Another Lab Wants Permission to Import Controlled Substances
Published Date: 11/26/2025
Notice
Summary
Irvine Labs, Inc. wants to become an official importer of some powerful controlled substances like LSD and marijuana extracts. People who make or use these drugs can share their thoughts or ask for a hearing by December 26, 2025. This move could shake up the drug import scene and might affect businesses dealing with these substances.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
No Finished Dosage Forms for Commercial Sale
The notice explicitly says authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. Approval will be limited to activities authorized under 21 U.S.C. 952(a)(2).
Irvine Labs Seeks Importer Registration
Irvine Labs, Inc. applied on October 6, 2025 to be registered as an importer of multiple Schedule I substances (examples listed include lysergic acid diethylamide (LSD), psilocybin, psilocyn, DMT, mescaline, peyote, and marijuana extracts). The company says it would import bulk substances to support internal research, clinical trials, analytical purposes, and distribution to its customers.
Marijuana Imports Limited to Raw Material & Extracts
For drug codes Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370), Irvine Labs plans to import raw plant material and extracts only, and the notice says no other activities for these drug codes are authorized for this registration. That means the registration would not authorize other marijuana-related import activities beyond raw material and extracts.
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Key Dates
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Previous / Next Documents
Previous: 2025-21174 — Bulk Manufacturer of Controlled Substances Application: Irvine Labs, Inc.
Irvine Labs, Inc. wants to become a big-time maker of marijuana and related substances for research. People already registered or interested can share their thoughts or ask for a hearing by January 26, 2026. This move could boost research supplies but won’t affect other drug activities or costs right now.
Next: 2025-21176 — Importer of Controlled Substances Application: Organic Standards Solutions International, LLC
Organic Standards Solutions International, LLC wants to become an official importer of certain controlled substances, like marijuana extract. People and companies involved with these substances can share their thoughts or ask for a hearing by December 26, 2025. This move could shake up who gets to bring these substances into the U.S., but no costs or changes are announced yet.