Contentious Weight Loss Drug Not Natural Warns FDA
A contentious ingredient often hidden in weight loss drugs is in the spotlight again as the FDA begins to clamp down on makers of weight loss drugs who claim that the ingredients they are using are natural; and thereby, allowable by law. Here is what the FDA found with a listing of specific products, plus their cover names that you should watch out for in your weight loss supplements.
In a recent study, researchers expressed concern over discovering that of 21 weight loss supplements tested, 11 were found to contain an amphetamine-like drug called “BMPEA” that health authorities fear could cause serious health effects like drug addiction, stroke and/or a heart attack.
BMPEA is believed by some in the supplement industry to aid weight loss and is reputed to be a “natural” compound found in a plant called Acacia rigidula―also known as “Vachellia rigidula” or “Blackbrush Acacia”―a shrub native to Texas and Mexico.
However, a recent analysis made by FDA chemists determined that BMPEA was not present in multiple plant samples of Acacia rigidula tested. Therefore, BMPEA is not “natural” as advertised and thereby puts its makers at fault of illegally misbranding their weight loss products by claiming BMPEA as a dietary supplement.
According to a statement made by the FDA:
“While BMPEA was listed as a dietary ingredient on the product labels, 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. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement. Additionally, relating to the two companies that identified the botanical Acacia rigidula as the source of the BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula. FDA considers these specific products to be misbranded for this reason, as well.”
Weight Loss Supplement Makers Cited
The FDA sent warning letters to the following makers, specifically listing product names of weight loss supplements accused of being misbranded:
• Hi-Tech Pharmaceuticals, Inc. (Products: Fastin-XR (extended release), Fastin-RR (rapid release), Lipodrene (Ephedra Free))
• Tribravus Enterprises, LLC d/b/a iForce Nutrition (Products: Conquer (Fruit Punch Slam & Raspberry Lemonade flavors))
• Train Naked Labs LLC (Products: Critical FX, Sudden Impact)
• Better Body Sports, LLC (Product: Phoenix Extreme)
• Human Evolution Supplements, Inc. (Product: Core Burner)
In addition, the FDA also warned consumers that they should avoid products containing BMPEA that may be listed under the following cover names on their labels:
• R-beta-methylphenethylamine HCl
• 2- phenyl-1-propanamine
According to the FDA’s website, the aforementioned companies have 15 business days from the date of receipt of their letter to contact the FDA and state the specific steps they will take to bring their products into compliance with the law.
For more about weight loss drugs you should be wary of, here is one recently reported to have caused the untimely death of a weight loss supplement user.
Reference: U.S. Food and Drug Administration― “BMPEA in Dietary Supplements”