The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease, among other conditions and symptoms. Problematically, however, “[t]hese statements have not been evaluated by the Food and Drug Administration,”[1] and, as a result, a flood of warning letters issued by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) has followed. That said, regulators have struggled to keep pace reviewing CBD marketing claims.
Although CBD products have been marketed for some time and the FDA has issued warning letters in due course to prevent “health fraud,”[2] the recent dramatic increase in CBD product marketing began shortly after passage of the 2018 Farm Bill (the Agriculture Improvement Act of 2018) that notably removed “industrial hemp” from the definition of “marijuana” laid out in the federal Controlled Substances Act (CSA).[3] In the Farm Bill, hemp is defined in Section 10113 as any part, derivative, or extract of a Cannabis sativa L. plant that contains 0.3% or less of THC (tetrahydrocannabinol) on a dry weight basis.
After the Farm Bill’s changes, the FDA opened a public comment period, soliciting scientific data and other information about products containing cannabis and cannabis-derived compounds, including CBD and its derivatives. More than 4,000 submissions were received by the FDA including personal anecdotes from individual consumers, recommendations from medical professionals to standardize quality and labeling metrics of CBD products, and requests from state officials and consumer advocacy organizations urging FDA intervention to preserve public health and safety interests. The comments remain under FDA consideration.
Despite the “significant public interest”[4] in hemp-derived CBD products, the FDA maintains its charge to incentivize rigorous, science-based research and drug development of new products. To that end, the agency has taken, and will continue to take, action against companies that undermine those objectives by marketing products with false or misleading claims. For example, on Nov. 22, 2019, alone, the FDA issued 15 warning letters to different companies for selling unapproved products containing CBD on the internet in ways that violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) (15 U.S.C. § 41 et seq.), including, for example, through the use of unsubstantiated claims that the products treat or prevent conditions such as teething pain and ear aches in infants, autism, ADHD, and Parkinson’s disease. The warning letters specifically point to the particular company’s use of its online store and social media websites to make unfounded claims about its CBD products, and noted that some of the products were also unlawfully marketed as dietary supplements. The FDA, in particular, has taken a hard-line stance on CBD products marketed for therapeutic or medical uses and indicated that the warning letters “should send a message to the broader market about complying with FDA requirements.” Thus far, the FDA has issued 22 warning letters for CBD-related products in 2019.
Fortunately for those in the industry, however, the FDA does “recognize the need to be clear and open about where things stand, and about the efficient and science-based way [the CBD industry should be] moving forward.”[5] With the regulatory framework continuing to evolve around the use of cannabis, here is what industry participants need to know[6]:
- Cannabis and cannabis-derived compounds continue to be subject to the same laws and requirements as FDA-regulated products that contain any other substance.
- Under the Federal Food, Drug & Cosmetic Act (FD&C Act), a product cannot be advertised to prevent, treat or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.
- The FDA has determined that food to which CBD has been added cannot be put into interstate commerce and CBD cannot be marketed as, or in, dietary supplements.[7]
- If a product, such as CBD, is being marketed as a drug (e.g., intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease), then it is regulated as a drug, and it generally cannot be sold without FDA approval.
- As of this writing, the FDA has not approved marijuana as a safe and effective drug for any indication. The agency has, however, approved one specific drug product (Epidiolex) that contains cannabis-derived purified CBD for the treatment of seizures, and three other drug products that contain a synthetic substance that acts similarly to compounds from marijuana.
- Researchers seeking to conduct clinical research with cannabis or cannabis-derived products that continue to be scheduled by the DEA should be mindful of the following[8]:
- For a Schedule I controlled substance under the CSA, DEA provides researchers with the necessary investigator and protocol registrations and has Schedule I-level security requirements, which need to be followed at the site cannabis will be studied.
- Researchers may obtain cannabis from National Institute on Drug Abuse (NIDA), which has long been a source for research-grade cannabis for scientific study, or another DEA-registered source.
- If researchers are seeking to conduct clinical research with cannabis or cannabis-derived products that could potentially lead to a new drug, they are expected to submit an investigational new drug (IND) application to the appropriate division in the Office of New Drugs with the Center for Drug Evaluation and Research depending on the therapeutic indication.[9] Based on the results obtained in studies conducted at the IND stage, sponsors of research may submit a marketing application for formal approval of the drug.
- With the passage of the Farm Bill, a DEA registration is no longer required to conduct research with hemp. With that said, if clinical research involving human subjects utilizes hemp (as defined in the Farm Bill), an IND must still be opened with the FDA in order to test the quality, safety and efficacy of hemp as an investigational product and the research substance must, among other requirements, be cultivated in accordance with a USDA-approved program at the state and/or federal level and in compliance with good manufacturing practice (GMP) requirements. As of this writing, the USDA has issued an interim final rule and opened a public comment period. The interim final rule will be effective for two years and then will be replaced with a final rule.
Companies and institutions exploring opportunities with cannabis or cannabis-derived products should be mindful to proactively review federal and state regulatory requirements related to the research and/or marketing of cannabis or cannabis-derived products to ensure compliance and minimize future interactions with federal or state agencies.
This document is intended to provide you with general information regarding enforcement actions against companies advertising and selling cannabidiol products. The contents of this document are not intended to provide specific legal advice. If you have any questions about the contents of this document or if you need legal advice as to an issue, please contact the attorneys listed or your regular Brownstein Hyatt Farber Schreck, LLP attorney. This communication may be considered advertising in some jurisdictions.
[1] 21 C.F.R § 101.93 (c)(2)
[3] 21 U.S.C. § 801 (2019)
[4] Abernethy, Amy M.D., Ph.D., FDA is Committed to Sound, Science-based Policy on CBD, (Jul. 17, 2019), https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/fda-committed-sound-science-based-policy-cbd, Accessed Oct. 25, 2019
[6] This article discusses the federal landscape around cannabis research and product development; stakeholders should also remain cognizant of requirements under the state(s) where research is conducted.
[7] Under the FT&C Act, if a substance, such as THC or CBD, is an active ingredient in a drug product that has been approved by the FDA, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a “dietary supplement” under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act (21 U.S.C. § 321(ff)(3)(B)). The FDA has approved one specific drug product that contains cannabis-derived purified CBD for the treatment of seizures and, as such, CBD is a drug subject to FDA oversight.
[8] FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD), (Oct. 16, 2019) https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#fdaroleresearch, Accessed Oct. 25, 2019.
[9] For research that seeks to develop an animal drug product, researchers are expected to submit an investigational new animal drug (INAD) application with the Center for Veterinary Medicine.