Recent CBD Enforcement Efforts, Priorities and Policy Outlook
The most recent round of FDA cannabidiol (CBD) warning letters, issued on April 23, 2020, closely follows the agency's enforcement priorities, outlined in its March update, to focus on CBD-containing products that present the "greatest risk" of public harm. FDA cited Biota Biosciences, LLC (Biota) and Homeo Corp DBA Natures CBD Oil Distributions (Homeo) for illegally marketing CBD products to treat opioid addiction and other serious medical conditions (e.g., AIDS, Alzheimer's Disease, Cancer). In its press release, FDA emphasized that it will continue to focus on unfounded treatment claims relating to opioid addiction. Dr. Amy Abernethy, FDA Principal Deputy Commissioner, stated "CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider." Separately, earlier in April, FDA issued warning letters to two CBD companies, Nova Botanix and CBD Online Store, for illegally marketing CBD products to treat COVID-19. To date, in all of the CBD warning letters it has issued, FDA has cited companies for unsupported treatment claims.
This Advisory begins with an overview of the recent opioid-related warning letters, highlights the types of health claims that are likely to trigger FDA and FTC enforcement, and discusses the current CBD-related policymaking outlook and perspectives amidst the heightened COVID-19 environment.
The Warning Letters
In its latest warning letters, FDA cited concerns with claims found on the companies' websites and social media accounts. In the first warning letter, FDA concluded Biota's injectable CBD and injectable curcumin products were considered unapproved new drugs and misbranded under the Federal, Food, Drug, and Cosmetic Act based on consumer directed claims that these products treated serious diseases, such as inflammatory auto-immune diseases, and were an alternative to opioids—e.g., "Fighting the opioid epidemic . . . BIOTA Biosciences produces and distributes effective all-natural alternatives with no side-effects. Join the growing ranks of pain, oncology, psychiatry, naturopathy healthcare professionals utilizing BIOTA Sterile CBD Vials." Importantly, FDA noted that the products' injectable form, which could "pose a serious risk of harm to users because they are delivered directly into the bloodstream" and have an "immediate effect on the body," as additional evidence establishing the products' intended use as drugs.
In the second warning letter, FDA also found Homeo's CBD topical product claims to treat serious diseases and opioid addiction rendered the products unapproved new drugs and misbranded—e.g., "Early Phase in the Development of CBD as a Treatment for Addiction: Opioid Relapse Takes Initial Center Stage," and "CBD Oil for AIDS Virus…Cancer…Alzheimer's Disease." Homeo's CBD products for dogs and cats were also considered unapproved new animal drugs based on their health claims.
FDA determined Homeo's addition of CBD to their "CBD Edibles" products was prohibited under 21 U.S.C. 331(ll). FDA takes the position that CBD may not be added to foods since the drug Epidiolex, which is approved for the treatment of seizures, contains a purified form of CBD. As with prior warning letters issued in November 2019, FDA recognized CBD as a food additive (any substance intentionally added to food is a food additive) which is subject to premarket review unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception. FDA stated that it is "not aware of any basis to conclude that CBD is GRAS for use in conventional foods" or "any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food" and thus, found the "CBD Edibles" to be adulterated food products.
To date, FDA has only taken compliance action against products that make high-risk therapeutic claims. To the extent that FDA cites other rationale in its warning letters, those other citations have always been in combination with high-risk therapeutic claims.
FDA & FTC Enforcement
FDA's latest warning letters together with its March update and Report to Congress (required by the Further Consolidated Appropriations Act to analyze and develop an enforcement discretion policy and evaluation of hemp-derived CBD in food and dietary supplements, as discussed here), highlight the agency's continued concern about potential safety risks from CBD and CBD-containing products. The Agency's message is clear—while it is exploring pathways for various types of CBD products (including food and dietary supplements), it needs more data in order to evaluate and make regulatory decisions about CBD. This includes reopening the public docket, as mentioned in the March update and originally opened for the agency's May 2019 public meeting on CBD, to collect additional information about the potential risks and benefits of CBD. The docket will be open indefinitely, allowing stakeholders to comment and share data with FDA on an ongoing basis and help the agency issue a "risk-based" enforcement policy for CBD products.
Additionally, recent FDA and FTC enforcement actions also highlight the agencies' focus on higher-risk therapeutic CBD claims. For instance, in March 2019, FDA and the FTC jointly issued warning letters to three marketers of CBD-containing products (Nutra Pure LLC, PotNetwork Holding, Inc., Advanced Spine and Pain LLC) relating to higher-risk claims to treat, among others, Alzheimer's disease, cancer, and autism. FDA alleged that these claims rendered the products unapproved new drugs and FTC alleged that these claims were unsubstantiated. In 2019, the FTC also independently issued three warning letters relating to disease cure and treatment claims made in marketing for CBD products.
Enforcement and Regulatory Policy Outlook
The risk of FDA and FTC enforcement of CBD products has been tied to claims to treat serious medical conditions. The agencies also have focused their attention on products that target vulnerable populations (e.g., infants and children). To date, lower-risk claims and product labeling as dietary supplement have not been subject to independent enforcement.
It is important to note that many in industry argue that the prohibition on adding an approved drug to foods (21 U.S.C. 331(ll)) and dietary supplements (21 U.S.C. 321(ff)(3)(B)(i)) does not apply to some CBD-containing products. For example, some argue that "full spectrum" or "broad spectrum" hemp extracts that contain relatively low levels of CBD as well as other naturally occurring cannabinoids are distinguishable from the concentrated form of CBD isolate in FDA-approved Epidiolex. Although it has not adopted this position, in its March update, FDA signaled that it would consider how "'full spectrum' and 'broad spectrum' hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products."
FDA Commissioner Stephen Hahn has bluntly stated that FDA must permit use of some CBD products. In February, Dr. Hahn said, "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." Certainly, the COVID-19 emergency presents challenges and shifts priorities and resources for FDA. It is natural to assume that CBD policymaking has slowed down, as FDA's Commissioner's Office is working on the COVID-19 pandemic. However, the work of many of the important hemp and CBD policymakers in FDA's Center for Food Safety and Applied Nutrition (CFSAN) is less affected by COVID-19. Thus, we believe that, although there may be some policymaking delays, it is still worthwhile for interested stakeholders to engage with FDA as the agency continues to develop a more clear regulatory regime for many CBD and hemp products.
We will continue to monitor developments in this area to assist clients with engaging the agency and stakeholders.
© Arnold & Porter Kaye Scholer LLP 2020 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.