Astaxanthin is the most abundant carotenoid pigment found in aquatic animals and the marine environment, and is found in seafoods such as salmon, trout, red sea bream, shrimp, lobster, and caviar. The main astaxanthin isomer (3S, 3S') found in the microalga Haematococcus pluvialis is exactly the same as that found in wild salmon.
As such, astaxanthin has been part of the human diet for centuries. Astaxanthin is responsible for the pigmentation of seafoods such as wild salmon, trout, red sea bream, lobster, and shrimp, and no adverse effects have ever been reported concerning the safety of astaxanthin for either human or animal consumption.
Astaxanthin from the microalga Haematococcus pluvialis has been available to consumers for the last 10 years as a food supplement in Europe, Japan , and the USA , among others.
Synthetic astaxanthin has been used for the last two decades to impart the characteristic pink color to farmed salmon, trout, and red sea bream.
For a review of the differences between natural and synthetic astaxanthin,
Pure astaxanthin (up to 80 mg/kg feed), is generally considered safe by the
FDA for use in salmon diets, resulting in astaxanthin's approved composition of 10 to
15 mg/kg in salmon fillets. Levels of astaxanthin naturally occurring in
seafood, and dietary studies on carotenoids, seafood, and salmon, also suggest
that a daily serving of 5 mg astaxanthin (the quantity in 125 grams of Sockeye
salmon fillet or less than 100 grams of krill), is safe.
A human safety study with Haematococcus pluvialis algal extract containing high levels of astaxanthin was performed by Spiller and Dewell from the Health Research and Studies Center in Los Altos , California in 2003. Thirty-five healthy adults were enrolled in an eight-week randomized, double blind, placebo-controlled trial wherein doses of 6 mg of astaxanthin per day were administered. The results revealed that 6 mg of astaxanthin per day from a Haematococcus pluvialis algal extract could be safely consumed by healthy human adults.
Ono et al. performed an oral toxicity study of Haematococcus pluvialis in rats with four different doses. No adverse effects related to treatment were noted in hematological and histopathological examinations and organ weights examinations. The conclusion was that ingestion of Haematococcus pluvialis in the diet for 13 weeks does not cause any toxicological changes in rats.
The FDA published for Cyanotech a 14-day oral toxicity study in rats consuming Haematococcus pluvialis at doses of up to 6 gr/kg/day. The conclusion was that ingestion of Haematococcus pluvialis in the diet for 14 days was very well tolerated and does not cause any adverse changes in rats.
Another acute oral toxicity study in rats was published by the FDA for Cyanotech, in which Haematococcus pluvialis was administered at 12 gr/kg doses for 14 days.
The results showed the LD 50 to be higher than 12 gr/kg, and no pathological changes were observed.
The FDA published a safety study in humans for Aquasearch (now Mera Pharmaceuticals) in which the safety consumption of Haematococcus pluvialis
was demonstrated by a daily ingestion of up to 19.25 mg astaxanthin per day for 29 days, with no adverse results regarding toxicity or safety.
All of these analyses and tests indicate that no adverse effects on health were observed from Haematococcus algae meal or the CO2 oleoresin as the dietary source of astaxanthin. Haematococcus algae are a safe and natural source of astaxanthin that has been shown to have excellent antioxidant properties beyond those of other carotenoids.