The Purchase of Agreement was signed with Hong Kong-based Health Elite Club Limited (HECL) for the distribution of ZanthoSyn in China, Hong Kong, Macau, and Taiwan.
"U.S. products with scientific and manufacturing credibility such as ZanthoSyn are highly prized in China," said Li Wu, Chairman of HECL.
Under the deal, HECL will be responsible for all regulatory approvals in the region, and will distribute the product under HECL’s house brand, Puerfons, with all packaging and marketing materials to feature the ZanthoSyn brand.
“We are excited to bring Puerfons ZanthoSyn into this important market," Wu added. “With China's increasing industrialization and associated pollution challenges, inflammatory health, with its relationship to longevity, is increasingly important, especially to its rapidly growing aging population."
Rocky ride for synthetic astaxanthin
Cardax first brought the synthetic astaxanthin finished product to market in 2016 with a test run in Hawaii, where the company is based. It went nationwide in GNC stores in August 2017.
Its launch in 2016 came at a sensitive regulatory juncture—around the same time the FDA updated its guidance on New Dietary Ingredients (NDI), putting the question of bioidentical or synthesized ingredients under the spotlight.
Instead of the NDI route, ZanthaSyn came to market via the Generally Recognized as Safe (GRAS) affirmation pathway. In a previous interview with NutraIngredients-USA, CEO David Watumull said the form of astaxanthin used in ZanthoSyn has demonstrated “excellent safety in peer-reviewed published studies and is designated as GRAS in accord with FDA regulations.”
The ingredient has come under attack by manufacturers of algae-derived ingredients who came together to form NAXA, or the Natural Algae Astaxanthin Association.
Four months ago, the association filed a citizen’s petition that sought regulatory action by FDA against the synthetic form of astaxanthin marketed by Cardax, claiming that the ingredient is not a legal dietary ingredient. If the FDA disagrees and determines that it is, then the ingredient should be subject to NDI provisions, the petition asserted.
Cardax refuted NAXA’s allegations in December, saying that the astaxanthin in ZanthoSyn is AstaSana, a synthetic astaxanthin ingredient manufactured by DSM Nutritional Products, and has been self-affirmed GRAS since 2015.
Other than a letter from the FDA acknowledging it has received NAXA’s citizen petition, there has been no recent activity on the matter.