More than 100 individuals and associations interested in nailing down a regulatory framework for the use and regulation of CBD addressed the Food and Drug Administration (FDA) during a public hearing last month.
The FDA will continue to collect statements until July 2, which means parties interested in CBD should expect a significant wait until they get clarity on the issue.
Background on the FDA Hearing
During the hearing, the FDA announced that it held the hearing to develop regulations, especially those related to CBD’s use in food and dietary supplements, to bring order, oversight and responsibility to a rapidly growing and mostly unconstrained industry.
Currently, the FDA bans the use of CBD in food, drinks, and supplements, though many such products are available nationwide. The FDA is doing its due diligence to keep up, issuing a few warning letters to any manufacturer that has made any unsubstantiated, false, or misleading claims about CBD. There is little scientific evidence to support that ingesting CBD is safe or beneficial.
A 2017 report of the National Academies of Sciences, Engineering and Medicine, which was submitted to the FDA by the American Medical Association, substantial evidence that cannabis or cannabinoids are effective for the treatment of chronic pain in adults (cannabis), as antiemetics in the treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids) and for improving patient-reported multiple sclerosis spasticity symptoms (oral cannabinoids). Evidence of other health benefits were dismissed as inefficient.
CBD advocates, including food manufacturers, urged the FDA to move quickly to clarify regulations, citing consumer confusion. Though the FDA recognized the need for a uniform regulatory framework, it noted that additional research is needed to provide greater direction to manufacturers and consumers.
Where the Confusion Started
Regulators have been trying to get a handle on the industry since the 2018 farm bill legalized hemp under certain conditions and allowed CBD products to be shipped interstate with limitations. Though the bill decriminalized hemp, it also blurred the lines between drugs and dietary supplements.
After the bill was signed into law last year, the FDA issued a statement, noting it had the authority to regulate these products because it had approved the CBD-based epilepsy medicine, Epidiolex. Once something is approved as a medication, it cannot be randomly added to food, drinks, and supplements.
At the time, the FDA stated it would treat other CBD products the same, meaning it could put each item through its rigid review process before it could be legally sold. Dietary supplements, however, do not face as much monitoring. Unfortunately, the agency is now left trying to figure out how it will review CBD products, if at all.
This has left both merchants and lawmakers scratching their heads because of the confusion the FDA created. It also triggered individual states to interpret the laws in their own ways. For instance, New York banned the sale of edible CBD products.
Government agencies move slowly. As the FDA continues to take comments and requests additional research, merchants should assume the journey to a regulatory framework won’t be short. As states and the federal government continue to discuss regulations, individual business owners need to proceed with caution. Thy need to check the rules where they live and plan to sell accordingly.
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