If you are marketing a CBD product online, beware of the regulatory pitfalls.
There is a rapidly growing market for products containing CBD: tinctures, creams, body products, edibles, and pet treats. The Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) broadened the business possibilities for these products by removing hemp from the definition of marijuana, and specifically defining hemp as cannabis or a cannabis derived product containing than no more than 0.3 percent THC on a dry weight basis. As long as CBD meets this definition, it is no longer illegal as a controlled substance.
However, the Farm Bill also specifically preserved the FDA’s ability to regulate products containing hemp and hemp-derived compounds, including CBD products. So while CBD itself is not a controlled substance, products containing CBD may still be regulated in other ways. Specifically, the US Food and Drug Administration (the “FDA”) regulates the safety and efficacy of food, drugs and cosmetics and the Federal Trade Commission (the “FTC”) protects consumers from fraudulent, deceptive, and untruthful business practices. As a result, the FDA is reviewing the sale CBD products and the FTC is keeping an eye on how those products are marketed.
Recently the FTC & the FDA jointly issued warning letters to companies marketing CBD products as a treatment or cure for serious diseases like cancer, Alzheimer’s, and epilepsy. The FTC Act makes it unlawful to say in your advertising or marketing that a product can prevent, treat, or cure human disease unless you have “competent and reliable scientific evidence substantiating that the claims are true.” Competent and reliable evidence must be research-based, rigorous, and objective, such as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”[1]
In addition, a product that is meant to diagnose, treat, cure, or prevent a disease or function of the body is, in the view of the FDA, being marketed as a drug and therefore subject to regulation as a drug. Furthermore, the Food, Drug and Cosmetic Act currently makes it unlawful to sell food or (other consumables, including animal feed or pet treats) containing CBD. The FDA also has specific requirements before you can call something a “dietary supplement,” and it specifically excludes CBD products from the definition of a dietary supplement.
In combination, these regulations make it very difficult to market and sell CBD products in compliance with law, and nearly impossible if those CBD products are for consumption.
But these regulations are likely to change in the near future, as the FDA continues to research the uses, benefits, and side effects of CBD, taking proactive steps to develop a path for the lawful marketing and sale of CBD products. Currently, both agencies are being selective in their enforcement, since they recognize that there is a market for and a benefit of CBD products.
In an October 10, 2019 Warning Letter to Rooted Apothecary, LLC, the FDA said “while we recognize the potential opportunities and significant interest in drug products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority.” In the meantime, the FDA has indicated that it will direct its resources at companies that go “over the line.” Specifically, the FDA is more likely to take action against companies that market products to children or other especially vulnerable people, and companies that promise treatment or cure for serious diseases, when those promises are not supported by valid, accepted, scientific research.
If you are marketing a CBD product, be careful and appreciate the risks when describing the features and benefits of a CBD product. Don’t suggest that your product treats serious conditions like autism, Alzheimer’s, or anxiety. In addition, don’t market products to children. Wherever possible, cite reliable scientific evidence to support any statements you make about your products. Even suggesting that the product “relieves pain” would require supporting scientific research. Until the FDA issues specific guidance and updates its regulations, the marketing and sale of CBD products will be scrutinized, but keeping these guidelines in mind will greatly reduce the risk of receiving a warning letter, fine, or other regulatory action.
[1] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food#ftn7
