A press release was issued to the general public by the U.S. Food and Drug Administration (FDA) on Thursday, March 5. Included in the release was a CBD regulatory update addressed to Congress. The update has been long-awaited by everyone involved in the budding market, which is estimated to reach $20 billion in the U.S. by 2024; according to a report by BDS Analytics and Arcview Market Research.

The primary purpose of the FDA’s regulatory update is to establish a more clear set of rules regarding the marketing of CBD (cannabidiol) products. Conundrances have been cropping up left, right and center among CBD business owners; many of whom have failed to market their product(s) correctly and have been slapped with warnings.

Examples of some companies that have been penalized for selling unapproved CBD products with unsubstantiated therapeutic/medical claims include Koi CBD LLC, of Norwalk, California, Pink Collections Inc., of Beverly Hills, California, Natural Native LLC, of Norman, Oklahoma, Whole Leaf Organics LLC, of Sherman Oaks, California and Noli Oil, of Southlake, Texas. Collectively, these companies were accused of breaching the terms laid out in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

CBD regulatory framework: FDA officials are exploring new pathways for compliant marketing

Despite the fact that the rules for CBD marketing and advertising are still being hashed out by the FDA, the Agency affirms that it is actively considering new avenues for CBD marketing that will clarify what’s allowed and what’s not. Moreover, the Agency hopes to establish marketing rules that would categorize CBD as a “dietary supplement”; enforcement discretion guidance is currently being prepared by the FDA.

Confusion pertaining to the rules for CBD marketing has proliferated ever since the 2018 Farm Bill went into effect; the bill legalized hemp and its derivatives, including CBD. Following its passing, the FDA was required to publish an update about CBD regulations within a 60-day period. However, the Agency failed to submit regulations before the deadline in February. Instead, the FDA released a report and notice on CBD enforcement policies during the first week of March.

“FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions,” the agency explained to lawmakers. “Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway.”

CBD regulatory framework: Public docket will be reopened by the FDA

There is a possibility that CBD could soon be marketed as a dietary supplement. According to the FDA’s report, the Agency maintains “the authority to remove this exclusion through rulemaking.” However, before this can happen, further information regarding the cannabis compound’s prospective risks and benefits must be gleaned from scientific research. 

Moreover, a public docket will be reopened as a means of gathering opinions from everyday people, not to mention government partners. FDA officials are optimistic that the docket – which will be open “indefinitely” for stakeholder submissions – will speed up the process of establishing a regulatory framework for CBD marketing.

Industry participants are invited to share their thoughts on CBD with the FDA. How? An online system is yet to be developed for the submission of proprietary data. The system “will enable responsible industry participants to share relevant information with FDA about specific products, which could help inform appropriate regulatory steps.”

The report notes that, despite the development of FDA-approved drugs containing CBD, the cannabinoid “is not a risk-free substance.” On the other hand, the Agency acknowledges that the cannabinoid may harbor therapeutic benefits and so, 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.” 

CBD regulatory framework: FDA considerations for regulating cannabis-derived products

In an attempt to accelerate the process of establishing CBD regulatory framework, the Agency is also “evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding FDA’s enforcement priorities while FDA potentially engages in the process of a rulemaking.”

“Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities based on the known risks to public health. As we move forward, FDA intends to continue taking action to address violations we identify that put the public at risk,” say Agency officials.

Numerous subjects are being brought to light by the FDA; the Agency is honing in on commonly asked questions amidst a lack of regulations for CBD products. According to the report/notice about CBD regulatory framework, the following questions will be pondered over as a means of determining whether or not the non-psychotropic cannabinoid should be marketed as a dietary supplement:

“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?”

“We recognize the high level of interest in dietary supplements as a potential pathway for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements,” said the FDA in an official statement. “Given the significant public interest in the potential for CBD dietary supplements, as well as the extent to which many such products are available on the market, FDA has been taking a highly proactive approach to analyzing relevant safety questions. Rather than waiting for data to be submitted, we have been actively working to identify and review all available data to understand the risk profile of CBD and the potential for CBD to be safely included in dietary supplements, under certain conditions of use.”

The Agency is also requesting information from trade groups and individual CBD manufacturers about ‘full spectrum’ and ‘broad spectrum’ hemp extracts; mainly, how they are derived and how they differ from CBD isolate products.

In summary, the report outlines significant progress on behalf of the FDA in terms of CBD regulatory framework. Nonetheless, officials admit that certain things require “timely attention.” Officials say that the popularity of CBD should not be ignored and that the FDA team will continue collaborations with “all stakeholders to ensure the protection and promotion of public health,” and particularly “with respect to our government partners at the federal, state, local, territorial, tribal and international levels.”