04.24.15
BMPEA does not meet the statutory definition of a dietary ingredient, FDA stated, issuing Warning Letters to five companies on April 23. A total of eight products from the companies (Hi-Tech Pharmaceuticals, Tribravus Enterprises, Train Naked Labs, Better Body Sports and Human Evolution Supplements) listed the stimulant as a dietary ingredient on labeling. Two of the companies further identified the source of BMPEA as the botanical Acacia rigidula.
FDA declared: “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 Acacia rigidula as the source of BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula. FDA considers these products to be misbranded for this reason, as well.
Under existing law, including the Dietary Supplement Health and Education Act (DSHEA), 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).
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.
According to FDA, BMPEA is also known as:
βMePEA
R-beta-methylphenethylamine
R-beta-methylphenethylamine HCl
Beta-methylphenethylamine
β-methylphenylethylamine
1-amino-2-phenylpropane
2-phenylpropan-1-amine
2-phenylpropylamine
alpha-benzylethylamine
1-phenyl-1-methyl-2-aminoethane
beta-methylbenzeneethanamine
beta-phenylpropylamine
2- phenyl-1-propanamine
FDA declared: “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 Acacia rigidula as the source of BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula. FDA considers these products to be misbranded for this reason, as well.
Under existing law, including the Dietary Supplement Health and Education Act (DSHEA), 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).
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.
According to FDA, BMPEA is also known as:
βMePEA
R-beta-methylphenethylamine
R-beta-methylphenethylamine HCl
Beta-methylphenethylamine
β-methylphenylethylamine
1-amino-2-phenylpropane
2-phenylpropan-1-amine
2-phenylpropylamine
alpha-benzylethylamine
1-phenyl-1-methyl-2-aminoethane
beta-methylbenzeneethanamine
beta-phenylpropylamine
2- phenyl-1-propanamine