Warning letter · FDA Warning Letters

Blue Forest Farms, LLC: FDA Warning Letter 711990 (Sep 11, 2025)

Agency action: Sep 11, 2025Record ID: fda_warning_-d487372d43c42e59
View official source ↗

What happened

Original notice title

Blue Forest Farms, LLC MARCS-CMS 711990, September 11, 2025

From the archived source record

FDA has determined that your products, Amanita Muscaria Microdose Capsules and Amanita Muscaria Magic Potion Tincture, are adulterated under section 402(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(f)(1)(B). Additionally, your Amanita Muscaria Magic Chocolate is adulterated under section 402(a)(2)(C)(i) (21 U.S.C. 342(a)(2)(C)(i)) of the Act. Adulterated Dietary Supplements The labeling of your Amanita Muscaria Microdose Capsules and Amanita Muscaria Magic Potion Tincture declares Amanita muscaria as a dietary ingredient. 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. The introduction of such adulterated dietary supplements into interstate commerce is prohibited under section 301(a) of the Act. Moreover, available information on the use of Amanita muscaria in products raises serious safety concerns. Adulterated Human Foods Based on a review of your product labeling, your Amanita Muscaria Magic Chocolate is a conventional food to which Amanita muscaria has been added. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the Act (21 U.S.C. 348(a)) and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act, 21 U.S.C. 342(a)(2)(C)(i).

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
e5afa4fd1ac3

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Supplement Facts; the Amanita muscaria in your Amanita Muscaria Microdose Capsules; Amanita Muscaria Magic Chocolate; a dietary supplement because your Amanita Muscaria Magic Chocolate product
Company
Blue Forest Farms, LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.