Safety

Fuji's Commitment to Safety

Astaxanthin, either as a purified Haematococcus pluvialis extract or in algal biomass, has been evaluated in multiple studies to determine its potential for adverse effects and genotoxicity. The study type, study design, test material and finding are summarized in the following tables.

AstaREAL® and Clinical Studies

The clinical database for AstaREAL® includes 25 human studies (15 double-blind, placebo-controlled trials) with more than 840 subjects undergoing treatments lasting from 2 weeks to 6 months. The doses used in these trials ranged from 2 to 45 mg/person/day. The trials were designed to investigate the safety and tolerance for AstaREAL® astaxanthin using different doses, treatment periods, research design and demographic variables including age, gender and ethnicity. All studies revealed No Observed Adverse Effect Level (NOAEL) based on hematological, serum chemistry, urinal analysis and self-report questionnaires. A summary of clinical trial designs, doses and adverse effects noted in these investigations is presented in Table 3-4. A double-blind controlled study conducted in Japan in 2010, 15 healthy adults' subjects ingested 45mg/daily of AstaREAL® Astaxanthin for 4 weeks - 7 times higher than the suggested dose of 6mg/daily.
The study revealed NOAEL on all standard examination parameters including eye intraocular pressure (review on Kajita et al., 2010).

AstaREAL® and Acute/Subchronic Test

The animal toxicological studies database for AstaREAL includes 11 trials ranging from single dose to 90-day subchronic test. The doses used in these trials ranged from 400 to 2000mg/kg. All studies revealed NOAEL. A summary of clinical trial designs, doses and adverse effects noted in these investigations is presented in Table 1-2. In vivo micronucleus test was conducted on mice after ingesting 2000 mg/kg of AstaREAL® in a single dosage (Takahashi et al. 2009). The study revealed NOAEL on food consumption, body weight, hematology, clotting, or detailed pathology and clinical observations. When tested for genotoxicity, there was no evidence for mutagenicity in Ames/Salmonella assays. Furthermore, subsequent in vitro study showed no induction of chromosome aberration and no mutagenicity effects. In a teratology study, rabbits, after ingesting 400mg/kg, revealed no maternal embryo-toxic or teratogenic effects over the gestational period.

AstaREAL® Safety Conclusion

A comprehensive set of studies in both animals and humans clearly constitute a sufficient database to evaluate the potential toxicity of astaxanthin in extracts or algal biomass. The lack of any toxicological findings from any study on astaxanthin is supportive of a reasonable expectation of safety from its recommended use. Furthermore, an independent expert, Harry G. Preuss M.D. of Georgetown University Medical Center, has reviewed the available literature through 2001 on the safety of astaxanthin. In his report, Dr. Preuss evaluated dietary, animal toxicity and human studies. His report concluded that astaxanthin, when used in proper doses, is safe and deserves no more safety concerns than the use of other carotenoids.

Table 1. Animal Toxicological Studies Conducted Using Astaxanthin Biomass

Table 2. Animal Toxicological Studies Conducted Using Astaxanthin Extract

Table 3. Human Studies Astaxanthin Biomass

Table 4. Human Studies with Astaxanthin Extract