Cardax: safety proven by DSM
In a statement circulated this morning, Cardax refuted NAXA’s allegations that it was piggybacking its ingredient on GRAS and NDI submissions from the companies that produce astaxanthin extracted from Haematococcus pluvialis algae. NAXA has raised questions in the past as to how the safety information that pertains to algal ingredients could be applied to a synthetic form, as it has emphasized the chemical differences between the two forms.
In the statement this morning, Cardax had this to say: “The astaxanthin in ZanthoSyn is AstaSana, a synthetic astaxanthin ingredient manufactured by DSM Nutritional Products, which is part of Koninklijke DSM N.V., a Dutch multinational health, nutrition, and materials company with more than 20,000 employees in 50 countries. DSM self-affirmed GRAS for AstaSana in 2015 Contrary to NAXA's claims, Cardax does not rely on the GRAS designations from any of the microalgal astaxanthin manufacturers.”
DSM has supplied synthetic astaxanthin as a color additive for aquaculture feed for many years and in 2013 started marketing it as a dietary ingredient for dietary supplements at a time when astaxanthin demand had spiked and supply was limited. DSM asserted the safety of the ingredient for this use by referring to the exhaustive testing required in the food additive approval process. As noted in the Cardax statement, DSM subsequently convened its own GRAS panel to vet the ingredient.
“We believe that the astaxanthin in ZanthoSyn has been more extensively safety-tested than microalgal astaxanthin,” the Cardax statement said.
Algal information referred to in past
While Cardax emphasizes in today’s statement that it is relying on the safety data for DSM’s material, it has publicly referred to safety data for algal forms in the past. It had this to say in its in its most recent 10K document, filed in March, 2017: “Astaxanthin has an exceptional safety profile,” which it said was based on “widely available astaxanthin research, peer-reviewed studies, and regulatory filings spanning several decades, including FDA GRAS and NDI regulatory filings related to microalgal astaxanthin” as well as the DSM information.
In addition to going public about the provenance of its ingredient, Cardax also refuted some of NAXA’s other claims that questioned Cardax’s use of structure function claims and its assertions that its supplement is both “clinically studied” and “physician recommended.” In particular it said that while it is true that the stereoisomer makeup of DSM’s ingredient is different from that of algal astaxanthin, “there is no credible scientific evidence that there is any meaningful biological difference between these astaxanthin isomers, from either a safety or efficacy standpoint.”