All AstaPure® , natural astaxanthin product forms are generally recognized as safe (GRAS) by the US FDA for food and beverage applications. Astaxanthin from Haematococcus pluvialis is found naturally in many fish and crustaceans. It has been consumed by humans for thousands of years without any known adverse effects.
The FDA first approved astaxanthin produced from Haematococcus pluvialis for use as a human dietary supplement in 20051. The European Food Safety Authority (EFSA) evaluated in vitro genotoxicity tests, indicating that H. pluvialis biomass and natural astaxanthin are not genotoxic2.
Various clinical trials have been conducted to determine the bioavailability, distribution, metabolism and pharmacological effects of astaxanthin in humans. In a review of these studies, EFSA concluded that no clinically relevant changes or adverse effects were observed after human consumption of astaxanthin-rich ingredients from H. pluvialis at daily doses of 2–40 mg for 10–90 days3. From the safety literature published, we can conclude that there is no indication that modest4 astaxanthin supplementation poses a risk to human health.
1 Department of Health and Human Services Memorandum.
2 EFSA, 2014; Takahashi et al., 2004.
3 EFSA, 2014.
4 European Commission acceptable daily intake (ADI) for astaxanthin is 0.034 mg/kg in body weight/day or 2.4 mg/day for a 70 kg (155 lb.) person.