BioAstin NDIN Clears FDA

KAILUA-KONA, HawaiiCyanotech announced it received a letter of no objection" from FDA regarding its new dietary ingredient notification (NDIN) for a 12-mg/d dose of BioAstin Hawaiian Astaxanthin; most astaxanthin is supplied at 4mg/d to 7.8mg/d dosages. Previously, FDA allowed the use of astaxanthin up to 7.8mg per daily serving.

GRAS Associates, a consulting firm based in Bend, OR, developed the NDI dossier; the firm had previously worked with Cyanotech to obtain GRAS (generally recognized as safe) status for BioAstin for food and beverage applications. Cyanotech is sponsoring a public relations (PR) and social media campaign to capitalize on the successful NDIN, and is already prepared with several top-quality softgel encapsulation partners to offer BioAstin in a 10 mg one-per-day softgel.

According to Cyanotech, a daily serving of 4mg  to 8mg is fine for most people, but for people with certain conditions or individuals whose bodies absorb carotenoids poorly, higher levels are indicated. For example, most of the human clinical research on astaxanthin showing efficacy for joint and tendon problems was done at 12mg per day.

Astaxanthin has been gaining popularity due in part to Dr. Mehmet Ozs praise of the antioxidant on his television show.