FDA continues finding products marketed as dietary supplements but containing the botanical acacia rigidula nearly a year after the agency identified the ingredient as the synthetic stimulant BMPEA.

Warning letters to six firms published March 15, like others FDA has submitted since April 2015, explain that acacia rigidula needs approval through a new dietary ingredient notification but is unlikely to be determined as safe, enforcement that the Council for Responsible Nutrition and American Herbal Products Associations commend.

The agency sent warning letters on March 7 to six firms, though it identified five because the sixth had not confirmed receiving the warning before the announcement was made. The five and the products found to contain acacia rigidula, a shrub native to Texas also known by the names vachellia rigidula, chaparro prieto and blackbrush, are:

Legendary Nutrition LLC , Jonesboro, Ark., Thermotropin
Ronnie Coleman Signature Series/Rcba Nutraceuticals LLC , Boynton Beach, Fla., Beta-Stim 45 Scoops
Nubreed Nutrition Inc. , Troy, Mich., Undisputed
Journey Health USA LLC , Austin, Texas, Journey To Weight Control
Achieve Health LLC , Biloxi, Miss., Achieve Energy

Journey Health USA also was warned about the use of banned ingredient ephedra. The firm's product label listed ephedra extract as an ingredient.

Each letter from FDA's Center for Food Safety and Applied Nutrition explained that the agency considers acacia rigidula a dietary ingredient that was not marketed in the US before the grandfather date set by the Dietary Supplements Health and Education Act for use in supplements without pre-market notification to the agency.

CFSAN Office of Compliance Director William Correll states that FDA has found no information demonstrating that acacia rigidula was marketed as a dietary ingredient in the US before Oct. 15, 1994, nor that it has been present in the human food supply in a form in which it has not been chemically altered.

Additionally, acacia rigidula likely would not be allowed for use in supplements "even if the required notification had been submitted," Correll stated in the letters. "In the absence of a history of use or other evidence of safety establishing that A. rigidula extract, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe."

Firms are not required to wait for FDA to respond to NDI notifications before marketing supplements containing the ingredients and the agency does not approve notifications, but advises firms whether their submissions were filed or did not support safe use of the ingredient as indicated. Like firms marketing products with NDIs that have not been notified to the agency, FDA can force firms to withdraw from the market products with ingredients described in notifications that are rejected.

Although the introduction of NDIs is a key for expanding supplement firms' offerings and driving sales growth, FDA has yet to publish a guidance on data needed to support NDI notifications. A draft guidance published in 2011 was met with universal criticism by the industry as imposing standards outside of DSHEA and FDA, after industry allies on Capitol Hill asked, began revising the guidance in June 2012; it remains in progress ([A#05150302008]).

“If the FDA believes it is a new dietary ingredient, the agency has to take a first step, make this first pronouncement as it did with these warning letters,” said AHPA President Michael McGuffin in an interview.

“The burden now shifts to the companies to find these pre-1994 documents,” which could include proof of sale, manufacturing records, the purchase of the ingredient or evidence of marketing, he said. AHPA records, however, do not show that acacia rigidula was marketed before 1994, McGuffin added.

The Supplement Facts label of Nubreed Nutrition's Undisputed supplement lists the ingredient acacia rigidula, which FDA says is not a dietary ingredient and which is linked to the synthetic stimulant DMBEA.

Duffy MacKay, CRN's senior vice president of scientific and regulatory affairs, commented in an email that companies marketing dietary supplements that contain NDIs without pre-market notification to FDA should know better.

“There is no excuse for companies not to file NDI notifications with FDA. FDA made its position on this ingredient clear and provided the industry ample time to come into compliance,” he said.

MacKay added any firm that fails to submit an NDI notification or that spikes acacia rigidula-labeled products with the stimulant beta-methylphenethylamine, or BMPEA, “should be held accountable and penalized.”

FDA's history of enforcing against acacia rigidula-containing supplements has not always elicited stakeholders' praise. Researchers in April 2015 published a study on finding BMPEA in 11 of 21 supplement products they tested that were labeled as containing acacia rigidula. They also noted that FDA also found BMPEA in acacia rigidula-labeled products in research published in 2013, but had yet to enforce against products containing the ingredient ([A#05150413006]).

However, less than a month later the agency sent warning letters to firms selling eight products containing BMPEA, including two with labels identifying the source of the substance as acacia rigidula. FDA said at that time that research establishes that BMPEA is not a constituent or extract of acacia rigidula ([A#05150427010]).

One of the firms targeted in those letters – Hi Tech Pharmaceuticals Inc. – also was identified as a source of BMPEA-containing supplements in the study that criticized the enforcement and filed a complaint alleging defamation against the researchers. However, a federal judge in Georgia dismissed the complaint earlier in March.

MacKay said CRN urges that when FDA finds an indication consumer safety is compromised, it should take action to remove products.

“Having rogue companies, who blatantly ignore the law and continue to tarnish the reputation of the dietary supplement industry, underscores the importance of the responsible, mainstream industry coming together to create initiatives that help consumers avoid illegal products and help FDA identify bad actors,” he said.

Acacia Rigidula Found In More Supplements; FDA Warns Six Firms

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