[co-author: Rachel Buff]
The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD). In addition to the various violations outlined by FDA in the letters under the Federal Food, Drug, and Cosmetic Act (FFDCA), the agency particularly highlighted its serious concerns about the potential health effects of delta-8 THC products. While this is the first time that FDA has ever issued Warning Letters for products containing delta-8 THC, we view this set of Warning Letters to signify FDA’s continuing enforcement of federal restrictions on the marketing and sale of products containing cannabis-derived ingredients.
The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FFDCA). 1 In these letters, the agency cited various FFDCA violations including the marketing of unapproved new drugs and the unlawful use of delta-8 THC and CBD in food and dietary supplement products. The agency also particularly noted its serious concerns with the potential health effects of delta-8 THC products.
Background
In light of significant industry interest in the development of consumer products derived from cannabis and its components, FDA has reinforced its position that CBD cannot be legally sold as dietary supplements or in a food under the exclusionary clause. 2 In the recently issued Warning Letters, FDA similarly asserts delta-8 THC cannot be sold as a food. Along with the Federal Trade Commission (FTC), FDA has previously issued Warning Letters to various companies selling CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases in violation of the FFDCA. Like CBD, delta-8 THC is also derived from the Cannabis sativa plant. While THC is a Schedule I controlled substance, delta-8 THC has not been listed by the Drug Enforcement Agency as a controlled substance. FDA describes delta-8 THC as a psychoactive substance and characterizes the amount of delta-8 THC from the plant as very low. In the Warning Letters, FDA expresses concern with the use of chemicals to convert other cannabinoids in the plant into delta-8 THC. FDA has not evaluated or approved any products containing delta-8 THC, nor are there any FDA-approved drugs containing delta-8 THC. Therefore, any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent disease is considered an unapproved new drug by the agency. In addition, like CBD, FDA considers delta-8 THC to be an unapproved food additive for use in any human or animal food product, as the substance is not generally recognized as safe (GRAS) or otherwise exempt from food additive requirements. FDA states it has serious safety concerns with delta-8 THC. FDA states it has received 104 reports of adverse events in patients who consumed delta-8 THC products between December 1, 2020 and February 28, 2022.
FDA Warning Letters
These new Warning Letters address a number of FDA concerns with the marketing and sale of CBD and delta-8 THC products. In particular, FDA highlighted the following –
- FDA considers delta-8 THC to pose serious health and safety risks. The agency stated that it has received numerous adverse event reports involving delta-8 THC-containing products. According to FDA, because the cannabis plant contains naturally low levels of Delta-8 THC, some manufacturers use potentially unsafe household chemicals in potentially unsanitary conditions to produce the substance through synthesis. The agency is concerned about the lack of controls during this process.
- Food products for human or animal consumption that contain CBD or delta-8 THC are considered adulterated under the FFDCA. FDA considers CBD and delta-8 THC to be unsafe and unapproved food additives. Therefore, any foods containing these substances are considered adulterated and may not be lawfully marketed.
- CBD and delta-8 THC products that make disease claims are unapproved new drugs. Any CBD or delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The marketing and sale of unapproved new drugs is unlawful under the FFDCA, as new drugs must undergo an approval process by FDA.
The products receiving the Warning Letters made various statements identified by FDA as human drug claims, for example:
- “Is Delta 8 THC Medicinal? . . . Yes! Delta 8 THC is used for a variety of symptoms including: . . . Pain Relief . . . Anxiety . . .Nausea . . . Brain Cell Protection . . . & Appetite Stimulation . . .”
- “Many individuals take advantage of Delta 8 gummies because of their anti-inflammatory properties.”
- “Delta 8 THC gummies can provide appetite stimulation among many users, making them ideal for treating eating disorders such as anorexia . . . “
- “High-level CBD can help manage symptoms of psychosis that come from schizophrenia.”
- “CBD oil is an effective natural treatment for OCD.”
- “If you have cancer, rheumatoid arthritis, and migraines, Delta-8 THC can help alleviate the pain because it has immunosuppressant properties.”
- “Studies Show Our Whole-Spectrum Extract Utilizing CBD. . .Can Prevent Infection From COVID-19.”
FDA also identified various statements as animal drug claims, for example:
- “[S]upport the reduction of symptoms associated with seizure disorders, ease inflammation and pain . . . and reduce anxiety and nervousness.”
- “Many CBD users have reported improvements in: Stress; Anxiety; Sleep; Pain levels; Skin conditions including acne and eczema; Epilepsy”
- “Like humans, our larger Ranch & Livestock pets have Endocannabinoid Systems that help bring balance to their bodies. Introducing a whole-spectrum hemp extract into your horses, cows, alpacas, and any other large variety Ranch & Livestock animals on a daily routine can help promote an overall balance and improved quality of life. Senior Ranch & Livestock Animals & Pets, those that live with certain conditions, and those in already good health can greatly benefit from a helping hand of natural cannabinoids found in Kingdom Harvest Ranch & Livestock formula.”
- Certain CBD and delta-8 THC products are also misbranded drugs. For certain CBD and delta-8 THC products already considered unapproved new drugs, FDA also flagged them as misbranded drugs under the FFDCA because their labelling failed to bear adequate directions for use. Adequate directions for use are required to ensure a layperson can use the drug safely for the purposes for which it is intended.
- CBD-containing products cannot be lawfully marketed as dietary supplements. Because CBD is an active ingredient in one drug product that has been approved by FDA without any prior use history as a dietary supplement, a CBD-containing dietary supplement cannot be lawfully marketed. FDA did not raise the exclusionary clause issue with delta-8 THC presumably because it has not been approved as a new drug or been the subject of substantial clinical investigations that have been public.
- FDA is concerned about the marketing of CBD products for food-producing animals. Finally, in one Warning Letter, FDA expressed concern over the marketing of CBD products for food-producing animals. The agency expressed worry for the wellbeing of the animals themselves and for the safety of any human food derived from those animals (e.g., meat, milk, and eggs). The agency cites a lack of data on the potential residues of these substances that would reach the human consumer.
Moving Forward
FDA has requested written responses from the companies within 15 working days, and failure to promptly address the violations in the Warning Letters may result in legal action, including product seizure and/or injunction.
As the agency continues to enforce federal restrictions on the marketing and sale of cannabis products, interesting questions may arise concerning the relationship of this regulatory framework with conflicting state laws.
We will continue to monitor FDA’s response to cannabis products. Please do not hesitate to reach out to us on this or any other matter.
https://www.jdsupra.com/legalnews/fda-cites-five-companies-for-illegally-9020073/
