Ever since the Agriculture Improvement Act of 2018 removed hemp with very low levels of THC from the definition of marijuana in the Controlled Substances Act, cannabidiol (CBD) products are, as the FDA recently noted,
available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products.
Yet, as the agency reminds the public, the only product legally approved to make therapeutic claims for CBD is one prescription drug (Epidiolex), used to treat two very rare, severe forms of epilepsy.
This disconnect between the ubiquity of CBD products and the evidence of safety and effectiveness for those products is one focus of a recent FDA Consumer Update and FDA Statement warning about the risks of taking CBD-containing products, summarizing the current evidence, and calling for more research. The agency also issued a Congressionally-required report on its progress in evaluating potential regulatory pathways for consumer products containing CBD.
Before we get into the weeds of the FDA’s latest pronouncements, a brief refresher on CBD and its current legal status. The Agricultural Improvement Act defines legal hemp as cannabis plants and derivatives containing no more 0.3 percent THC. In addition to THC, there are dozens of biologically active compounds in cannabis, CBD among them. But, although legal hemp may contain CBD, that does not mean that CBD in any form, from any source, is also legal.
Depending on the form in which it is marketed, CBD is subject to the Food, Drug, and Cosmetic Act of 1938 and FDA regulations. At present, CBD is not a legal ingredient in any product marketed as
- a prescription or over-the-counter drug (except Epidiolex);
- a dietary supplement; or
- a human or animal food, if the food is introduced into interstate commerce (leaving to state regulation your CBD-containing brownies and dog biscuits from the local bakery).
Currently, federal law does not prohibit the use of CBD in cosmetics, which do not require FDA pre-market approval (except for color additives), as long as the cosmetic otherwise complies with the law, including refraining from making drug claims (that is, claims that the product prevents, diagnoses, mitigates, or treats disease) or false advertising, and as long as it doesn’t pose a safety risk.
With that background, let’s turn to the FDA’s most recent statements on CBD: it’s safety concerns, call for research, and development of a risk-based enforcement policy.
Safety of CBD
In its Statement, “FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity”, the agency says it is concerned that the public wrongly thinks the myriad of CBD products on the market — such as oil drops, capsules, syrups, food products (e.g., chocolate bars and teas), cosmetics, topical lotions, creams, and pet products – have been evaluated by the FDA and determined to be safe or that using CBD “can’t hurt”.
To disabuse people of those notions, the agency provides a long list of potential harms and side effects in the Consumer Update, including
- liver injury
- affecting how other drugs you are taking work, potentially causing serious side effects
- use of CBD with alcohol or other drugs that slow brain activity (e.g., anxiety drugs), increasing the risk of sedation
- male reproductive toxicity, or damage to fertility in males or male offspring of women who have been exposed, as reported in animal studies
- changes in alertness and mood
- gastrointestinal distress.
Among the many unknowns, according to the FDA, are
- effects of taking CBD daily for an extended time
- what intake level triggers known risks of taking CBD
- how the method of consumption (e.g., oral, topical) affects level of intake
- effects on the developing brain, the developing fetus, and breastfed babies
- interaction with herbs and other plants.
In addition to inherent safety risks, the FDA is also concerned with the lack of appropriate processing controls: it has tested the chemical content of cannabinoid compounds in some products, finding that many did not contain the levels of CBD claimed. It is also investigating reports of CBD products containing contaminants like pesticides, heavy metals, and THC.
Finally, there is the danger of unproven claims of benefit, like those made by companies, warned by the FDA, that their products prevent, diagnose, treat, or cure serious diseases, such as cancer, Alzheimer’s disease, psychiatric disorders, and diabetes.
Research and regulation of CBD
While legalizing some cannabis and cannabis derivatives actually opened up new opportunities for research, the FDA told Congress that “outside groups have not provided the robust data and information needed to fully inform potential paths forward”. The agency itself has initiated a couple of research projects – on CBD exposure during pregnancy and to assess sensitization and dermal penetration of THC and CBD applied topically. As mandated by Congress, it is performing a sampling study of the CBD marketplace to determine the extent to which products are mislabeled or adulterated, although that report is several months out. It is also relying on “engagement” with other federal, state, and international agencies to further its understanding of issues related to CBD, including safety.
Other than that, the FDA has reopened a public docket to “enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products”. It is “particularly interested in data that may help to address uncertainties and data gaps related to the safety of cannabidiol (CBD)”. Unlike most public dockets, which limit the time for submitting comments on a particular issue, this one will remain open indefinitely.
The lack of safety and efficacy data complicates the FDA’s constructing a regulatory path forward. The agency believes the drug approval process is currently
the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are in need of appropriate medical therapy.
Of course, given the time, expense, and uncertainty involved in that process, it would be much easier to make a bundle selling CBD as a dietary supplement, either alone or in combination with other supplement ingredients. The fuzzy line between the “structure/function” claims allowed for dietary supplements and the claims allowed for FDA-approved drugs – that they can prevent, diagnose, mitigate, or treat disease – as well as the public’s misperception that dietary supplements are evaluated for safety and effectiveness by the FDA, make the advantages of going the dietary supplement route obvious.
The prospect of a vast market has put pressure on the FDA from the dietary supplement industry and its friends in Congress to allow CBD in supplements. The FDA could accomplish this via rulemaking, although the agency told Congress it would take three to five years. This prompted four dietary supplement industry associations to write Congress last fall urging it to pass legislation making CBD derived from hemp a legal dietary supplement ingredient, obviating the need for a new rule. One of the industry groups, the Consumer Healthcare Products Association, also filed a Citizen Petition with the FDA advocating ways to shortcut the time-consuming rulemaking process.
Members of Congress wrote the FDA as well, urging it to “act quickly to provide legal clarity” in light of “growing consumer demand and the expected surge in hemp farming in the near future”.
Regulatory certainty will allow the legal hemp industry to flourish while opening up exciting new economic opportunities for farmers and entrepreneurs in a way that protects the public.
In response, the FDA pointed out, in its latest report to Congress, that the (woefully inadequate) Dietary Supplement Health and Education Act posed a number of challenges to successfully introducing CBD into the dietary supplement market. These include lack of authority to require supplement companies to tell the FDA what products they are making and selling to consumers and the limited authority to identify and address products that violate the law and put the public at risk. The agency also noted the drain on its very limited resources for policing the supplement market that would be caused by introducing a large number of new CBD products into the market.
As for now, the FDA is considering issuing a “risk-based enforcement policy” clarifying what factors it will take into account in prioritizing enforcement decisions until it can figure out a final regulatory policy on CBD. During this interim, it will continue to take action “to address violations we identify that put the public at risk.” As the FDA Law Blog pointed out in a November, 2019, post, although FDA maintains its position that the use of CBD in food and dietary supplements is illegal, FDA enforcement has been relatively minimal. Given the agency’s current, and understandable, consumption by the COVID-19 pandemic, except for the most egregious violations, I imagine CBD marketers have little to fear.