Alerts and Updates
FDA Warns Cannabidiol-Infused Products Manufacturers Over Health Claims
November 14, 2017
The FDA has recently issued warning letters to four companies concerning the marketing of products containing cannabidiol, alleging that claims made online concerning the health benefits of CBD violated the Federal Food, Drug and Cosmetic Act.
The U.S. Food and Drug Administration (FDA) has recently issued warning letters to four companies concerning the marketing of products containing cannabidiol (CBD). FDA alleged that claims made on websites and social media webpages concerning the health benefits of CBD violated the Federal Food, Drug and Cosmetic Act (the Act). The products at issue included CBD-infused oils, edibles, tinctures and creams, and the manufacturers included statements claiming various health benefits from CBD, such as:
- CBD “actually kills cancer cells”
- CBD is “anti-tumor”
- “CBDs are effective against MRSA (antibiotic-resistant bug)”
- “Research showing benefits of cannabinoids for autism”
- CBD provides “better relief than prescription drugs”
- Providing specific “Cancer Dosing Guidelines” for adults and children
- Providing links to third-party websites “that promote CBD for diseases including but not limited to Alzheimer’s disease, Breast Cancer, Diabetes, Leukemia, Lung Cancer, Parkinson’s disease, Stroke and others”
- Retweeting and responding to customer social media posts suggesting CBD is effective against autism and concussion-related injuries
- “CBD [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow.”
- “Almost all studies recognize CBD’s potential in preventing both cancer spread and growth…”
- “Adding CBD oil as part of your daily Alzheimer’s medicine routine has a good chance at delaying the progression of the disease…”
- “[CBD] has antipsychotic properties, which makes it very useful for treating bipolar disorder.”
According to FDA, the CBD-infused products met the definition of a “drug” under the Act because marketing claims like the above demonstrated the products were intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or to affect the structure or any function of the body. FDA further took the position “that CBD products are excluded from the dietary supplement definition” under the Act because CBD had “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,” citing a 2007 clinical trial. FDA alleged the companies had violated the Act by mislabeling products that “are not generally recognized as safe and effective for the above referenced uses,” by failing to provide adequate directions for use, and by failing to accurately state the levels of CBD in the products. The companies were directed to cure the violations or face punitive action, including possible seizure and injunction of the products.
Whether a product meets the definition of a drug under the Act is dependent, in part, on its intended use. Products marketed as intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or to affect the structure or any function of the body may fall within the definition of a drug and be subject to corresponding federal law and FDA regulations. Products considered drugs under the Act may be subject to stringent manufacturing, registration and labeling requirements, and expose manufacturers to possible civil and criminal liability in instances of noncompliance with FDA regulations.
Violations of the Act may carry significant penalties. FDA has broad authority to investigate alleged violations of federal law and to initiate enforcement actions to enjoin offending products from commerce, including seizing such products without notice. It can also recommend criminal prosecutions that may result in misdemeanor or felony convictions. Accompanying misdemeanor fines under the Act can reach $500,000 under some circumstances. Further, a violation of the Act may result in product liability suits brought by state attorneys general or individuals, including class actions.
The CBD-infused products market is growing fast, with a proliferation of CBD-infused product manufacturers keen on providing patients with the health benefits of hemp-derived CBD that cannot be supplied with marijuana-derived CBD because marijuana is still a Schedule 1 drug under the Controlled Substances Act, 21 U.S. Code § 812. The recent warning letters are a good reminder to these manufacturers that FDA is watching. In fact, since 2015, FDA has issued warning letters pertaining to approximately 70 CBD-infused products that claimed to have health benefits.
The good news is that mislabeling CBD-infused products is avoidable. Companies can and should engage professionals with expertise in FDA regulations before marketing and selling CBD-infused products to the public to prevent FDA from defining them as drugs. Products already in the marketplace can and should be reviewed for compliance. Additionally, companies should consider retaining legal counsel early to address FDA warning letters and mitigate possible exposure to civil and criminal liability.
For Further Information
If you have any questions about this Alert, please contact Seth A. Goldberg, Steven T. Knipfelberg, any of the attorneys in our Cannabis Practice Group, attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food Practice Group, or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.