Marijuana Moment: New FDA Enforcement Memo Clears Way For Hemp CBD Product Coverage Under New Medicare Plan

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The Food and Drug Administration (FDA) has issued guidance making clear that it does not intend to interfere with implementation of a new Trump administration initiative to cover up to $500 worth of hemp-derived products each year for eligible Medicare patients.

FDA Commissioner Marty Makary wrote in a two-page memo on Wednesday that the agency “does not intend to enforce” certain sections of the Federal Food, Drug, and Cosmetic Act “with respect to an orally administered, hemp-derived CBD product solely on the basis that it contains CBD,” provided that it meets certain requirements.

In particular, in order to avoid enforcement of laws that deem a drug misbranded if its label lacks adequate directions for use and that require premarket approval for new drugs, CBD products under the new FDA guidance must meet the following conditions:

1. be manufactured, marketed, and labeled in a manner that would be consistent with the dietary supplement framework, including bearing a supplement facts panel and structure/function claims,
2. not be contaminated,
3. not be packaged or labeled in a manner that would be attractive to or marketed for children, and
4. be provided to a beneficiary through a program of medical items or services payable under Title XVIII of the Social Security Act, under the direction of the patient’s treating physician, in a manner ancillary to the covered items or services furnished under such program.

Makary’s memo, titled “Hemp-Derived Cannabidiol Products in Medical Research Models,” came on the same day the hemp product coverage program being administered by the Centers for Medicare & Medicaid Services (CMS) launched. That effort focuses largely on CBD but also allows a certain amount of THC in products.

THC, however, was not mentioned in the new FDA guidance.

More generally, Makary’s letter, which is addressed to FDA’s deputy commissioner for human foods and the acting director of the agency’s Center for Drug Evaluation and Research, says that “FDA-regulated products containing cannabidiol (CBD) are subject to the same legal and regulatory requirements as other FDA-regulated products.”

“The applicable regulatory framework, and the relevant legal requirements, that apply to a given FDA-regulated CBD product will depend on the type of product at issue,” the commissioner wrote. “FDA has jurisdiction over a variety of product types, and an FDA-regulated product that contains CBD is subject to the framework and requirements that apply to that product type (food, drug, cosmetic, etc.).”

Hemp industry advocates cheered the guidance.

“It’s very encouraging that the FDA appears to be allowing the Medicare pilot program to proceed. This is a sign that the executive branch is becoming comfortable with hemp-derived products,” Jim Higdon, co-founder and chief communications officer for Cornbread Hemp, which is participating in the CMS effort as a product supplier, told Marijuana Moment. “Now, we just need Congress to agree.”

“The historic implications of this moment are difficult to overstate,” Higdon said. “We could be entering a new era of cannabis legalization that has opened the door to insurance coverage and access for all.”

The CMS initiative comes after President Donald Trump signed an executive order in December calling on the attorney general to finalize a rule federally rescheduling marijuana that also contained components to “improve access” to full-spectrum CBD products.

Under the program, inhalable preparations are not allowed, and products can contain no more than 0.3 percent delta-9 THC by dry weight and can have up to 3 milligrams of total THC per serving.

The THC limit could potentially change if a law the president signed late last year takes effect as scheduled this November. That policy would strictly limit the types of cannabis products that are currently permitted under the 2018 Farm Bill that Trump signed in his first term, expressly prohibiting hemp derivatives containing more than 0.4 milligrams of total THC per container.

The Medicare cannabis product plan is being challenged in a lawsuit filed this week by a coalition of anti-marijuana organizations. A federal judge denied their motion for a temporary restraining order to halt it from launching, but scheduled a hearing for April 20 on their separate request for a preliminary injunction.

Meanwhile, the White House Office of Management and Budget is holding a series of meetings this week and next week about an FDA CBD products enforcement policy.

Makary, for his part, said in February that while the Trump administration is taking the potential harms of marijuana use among youth “very seriously,” it’s also important to preserve access to cannabis for medical purposes—and that’s part of the thinking behind the push to federally reschedule it.

Last year, the FDA commissioner said exploring the therapeutic potential of psychedelics such as psilocybin and ibogaine is a “top priority” for the Trump administration, especially when it comes to helping military veterans grapple with trauma from being sent to fight “unnecessary wars.”

Meanwhile, asked about the widespread availability of intoxicating cannabinoid products, such as delta-8 THC, Makary warned last year that the use of cannabinoids can lead to cardiac problems and psychosis.

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