Safety of Prevagen

Prevagen contains apoaequorin which has been shown to have a positive relationship with cognitive function in clinical and non-clinical studies. Apoaequorin was originally discovered in jellyfish and is now produced at a cGMP compliant facility.

Food and Chemical Toxicology

The safety studies conducted on the toxicity and allergenicity of apoaequorin in clinical and non-clinical studies, show that apoaequorin had no observed adverse effect on general appearance and condition of animals, following subchronic administration of amounts up to 667mg per kilogram of body weight per day.1 This was the maximum dosage that was tested. Researchers concluded,

“The administration of the Apoaequorin preparation did not result in any mortality. There were no further clinical or opthalmological signs, body weight, body weight gain, food consumption, food efficiency, clinical pathology, or histopathological changes attributable to administration of Apoaequorin.”2

Dosing in the study was the equivalent of 4,000 times the recommended daily amount of Prevagen 10mg and 2,000 times the recommended daily amount of Prevagen Extra Strength 20mg. There was No Observed Adverse Effect Level (NOAEL) at the highest dose.

Apoaequorin achieved self-affirmed GRAS status (generally recognized as safe) after an independent panel of expert scientists concluded that apoaequorin is safe for use in food products.
You can read this notification on the FDA website.


References:

1. Marone, P.A., Bauter, M., Hofman-Hüther, H., and Moran, D. (2013). Safety assessment of Apoaequorin preparation: Subchronic toxicity study in rats. Food and Chemical Toxicology 57. Research was conducted by Eurofins/Product Safety Labs under the advisement of Soni and Associates, Inc. Funding provided by Quincy Bioscience.

2. Marone, P.A., Bauter, M., Hofman-Hüther, H., and Moran, D. (2013). Toxicologic Evaluation of Apoaequorin. Poster presented at the Society of Toxicology Annual Meeting, San Antonio, Texas. Research was conducted by Eurofins/Product Safety Labs under the advisement of Soni and Associates, Inc. Funding provided by Quincy Bioscience.