"Industry Leaders Are Right to Question Hemps Chemically Converted Cannabinoids of Unknown Composition. MMJ Says the Same Questions Must Be Asked of State-Licensed Marijuana Products Granted Federal Schedule III Treatment Without FDA Review," stated Duane Boise CEO MMJ International Holdings.
WASHINGTON, DC / ACCESS Newswire / August 4, 2026 / MMJ International Holdings today called on the cannabis industry to apply evenly the product integrity standards its own leaders are demanding of intoxicating hemp products - and said the April 2026 Marijuana Rescheduling Order granted federal medical classification to an entire category of state licensed products without requiring the evidence those standards exist to produce.
During a recent Trade to Black discussion hosted by Anthony Varrell of The Dales Report, Michael Bronstein, founder and president of the American Trade Association for Cannabis and Hemp, described serious deficiencies in parts of the intoxicating-cannabinoid market: consumers may not know what is in these products, where the ingredients originated, whether established manufacturing practices were followed, whether testing is consistent, or what prolonged exposure may do to the human body. He compared the situation to tobacco during the 1970s and 1980s and warned the industry cannot build its future on the "quicksand" of synthetic and chemically converted cannabinoids.
MMJ's position is that those concerns are well founded - and incomplete.
The federal standard does not stop at the plant
Federal law distinguishes among marijuana, hemp and synthetically derived cannabinoids, and the April 2026 Order itself excludes synthetically derived THC from its Schedule III treatment. But when a product is promoted for pain, sleep, nausea, spasticity or another therapeutic purpose, the federal question is not simply whether the active ingredient originated in a plant. It is whether the finished product has been adequately characterized, consistently manufactured, and demonstrated to be safe and effective for its intended use.
That is the function of the Federal Food, Drug, and Cosmetic Act and the FDA drug-approval process. FDA has already published how a plant-derived preparation may be developed as a medicine. Its Botanical Drug Development guidance addresses botanical raw-material controls, chemical characterization, manufacturing processes, batch-to-batch consistency, stability, nonclinical safety and clinical evidence - the same questions the industry is now asking about intoxicating hemp products.
Applying the questions evenly
The April Order does not require state-licensed marijuana placed in Schedule III to have completed an Investigational New Drug development program. It does not require FDA review of a finished product's chemistry, manufacturing controls, specifications, stability or labeling. It does not require adequate and well-controlled clinical evidence that a particular product is effective for any medical condition. And it does not require proof that two products sold under the same general description share the same chemical composition, pharmacokinetic profile or clinical effect.
Instead, the federal classification turns principally on whether the marijuana is covered by a qualifying state medical-marijuana license.
"A state license may authorize an entity to cultivate, manufacture, distribute or dispense marijuana under state law," said Duane Boise, Chief Executive Officer of MMJ International Holdings. "It does not establish that every product that licensee makes has been demonstrated to be safe and effective. It does not create an FDA-reviewed label. It does not supply controlled clinical evidence. A state license does not replace chemistry, market popularity does not replace clinical evidence, and repetition of a therapeutic claim does not make the claim true."
What Schedule III does and does not mean
Schedule III is not an FDA seal of approval. Under the Controlled Substances Act it is a classification for a substance determined to have a currently accepted medical use in treatment in the United States, an abuse potential lower than substances in Schedules I and II, and the dependence profile Congress specified. FDA approval and CSA scheduling are legally distinct systems.
Marinol, an FDA-approved dronabinol product classified in Schedule III, reached the market with defined chemistry, fixed dosage, pharmacokinetic evidence, manufacturing controls and federally reviewed labeling that a physician can prescribe from. The April Order extended the same scheduling classification to a fundamentally different category - marijuana in any form covered by a qualifying state medical-marijuana license - based substantially on HHS's conclusion that widespread experience under state-authorized programs could establish a currently accepted medical use. That conclusion is now being challenged.
Why the process matters
The Attorney General issued the April Order under the treaty-implementation authority at 21 U.S.C. § 811(d)(1), and the government maintains that authority permitted immediate classification without the formal rulemaking otherwise required under § 811(a). MMJ and the other petitioners contend the treaty provision did not authorize that shortcut, because the Single Convention did not compel the particular scheduling arrangement selected. That question is before the U.S. Court of Appeals for the District of Columbia Circuit.
On the same day it issued the immediately effective Order, the government published a separate notice acknowledging that broader rescheduling must proceed through formal rulemaking on the record after opportunity for a hearing.
"A formal hearing creates an evidentiary record," Boise said. "Experts testify. Assertions get challenged. Witnesses are cross-examined. Scientific disagreements have to be confronted, and the agency has to explain the basis for its findings to a reviewing court. Schedule III treatment was granted before any of that examined the underlying evidence. The argument is happening afterward - in podcasts, trade publications and conferences, where nobody testifies under oath and no agency is required to resolve the contradictions."
MMJ notes that the industry does not agree among itself on which cannabinoids should be permitted, which manufacturing methods are acceptable, what testing should be required, what contaminants must be disclosed, or what evidence is necessary before therapeutic claims are made. Those disagreements, the company says, are not an argument against standards - they are the reason standards must be established through a transparent and legally accountable process, before industries reorganize around the outcome.
A federal pathway already exists
MMJ International Holdings has pursued the FDA botanical-drug pathway since 2017. Its work includes Investigational New Drug programs for Huntington's disease and multiple sclerosis, an FDA Orphan Drug Designation, a DEA-registered Schedule I analytical laboratory, investigational soft-gelatin dosage forms manufactured with Catalent Pharma Solutions, and a federal bulk-manufacturer registration application filed in December 2018 that remains undecided. The company has invested more than $10 million over nearly a decade.
MMJ's investigational products have not been approved by FDA, and the company makes no claim that their safety or efficacy has been established. That, the company says, is precisely why the development process must continue - and why access to federally lawful pharmaceutical-grade material matters.
"I do not believe cannabis is the devil's lettuce," Boise said. "I have spent most of a decade trying to develop cannabinoid medicines through the only federal process in which proving safety and effectiveness legally counts. Michael Bronstein was right that the industry cannot build its future on quicksand. But the unstable foundation is not limited to cannabinoids converted from CBD in a laboratory. It includes a federal medical classification granted to an entire state-licensed category without product-specific proof, through a process that bypassed the hearing where the government would have had to defend that distinction on the record. If cannabis wants the designation of medicine, it has to produce the evidence medicine requires."
About MMJ International Holdings
MMJ International Holdings, Inc., with its subsidiaries MMJ BioPharma Cultivation, Inc. and MMJ BioPharma Labs, Inc., is a pharmaceutical company developing FDA-regulated cannabinoid therapeutics for Huntington's disease and multiple sclerosis. MMJ holds a DEA-registered Schedule I analytical laboratory and has pursued FDA approval through the botanical drug development pathway, including Investigational New Drug programs and Orphan Drug Designation, since 2017.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
MMJ International Holdings, Inc. MMJ International Holdings, MMJ BioPharma Cultivation and MMJ BioPharma Labs are participating in litigation challenging the April 2026 Marijuana Rescheduling Order in the U.S. Court of Appeals for the District of Columbia Circuit, Nos. 26-1106, 26-1130 and 26-1136. This statement reflects MMJ's views on federal regulatory standards and pending litigation. It is not legal, medical, tax or investment advice, does not predict any litigation outcome. Characterizations of industry commentary are the author's summary of publicly available discussions. The rule discussed appears at 91 Fed. Reg. 22714 (Apr. 28, 2026).
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/marijuana-industry-is-drowning-in-confusion-why-is-industry-now-deman-1201565
