FDA Warning Letters demand “immediately cease distribution” of dietary supplements with BMPEA

On April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss,  energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat.

These warning letters come over one year after FDA published studies from an FDA investigation that found nine (9) out of 21 dietary supplements containing Acacia rigidula also contained BMPEA even though the plant itself does not contain the substance.

It is believed that the FDA was pushed to action after a study in the journal Drug Testing and Analysis published earlier this month showed BMPEA-containing products were still on the market more than a year after the FDA published its findings.

FDA warning letters were issued to at least five dietary supplement companies marketing products that included BMPEA in one way or another, asking them to “immediately cease distribution” of the supplements listed in the individual warning letters.  Each of the five warning letters states:

“Under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)], a dietary ingredient is 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 not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, BMPEA is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, BMPEA is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Accordingly, BMPEA is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Declaring BMPEA in your product labeling as a dietary ingredient causes your product marketed as a dietary supplement to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.”

This latest action by the FDA should serve as a reminder to the dietary supplement industry that under the Dietary Supplement Health and Education Act (DSHEA) of 1994, Congress defined a “dietary supplement” as a product taken by mouth, that contains a “dietary ingredient”, and is intended to supplement the diet.  As new dietary supplement products are introduced into the U.S. market everyday, firms must ensure that their product meets the statutory definition of a dietary supplement or they may be forced to take their products off the market, as we saw in this latest string of FDA Warning Letters.

To speak with an experienced FDA compliance attorney, who can assist you in bringing a new dietary supplement to market or bringing an existing dietary supplement into compliance, contact Ann Marie Gaitan, Esq. at 305.443.8900 or via e-mail to [email protected].

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