Acacia rigidula still popping up on market
The Food and Drug Administration recently sent a warning letter to a New Jersey company called Natural General Nutrition citing the fact that the company marketed a product containing the ingredient. FDA cited the company for having a New Dietary Ingredient for which there is no notification on file. Acacia rigidula is a bush-like plant native to Texas and northeastern Mexico and purported extracts of the plant have appeared in weight management and pre-workout products.
BMPEA issue sidestepped
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 a paper published in the journal Drug Testing and Analysis, Dr. Pieter Cohen of Harvard and his co-authors found BMPEA in 11 of 21 supplements tested that listed Acacia rigidula as an ingredient (the rest had no detectable amount of BMPEA).
Importantly, the agency made no mention of BMPEA in its warning letter to Natural General Nutrition and focused exclusively on A. rigidula.
The agency said the offending product sold by Natural General Nutrition was adulterated because, “it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”
Ingredient finds its way onto market
FDA cited Natural Generation Nutrition for a number of labeling violations as well, but the Acacia rigidula issue formed the bulk of the letter. Supplements that contain ingredients that have little or no case to make as an ODI continue to crop up in the market. Attorney Marc Ullman, of counsel with the firm Rivkin Radler, said the low barriers to entry and insufficient penalties means that many more will likely crop up in the future.
“It’s FDA playing whack-a-mole,” Ullman told NutraIngredients-USA. “When the consequence is just getting a warning letter I would expect it to continue like this.
“I would suspect that this stuff is still coming into the country. My guess is that it is not manufactured here. The resources aren’t there to inspect every shipment,” he said.