FDA warns companies with products listing Acacia rigidula as a dietary ingredient

15-Mar-2016 - Last updated on 31-Mar-2017 at 16:44 GMT

The US Food and Drug Administration has issued five warning letters about products containing Acacia rigidula, which it considers a new dietary ingredient (NDI) lacking a successful NDI notification.

The FDA issued five warning letters to six companies regarding a total of six products, which it states are adulterated because A. rigidula has not satisfied the conditions regarding the use of the ingredient as an NDI.

“Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the 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 lacks evidence of safety) or misbranded (e.g., that the labeling is false or misleading),” wrote the FDA on its What's New in ‎Dietary Supplements webpage.

The warning letters were sent to: Nubreed Nutrition, Inc; Ronnie Coleman Signature Series/ Rcba Nutraceuticals LLC; Achieve Health, LLC; Legendary Nutrition , LLC; Journey Health USA, LLC.

BMPEA & A. rigidula

Interest in A. rigidula-containing supplements goes back several years and is linked to the controversial compound BMPEA (beta-methylphenylethylamine). The plant has been cited as a natural source of BMPEA, but a 2014 study by FDA scientists (Journal of Pharmaceutical and Biomedical Analysis, Vol. 88, pp. 457-466) concluded: “Given the low natural abundance of PEA in the plant materials, it appears nearly impossible to achieve the amounts of [BM]PEA found in the dietary supplements by formulating them with plant material or extracts of A. rigidula. [BM]PEA, a positional isomer of AMP, was found in 9 of 21 dietary supplements analyzed at levels ranging from 963 to 60,500 micrograms per gram. We found no safety data on the biological effects of this isomer in humans.”

This was followed by a paper in Drug Testing and Analysis by Dr Pieter Cohen et al, which found BMPEA in varying quantities in 11 of 21 dietary supplements tested whose formulations were listed as being based on Acacia ridigula extracts.

Following Cohen’s paper US Senators Dick Durbin, D-IL and Richard Blumenthal, D-CT and well as US Sen. Chuck Schumer, D-NY, called on FDA to ban BMPEA.

In addition to the warning letters about A. rigidula, the FDA has sent warning letters to five companies over their use of BMPEA. The Agency only sent letters to company with BMPEA listed on the products labels, because FDA considers BMPEA to not be a lawful dietary ingredient, and therefore products containing it are considered adulterated. Those warning letters did not address whether A. rigidula is a legal dietary ingredient. The new warning letters answer that question.

The companies receiving the A. rigidula letters 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.

“The warning letters also caution the companies that the FDA may take further enforcement action without warning if they do not immediately cease distribution of the products,” said the FDA on its What's New in ‎Dietary Supplements webpage.

According to the Dietary Supplement Label Database (DSLD), there are 30 products containing "rigidula" anywhere on the label.