Imagine That IP Law Blog

To the dismay of CBD enthusiasts everywhere, the FDA recently issued a highly anticipated report on the status its efforts to develop regulations for the sale of hemp-derived CBD products. Unfortunately for the CBD industry, the report offered little in terms of policy updates for cannabidiol products and instead described the agency’s concerns and its efforts to develop regulations to safely allow use of the ingredient.

The 2018 Farm Bill legalized hemp and its derivatives containing less than .3 percent THC, thus allowing the introduction of CBD products. Today, you can find CBD in a wide array of goods, including bath salts, gummies, shampoo, chocolate, beauty serums, balms, lotions, and even pet treats; however, murky legalities related to CBD persist.

As CBD goods flood the marketplace, the FDA struggles in its regulatory efforts of the product. An appropriations bill passed by Congress in December 2019 mandated a report within 60 days from the FDA on potential regulatory pathways for the sale of CBD products. That report was released on March 5, 2020.

In the report, the FDA focuses on the need to study the CBD compound before it takes action; it also acknowledges the need to balance the governmental interest in public safety and proper enforcement of regulations with the obligation to provide clarity to the quickly growing hemp and CBD industries. The FDA has in the past issued warnings to CBD companies that make unsubstantiated claims about their products; these concerns persist and in its report, the FDA confirmed ongoing efforts to enforce against this.

According to the report, next steps for the agency include evaluating a potential regulation to allow CBD in dietary supplements, while, at the same time, possibly issuing a risk-based enforcement discretionary policy to provide more transparency to the industry regarding the FDA’s enforcement priorities.

The lack of data related to CBD due to its previous classification as a Schedule 1 Controlled Substance is a hindrance to the FDA’s efforts. The agency indicated it is “actively evaluating what and how much data would be sufficient to support a conclusion that CBD can safely be allowed in dietary supplements under certain conditions.” To that end, the FDA proffered several issues that will guide its development of CBD regulation:

1. What happens if you use CBD daily for sustained periods of time?

2. What level of intake triggers the known risks associated with CBD?

3. How do different methods of exposure affect intake (e.g., oral consumption, topical, smoking or vaping)?

4. What is the effect of CBD on the developing brain (such as children who take CBD)?

5. What are the effects of CBD on an unborn child or breastfed newborn?

6. How does CBD interact with herbs and botanicals?

7. Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

8. Are there differing safety concerns for use in certain animal species, breeds, or classes?

9. Are any residues formed in edible tissues of food producing animals?

Soliciting answers to these questions through an open public docket and discussions with lawmakers, manufacturers, and trade groups will facilitate the FDA in its rulemaking and clarify industry standards.

The report acknowledged the high level of interest in CBD products, but stressed the need for regulation to ensure public safety. Ultimately, the FDA reported “we…are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.”

One thing is apparent in the aftermath of the report: as the industry anxiously awaits clarification of the FDA’s rules, they’ll likely need a large dose of CBD to calm their nerves.