For the first time, the Federal Food and Drug Administration (FDA) of the United States issued this week consumer warnings and sent letters to five companies, alleging that they sell products in a way that viola Food, Drug, and Cosmetic Act (the “FD&C Act”). This regulatory action has significant implications for companies that label and sell products that contain delta-8 tetrahydrocannabinol (or “Delta-8 THC”). This customer alert summarizes the FDA’s actions and provides practical guidance to companies that market and sell products containing Delta-8 THC.
The FDA has three broad sets of concerns: First, it is seeing an “increase in adverse event reporting” related to Delta-8 THC, and the FDA describes a number of adverse health effects that consumers experience (a significant number of them). minors) more than half of whom have required medical intervention; second, marketing, with an emphasis on the online marketing of “child-appealing” Delta-8 THC products and making claims or inferences about those products that have not 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 controls to ensure product safety.
Since 2015, the FDA has sent warning letters to companies allegedly illegally selling unapproved cannabinoid (CBD) products. FDA warning letters warn sellers about the claims they make to market their products. Specifically, the FDA challenges marketers’ marketing wording and labeling. In the FDA’s words, “these products diagnosed, cured, mitigated, treated, or prevented various diseases.” The FDA considers these claims to be tantamount to companies selling unapproved “drugs” in violation of the FD&C Act.
The FDA explains that it is monitoring the sale of CBD and Delta-8 THC products because of growing safety concerns. CBD and Delta-8 THC products are produced and traded in a largely unregulated market. The FDA has cited many examples of ways in which these products are misbranded, mislabeled, and pose challenges for consumers to assess exactly what they are buying. When testing the chemical content of CBD in the products it regulates, the FDA reports that it often finds that the levels of CBD it detects in the products differ from the levels of CBD that sellers claim the products contain.
The only way for customers to know the levels of cannabinoids and other ingredients contained in these products is by reviewing labels, marketing claims and checking certificates of analysis. A seller of CBD products is generally 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 products’ CBD levels and that customers can trust. . 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 product labels to ensure that they provide customers with a way to see the COAs associated with those products. It’s important to note that while the FDA has jurisdiction over labeling issues in the cannabinoid world, so does the Federal Trade Commission (the “FTC”). The FTC has one long history to bring enforcement actions against a wide range of sellers of products whose labels do not accurately or adequately describe the products being sold, or who make claims that turn out to be false.
Because there are no FDA-approved drugs that contain Delta-8 THC, the FDA believes that sellers of Delta-8 THC products cannot legally claim that their products can diagnose, cure, mitigate, treat, or prevent disease. At this time, the FDA has not evaluated what, if any, these products are effective for and what appropriate doses might be, or whether there are contraindications for people taking other drugs or having other health problems. In short, the FDA has not evaluated or recorded all dangerous side effects or safety concerns.
FDA 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. FDA evaluates marketers’ product claims, graphics, and descriptions, including products marketed to animals, food additive information, and social media websites. The FDA concludes, based on its analysis of language used by companies to market their products or to drive consumers on social media to buy products on their websites, that sellers are selling “unapproved new drugs” in violation of the FD&C Act. Additionally, the FDA has concluded that these Delta-8 THC products are misbranded. “Misbranding” is an FD&C Act term of art that refers to the inadequacy of information on a product’s label about its proper use, dosages, side effects, and other considerations). Some examples of marketer language that the FDA considers illegal include:
“Our line of CBD oil…is ideal for insomnia, epilepsy, MS, schizophrenia and chronic pain.” “Preclinical data support potential use of CBD with panic disorder…bipolar disorder.” “High-level CBD may help control symptoms of psychosis.” “Taking CBD can relieve pain.” “In non-medical terms, researchers linked Delta 8-THC to benefits against nausea, anxiety and pain relief, 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 that it can be safe and effective for a variety of health conditions.”
To conclude, what are some important practical steps that companies marketing Delta-8 THC 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 ensure that it adequately describes the product, contains a QR code to take the customer to the certificate of analysis for that product, and provides clear and reasonable instructions on the proper use of the product (including any security). warnings, potential side effects, how to get more information). FDA warning letters include specific wording or phrasing that FDA considers illegal. Read these examples in the FDA warning letters and avoid using them. Carefully review your online and social media marketing wording to avoid offering medical advice or making it seem like there are FDA-approved Delta-8 THC products of any kind. Please note expressly that there are no FDA approvals for your products in a place on your website that is visible and viewable by guests.
Be careful about attracting minors to your website. The FDA noted that many Delta-8 THC and CBD products are labeled and described in a way that appeals to minors. Design websites and social networks with clear explanations that they are not intended for and should not be used by minors. If you monitor 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 to confirm their age before any website information can be viewed. Clearly state in all online marketing, social media and other resources used to attract or market to potential customers that your website and products are not intended for minors. Consider requiring additional age information to make sales and avoid marketing strategies that are attractive or positioned in places likely to be frequented by minors.
Obtain COA for marketing and sale of all products. The FDA and other state regulators test the chemical composition of CBD and Delta-8 THC products. Be sure to obtain attribution certificates and have them prominently and easily available to customers and potential customers.
Avoid health, medical and medicinal marketing statements and claims. When the word medical and diagnostic appears on your product labels, social media, and marketing, the FD&C Act recharacterizes the products you offer as “drugs,” and in this case, drugs that are not approved by the FDA and therefore sold illegally. Examples of wording to avoid are representations and claims that CBD or Delta-8 THC products have the ability to cure or alleviate particular diseases, medical conditions, syndromes or symptoms, whether anecdotal or scientific. Once your website includes information that CBD or Delta-8 THC products are useful for treating specific medical conditions, the lessons learned from both the FDA and FTC regulatory actions are that these federal regulators might assume that market drugs and medicines that are not approved by the FDA: to consumers in violation of the law. If your marketing characterizes Delta-8 THC as a food or food additive, please note that Delta-8 THC is not an FDA-approved “food additive.” Carefully consider how you describe and market your food ingredients related to CBD and Delta-8 THC.
Be kind to animals. The FDA also has authority over products marketed for use on animals. Avoid making any claims about the suitability of specific CBD or Delta-8 THC products for animals or to cure animal diseases or ailments.
Website label. Make sure 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 using your website and explaining what your privacy policies are. California, Utah, Colorado, Nevada, Virginia and Connecticut have laws relating to the information you collect about individuals through your website and how you use and disclose it, which you should be familiar with before you begin collecting and share information about your website visitors.