FDA to Consider CBD As a Dietary Supplement
The US Food and Drug Administration has announced that it will hold a public hearing next month to discuss whether CBD can be marketed as a dietary supplement in foods and beverages.
In a press statement, the current FDA Commissioner Dr Scott Gottlieb described the hearing, which will take place on May 31st, as an opportunity for the public to inform “lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient.”
The hearings will also be a chance for the FDA to “gain additional information and data to consider with respect to products containing cannabis and cannabis-derived compounds.”
The public meeting could be a turning point for the FDA’s stance on CBD, which has been mostly restrictive. As recently as December last year, the organization stated it could not permit any hemp-derived cannabinoid to be marketed as a dietary supplement in foods or beverages. In that statement, Gottlieb wrote that it was “unlawful under the [Federal Food, Drug and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
The decision was a major blow to many in the CBD industry that were hoping the 2018 farm bill could be a boon for the CBD-infused edibles and drinks market. But the FDA’s new public hearing may be a sign that the administration is willing to soften its stance on the popular cannabinoid, at least when it's marketed as a dietary supplement.
When it comes to advertising a product for its supposed medical benefits, the FDA still doesn't take any claim lightly.
“I am deeply concerned about any circumstance where product developers make unproven claims to treat serious or life-threatening diseases,” Gottlieb wrote in the recent press statement. “And where patients may be misled to forgo otherwise effective, available therapy and opt instead for a product that has no proven value or may cause them serious harm.”
Using the letter to decry businesses that make unsubstantial claims about cannabis’ medical properties, the commissioner named and shamed three companies and listed some of their “egregious, over-the-line claims,” which included:
- “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.”
- “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.”
While egregious as a marketing tool, some of these claims can be traced back to real clinical studies. For example, cannabis compounds have been shown to inhibit the growth of cervical cancer cells lines. But due to fierce international regulation, results such as these are rarely tested in randomized human clinical trials. Without surpassing this professional golden-standard, it’s practically impossible for any marketed medical benefit to be approved by the FDA, let alone be endorsed by medical bodies.
“We won’t tolerate this kind of deceptive marketing to vulnerable patients,” Gottlieb continued. “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.”
However, while CBD and THC are still viewed harshly by the FDA, Gottlieb has made clear in the past that foods derived from hemp plants that don’t contain the cannabinoids could be marketed with FDA approval. Following the passing of the farm bill in December 2018, he wrote that the FDA had little issue with hulled hemp seeds, hemp seed protein, and hemp seed oil being marketed in human foods, provided they too “comply with all other requirements and do not make disease treatment claims.”
For now, and until the new public hearing in May, these hemp products are still the only cannabis-infused foods allowed to marketed as dietary supplements in the US.