Generally Recognized as Safe (GRAS) is a United States Food and Drug Administration (FDA) designation indicating that an ingredient is safe for use in human food products. It means that an ingredient has been rigorously tested to ensure that it has no toxic effects when regularly consumed as food.

It should be noted that FDA GRAS data recommends the maximum concentration of beta caryophyllene for use in food, whereas Nápreva contains the same material in a more concentrated form. However, pre-clinical toxicity studies indicate that for proposed therapeutic use, much higher concentrations have proven to have no toxic side effects – such as rash, nausea, dizziness or more significant effects on kidneys, liver or the GI system. For the key active ingredient in Nápreva, a serving of as much as 700 - 2000 mg per kilogram of body weight produced no toxic effects.  A single serving of Nápreva contains just a very small fraction of that amount.

To further ensure the safety of Nápreva products, we have conducted pre-clinical animal tests for toxicity and have observed none.

In real-world use, FDA data indicates that one of Nápreva’s primary active ingredients, beta caryophyllene, is found in 80 different food additives. This includes spices like cloves and black pepper, as well as food products containing concentrated flavorings from cloves, black pepper and other herbs and spices used as flavoring.

The possible average daily intake from regularly consumed foods and beverages is estimated to be >10 mg. The same data indicates that there are no known adverse side effects.  The suggested serving of Nápreva is 1 ml once or twice a day.

In contrast, popular supplements like ginkgo biloba, melatonin and red yeast rice do not have GRAS status. Although ginseng and caffeine are GRAS, many products have been investigated and pulled from the market by the FDA for having high concentrations that grossly exceed GRAS recommended use. Substances such as caffeine, vitamin E and turmeric, when taken in excessive doses for prolonged periods of time, have demonstrated toxic effects.

While GRAS status doesn’t completely replace FDA-compliant clinical testing, using ingredients within FDA GRAS guidelines help to ensure that products are safe.

Learn More:

FEMA GRAS Assessment  chromeextension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.femaflavor.org/sites/default/files/Adams%20et%20al.%2C%202011%28terpene%20hydrocarbons%29.pdf

Toxicological Evaluation of β-Caryophyllene Oil  https://pubmed.ncbi.nlm.nih.gov/27358239/