On July 22, 2020, the U.S. Food and Drug Administration sent to the White House Office of Management and Budget (OMB) for review its draft “Cannabidiol Enforcement Policy,” signaling to the industry that long-awaited federal guidance on cannabidiol (CBD) products is nearing.
Guidance regarding CBD has been hotly anticipated since the FDA announced its plan to create and issue regulations early this year. The FDA and the Federal Trade Commission have been stepping up enforcement in the interim and, in the past several months, have issued numerous warnings to CBD companies making unsubstantiated claims about the therapeutic potential of their products.
While the draft regulations are not yet available to the public, the FDA’s guidance is likely to introduce comprehensive regulations on claim substantiation and product quality standards. FDA Commissioner Stephen Hahn noted that “any enforcement policy would need to further the goals of protecting the public and providing more clarity to the industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.” Following approval from the OMB, the release of the enforcement policy could be made public in a matter of weeks.
Notably, the draft guidance was submitted the same week the FDA announced separate guidance on conducting research into developing cannabis-based drugs.
Though still speculative, it does not appear likely that the regulations will provide guidance on CBD foods and beverages. In November 2019, the FDA said it could not conclude that CBD is “generally recognized as safe for human consumption,” a prerequisite to manufacturers introducing CBD into foods and beverages. The agency reiterated this position this past March, stating that “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”
The FDA’s regulations are expected to shed much-needed light on regulatory compliance in the CBD industry, which some analysts predict could exceed $1 Trillion by 2025.
* Shuqing Li contributed to this post.