Blue Forest Farms, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

A dietary supplement is adulterated under section 402(f)(1)(B) of the Act (21 U.S.C. 342(f)(1)(B)) if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Based on our evaluation of the relevant safety evidence, there is inadequate information to provide reasonable assurance that *Amanita muscaria* does not present a significant or unreasonable risk of illness or injury. Therefore, your dietary supplements containing *Amanita muscaria* are adulterated under section 402(f)(1)(B) of the Act.

Passage 2

There is no food additive regulation that authorizes the use of *Amanita muscaria*. We are not aware of any information to indicate that *Amanita muscaria* is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that *Amanita muscaria* is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).