The warning letter was issued to a company that does business as Condemned Labz. The parent company, Supplement Science Corp., is based in Brooklyn, NY.
The warning letter, which like many such letters issued during the global pandemic arose from a review of the company’s website, not a physical inspection, cited a long list of allegedly impermissible disease claims. FDA alleged in the letter that the company was claiming to treat diabetes and relieve pain via the statements and testimonials it published on its website.
In addition, the company allegedly was promoting the use of higenamine in one of its products for its use as a bronchodialator.
Higenamine in news since at least 2018
Prominent industry critic Dr Pieter Cohen, MD, of Harvard Medical School, called higenamine into question in a 2018 paper published in the journal Clinical Toxicology. John Travis, PhD, of NSF International, and others, including researchers associated with the Dutch National Institute for Health and the Environment were listed as coauthors. The report analyzed the contents of 24 supplements that were labeled to contain higenamine or one of its synonyms, such as norcoclaurine or demethylcoclaurine.
Higenamine, according to the authors, is a stimulant ingredient that can be isolated from several botanical sources, including Aconitum carmichaelii and Nandina domestica. The authors said it “has beta-agonist activity with chronotropic and inotropic properties.”
In 2018 higenamine was a fairly new entrant on the list of dietary supplement ingredients. It seems to be part of the constant churn of new ingredients in the sports and weight loss categories, Travis said at that time. As stimulant ingredients are discredited or banned outright, product developers move on to others.
“I heard whispers about it right after the DMBA paper came out,” Travis told NutraIngredients-USA in 2018. “A raw material supplier came to us asking about it, though they were using one of the synonyms. I think it’s fair to say that this is the ‘next new thing’ after DMBA.”
FDA has since placed higenamine on its Dietary Supplement Ingredient Advisory List. The World Anti Doping Agency (WADA) has also added it to its list of banned ingredients.
Adulteration because of lack of NDIN
FDA noted in the warning letter to Condemned Labz that while higenamine might qualify on its face as a dietary ingredient, it is a New Dietary Ingredient. No company has filed an NDI Notification on this substance, meaning any product that contains it is de facto adulterated. This was the reasoning behind an import alert FDA issued on the substance earlier this year. As part of that enforcement action FDA seized products from two Chinese manufacturers as part of its Detention Without Physical Examination authority.