It’s been a busy week at the U.S. Food and Drug Administration (FDA). It almost seems like the departing chief, Dr. Scott Gottlieb, wants to clear his desk before he leaves. He issued a statement this week on tobacco use and e-cigarettes and another on the how the agency should begin to look at regulating cannabis and cannabis-derived products.
Citing the passage of the 2018 Farm Bill that legalized hemp production and hemp-derived products, Gottlieb noted that Congress explicitly left intact the FDA’s authority to regulate products containing cannabis and products derived from the plant. Hemp and cannabidiol (CBD) products, both contain little or none of the psychoactive ingredient tetrahydrocannabinol (THC) that is associated with the classic marijuana high.
For makers of hemp products, this means that the FDA treats them in the same way it does other products it regulates. Gottlieb said, “meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
To that end, on Tuesday Gottlieb said in a detailed statement that the FDA would hold a public hearing on May 31 to form a “high-level” internal committee to determine “pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”
The velvet glove is covered an iron fist, however. In the same statement, Gottlieb revealed that the FDA had issued “multiple” warning letters to companies selling CBD products “with egregious and unfounded claims that are aimed at vulnerable populations.” He also gave a few examples of these claims:
- CBD successfully stopped cancer cells in multiple different cervical cancer varieties.
- For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.
- Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.
- Cannabidiol May be Effective for Treating Substance Use Disorders.
- CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.
These claims may be true (unlikely as it seems), but none has been subjected to FDA scrutiny nor received legally required FDA approval before being made. Gottlieb said:
Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk. These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. Additionally, because they are not evaluated by the FDA, there may be other ingredients that are not disclosed, which may be harmful.
Of equal concern to Gottlieb was the announcement by retail drugstore chain Walgreens that it would soon begin selling CBD products in states where cannabis sales are legal. Noting that several other pharmacy chains also sell or plan to sell CBD products, Gottlieb said in a tweet that the agency will “remind them of FDA obligations and our commitment to protect consumers against products that can put them at risk.”
The marijuana industry’s reaction has been remarkably muted. The largest companies grow cannabis and mostly sell it to other firms than refine and concentrate it in consumer products. The smaller makers of CBD products don’t want to get sideways with the FDA, so they have remained quiet as well. And the hemp producers and hemp product makers probably believe they are protected by the enactment of the Farm Bill.
All these actions are just the first steps in regulating the composition of CBD and cannabis-derived consumer products and how those products may be advertised and sold. Stay tuned.