Comments have been rolling in as the Food and Drug Administration decides how to regulate cannabis products, include those containing non-psychoactive cannabidiol (CBD).
The FDA held its first public hearing about cannabis products last Friday. Hemp companies, academics, cannabis distributors, nonprofits, private citizens and healthcare organizations presented their arguments about cannabis regulations.
FDA is concerned about CBD in food because the compound is also an active ingredient in an approved drug, GW Pharma’s seizure treatment Epidiolex. Because of that, the FDA believes that allowing CBD in food products would undermine the drug-approval process, because foods are not subject to the same clinical trials as medicine, according to the proposed rule.
The federal agency is looking for public input on health and safety, manufacturing, product quality, marketing, labeling and sales of CBD products.
Many healthcare organizations have already weighed in on the issue.
American Medical Association
The AMA took a scientific approach in its comment on cannabis. The group submitted its recent report that analyzed studies on the health effects of cannabis products, from cannabis for pain relief to an increase in vehicle crashes due to legalization.
The report’s section on medical cannabis reads: “AMA: (1) believes that scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis products for medical use; (2) opposes the legalization of cannabis for medicinal use through the state legislative, ballot initiative, or referendum process; (3) will develop model legislation requiring the following warning on all cannabis products not approved by the U.S. Food and Drug Administration: ‘Marijuana has a high potential for abuse. This product has not been approved by the Food and Drug Administration for preventing or treating any disease process.’”
Biotechnology Innovation Organization
The biotech industry trade group, BIO, proposed that the FDA closely monitor cannabis in food and drinks as dietary supplements. It also said the FDA needs to continue to make the distinction between approved drugs and dietary supplements clear.
“We are concerned that a lack of enforcement against unsupported medical claims by dietary supplement manufacturers will reduce incentives to study and invest in more targeted drug products in this similar ingredient category,” the comment reads. “This could rob patients of the potential for new treatments that may evolve from intensive and thorough research, and instead increasingly subject them to relying on unsubstantiated claims being marketed by non-compliant dietary supplement products.”
Depression and Bipolar Support Alliance
The patient advocacy group was largely against allowing unregulated CBD in the market. Some claim that CBD can be used to control mood disorders like anxiety. Like BIO, this group also suggested making a clear distinction between CBD as a dietary supplement and as an approved drug. It also suggested creating a pathway to conduct more clinical trials on cannabis.
“The unregulated production, labeling and marketing of these products put people at risk—especially those living with mood disorders seeking to find their personal wellness,” the group said. “There are too many unknowns related to these products.”
Child Neurology Foundation
This advocacy group noted that there is a growing interest in its patient community about the potential of CBD, but is concerned about the current unregulated products on the market.
“To that end, we advocate for emerging treatments to be studied properly to ensure their safety and effectiveness,” the group said. “Moreover, and with the acknowledgment of the cannabidiol discussion’s evolution, we urge for greater access to and promotion of research studies utilizing rigorous scientific methodology.”
The company is in favor of allowing the public access to CBD products. Amyris, which struck a licensing deal with a cannabinoid company this year, develops sustainable ingredients within the health, wellness, beauty and fragrance markets.
“The U.S. market needs safe CBD product solutions,” the company said. “The US market needs affordably priced CBD product solutions. The biotech industry urges FDA to provide clarity of all potential regulatory pathways to market. [The] biotech industry looks to partner with and serve as a resource for FDA for rapid establishment of safety processes and quality endpoints. We think that appropriate controls are critical to ensure that ingredients and products are safe.”