"Approaching FDA for Formal Approval Is the Right Way to Move Forward" with Cannabinoid Drug Development" stated Dr. Oz. "
However his Agency Created a Medicare Program That Does Not Require It. MMJ Has Spent More Than $10 Million Pursuing FDA Approval, CMS Is Defending a Federal Program Allowing Medicare Beneficiaries to Receive Up to $500 Annually per patient in Non-FDA-Approved Cannabinoid Products," stated Duane Boise CEO MMJ International Holdings.
WASHINGTON, DC / ACCESS Newswire / August 7, 2026 / MMJ International Holdings Took the Route Dr. Oz Described - Eight Years, $10 Million, and a Federal Application Still Undecided. Meanwhile CMS Placed Non-FDA-Approved Cannabinoid Products Into Physician-Directed Medicare Care.
MMJ International Holdings agrees. The company has spent more than $10 million and nearly a decade doing precisely that.
The difficulty is what the Administrator's own agency has built alongside it.
The program CMS created
Under the CMS Substance Access Beneficiary Engagement Incentive, participating healthcare organizations may furnish eligible Medicare beneficiaries with up to $500 annually in orally administered hemp-derived cannabinoid products that have not been approved by FDA. The products are selected to improve symptom control, furnished through an affiliated physician, and may contain up to 3 milligrams of total THC per serving.
This week Administrator Oz urged United States senators to oppose an amendment that would allow a hemp product ban to proceed on schedule, writing that it would "undo significant gains that have been made to make clinically-appropriate full-spectrum hemp-derived CBD accessible to the senior citizens and individuals with disabilities that rely on the Medicare program," and would "rip away from millions of seniors and disabled Americans the opportunity to benefit from these new programs." He identified the conditions at issue as "cancer, debilitating seizure disorders, and other chronic pain."
The same letter states that CMS is "committed to innovation that meets patients where they are while maintaining strong safeguards and clinical oversight," and that officials "remain focused on preventing dangerous products from reaching Americans."
"I take the Administrator at his word about the right way to move forward, because it is the road my company chose," said Duane Boise, Chief Executive Officer of MMJ International Holdings. "What I cannot reconcile is a federal agency describing FDA approval as the right way while creating a Medicare benefit for cannabinoid products that never went near it."
Hemp status is not FDA approval
Eligible products are defined principally by reference to federal hemp law - derived from hemp, no more than 0.3 percent delta-9 THC by dry weight, and no more than 3 milligrams of total THC per serving when taken orally.
But removal from the Controlled Substances Act does not authorize a product to be furnished for therapeutic use under the Federal Food, Drug, and Cosmetic Act. FDA has stated that cannabis-derived products promoted to diagnose, cure, mitigate, treat or prevent disease are drugs subject to the same approval requirements as any other drug, and has warned that unapproved cannabis-derived products have not been reviewed for safety, efficacy, manufacturing consistency, dosing, labeling or drug interactions.
"Hemp status answers a Controlled Substances Act question," Boise said. "It does not answer the FDA question. The Farm Bill is not a substitute for clinical trials, an approved application, or proof that a specific product is safe and effective for a specific use. Strong safeguards and clinical oversight are exactly what the FDA review process provides - and these products did not go through it."
An approved cannabis-derived seizure medicine already exists
Seizure disorders are among the conditions the Administrator named. An FDA-approved, cannabis-derived prescription medicine already exists for certain seizure disorders. It reached patients only after its sponsor conducted controlled clinical trials and established chemistry, manufacturing, safety, efficacy, dosing and labeling. That sponsor was not permitted to substitute a certificate of analysis or physician discretion for approval.
"That company approached FDA for formal approval - the right way to move forward, in the Administrator's words," Boise said. "It cost years and a great deal of money, and the result is a medicine physicians prescribe with confidence. CMS is now facilitating physician-directed access to different cannabinoid products for the same category of vulnerable patients, without requiring any of it."
The market is not hypothetical
Cornbread Hemp has publicly announced an exclusive supply agreement with Alliant Purchasing, a national group purchasing organization reporting approximately 68,000 healthcare locations served, under which members may purchase its products through an established institutional supply chain, subject to each organization's CMS-approved implementation plan. Other hemp companies have publicly positioned products for the initiative.
MMJ does not allege that any supplier has violated the law. It contends these arrangements demonstrate that the federal program has created a real commercial market - one MMJ is excluded from because it chose the pathway the Administrator endorsed.
Why this matters in court
MMJ International Holdings et al are plaintiff-appellants in Smart Approaches to Marijuana v. Kennedy, No. 26-5205, pending in the U.S. Court of Appeals for the D.C. Circuit. The district court dismissed the action on May 22, 2026, holding that plaintiffs had not demonstrated an injury sufficient for Article III standing.
"CMS is telling Congress this program is important enough to protect because millions of Americans may benefit from it," Boise said. "The government cannot simultaneously tell a court that the same program is too insignificant to injure a company developing competing medicines. Both statements are being made by the same administration in the same month."
What MMJ is asking the agencies to disclose
MMJ calls on CMS, HHS and FDA to make public:
1. Every organization approved to implement the program, and every product and manufacturer named in an approved implementation plan.
2. Every supplier, distributor and purchasing organization furnishing products, and amounts paid or committed to each.
3. The scientific evidence supporting each approved product, dose and intended use.
4. All FDA legal or regulatory analyses addressing these products' status under the Food, Drug, and Cosmetic Act.
5. Communications among CMS, FDA, the White House and commercial hemp companies concerning the program.
6. The evidentiary basis for the $500 annual limit and the 3-milligram total-THC-per-serving ceiling.
7. The safeguards used to monitor adverse events, drug interactions, product variability and long-term exposure.
The same pattern, twice
MMJ is separately among the petitioners challenging the April 2026 Marijuana Rescheduling Order in consolidated D.C. Circuit Nos. 26-1106, 26-1130 and 26-1136, contending the Attorney General extended Schedule III treatment - carrying potential relief from Internal Revenue Code Section 280E and expedited DEA registration - to marijuana handled under qualifying state licenses without FDA approval of the resulting products.
MMJ's own federal bulk-manufacturer application, filed in December 2018 to support FDA-regulated pharmaceutical research, remains undecided after more than seven years.
MMJ is developing standardized oral cannabinoid medicines for Huntington's disease and multiple sclerosis. Its investigational soft-gelatin capsule contains defined quantities of cannabidiol and tetrahydrocannabinol. The company has manufactured pharmaceutical-grade capsules, completed chemistry and stability work, maintained Investigational New Drug programs, received FDA Orphan Drug Designation, and operates a DEA-registered Schedule I analytical laboratory. MMJ makes no claim that its investigational products are approved or that their safety or efficacy has been established - which is the point.
"We approached FDA for formal approval. We are still waiting," Boise said. "MMJ is not asking for a shortcut. MMJ is asking why the federal government built one for everyone else. If FDA approval is the right way to move forward, it has to be the right way for every company - not only the ones without a faster option."
About MMJ International Holdings
MMJ International Holdings, Inc., together 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 registration and has pursued FDA approval through the botanical drug-development pathway, including Investigational New Drug programs and FDA Orphan Drug Designation, since 2017.
CONTACT:?Madison Hisey?MHisey@mmjih.com?203-231-8583
SOURCE: MMJ International Holdings, Inc. MMJ is a plaintiff-appellant in Smart Approaches to Marijuana v. Kennedy, No. 26-5205 (D.C. Cir.), on appeal from No. 1:26-cv-01081-TNM (D.D.C.), and a petitioner in Nos. 26-1106, 26-1130 and 26-1136 (D.C. Cir.). This statement reflects MMJ's position as a party to pending litigation. It is not legal, medical, tax or investment advice, does not predict any outcome, and makes no claim regarding the safety or efficacy of any MMJ investigational product, none of which has been approved by FDA. Remarks attributed to the CMS Administrator are drawn from publicly available recorded remarks and from published reporting on his letter to United States senators. Descriptions of third-party commercial arrangements are drawn from those companies' public announcements; MMJ does not allege that any supplier or purchasing organization has violated any law. References to other companies' approved products are illustrative and imply no affiliation.
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/something-is-rotten-at-cms-dr.-oz-demands-fda-approval-then-defends-a-1204902
