For the first time, the U.S. Federal Food and Drug Administration (“FDA”) this week issued consumer warnings and sent letters to five companies, alleging that they are selling products in a way that violates Food, Drug and Cosmetic Act (the “FD&C Act”). This regulatory action has important implications for companies labeling and selling products containing delta-8 tetrahydrocannabinol (or “Delta-8 THC”). This client alert summarizes the FDA’s actions and offers practical guidance to companies marketing and selling products containing Delta-8 THC.
The FDA has three main sets of concerns as follows: first, it is observing an “uptick in adverse event reporting” related to Delta-8 THC and the FDA describes a number of the adverse health effects consumers are experiencing (a significant number of them minors) over half of which required medical intervention; second, marketing, with emphasis on online marketing of Delta-8 THC products “appealing to children” and making claims or inferences about these products that have neither been verified, tested or approved in any way by the FTC; and third, significant concerns about the processes or methods by which Delta-8 THC products are being manufactured that may introduce contamination or otherwise lack quality or other control to assure the safety of the products.
Since 2015, the FDA has sent warning letters to companies allegedly illegally selling unapproved cannabinoid (CBD) products. The FDA warning letters caution sellers about claims they make to market their products. Specifically, the FDA challenges the sellers’ marketing wording and labeling. In the FDA’s words, “these products diagnosed, cured, mitigated, treated or prevented various diseases.” The FDA views these claims as being tantamount to the companies selling unapproved “drugs” in violation of the FD&C Act.
The FDA explains it is monitoring the selling of CBD and Delta-8 THC products out of a growing safety concern. CBD and Delta-8 THC products are produced and marketed in a largely unregulated marketplace. The FDA has cited many examples of ways in which these products are misbranded, mislabeled, and pose challenges for consumers to evaluate exactly what they are buying. When it tests the chemical content of the CBD in the products it regulates, the FDA reports it often finds that the levels of CBD it detects in the products differ from the levels of CBD the sellers claim the products contain.
Customers’ only way to know the levels of cannabinoids and other ingredients these products contain is by reviewing labels, marketing claims, and checking certificates of analysis. Generally, a CBD product seller is expected (or required by law) to provide customers with access to a “certificate of analysis” or “COA” associated with specific products, which COA confirms the levels of CBD in products and upon which customers can rely. COAs are generally issued by accredited laboratories and many states require sellers to include COAs with each cannabis or CBD product. Some states require all product labels to have custom QR codes that link to a COA. Sellers of CBD products are encouraged to check applicable state laws when designing their products’ labels to assure they provide customers with a way to view COAs associated with those products. It is important to note that while the FDA has jurisdiction over labeling issues in the world of cannabinoids, so does the Federal Trade Commission (the “FTC”). The FTC has a long history of bringing enforcement actions against a wide range of sellers of products whose labels do not accurately or appropriately describe products being sold – or that make claims that prove to be false.
Because there are no FDA-approved drugs containing Delta-8 THC, the FDA takes the position that sellers of Delta-8 THC products may not lawfully claim that their products can diagnose, cure, mitigate, treat or prevent diseases. At this time the FDA has not evaluated what, if anything, these products are effective for and what appropriate doses might be, or whether there are counterindications for persons taking other drugs or having any other health conditions. In short, the FDA has not evaluated or logged all dangerous side effects or safety concerns.
The FDA’s investigations into online sales of products containing CBD or Delta-8 THC are described in their warning letters. The FDA’s warning letters tell the public that the FDA reads and reviews companies’ websites, labels, social media, and marketing language. The FDA evaluates sellers’ claims, graphics, and product descriptions – including products marketed for animals, information about food additives, and social media websites. The FDA concludes, based upon its analysis of the language the companies use to market their products or to drive consumers from social media to purchase products on their websites – that the sellers are selling “unapproved new drugs” in violation of the FD&C Act. Moreover, the FDA has concluded that these Delta-8 THC products are misbranded. “Misbranded” is a term of art under the FD&C Act that refers to the inadequacy of information on a product’s label about its proper use, dosages, side effects, and other considerations). Examples of sellers’ language the FDA views as illegal are the following:
- “Our line of …CBD oil … is great for insomnia, epilepsy, MS, schizophrenia, and chronic pain.”
- “Pre-clinical data support the possible use of CBD with Panic Disorder…Bipolar Disorder.”
- “High level CBD can help manage symptoms of psychosis.”
- “Taking CBD can relieve pain.”
- “In non-medical terms, researchers linked Delta 8-THC to anti-nausea, anti-anxiety, and pain relief benefits, among other effects.”
- “Delta-8 is known to be successful in many cancer treatments.”
- “CBD is not a cure-all, but there is anecdotal evidence to show that it can be safe and effective for a variety of health conditions.”
To conclude, what are some important practical steps companies marketing Delta-8 THC companies should take away from the FDA’s warning letters and consumer alerts? Here are six key considerations:
- Labeling and Marketing Words. Take care in labeling each and every product to assure it adequately describes the product, contains a QR code to take a customer to the certificate of analysis of that product, and offers clear and reasonable instructions on the proper use of the product (including any safety warnings, potential side effects, how to get more information). The FDA’s warning letters include specific wording or phrasing the FDA found to be illegal. Read those examples in the FDA’s warning letters and avoid using them. Review your online and social media marketing words carefully to avoid offering medical advice or making it appear as though there are FDA-approved Delta-8 THC products of any sort. Expressly note that there are no FDA approvals for your products in a spot on your website that is visible and viewable by guests.
- Beware of attracting minors to your website. The FDA noted that many of the Delta-8 THC and CBD products are labeled and described in a way that is attractive to minors. Design websites and social media with clear explanations that they are not intended for nor should they be used by minors. If tracking traffic to your website and social media, trust but verify that minors are not suspected users and buyers of CBD or Delta-8 THC products. Insist on having an age gate on your website that a potential visitor must click through to confirm their age before any website information is viewable. Clearly note conspicuously in all online marketing resources, social media, and other resources used to attract or market to prospective customers, that your website and products are not meant for minors. Consider requiring additional age information to conduct sales and avoid marketing strategies attractive to or positioning in places likely to be frequented by minors.
- Obtain COAs for all product marketing and selling. The FDA and other state regulators test the chemical composition of CBD and Delta-8 THC products. Assure you obtain COAs and have them prominently and readily available for customers and prospective customers.
- Avoid health, medical, and medicinal market statements and claims. When medical and diagnostic wording appears in your product labels, social media, and marketing, the FD&C Act recharacterizes those goods you are offering as “drugs” – and in this case, drugs that are unapproved by the FDA and therefore being illegally sold. Examples of wording to avoid are representations and claims stating CBD or Delta-8 THC products have the ability to cure or relieve illnesses, medical conditions, syndromes, or particular symptoms, whether anecdotal or scientific sounding. Once your website includes information about CBD or Delta-8 THC products being useful in treating specific medical conditions, the lessons learned from both the FDA and FTC regulatory actions are that these federal regulators could assume you are marketing drugs – and drugs that are unapproved by the FDA – to consumers in violation of the law. If your marketing characterizes Delta-8 THC as food or additive to foods, be aware that Delta-8 THC is not an FDA-approved “food additive.” Consider carefully how you describe and market the ingredients in your CBD and Delta-8 THC-related foods.
- Be kind to animals. The FDA also has authority over goods marketed for use with animals. Avoid making any claims about the suitability of specific CBD or Delta-8 THC products for animals or to cure illnesses or diseases in animals.
- Website etiquette. Assure your website includes appropriate disclosures, such as that the FDA has not approved Delta-8 THC products, telling website visitors what the terms and conditions are for the use of your website, and explaining what your privacy policies are. California, Utah, Colorado, Nevada, Virginia, and Connecticut have laws related to the information you collect about persons via your website and how you use and disclose it with which you should be familiar before you begin collecting and sharing your website visitors’ information.
This client alert does not provide legal advice. Should you wish to discuss these topics or how they may apply to your business, contact the article’s authors Michelle R.E. Donovan or Leslie Bender. This article reflects the interpretations of recent regulatory action by its authors and may not reflect the views of Clark Hill PLC.