FDA seizes Chinese imports due to NDI status
The alert, which was issued on Friday, covers the products of two Chinese companies. In both cases, Chinese companies have listed the products as higenamine, a stimulant. The products were seized under the detaining authority without a physical examination by the FDA. Companies can apply for the release of products if they meet certain agency conditions.
Leading industry critic Dr Pieter Cohen, MD, Harvard Medical School, questioned higenamine in a 2018 article published in the journal Clinical toxicologyIn addition to this, you need to know more about it.. John Travis, PhD, of NSF International, and others, including researchers associated with the Netherlands National Institute for Health and Environment, have been listed as co-authors. The report analyzed the contents of 24 supplements labeled as containing higenamine or one of its synonyms, such as norcoclaurin 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 so “has beta-agonist activity with chronotropic and inotropic properties.”In addition to this, you need to know more about it.
In 2018, higenamine was a new addition to the ingredient list of dietary supplements. It seems to be part of the constant flurry of new ingredients in the sports and weight loss categories, Travis said at the time. As stimulant ingredients are discredited or outright banned, product developers move on to others.
“I heard rumors about this right after the publication of the DMBA document”, Travis told NutraIngredients-USA in 2018. “A raw material supplier came to ask us about this, while he was using one of the synonyms. I think it’s fair to say it’s the “next big thing” after DMBA.In addition to this, you need to know more about it.
Higenamine firmly bound to the botanical source
Travis said that unlike DMBA or DMAA, there is no debate about the botanical origins of higenamine. That the higenamine used in the products that Cohen et al. tested came from plants or were synthesized is another issue, which was not addressed in the study. There is also no information on whether the Chinese products seized on Friday are true botanical extracts or synthetic versions.
The two Chinese companies named in the alert are Jingjiang Jiangyang Fine Chemicals Co., Ltd., based in Jiangsu, and Suzhou Win Health International Co., Ltd., based in Dongtai City. Neither company could be reached for comment in time for the publication of this article.
Industry players welcome development
Marc Ullman, lawyer for Rivkin Radler, said the FDA’s decision was welcome. Ullman has long criticized the Agency for its weak enforcement of the NDI provision. Ullman has often argued that if companies could bring new ingredients to market without fear of retaliation, it would deter responsible companies from going through the long, expensive and potentially risky process of submitting an NDI notification.
“This import alert has the potential to be particularly important because it is the first time that the FDA recognizes that non-compliance with the law as it applies to new food ingredients may be the basis for block the importation of a dietary supplement product. Although it took 24 years for the Agency to actually use this authority, the fact that it finally took this kind of step may give hope to the many companies that have complied with the law and completed the notification process for new food ingredients but are forced to compete. with counterfeit products that are imported into the United States every day without fear that the FDA will take action to stop them at the border ”,Ullman said.
“We are delighted if it is used for more than higenamine”,Said Daniel Manufacturer, PhD, President and CEO of the Natural Products Association. “We insisted on this for a while. This is an important part of the statute (DSHEA) which must be fully implemented.In addition to this, you need to know more about it.
Steve Mister, President and CEO of the Council for Responsible Nutrition, said: “CRN commends the FDA for its efforts to prevent illegal ingredients from entering the dietary supplement market. Higenamine was not notified to the agency as a new food ingredient and was identified as a banned substance by the World Anti-Doping Agency (WADA) several years ago. CRN has previously warned consumers to avoid purchasing products containing this ingredient. CRN has also urged higenamine companies and recipients here in the United States to be on alert to end their affiliations with these sources and implement increased testing of incoming ingredients. the import recall is good news and long overdue. “In addition to this, you need to know more about it.