in October 2015.
The product comes in a white bottle with a white cap, and it holds 40 power servings.
No injuries or illnesses have been reported in association with the drug thus far, but anyone with the product in hand should stop using it immediately. Consumers who experience adverse effects should consult a physician and report problems to Nubreed Nutrition and to the FDA’s Medwatch Adverse Event Reporting program.
“We sincerely regret any inconvenience to consumers,” the company said in a statement. “Nubreed Nutrition has taken this voluntary action out of concern for the health and safety of consumers.”
The FDA warned companies in April 2015 to stop distributing products containing the widely untested Acacia rigidula. Many of the “natural” acacia products on the market contain beta-methylphenylethylamine, a laboratory-created substance.