Algae Life Sciences recently announced it had 239 “FDA-allowed” structure-function claims for its AstaZine astaxanthin ingredient. But its competitor, AstaReal, challenges the significance of these claims.
Astaxanthin supplier AstaReal (Burlington, NJ) is challenging the significance of the 239 “FDA-allowed” structure-function claims recently announced by its competitor, Algae Life Sciences Inc. (Irvine, CA). Rather than the “landmark achievement” depicted by Algae Life Sciences, AstaReal said the claims are neither brand-specific nor officially “allowed” by FDA.
Algae Life Sciences, a subsidiary of BGG, first shared news of the claims in May, when it announced that it had submitted to FDA 241 variations of claims for its AstaZine astaxanthin ingredient. The structure-function claims covered health areas including skin health, brain health, joint health, eye health, muscle health, cardiovascular health, and more. Of the 241 submitted claims, Algae Life said 239 made it through the comment period without receiving objections from FDA-a development Algae Life billed as “239 FDA-allowed structure/function claims.”
“We’ve been working for months to attain this landmark achievement, which now makes us the leader in this critical marketing category,” said Bob Capelli, executive vice president of global marketing for Algae Life Sciences, in the original claims announcement.
AstaReal Cries Foul
But earlier this week, AstaReal issued a pointed response to the claims news from Algae Life Sciences. In particular, the rival astaxanthin supplier raised concerns with the phrase “FDA-allowed.”
“It is our understanding that the FDA does not ‘allow’ the use of structure/function claims merely because a company submitted a notification letter, and that the receipt or non-receipt of a ‘courtesy letter’ does not in any manner indicate that a submitted claim has been ‘allowed’ by the FDA,” said Joe Kuncewitch, national sales manager, AstaReal.
AstaReal also said that FDA requires structure-function claims notifications be submitted for each specific brand name that will carry the claim, whereas the claims submitted by Algae Life Sciences were written for generalized astaxanthin. Submitting a generalized structure-function notification without a specific brand name, Kuncewitch added, is “a meaningless act.”
AstaReal warned that astaxanthin manufacturers should properly research astaxanthin label claims and consult legal counsel, as it is often manufacturers, not suppliers, that are on the hook if structure-function claims are ever challenged by FDA, FTC, or other contesting parties.
On top of questioning the significance of the Algae Life claims, AstaReal also criticized Algae Life for citing scientific studies conducted on astaxanthin ingredients supplied by other companies, including AstaReal, without providing appropriate attribution.
Algae Life Responds
In response to AstaReal’s criticism, Algae Life’s Capelli issued the following statement:
“We never claimed the submitted information was uniquely the property of BGG and used supporting data available in the public domain. We join the industry in thanking all the many companies, manufacturers, and health professionals that join us in bringing an increased public knowledge of astaxanthin’s benefits which we highlighted through our correctly submitted FDA filing.”
Capelli added that BGG is committed to increasing the body of research on astaxanthin's health benefits, including results of a BGG-funded, multi-pronged human clinical trial that BGG expects to be published by the end of 2016.
"We look forward to sharing our results with everyone in the astaxanthin industry who, like BGG, wants to increase consumer awareness of this remarkable, health-giving nutrient," Capelli said.
Nutritional Outlook Magazine