Algae Life is a subsidiary of Chinese ingredient manufacturer BGG. In the past year the company has brought to full capacity a closed-tube facility in Yunnan Province in southwestern China for the cultivation of Haematococcus pluvialis. AstaReal, itself a subsidiary of Japanese company Fuji Chemical Co has is own closed growth system for the algal species at a newly expanded facility in Moses Lake, WA.
Strains in the astaxanthin sector
AstaReal was one of the founding members of NAXA, the Natural Algae Astaxanthin Association, a group of ingredient and finished goods manufacturers that came together to bolster the case for the algal forms of astaxanthin in an effort to distinguish it from the less expensive, chemically synthesized forms. BGG became a member last year.
Strains have been showing in the nascent organization, and AstaReal made the decision earlier this year to withdraw from the group. While AstaReal characterized the breakup as cordial, the company did say that it believed continued membership would imply that all members are making astaxanthin of similar quality, whereas the company has strongly implied that some astaxanthin produced by other members is inferior.
In May, AlgaeLife said it had submitted 241 claims on astaxanthin to FDA, and that 239 of the structure/function claims had made it through the notification period without objection from the agency.
The claims focus on ten health benefit categories, including: Eye health; brain health; skin health & UV exposure, anti-aging / DNA & cellular health; anti-inflammatory / joint, tendon & muscle health; athletes & energy; cardiovascular health; immunity; and antioxidant [the tenth is male fertility but that is not included in the structure-function claim list].
“We’ve been working for months to attain this landmark achievement which now makes us the leader in this critical marketing category,” Bob Capelli, EVP of global marketing for Algae Life Sciences, said at the time.
Overstating the case?
AstaReal cried foul at the wording of Algae Life’s press release, and said that it implied that the agency had done more than it really had.
“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 for AstaReal.
AstaReal warned potential Algae Life customers that they still must do their own due diligence on whatever claims they might want to make on their products, issuing what they called “a caution to retail manufacturers of their legal obligations to evaluate their astaxanthin label claims based on the facts and their own substantiation reviews.”
AstaReal also criticized Algae Life for referring to scientific studies that were conducted on ingredients supplied by other companies and with those companies’ support, including studies done by AstaReal itself.
Partners in astaxanthin promotion
Algae Life’s Capelli responded with this 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.
“BGG is fully dedicated to increasing the critical mass of published research on the many health benefits of Natural Astaxanthin; for example, we are currently wrapping up a BGG-funded, multi-pronged human clinical trial and expect to publish the results later this year. We look forward to sharing our results with everyone in the Astaxanthin industry.”
Truth in claims
Attorney Ivan Wasserman said that when ingredient suppliers provide support to clients on marketing claims it is important to not overstate what FDA has communicated. “FDA approved” is an example of a common error or infraction of this sort.
“You can’t be misleading in what the agency has done or hasn’t done,” he said. “You could make a claim that is true but do it in a way that implies more than what the agency has actually done.”
Wasserman said that is is also important to note that when FDA reviews structure function claims it looking for the answer to one question: Disease claim? Or no? In the case of the claims that Algae Life submitted, the absence of an FDA objection on 239 of them means the agency believes those claims do not step over the line into drug claim territory. Nothing more.
“FDA does not evaluate the substantiation of a claim,” Wasserman said.
And this ‘allowance’ does not absolve the marketer of a product from the responsibility to submit any potential claims language to the agency on products that feature Algae Life’s astaxanthin. What the supplier has done has merely provided a road map for that process, he said.