The notification, which will be placed on public display at FDA's Division of Dockets Management as new dietary ingredient notification report number 943, lists the use of astaxanthin at a dose that does not exceed 24mg per day for a period of thirty days.
“Based on published studies we generally recommend a dosage of 4mg – 12mg per day over longer periods; however, we are aware that a growing number of people are voluntarily dosing at well over the 12mg upper dosage range,” said Lixin Ding, PhD, Chief Operating Officer of AlgaeHealth.
“In particular, many athletes report that they get better results in the 24mg per day dosage range.”
The company previously had an NDI notification accepted by the FDA for the use of its AstaZine-branded ingredient as a bulk dietary ingredient at a dose that does not exceed 12mg of astaxanthin per day. The new 24mg per day dosage is the first in the Astaxanthin industry over 12mg per day.
Joe Huff, CEO of AlgaeHealth’s North American operation, said the company would have preferred not to have the 30-day stipulation, but it is nevertheless happy to have something new to offer in the US market, and the company is targeting two specific niches:
1. For new users to raise their astaxanthin levels;
2. For athletes during the month leading up to an important event
On the first point, Bob Capelli, EVP Global Marketing for AlgaeHealth, told us that clinical research has shown that most people don’t feel any effects of Astaxanthin for at least two weeks, and data from studies on inflammatory conditions like joint pain have indicated that astaxanthin levels may not be fully realized after one month.
“So we see that it takes time for astaxanthin to concentrate in the body,” he said. “These studies were done at 12mg per day; what we hope to do is accelerate the process by a loading phase and realize the results more quickly. Our theory is that we may be able to get results at 24mg within a month that took 6 – 8 weeks to achieve at 12mg.”
Dosages
The leading products currently on the market are formulated with a range of doses, from 4 to 12 mg per day. Kora Lazarski, Sr. Strategic Alliance Manager for SPINS LLC, told us that Nutrex Hawaii’s BioAstin is responsible for about half the dollar sales in supplements with astaxanthin as a functional ingredient, and the 12mg dosages are outselling the 4mg by almost double.