Cannabidiol (“CBD”) products have gained popularity across the country, but clear regulation from the Food and Drug Administration (“FDA”) is still forthcoming. This July, FDA announced an intent to fast- track the process to create these much-needed regulations. Currently, nearly 90% of CBD businesses operate in a so-called “gray area,”1 and a framework of FDA regulations would provide safety and stability to this booming market, not only for businesses but for consumers as well.
Plans to release a report on CBD regulations has bipartisan support in Washington, with senators from both sides of the aisle urging the FDA to speed up the process. The Agriculture Improvement Act of 2018 (the “2018 Farm Bill”) legalized hemp and hemp derivatives at the federal level, including CBD. The legalization of hemp is popular in both red and blue states. The finalization of rules around its derivatives will add important clarity for companies invested in this industry.
The seemingly inevitable and fast-paced drive towards mass adoption of cannabinoid products produced from hemp still has some significant roadblocks to overcome. FDA has acknowledged the medicinal properties and benefits of CBD, but since the agency currently classifies CBD to be an Active Pharmaceutical Ingredient (“API”) in a scheduled drug (Epidiolex), its enabling statutes prohibit FDA from allowing CBD to be treated as a food, a food additive, or a dietary supplement. Due to the regulatory structure created by the Food, Drug, and Cosmetic Act (the “FD&C Act”), the process of creating a comprehensive system of new regulations could take years.
While many entrepreneurs and consumers are uncertain about FDA’s involvement in the regulation of cannabinoids, the path towards a safe and productive market for CBD products relies on such regulations. Currently, companies making CBD and CBD infused products are not required to provide information on fillers, the source of any ingredients, or accurate measurements of CBD content. FDA regulation would force companies to comply with a universal standard, and could provide for mandatory product testings.
FDA held hearings on May 31st of this year, with the purpose of eliciting testimonies from experts in the CBD industry, industry stakeholders, and lawmakers. The Rodman Law Group has been monitoring this situation for years and firm founder and Managing Partner Dave Rodman was selected to give testimony at the hearing. In addition to these testimonies, a comment period was open until July 16th for industry professionals and the general public to submit comments on the health and safety risks of CBD, as well as to comment on marketing standards.
Amy Abernethy, FDA’s Acting Chief Information Officer released a statement about the on-going process on Twitter this July. “We are enthusiastic about research into the therapeutic benefits of CBD products but also need to balance safety,” said Abernethy, “FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders.” Abernethy stated that FDA hopes to report its progress “around the end of summer/early fall.”
As previously stated, The Rodman Law Group has closely monitored FDA updates regarding the agency’s ongoing efforts to establish CBD regulations. If you have any questions on the state of federal CBD guidelines, we encourage you to contact us.
- Gray not so much in that the rules are unclear, they are actually quite clear in that aside from Epidiolex, consumable CBD products are illegal, but gray as in FDA doesn’t enforce its own rules uniformly or effectively.