Not federally scheduled; FDA says A. muscaria, muscimol, ibotenic acid are unapproved food additives, unsafe in food.
Verified October 8, 2026Neither A. muscaria, muscimol nor ibotenic acid appears in 21 CFR 1308.11 (eCFR current through Aug. 27, 2026 amendments), so there is no CSA control or federal analogue hook of note. On Dec. 18, 2024 FDA announced a post-market determination that A. muscaria, its extracts and constituents are not GRAS and are unapproved food additives in conventional food. The Sept. 11, 2025 warning letter to Blue Forest Farms extended this to dietary supplements, calling A. muscaria, its extract, ibotenic acid, muscarine and muscimol new dietary ingredients with inadequate safety assurance, and charging capsules, tincture and chocolate as adulterated. This is an agency interpretation enforced case by case, not a rulemaking, so status is 'restricted' rather than 'illegal'; inhaled products (vapes) fall outside the food and supplement authorities. Watch for more warning letters and any DEA or HHS scheduling review.
Today, the U.S. Food and Drug Administration (FDA) issued a letter to food manufacturers that Amanita muscaria ( A. muscaria ), its extracts, and certain of its constituents (muscimol, ibotenic acid, and muscarine) are not authorized for use as ingredients in conventional food.
7ab98a2c6d4fbc64SUMMARY: The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Controlled Substances Code Number (drug code) for 6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-hexahydro-6H-benzo[c]chromen-1-ol (also known as hexahydrocannabinol, and HHC) in schedule I of the Controlled Substances Act (CSA). Although hexahydrocannabinol is not specifically listed in schedule I of the CSA with its own unique drug code, it is a schedule I controlled substances in the United States under drug code 7370 because it meets the definition of tetrahydrocannabinols, a schedule I hallucinogen. Therefore, DEA is simply amending the schedule I hallucinogenic substances list to separately include hexahydrocannabinol. DATES: Effective May 4, 2026. HEXAHYDROCANNABINOL CONTROL: Hexahydrocannabinol (also known as 6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-hexahydro-6H-benzo[c]chromen-1-ol, and HHC) is a synthetic substance that is structurally related to tetrahydrocannabinols. Hexahydrocannabinol is currently controlled in schedule I as a tetrahydrocannabinol. The Agriculture Improvement Act of 2018 (AIA), Public Law 115-334, amended the CSA to remove "tetrahydrocannabinols in hemp" from control. Importantly, the AIA defined the term "hemp" to mean "the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9-tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis." Thus, only tetrahydrocannabinols in or derived from the cannabis plant -- not synthetic tetrahydrocannabinols -- are excluded from control as "tetrahydrocannabinols in hemp." To clarify further, tetrahydrocannabinols produced through chemical conversion, even when hemp derived are considered synthetically produced for purposes of the CSA, do not qualify as "tetrahydrocannabinols in hemp" under the AIA. LEGAL AUTHORITY: This rule is prompted by a letter dated June 9, 2025, in which the Secretariat of the United Nations informed the United States government that hexahydrocannabinol had been added to Schedule II of the United Nations Convention on Psychotropic Substances of 1971 (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. This letter was provoked by a decision at the 68th Session of the Commission on Narcotic Drugs (CND) in March 2025 to schedule hexahydrocannabinol under Schedule II of the 1971 Convention (CND Decision 68/5). After receiving official notice of this decision, DEA sent a letter to the Department of Health and Human Services (HHS) dated October 9, 2025, outlining its intention to specifically list hexahydrocannabinol in schedule I of the Controlled Substances Act (CSA) pursuant to treaty obligations. HHS responded in a letter dated December 3, 2025, that there are no approved new drug applications or investigational new drug applications for hexahydrocannabinol. In addition, HHS concurs with the direct listing and drug code assignment of hexahydrocannabinol in the CSA. As discussed above, hexahydrocannabinol -- by meeting the definition of "tetrahydrocannabinols" and being synthetically produced -- has been controlled in schedule I of the CSA. Therefore, all regulations and criminal sanctions applicable to schedule I substances have been and remain applicable to hexahydrocannabinol. Drugs controlled in schedule I of the CSA satisfy and exceed the required controls of Schedule II under Article 2 of the 1971 Convention. EFFECT OF ACTION: As previously stated, this rule does not affect the continuing status of hexahydrocannabinol as a schedule I controlled substance in any way. This action, as an administrative matter, establishes a separate, specific listing for hexahydrocannabinol in schedule I of the CSA and assigns a DEA drug code for this substance. This action will allow DEA to establish an aggregate production quota and grant individual manufacturing and procurement quotas to DEA-registered manufacturers of hexahydrocannabinol, who had previously been granted individual quotas for such purposes under the drug code for tetrahydrocannabinols. AMENDMENT: For the reasons set out above, DEA amends 21 CFR part 1308 as follows: PART 1308 -- SCHEDULES OF CONTROLLED SUBSTANCES. 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted. 2. Amend Sec. 1308.11 by adding paragraph (d)(115) to read as follows: Sec. 1308.11 Schedule I. (d)(115) 6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-hexahydro-6H-benzo[c]chromen-1-ol (other names: hexahydrocannabinol, HHC) -- drug code 7220.
64f08c44fe0ffc53(d) Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of this paragraph only, the term “isomer” includes the optical, position and geometric isomers): (31) Tetrahydrocannabinols | 7370 (i) Meaning tetrahydrocannabinols, except as in paragraph (d)(31)(ii) of this section, naturally contained in a plant of the genus Cannabis (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis plant, or in the resinous extractives of such plant, and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plant, such as the following: 1 cis or trans tetrahydrocannabinol, and their optical isomers 6 cis or trans tetrahydrocannabinol, and their optical isomers 3, 4 cis or trans tetrahydrocannabinol, and its optical isomers (Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.) (ii) Tetrahydrocannabinols does not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.
8b4490925423972b21 U.S.C. 802(32): (32)(A) Except as provided in subparagraph (C), the term "controlled substance analogue" means a substance- (i) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II; (ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or (iii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II. (B) The designation of gamma butyrolactone or any other chemical as a listed chemical pursuant to paragraph (34) or (35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a controlled substance analogue. (C) Such term does not include- (i) a controlled substance; (ii) any substance for which there is an approved new drug application; (iii) with respect to a particular person any substance, if an exemption is in effect for investigational use, for that person, under section 355 of this title to the extent conduct with respect to such substance is pursuant to such exemption; or (iv) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance. 21 U.S.C. 813. Treatment of controlled substance analogues: (a) In general A controlled substance analogue shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I. (b) Determination In determining whether a controlled substance analogue was intended for human consumption under subsection (a), the following factors may be considered, along with any other relevant factors: (1) The marketing, advertising, and labeling of the substance. (2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose. (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. (4) The diversion of the substance from legitimate channels and the clandestine importation, manufacture, or distribution of the substance. (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. (6) Any controlled substance analogue that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug laws. (c) Limitation For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption.
Amanita muscaria / Muscimol by state · How federal precedence works · Temporary scheduling
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