Charlotte’s Web announced its first quarter financial results this morning. There are a few surprises. For one thing, Charlotte’s Web (CW) announced a transaction with BT DE Investments Inc., a subsidiary of British American Tobacco (BAT). For another, the transaction will wipe out CW’s $3 million annual interest costs, strengthen shareholders’ equity, and provide $10 million in new capital to be able to share in the profits of the Center for Medicare and Medicaid (CMS) Beneficiary Engagement Incentive (BEI) program.

What does BAT get in return? Forty percent of Charlette’s Web shares.

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Previously, Charlotte’s Web said it had worked with CMS to shape its new BEI program. That program, initiated by CMS administrator Mehmet Oz, enables Medicare patients to obtain up to $500 of CBD every year for those who request it. The US Food and Drug Administration has not approved CBD, although FDA Administrator Marty Makary, MD, issued a statement supporting the program.

Dr. Makary resigned yesterday under pressure from President Trump, who was unhappy with Dr. Makary’s performance. Tobacco executives had lobbied the president intensely because Makary was not allowing fruity flavors to once again be marketed in the US. But after an RJ Reynolds executive spoke with President Trump in Florida, FDA capitulated, according to Politico, enabling the first fruity flavors to be reinstated since 2019, when adolescent use of flavored vapes peaked.

Apparently, with the Trump Administration, all billionaires need is to chat with the president. After both the marijuana and hemp industries prevailed with President Trump in December, when Mehmet Oz announced the CMS program, BAT moved to share the profits of providing an FDA-unapproved drug to seniors on Medicare.

A qualitive study from the Universities of Utah and Colorado published last week shows that 169 older adults are increasing their use of cannabis edibles. Most selected THC and CBD combinations (57.5%) or CBD-only (28.7%), rather than THC-containing products (13.8%). (Qualitative studies focus on non-numerical data like interviews, observations, and text.)

The study notes:

Across all 3 product types a primary motivation for cannabis use was the belief, often informed by product marketing or anecdotal evidence, that cannabis could manage symptoms such as sleep difficulties, pain, anxiety, and depression.

Yet study after study shows marijuana has little to no effects on such problems.

Still, whether you are rich or just a start-up, it’s nice to have money.

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Both complaints say that all four companies market and promote their marijuana products to an unsuspecting public by making health claims backed by pseudoscience, while refusing to warn consumers of the very real dangers of marijuana backed by legitimate science.

The complaints allege that the four companies promote their products as “safe and effective” when they know or should have known that the Food and Drug Administration (FDA) has not approved a single medical marijuana or recreational marijuana product anywhere in the US.

Both complaints present a flurry of meta-analyses of individual studies showing that marijuana can cause psychosis, schizophrenia, suicidal ideation, depression, PTSD, anxiety, heart disease, hyperemesis (“scromiting,” a combination of screaming and vomiting that can last for several days), and addiction, among other illnesses.

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(A meta-analysis is how scientists build consensus. If one study shows a drug can cause Problem X in 100 people and scientists can find 50 studies involving thousands or millions of people who use the drug and have Problem X, you can be fairly certain that the drug is causing Problem X.)

Moreover, the complaints offer multiple examples of the ways in which these companies try to hide scientific consensus by making many false claims on their websites, in their dispensaries, and on social media about marijuana’s “health effects.”

The complaint against Curaleaf, for example, describes how Curaleaf established a U.K. Medical Cannabis Registry which uses industry data from European cannabis companies to publish studies touting the benefits of cannabis. Curaleaf says it considers registry research to “be strategically important in the future education of patients, public, and healthcare professionals.”

Researchers using data from the registry often cite researchers employed by the Medical Cannabis Research Group of the Imperial College of London. The complaint reveals that the research group is headed by Dr. Mikael Sodergren, who also happens to be the chief medical director of Curaleaf International.

A study he coauthored, which found that marijuana improved life for marijuana users, turned out to be a survey involving 34 participants of whom 29 used the drug prior to participating in the survey.

Both complaints display how the websites of all four companies work hard to promote marijuana as “health focused,” instead of a danger to health.

For their multi-state class action, plaintiffs assert a claim under the Racketeer Influenced and Corrupt Organizations Act (RICO), as well as several counts in the state where they operate.

For their state subclass actions, plaintiffs allege that many state laws are violated, such as unfair trade practices, unlawful advertising, common law fraud, and unjust enrichment among others.

Both complaints request jury trials.

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First it was Mehmet Oz, the guru of pseudoscience, who began giving an FDA-unapproved drug—CBD—to Medicare patients . Then it was Todd Blanche who moved another FDA-unapproved drug—this time medical marijuana—into Schedule III. Both acted on Executive Orders signed by President Trump.

In the first sentence of Todd Blanche’s final order, issued last Thursday, he says:

“With the issuance of this final order, the Acting Attorney General of the U.S. Department of Justice places drug products containing marijuana that have been approved by the Food and Drug Administration (FDA) in Schedule III of the Controlled Substances Act (CSA).”

Here’s the problem. The FDA has not approved any drug product that contains marijuana!

FDA has approved Marinol (dronabinol) at low doses and Cesamet (nabilone) at exceedingly low doses. Neither drug contains marijuana. Instead, both were made using pure chemicals. See my Substack from last week.

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The Acting Attorney General cites Marinol (dronabinol) and Syndros, but not Cesamet (nabilone). Syndros was taken off the market last year by its manufacturer. FDA approved Marinol in 1985 to treat nausea and vomiting in cancer chemotherapy patients who did not respond to standard medications and in 1992 to treat wasting in HIV/AIDS patients. Cesamet (nabilone) was approved for both uses in 1985.

All three drugs are/were made using pure chemicals, thus eliminating the threat of contaminants. None of these drugs contains marijuana, yet the Acting Attorney General uses the term “FDA-approved drugs containing marijuana” at least 26 times throughout his final order.

In 2018, FDA approved Epidiolex, a drug made from purified CBD. However, the Acting Attorney General makes clear that nothing in his final order applies to hemp products from which purified CBD is made.

He does not understand the scientific term “synthesis.” However, 40 percent of the drugs we use today are synthesized, meaning they are made with pure chemicals to eliminate any chance of contaminants in “natural” products. That’s so you don’t have to chew willow bark (aspirin), for example, to get rid of a headache or fever.

The Acting Attorney General believes synthesis can only be bad, as in synthetic Delta-8 or Delta-10 THC. Ironically, this misunderstanding leads him to say on page 16, last sentence, “Therefore, synthetic THC remains in Schedule I.”

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Worse, a medical marijuana license from 40 states will eliminate all requirements of the UN Single Convention and the US Controlled Substances Act, which is based on the Convention, except that dispensaries will have to register with DEA.

In other words, states that legalized medical marijuana will be accountable for strictures specified in the UN Convention and the CSA. The Acting Attorney General says, “[DEA] registrants may rely on state-law labeling, packaging, disposal, and physical security requirements in lieu of the otherwise-applicable federal requirements.”

Based on the strength of a state’s legalization law, doctors can now prescribe an FDA-unapproved drug—medical marijuana—to patients. Prescribing such a drug is considered prescribing an “unapproved new drug,” which is prohibited and carries significant legal and safety risks. So where does that leave doctors? Dentists? Physician Assistants? Nurse Practitioners? Hospitals?

According to the final order, prescriptions must include “the drug name, strength, dosage form, quantity prescribed, and directions for use, among other items.” If you live in a medical marijuana state, does the agency that monitors legal medical marijuana require these safeguards? Heretofore, the medical community was only able to recommend medical pot, not prescribe it, because it is illegal.

To clarify the difference between illegal growers and legitimate growers, Article 23 of the Single Convention on Narcotic Drugs requires that only governments can grow marijuana. Therefore, each medical marijuana company will have to sell its crops to DEA at a nominal fee and DEA will sell the crops back to each company for the same price, plus a fee that will finance the endeavor.

MJBizDaily interviewed several marijuana companies about their reaction to the Acting Attorney General’s final order. Some are seeking partnerships for clinical studies. We have learned from the tobacco and alcohol industries how successful that gambit is.

Others are developing strategies to scale their operations. Here’s what George Archos, CEO of the Chicago-based multi-state operator Verano Holding Corporation, told MJBizDaily. “Completing the historic rescheduling of cannabis to Schedule [III] promises to unlock the full medical, research, and commercial potential of this miracle plant and support the growth and normalization of America’s next great industry in the United States.”

ID 261391534 | Formula Thc © Allexxandar | Dreamstime.com

Recently I have been writing about the Trump Administration’s proclivity to shape drug policy by Executive Order. There is more to say about the subject.

In the late 19^th century, drugs began to be developed using pure chemicals. Before that plants were all we had throughout history to relieve pain and suffering. About 40 percent of the drugs we use today originated in plants, but they are now made with pure chemicals. That process is called synthesis.

Why have pharmacologists switched to synthesizing natural plants? Because plant roots can suck up heavy metals from the ground and thus contaminate the resulting drug. Plants can also add pesticides to the mix. Both medical marijuana and medical hemp do these things. Both plants can also grow mold, mildew, aspergillus, and other contaminants.

Chemicals are pure and pharmacologists do not have to worry about anything that can make a drug unsafe. Creating the drug with pure chemicals eliminates that concern.

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In 1985, FDA approved low-dose (2.5 mg, 5 mg, and 10 mg) Marinol (dronabinol) to treat nausea in chemotherapy patients who did not respond to standard medications. Seven years later, FDA also approved Marinol to treat wasting in HIV/AIDs patients. Cesamet (nabilone) was approved for both uses in 1985.

Cesamet was made by Ely Lilly but in 1989 the company pulled it from the market for commercial reasons. In 2006, another company, Valient, received FDA approval of Cesamet at low doses (1 mg to 2 mg twice a day; maximum dose 6 mg 3 times a day).

In 2016, FDA approved Syndros, an oral solution rather than pills, at low doses (5 mg/mL). However, it was later withdrawn from the market, again for commercial reasons.

All these drugs were made using pure chemicals.

Exceptions to the pure-chemicals rule occur with vaccines, some antibiotics, and in 2018 when FDA approved a purified version of CBD called Epidiolex for the treatment of three rare forms of seizures in children age one and above. Such seizures are so rare that most children who have them do not live to adulthood. “Purified” is a key word here.

FDA warns that purified CBD has many harms as well as unanswered questions revealed in clinical trials when FDA approved it for rare seizures. These include liver damage and toxicity in male animal studies and concerns about side effects when CBD is mixed with other medications.

If purified CBD could have such negative effects, what could raw CBD do to health?

Because the hemp industry found ways to add extremely high levels of THC to CBD, late last year Congress banned any CBD containing more than 0.4 mg of THC. The ban becomes effective in November of this year.

Nevertheless Dr. Memet Oz, head of the Center for Medicare and Medicaid (CMS), began giving FDA-unapproved raw CBD to Medicare patients on April 1, 2026. What’s more, FDA head Marty Makary says FDA will not interfere with the CMS plan.

Doctors can prescribe FDA-approved Marinol, Cesamet, and Epidiolex, and patients or their caregivers can buy them at pharmacies. Doctors cannot prescribe, but only recommend medical marijuana that states have “legalized” or medical hemp that Congress “legalized” until November 2026. Patients buy “legalized” cannabinoids found in marijuana and hemp at gas stations, convenience stores, vape shops, or dispensaries.

What kind of “medicine” is that? Why is FDA allowing this to happen?

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Last week I wrote “Why Medical Marijuana and Medical Hemp Weren’t—Until Trump 2.0” with a subhead of “Your Tax Dollars Are Being Used to Give an FDA-Unapproved Drug to the Elderly.” The subhead turns out not to be true. However, it’s even worse.

Through two cost-savings model organizations, the Center for Medicare and Medicaid’s ARCO Reach and EOM, are giving an FDA-unapproved drug—non-smokable CBD—to Medicare recipients age 65 and older. The model organizations are paying up to $500 a year for hemp products containing 3 mg of THC per serving. A third model, LEAD, will become effective January 1, 2027.

“If a model provider’s investment … reduces the elderly’s total cost of care, the provider and CMS share in the resulting savings. If it does not, the provider absorbs the loss,” according to Eliot Fishman, Director of Policy and Programs Group at the Center for Medicare and Medicaid Innovation.

In other words, CMS is gambling that an FDA-unapproved drug will save money in the overall healthcare cost of treating seniors.

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Who advocates for this program? President Donald Trump, RF Kennedy, who heads the National Institutes of Health, Memet Oz, MD, who heads the Center for Medicare and Medicaid, and hemp industry representatives with whom the White House has been meeting repeatedly for weeks. Not scientists. Not doctors. Not families.

Smart Approaches to Marijuana and other prevention organizations sued CMS, Mr. Kennedy, and Dr. Oz. A hearing was held March 31 in which Judge Trevor N. McFadden rejected their request for a temporary restraining order to halt the program from launching on April 1.

Judge McFadden scheduled a new hearing on April 20 to consider other aspects of the complaint. He could have chosen any other day of the year but chose 4/20, the unofficial day when marijuana enthusiasts celebrate so-called marijuana reform by openly smoking pot at 4:20 pm. Was this intentional? Or is the judge so out of touch with marijuana culture that he doesn’t know that?

Meanwhile, a company that has been trying to do things the right way by earning FDA approval of CBD to treat Huntington’s Disease and multiple sclerosis programs has joined SAM and others in the case.

Since 2015 FDA has been sending warning letters to hemp companies that sell CBD. Typical of the warning letters is this one in 2024 from FDA to Root Bioscience Brands.

You can read SAM’s original complaint here. You can read SAM’s amended complaint as well as the government’s response here.

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You wake up sick and go to the doctor. She prescribes a drug. On the way home, you drive by the pharmacy to pick up the prescription. Behind it lie multiple years of drug development by the manufacturer and approval by the US Food and Drug Administration (FDA) before the company is allowed to market the drug in the United States. Most Americans do not understand how the FDA protects us from snake oil medicines.

Here are the key stages of FDA drug approval:

Preclinical Research—Researchers identify a new drug and test it in the laboratory and in animals to determine if the drug is safe enough for human testing.

Clinical Research—Manufacturers submit preclinical results to FDA and apply for an Investigational New Drug Application (IND) to start human trials. An important protection is informed consent, where patients are told all known harms of the drug being tested so they can decide whether to participate in the trials.

• Phase 1 trials test safety and dosage on a small group (20–80) of healthy volunteers.

• Phase 2 trials test effectiveness and safety in hundreds of patients.

• Phase 3 trials confirm effectiveness and monitor adverse reactions in thousands of patients.

FDA Approval or Not—Manufacturers submit a formal New Drug Approval (NDA) which contains all data for the FDA to review. A team of FDA scientists evaluates the NDA to decide on approval. Only about 10 percent of drugs that enter the human testing phase make it through this process to final approval. The FDA inspects facilities where the drug will be manufactured to ensure safety and quality standards.

After Approval—FDA, doctors, and patients continuously monitor the drug’s safety once it is on the market. Side effects that weren’t caught during clinical trials are added to the drug’s label. Sometimes the drug is so dangerous it must be taken off the market.

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All these FDA protections flew out the window towards the end of last year with the second Trump Administration. President Trump and his cabinet have been meeting with the marijuana industry and the hemp industry, but not with scientists, doctors, or families.

• FDA has not approved a single medical marijuana or hemp product even though 42 states “legalized” medical marijuana and Congress “legalized” hemp in 2019.

• No state has permission from FDA to market medical marijuana or hemp in the United States.

• FDA has not approved any state’s testing of medical marijuana or hemp to ensure it is safe for humans. Instead, 42 unique systems, each of varying quality, each test for contaminants, pesticides, and heavy metals.

• States do not inspect the fields or labs where medical marijuana and hemp are grown and processed to ensure safety and quality standards.

• Neither state medical marijuana nor hemp are monitored for side-effects once both have been “legalized” as medicine.

Hemp is a nonintoxicating component of marijuana which Congress legalized in 2019 for the purpose of creating rope, cloth, and other non-ingestible, non-intoxicating products. However, a loophole allowed manufacturers to produce exceedingly high levels of Delta 8 THC, Delta 9 THC, and Delta 10 THC, the cannabinoids that make people high.

Congress banned all but 0.4mgs of THC in any hemp in late 2025. That law passed and will become effective November 2026. President Trump signed it but now he is backtracking.

Until November 2026, hemp products can be bought at gas stations, convenience stores, vape shops, and on the internet, where proof of age is winked at, allowing adolescents to access them. Note that none of these are pharmacies which sell prescription drugs because FDA has not approved medical marijuana or hemp.

In September of last year, President Trump posted on Truth Social a video extolling the virtues of medical hemp. The video was made by billionaire Howard Kessler, a member of President Trump’s Mar-a-Lago Club, where Mr. Kessler dines frequently. He also owns a CBD dispensary.

In December last year, President Trump announced at a public White House meeting that he was issuing an executive order to instruct the Attorney General to move marijuana from Schedule I to Schedule III of the Controlled Substances Act. This would not legalize marijuana but would allow the marijuana and hemp industries to deduct expenses from their tax returns, thus greatly enriching both industries.

In attendance at that meeting were:

• Howard Kessler,

• Kim Rivers, CEO of Trulieve which has several hundred medical marijuana dispensaries in Florida and other states and contributed $750,000 to President Trump’s Inaugural Committee,

• Jim Hagedorn, from Scotts Miracle-Gro, a fertilizer used to grow marijuana and hemp,

• Robert F. Kennedy, head of the National Institutes of Health,

• Memet Oz, head of the Center for Medicare and Medicaid, and

• Marty Makary, head of FDA.

At the December White House meeting, Dr. Oz indicated that Medicare would finance giving the FDA unapproved drug, CBD, to those over age 65 at taxpayer expense. On March 20, he expanded that statement by saying that as of April 1, 2026, a mere eleven days later, taxpayers would subsidize up to $500 a year for seniors to purchase CBD products.

Several days later, Marty Makary issued a statement that FDA would not interfere in the CMS plan, even though FDA has not approved CBD/hemp as a safe or effective medicine.

Postscript 1—The FDA approved Marinol (dronabinol) on May 31, 1985, in low doses of THC (2.5mg, 5mg, and 10mg) for treating nausea and vomiting associated with cancer chemotherapy in patients who failed to respond to conventional treatments. It was later approved on December 22, 1992, to treat anorexia associated with weight loss in HIV/AIDS patients.

Postscript 2—This month, Lancet Psychiatry published the largest review to date of randomized controlled trials (RCTs) of the effectiveness of cannabinoids to treat several conditions. It finds,

• “There were no significant effects on outcomes associated with anxiety, anorexia nervosa, psychotic disorders, post-traumatic stress disorder, and opioid use disorder.

• “There was insufficient data to meta-analyse studies of ADHD, bipolar disorder, obsessive-compulsive disorder, and tobacco use disorder.

• “There was an absence of RCT evidence for the treatment of depression.

• “There was some evidence that cannabinoids can reduce symptoms of cannabis use disorder, insomnia, tic or Tourette’s syndrome, and autism spectrum disorder, but the quality of this evidence was generally low….

• “Given the scarcity of evidence, the routine use of cannabinoids for the treatment of mental disorders and substance use disorders is currently rarely justified.”

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A hearing has been scheduled for all to participate on March 23, 2026. Interested parties may submit written testimony:

Send email testimony to SpecialJointCommitteeonInitiativePetitions@malegislature.gov or snail mail testimony to “Special Committee on Initiative Petitions at 24 Beacon Street, Room 235, Boston, MA 02133.” The deadline to submit written testimony is March 27 by 5:00 PM ET.

See hearing details here. View the hearing here on March 23 from 2:00 to 4:30 PM ET.

The petition is notable for several reasons. It allows those age 21 or older to possess up to one ounce of marijuana. It defines possession of more than 1 ounce up to 2 ounces as a civil (but not criminal) offense, subject to a $100 fine and forfeiture of the marijuana.

For those under age 21, possessing any marijuana up to 2 ounces would be a civil infraction with a $100 fine and require completion of a drug awareness program, community service, and notification of parents or legal guardians of the offense and penalties.

The proposed law would enable recreational dispensaries to apply for a license to sell medical marijuana. It would modify the authority of the Cannabis Control Commission to regulate only medical marijuana.

We thank Marijuana Moment, which represents the marijuana industry, for providing

this information.

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Their research found that cocaine (95%) and amphetamines (122%) doubled the risk of stroke, while cannabis increased stroke risk by 37%.

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The researchers studied all ages, including young users. They conclude, “Our findings provide consistent observational and genetic evidence that several forms of substance misuse increase stroke risk, particularly cocaine, amphetamines, and cannabis. These findings suggest important public health implications for prevention strategies targeting substance use disorders to mitigate stroke risk.”

We thank DB Recovery Resources for providing his information.

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