After the 2018 Farm Bill decriminalized industrial hemp, the cannabis industry witnessed a meteoric rise in demand for hemp-derived CBD in a variety of consumer products. But even as CBD products have exploded across the retail market, the U.S. Food and Drug Administration has continued to prohibit using CBD in ingestible products like foods, beverages and supplements.
And although it once seemed like the agency was headed toward issuing clearer guidance on its CBD Enforcement Policy, the FDA later withdrew such guidance in 2021, leaving industry participants to continue navigating the hazy regulatory limbo created by conflicts between federal and state policies on CBD.
As an agency tasked with protecting consumer safety, the FDA has historically focused on ensuring that CBD products will not harm consumers. Since 2018, the agency has continually emphasized that it wants to learn as much as possible about the safety of CBD to develop sound, science-based policy for regulating CBD products. The FDA has also consistently maintained that selling foods or supplements containing CBD violates the Food, Drug and Cosmetic Act because CBD is the active ingredient in an FDA-approved drug.
Nevertheless, CBD products have appeared on the consumer market in every form imaginable, including ingestible products like edibles, tinctures and beverages. To date, the FDA’s CBD enforcement has largely targeted “egregious” offenders, such as brands advertising CBD products with claims about their curative or health benefits. But instead of issuing guidance to create a clearer path forward for regulating CBD products, which the cannabis industry has long hoped for, the FDA has only committed to continuing to fill the “knowledge gaps” behind its concerns about cannabinoid safety. Meanwhile, some states, frustrated by the agency’s slow progress, enacted their own regulatory schemes permitting the sale of CBD products within their borders, creating a patchy map of unpredictable and sometimes contradictory laws and regulations.
For now, it’s still not clear what the future will hold for the FDA’s regulation of CBD products, even as they continue to become more prevalent and popular with consumers. In late 2021, the FDA during an industry summit reiterated that its stance on CBD has not changed and that it still needs to gather and review more data to develop a better understanding of CBD’s safety before it will move forward with promulgating clearer regulations. This doesn’t provide much clarity on whether, or when, the agency will issue further guidance or take additional steps toward regulating the use of CBD in ingestible products. However, because some states have started allowing the sale of CBD products under their own regulations, there are still steps that industry participants can take to reduce risk while still claiming space in this growing industry.
Excerpted from Marijuana Venture. To read the full article, click here.