Plenty of products containing cannabidiol, or CBD, are already on the market: You can buy balms, lotions, mascara, and even smoothies infused with the oil, which provides therapeutic benefits without the psychoactive side effects of tetrahydrocannabinol (THC).
Demand for these items has only grown since the United States Food and Drug Administration legalized products derived from hemp, including CBD, in December of 2018. Now, the agency has announced plans to assess the regulatory pathway for dietary supplements and conventional foods containing CBD, starting with a public hearing in May.
In a statement on Tuesday, outgoing FDA Commissioner Scott Gottlieb said the agency had observed interest in CBD products ranging from those “marketed as human drugs” to cosmetics, and recognizes that “stakeholders are looking to the FDA for clarity on how our authorities apply to such products.”
Here’s what the agency will be looking at, and why.
Addressing ‘Unanswered Questions’
Although the FDA has not finalized its stance on certain CBD products, many companies have continued to develop them, Forbes reports. In Tuesday’s statement, the agency reiterated the need to conduct more research on CBD first, testing its safety and effectiveness through clinical trials. “While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” Gottlieb said.
As the New York Times has reported, few of these trials have been conducted, and scientists say the evidence on CBD’s effects is not conclusive. “It is a kind of a new snake oil in the sense that there are a lot of claims and not so much evidence,” Dustin Lee, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, told the Times. To address this, the FDA said it will be seeking data and information on CBD’s safety at the May 31st hearing and during the public comment period.
CBD in Food and Dietary Supplements
The FDA has only approved certain types of CBD products, including one drug containing the substance that’s used to treat two rare forms of epilepsy. While you will soon be able to get creams and sprays for “an alternative source of relief” at CVS Pharmacy, NBC News reports, the sale of dietary supplements and foods containing CBD is still illegal in “interstate commerce.”
In the announcement on Tuesday, Gottlieb said the FDA would be looking into regulatory pathways for food items “in view of all the evidence before us and our agency’s fundamental public health mission.” He noted that this could take some time, but that the public could expect more information in the summer of 2019.
Cracking Down on Deceptive Marketing
As part of the agency’s new approach, the FDA announced that it had also issued warning letters to three companies that made “unsubstantiated claims” about their products’ health benefits. The letters, sent to Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC, and PotNetwork Holdings Inc., accuse the companies of marketing CBD oils and gummies as treatments or cures for specific diseases.
Gottlieb cited marketing campaigns for products that claimed to cure cervical cancer, Alzheimer’s disease, diabetes, substance abuse disorders, and more. “I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” he said.
