The U.S. Food and Drug Administration (FDA) recently issued warning letters to five companies that sell products that contain delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD) in ways that violate the law. Federal Food, Drug and Cosmetic (FFDCA). . 1 In these letters, the agency cited several violations of the FFDCA, including the marketing of new unapproved drugs and the illegal use of delta-8 THC and CBD in food and dietary supplements. The agency also noted in particular its serious concerns about the possible health effects of delta-8 THC products.
Fund
In view of the industry’s significant interest in the development of consumer products derived from cannabis and its components, the FDA has strengthened its position that CBD cannot be legally sold as a dietary supplement or in a food under the exclusion clause. 2 In recently issued warning letters, the FDA similarly states that delta-8 THC cannot be sold as food. In conjunction with the Federal Trade Commission (FTC), the FDA has previously issued warning letters to several companies selling CBD products claiming 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. Although THC is a controlled substance in Annex I, delta-8 THC has not been included by the Drug Control Agency as a controlled substance. The FDA describes delta-8 THC as a psychoactive substance and characterizes the amount of delta-8 THC in the plant as very low. In the warning letters, the FDA expresses concern about the use of chemicals to convert other plant cannabinoids into THC delta-8. The FDA has not evaluated or approved any products that contain delta-8 THC, nor is there any FDA-approved drug that contains delta-8 THC. Therefore, any delta-8 THC product that claims to diagnose, cure, mitigate, treat, or prevent disease is considered a new drug not approved by the agency. In addition, like CBD, the 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 is exempt from food additive requirements. The FDA claims it has serious safety issues with delta-8 THC. The FDA states that 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 regarding the marketing and sale of CBD and delta-8 THC products. In particular, the FDA noted the following:
- The FDA considers delta-8 THC to pose a serious health and safety risk. The agency stated that it has received numerous reports of adverse events related to products containing THC delta-8. According to the FDA, because the cannabis plant contains naturally low levels of Delta-8 THC, some manufacturers use potentially unsafe household chemicals in potentially unhealthy conditions to produce the substance by synthesis. The agency is concerned about the lack of controls during this process.
- Foods for human or animal consumption containing CBD or delta-8 THC are considered adulterated according to the FFDCA. The FDA considers CBD and delta-8 THC to be unsafe and unapproved food additives. Therefore, any food containing these substances is considered adulterated and cannot be legally marketed.
- CBD and delta-8 THC products that report disease are new unapproved drugs. Any CBD or delta-8 THC product that claims to diagnose, cure, mitigate, treat, or prevent disease is considered an unapproved new drug. The marketing and sale of unapproved new drugs is illegal under the FFDCA, as new drugs must be subject to an FDA approval process.
The products that received the warning letters made several statements identified by the FDA as claims of human drugs, for example:
- “Is Delta 8 THC Medicinal?… Yes! Delta 8 THC is used for a variety of symptoms including:… Pain relief… Anxiety… Nausea… Cell Protection Brain cells… & Appetite stimulation… ”
- “Many people take advantage of Delta 8 jelly beans for their anti-inflammatory properties.”
- “Delta 8 THC jelly beans can stimulate appetite among many users, making them ideal for treating eating disorders such as anorexia.”
- “High-level CBD can help control the 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 relieve pain because it has immunosuppressive properties.”
- “Studies show that our full-spectrum extract uses CBD. It can prevent COVID-19 infection.”
The FDA also identified several statements as animal drug claims, for example:
- “[S]Promote the reduction of symptoms associated with seizures, relieve inflammation and pain. . . and reduce anxiety and nervousness. “
- “Many CBD users have reported improvements in: Stress; Anxiety; to sleep; pain levels; Skin conditions such as acne and eczema; epilepsy ”
- “Like humans, our largest ranch and cattle pets have endocannabinoid systems that help bring balance to their bodies. Introduce a full-spectrum hemp extract to your horses, cows, alpacas and any other variety of Farm animals and livestock in a daily routine can help promote overall balance and a better quality of life. benefit greatly from a handful of natural cannabinoids found in the Kingdom Harvest Ranch & Livestock formula.
- Some CBD and delta-8 THC products are also poorly labeled drugs. For certain CBD and delta-8 THC products that were already considered new unapproved drugs, the FDA also labeled them as incorrectly labeled according to the FFDCA because their labeling did not show proper instructions for use. Proper instructions for use are required to ensure that a lay person can use the drug safely for its intended purpose.
- CBD-containing products cannot be legally marketed as dietary supplements. Because CBD is an active ingredient in a drug that has been approved by the FDA without any prior use as a dietary supplement, a CBD-containing dietary supplement cannot be legally marketed. The FDA did not raise the issue of the delta-8 THC exclusion clause presumably because it has not been approved as a new drug nor has it been the subject of substantial clinical research that has been made public.
- The FDA is concerned about the marketing of CBD products for food-producing animals. Finally, in a warning letter, the FDA expressed concern about the marketing of CBD products for food-producing animals. The agency expressed concern about the welfare of the animals themselves and the safety of any human food derived from these animals (e.g., meat, milk, and eggs). The agency cites the lack of data on possible residues of these substances that would reach the human consumer.
Moving forward
The FDA has requested written responses from companies within 15 business days, and if the violations of the warning letters are not addressed promptly, legal action may be taken, including confiscation of the product and / or the court order.
As the agency continues to enforce federal restrictions on the marketing and sale of cannabis products, interesting questions may arise about the relationship of this regulatory framework to conflicting state laws.
We will continue to monitor the FDA’s response to cannabis products. Please do not hesitate to contact us for this or any other matter.
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