Cannabis derived consumer products seem to be everywhere despite the unclear regulatory landscape. When it comes to the regulation of consumer products derived from cannabis, it remains the wild wild west. And many retailers, processors, and entrepreneurs seem to have adopted a "act now, and figure it out later" mantra.
But the outgoing commissioner of the Federal Food and Drug Administration (FDA) is out to change that (or at least attempt to make the regulatory forecast clearer).
Scott Gottlieb, recently outlined the agency’s plan for promulgating new regulations regarding the sale of products derived from the hemp plant, including products containing cannabidiol (CBD) in a lengthy press release.
The statement contained three notable initiatives the FDA will undertake over the next few months.
First, the FDA will hold a public hearing on May 31, 2019 to allow stakeholders to voice concerns and offer input on the direction that future regulation of the industry should go. The public hearing will be supplemented by a public comment period, in which interested parties may submit concerns or comments to the FDA for consideration.
Second, the FDA will form a “high-level internal working group” to promulgate new regulations regarding hemp-derived products. The goal of the working group is to fashion sensible, safe pathways for producers to develop and market products containing CBD to the public. Although Dr. Gottlieb did not make any guarantees, an area of particular interest that was mentioned in his statement was the inclusion of CBD products in food products and dietary supplements. There is no indication which direction the FDA will go regarding its decision, however. Expect more direction regarding new regulations to take shape following the public hearing.
Third, Dr. Gottlieb stated that the FDA will increase its efforts to crack down on the use of false or misleading claims on the benefits of CBD containing products.
This is important for a few reasons. First, it demonstrates and reinforces the FDA’s commitment to assume responsibility for the regulation of the hemp industry now that hemp has been removed from the controlled substances list (and no longer the subject of DEA enforcement).
It also gives producers an idea of what the FDA’s priorities will be regarding enforcement. The FDA’s main concern is the use of false and misleading claims regarding the benefits of CBD or other hemp-derived products. This isn't the only area consumers and retailers need to look out for when purchasing CBD products, but it does mean that market participants need to be especially careful about what products they are selling/purchasing.
In addition to discussing the FDA’s plans for future regulations, the press release also clarified the FDA’s existing stance on hemp-derived products. This has an area that has caused considerable confusion since the passage of the 2018 Farm Bill.
Dr. Gottlieb reinforced two important considerations to keep in mind when producing or selling products containing CBD. First, any product that markets itself as providing a therapeutic benefit must be approved by the FDA before it enters interstate commerce. This is true for all products, not just those containing CBD or any other hemp-derived ingredient.
Second, food or beverage products entering interstate commerce may not contain CBD (at least under current regulations). This is true because of an existing rule, known as the drug exclusion rule, which states that any product that is an active ingredient in an FDA-approved drug may not be contained in any food or beverage products without a regulation explicitly permitting the substance’s use in such products.
CBD currently is an active ingredient in Epidiolex—a recently approved drug used to treat certain seizure disorders—rendering CBD subject to this rule. As of yet, the FDA has not issued a regulation allowing use of CBD in food or beverage products, although this may change following the public hearing and decisions of the FDA working group over the next few months.