False and baseless assertions about our dietary supplement ZanthoSyn® have recently been in the news, so we want to set the record straight about its anti-inflammatory health benefits, safety, and regulatory status. Promoting the health and well-being of our consumers is and always will be our paramount focus at Cardax. It is in this spirit that we wanted to share with you the following information about this pure and highly absorbed form of astaxanthin that is recommended by healthcare professionals for inflammatory health and longevity.*
ZanthoSyn® is supported by more than 1,500 peer reviewed papers and 50 proof-of-concept human clinical studies, and the product carries a GRAS (Generally Recognized as Safe) safety designation in accordance with Food and Drug Administration (FDA) regulations. Moreover, ZanthoSyn® offers superior purity and absorption advantages compared to microalgal astaxanthin.*
We’ve compiled the following key points about ZanthoSyn®’s composition, safety, and regulatory compliance:
- The astaxanthin in ZanthoSyn® is Generally Recognized as Safe (GRAS).
The astaxanthin in ZanthoSyn® is AstaSana™, a synthetic astaxanthin ingredient manufactured by DSM Nutritional Products (DSM), 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 (see DSM Astaxanthin GRAS Press Release). Cardax does not rely on the GRAS designations from any of the microalgal astaxanthin manufacturers.
- The astaxanthin in ZanthoSyn® has robust safety data.
The astaxanthin in ZanthoSyn® (AstaSana™ from DSM) has been extensively safety-tested and these data are publicly available (see DSM Astaxanthin Short Safety Summary). We believe that the astaxanthin in ZanthoSyn® has been more extensively safety-tested than microalgal astaxanthin. The DSM Astaxanthin Short Safety Summary also supports the labeled ZanthoSyn® astaxanthin dosage.
- ZanthoSyn® does not need an NDI notification.
Synthetic copies of natural substances that are present in the human diet as food additives (including those that are self-affirmed as GRAS for direct addition to food) may be used as dietary ingredients in dietary supplements without New Dietary Ingredient (NDI) notification, in accordance with FDA regulations (see FDA Official Clarifies Agency’s Position on NDI Filing Exemption). The astaxanthin in ZanthoSyn® (AstaSana™ from DSM) has been present in the human diet for over 20 years, having been approved by the FDA in 1995 for use in the feed of animals to be consumed by humans; AstaSana™ was also self-affirmed GRAS for use in human food in 2015. Therefore, it is suitable for use as a dietary ingredient in dietary supplements without NDI notification.
- The ZanthoSyn® label correctly states that astaxanthin is “clinically studied.”
Astaxanthin has been clinically studied and the active ingredient in ZanthoSyn® is astaxanthin. Both ZanthoSyn® and microalgal astaxanthin deliver astaxanthin to the bloodstream. Cardax demonstrated in a human clinical study that ZanthoSyn® is more orally bioavailable than BioAstin® (microalgal astaxanthin), as measured by the levels of astaxanthin in the blood stream (see ZanthoSyn® Absorption Human Clinical Study). ZanthoSyn® does have a different isomeric mix than microalgal astaxanthin: microalgal astaxanthin consists mostly of the 3S,3’S optical isomer of astaxanthin and ZanthoSyn® is a mixture of 3S,3’S, 3R,3’R, and the meso forms of astaxanthin. All of these isomers are found in nature, and there is no credible scientific evidence that there is any meaningful biological difference between these astaxanthin isomers, from either a safety or efficacy standpoint.
- ZanthoSyn®’s “anti-inflammatory” structure/function claims are fully compliant with FDA regulations.
The FDA is very clear that the phrase “anti-inflammatory” is permitted, provided it is in context with a structure/function claim. (Please see FDA Guidance on Structure Function Claims and refer to the specific guidance regarding an anti-inflammatory claim in Criterion 5: “…claiming to be […] an anti-inflammatory […] will not be a disease claim if there is context that makes clear that the intended effect of the product is on structure/function and not disease.”) Cardax provides the appropriate structure/function context in ZanthoSyn®’s product labeling and sales materials.
- ZanthoSyn® is endorsed by physicians.
Prominent physicians and other healthcare professionals recommend ZanthoSyn® to their patients based on the underlying science of astaxanthin and the superior purity and absorption advantages of ZanthoSyn® compared to microalgal astaxanthin. Cardax has conducted intensive educational meetings on ZanthoSyn®/astaxanthin with well over 250 physicians and other healthcare professionals—many of whom are using ZanthoSyn® themselves.
If you have any questions about ZanthoSyn®, please contact us in either of the following ways:
* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.