[USA] The Natural Algae Astaxanthin Association (NAXA) has filed a citizen petition with the U.S. Food and Drug Administration (FDA) asking the agency to make the determination that Cardax’s ZanthoSyn product is misbranded and adulterated.
The petition states that ZanthoSyn “does not meet the definition of a ‘dietary supplement'”, and even “if ZanthoSyn is found to meet the definition of ‘dietary supplement’,” NAXA has requested that FDA make the determination that it is a new dietary ingredient (“NDI”). NAXA has found no evidence that Cardax has submitted an NDI notification and the organization believes ZanthoSyn is not exempt from FDA notification, thus causing the product to be adulterated. Further, NAXA has requested that FDA “make a determination that Cardax’s ZanthoSyn product is a drug… because it is intended for use in the cure, mitigation, treatment or prevention of disease and that ZanthoSyn’s synthetic astaxanthin is not generally recognized as safe and effective for its intended uses.”
“We are expecting FDA to take action regarding this matter, as NAXA believes Zanthosyn and Cardax’s activities may potentially pose a risk to consumers, and are a plausible misrepresentation of the status of this product,” notes NAXA President Scott Steinford.
If FDA determines the product is marketed or sold in violation of the law, the agency may take actions including, but not limited to, requiring that Cardax cease distribution of the product, pursuing injunctions against the manufacturers and distributors, and seizing violative products.
“The entire dietary supplement industry and especially single ingredient trade associations have the obligation to self-police,” said Steinford. “This filing was action on behalf of a responsible industry to ensure FDA is aware of this important issue.”
The FDA should provide feedback within 180 days of its acceptance of a citizen petition submission. The complete petition may be accessed here.