In response to a recent directive from Congress, the U.S. Food and Drug Administration (FDA) has released a report that describes "the agency's progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and the process in which CBD meeting the definition of hemp will be evaluated for use in products." The report outlines a variety of actions taken or being considered by the FDA to advance the potential regulatory pathways for CBD.
Reiterating many of its long-standing positions, the FDA stood firm and expressed its primary concern for consumer safety and lack of scientific data on CBD products. The report maintains the FDA's hands-off approach to CBD in cosmetics and does little to advance the agency's stance on CBD in human and animal drugs and foods. But, for perhaps the first time, the FDA signaled a policy shift and potential regulatory pathway for CBD in dietary supplements.
Recognizing its authority to create an exemption through rulemaking that would allow CBD products to be sold as dietary supplements, the FDA will continue evaluating the differences between full-spectrum and broad-spectrum products compared with isolate products. This shift hints at a regulatory pathway that the industry has suspected for some time.
Safety Concerns Remain the Priority
The FDA continues to highlight its concern over the potential safety risks of using CBD, including risks associated with liver injury, drug interactions, drowsiness that may affect driving, and potential male reproductive toxicity. Also of concern are the long-term effects of using CBD, cumulative exposure and use by vulnerable populations such as children, the elderly and women who are pregnant or lactating.
Essential questions include: What happens if you use CBD daily for sustained periods of time? What level of intake triggers the known risks associated with CBD? How do different methods of exposure affect intake, such as oral consumption, topical use or vaping? What is the effect of CBD on the developing brain?
The FDA's Position on CBD in Drugs, Food and Cosmetics Remains Unchanged
The FDA has not changed – and almost certainly will not change – its position with respect to the use of CBD as a drug. Under the Food, Drug and Cosmetics Act's drug exclusion rule, once a substance that was never in the food supply is (1) an active ingredient of an approved drug product or (2) an active ingredient of a product in clinical trials that have been made public, a food or supplement containing that substance cannot be shipped in interstate commerce.
The FDA has cited Epidiolex® as an example of a clinical investigation regarding CBD that has been made public. Epidiolex was approved by the FDA in June 2018 for treatment of childhood seizures associated with two rare forms of epilepsy. The Agency has therefore concluded that CBD products are in fact drugs and require FDA approval.
The FDA again maintains a strong position that CBD cannot lawfully be added to human or animal food because "the data currently available to FDA raise safety concerns about the use of CBD in food." The report encourages the continued development and sharing of information with the FDA "regarding whether there are conditions under which CBD could safely be added to food."
The report does not materially change the FDA's position with respect to CBD in cosmetic products. The agency has stated previously that although certain cosmetic ingredients are prohibited or restricted by regulation, "currently that is not the case for any cannabis or cannabis-derived ingredients."
Nevertheless, the FDA warns that no ingredient − including cannabis-derived ingredients – can be used in a cosmetic if "it causes the product to be adulterated or misbranded." A cosmetic may be considered adulterated "if it bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling."
The FDA also cautions that a product may be considered both a cosmetic and a drug − even if it affects the appearance − if it is "intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease."
The report states that the FDA is aware of only limited data on CBD when used topically. The FDA points to some animal studies that provide information on the skin permeability of CBD cream or gel, but notes that clinical evidence of safety is lacking. The agency has initiated a research study to evaluate CBD and THC levels in a sample of cosmetic products to assess sensitization and dermal penetration.
The FDA Anticipates Rulemaking for Allowing CBD in Dietary Supplements
Though CBD products cannot be marketed lawfully as dietary supplements, the FDA is considering using its authority to create an exemption through its rulemaking process. The report cautions that the FDA is considering how potential CBD rulemaking may impact the agency's ability to provide effective oversight not only for CBD products but also for other types of dietary supplements.
For example, the FDA lacks clear authority to require dietary supplement companies to disclose what products they are making and selling to consumers. There also is concern that expanding the FDA's responsibility to include a large number of new products will impact the agency's overall workload and the prioritization of CBD over other dietary supplements. The report nevertheless outlines several "additional next steps" that may facilitate this rulemaking, discussed below.
The FDA deftly sidesteps its lack of regulatory authority over CBD vape products. The report acknowledges that the FDA has no regulatory oversight over some products containing CBD that fall outside its jurisdiction "even to address potentially serious matters of public health and safety." The report identifies certain public health questions with vaping CBD, including toxicity concerns as well as the potential use by children and other vulnerable populations.
The FDA affirms that it will regulate CBD-containing vape products that meet the definition of "tobacco products," which cannot be marketed without FDA premarket authorization. Left unsaid in the report, however, is the fact that the vast majority of CBD vape products do not contain tobacco or nicotine, such that they are not currently regulated by the FDA. For these products, the report merely concludes that "more safety data and research are needed on this route of administration and potential applications for local and systemic effects."
Additional Next Steps
The FDA identifies several "additional next steps" relating to its enforcement policy, including the need for additional safety information, further engagement with other regulatory partners, evaluation of full-spectrum and broad-spectrum hemp extracts, new research and CBD product sampling.
The report confirms that the "FDA has been actively monitoring the CBD market for violative products that pose the greatest risk to consumers." This includes products being marketed with unsubstantiated therapeutic claims, as well as products that put the public at risk in other ways, such as through contamination, incorrect statements about the amount of CBD and products marketed for use by vulnerable populations such as children.
With regard to possible changes to its enforcement policy, the report states that the "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."
Distinguishing Full-Spectrum and Broad-Spectrum Hemp Extracts from CBD Isolate Products
For the first time, the FDA has stated publicly that it intends to evaluate whether "full-spectrum" or "broad-spectrum" hemp extracts should be treated differently than other CBD products, including those that contain highly concentrated CBD isolate. See our recent article on this topic, "Uncertainty Surrounds Legality of Different CBD Forms."
The FDA report states:
Products that are being marketed with such terms can vary widely in their characteristics, but our understanding is that such terms generally are intended to convey that the product is not a CBD isolate, and that the products contain other substances extracted from the plants. At the same time, we are aware that many products currently marketed as "full-spectrum" or "broad-spectrum" hemp extracts may contain very high concentrations of CBD, and may be derived from varieties of the hemp plant that have been selected specifically for their high CBD content.
The FDA is actively seeking information regarding the manufacturing processes for full- and broad-spectrum hemp products and how they compare with CBD isolate products. "Such information will be critical to informing our evaluation of the regulatory status of such products."
Receipt of Safety Information; Further Collaboration, Research and Product Sampling
To facilitate receipt of additional product-specific information, the FDA is reopening indefinitely the docket established as part of its May 2019 public meeting in order to have a central publicly accessible place to receive new information.
The FDA also will collaborate with state and local regulators, other federal agencies and foreign regulatory counterparts to share information on cannabis-derived compounds, including CBD. In addition, the FDA continues to pursue additional research into CBD products, including studying CBD exposure during pregnancy and the use of CBD in cosmetic products, among other studies.
The report also explains that Congress has instructed the FDA to perform a sampling study of the current CBD marketplace "to determine the extent to which products are mislabeled or adulterated." The agency will report the results of its sampling study to Congress within 180 days. This inevitably recognizes the proliferation of CBD products in the marketplace and the extent to which bad actors could harm consumers. When the FDA last randomly sampled CBD products in 2015, just 2 of the 24 products sampled contained the amount of CBD claimed on the label.
While the FDA is firmly entrenched in its position regarding CBD in foods and beverages, it has finally expressed a clear intent to create a viable regulatory pathway for CBD as a dietary supplement. The new report clearly indicates a desire by the agency to strike a balance between consumer demand and concerns over safety.
Whereas many have been frustrated by a perceived lack of action on the part of the FDA, this report lays out several concrete steps that may pave the way for CBD as a dietary supplement through FDA rulemaking. These steps include a focus on obtaining safety and use data on specific CBD products, completion of research studies already under way and conducting a sampling study on CBD products to help prevent product mislabeling and adulteration.
The FDA's report has been issued amid other signs that CBD policy is advancing in the United States and abroad. FDA's newly appointed commissioner, Stephen Hahn, acknowledged on February 26, 2020, that CBD products are here to stay. "People are using these products. We're not going to be able to say you can't use these products. It's a fool's game to try to even approach that."
Commissioner Hahn further recognized that "We have to be open to the fact that there might be some value in these products and certainly Americans think that's the case. But we want to get them information to help them make the right decisions."
New guidance on CBD products also has been issued in the United Kingdom by its Food Standards Agency (FSA). This guidance allows current CBD products to remain on the shelves but requires businesses to submit novel food authorization applications by March 31, 2021. After that date, only products for which the FSA has a valid application will be allowed to remain on the market. The guidance should facilitate the availability of regulated CBD products in the United Kingdom.
The World Health Organization (WHO) also recently weighed in on CBD products, emphasizing that CBD is not subject to control under the 1961 Single Convention because it "shows no potential for abuse or dependence and any ill-effects are minimal." In its January 31, 2020, report for the United Nations Commission on Narcotic Drugs, WHO stated that it was "aware that CBD products, such as foods, are being sold in many countries," and that "Member States can regulate its availability using their own national legislation."
Those who wish to see movement toward a regulatory pathway for CBD in the United States should take encouragement from the FDA's report to Congress. Given that the agency moves notoriously slowly in its regulation of drugs, food and supplements, there appears to be good progress made since public hearings were held by the FDA in May 2019. All eyes are now on the results of the FDA's CBD product sampling study, which is due to be reported to Congress by June 20, 2020.
This article appeared in the March 16, 2020, edition of Law360.
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