FDA Cites Five Companies for Illegally Selling Delta-8 THC and CBD Products | Hogan Lovells

The U.S. Food & Drug Administration (FDA) recently issued warning letters to five companies that sell products containing delta-8-tetrahydrocannabinol (delta-8-THC) and cannabidiol (CBD) that violate the federal Food, Drug and Drug Administration Act Cosmetics (FFDCA) violated. . 1 In those 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 supplements. The agency also specifically noted its serious concerns about the potential health effects of delta-8 THC products.

background

Given the significant industry interest in developing consumer products made from cannabis and its components, the FDA has reiterated its position that CBD cannot be legally sold as a dietary supplement or in a food product under the exclusion clause. 2 In the recent Warning Letters, the FDA similarly asserts that delta-8-THC cannot be sold as food. The FDA, along with the Federal Trade Commission (FTC), has previously issued warning letters to various companies that sell CBD products that claim to diagnose, cure, alleviate, treat, or prevent various diseases in violation of the FFDCA. Like CBD, delta-8-THC is derived from the Cannabis sativa plant. While THC is a Schedule I controlled substance, delta-8-THC has not been listed as a controlled substance by the Drug Enforcement Agency. The 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, the FDA expresses concern about the use of chemicals to convert other cannabinoids in the plant into delta-8-THC. The 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 that claims to diagnose, cure, mitigate, treat, or prevent disease is considered an unapproved new drug by the agency. Additionally, like CBD, the FDA considers delta-8-THC to be an unapproved food additive for use in human or animal foods because the substance is not generally recognized as safe (GRAS) or otherwise exempt from food additive requirements. The FDA states that it has serious safety concerns with Delta-8-THC. The FDA states that it received 104 adverse event reports from patients who consumed delta-8-THC products between December 1, 2020 and February 28, 2022.

FDA warning letter

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 highlighted the following –

  • The FDA considers Delta-8-THC to be a serious health and safety concern. The agency said it has received numerous reports of adverse events associated with products containing delta-8 THC. According to the FDA, some manufacturers use potentially unsafe household chemicals under potentially unsanitary conditions to synthesize the substance because the cannabis plant naturally contains low levels of delta-8-THC. 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. 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 lawfully marketed.
  • CBD and Delta-8-THC products that make disease claims are unapproved new 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 unlawful under the FFDCA because new drugs must go through an FDA approval process.

The products that received the Warning Letters made various claims identified by the 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 . . . Fear . . .nausea . . . protection of brain cells. . . & appetite stimulation. . .”
  • “Many people use Delta-8 gummies for their anti-inflammatory properties.”
  • “Delta 8 THC gummies can stimulate the appetite in many users, making them ideal for treating eating disorders such as anorexia. . . “
  • “High-level CBD may help treat the symptoms of psychosis that result from schizophrenia.”
  • CBD oil is an effective natural treatment for OCD.”
  • “If you suffer from cancer, rheumatoid arthritis and migraines, delta-8-THC may help reduce pain as it has immunosuppressive properties.”
  • “Studies show that our full-spectrum extract uses CBD. . .Can prevent infection by COVID-19.”

The FDA also identified various statements as veterinary drug claims, for example:

  • “[S]help reduce symptoms associated with seizure disorders, reduce inflammation and pain . . . and reduce anxiety and nervousness.”
  • “Many CBD users have reported improvements in: stress; Fear; Sleep; pain levels; skin conditions including acne and eczema; Epilepsy”
  • “Like humans, our larger ranch and farm animals have endocannabinoid systems that help bring balance to their bodies. Introducing a full-spectrum hemp extract into your horses, cows, alpacas, and other large species of ranch and livestock daily can help promote overall balance and an improved quality of life. Senior Ranch & Livestock Animals & Pets, those living in certain conditions and those already in good health can benefit greatly from a helping hand of natural cannabinoids found in the Kingdom Harvest Ranch & Livestock formula.”
  • Certain CBD and Delta-8-THC products are also mislabeled drugs. Certain CBD and delta-8-THC products that are already considered unapproved new drugs have also been labeled by the FDA as misnamed drugs under FFDCA because their labeling did not provide adequate instructions for use. Adequate instructions for use are required to ensure that a layperson can safely use the drug for the purposes for which it is intended.
  • Products containing CBD may not be lawfully marketed as dietary supplements. Because CBD is an active ingredient in a drug that has been approved by the FDA as a dietary supplement with no prior history, a dietary supplement containing CBD cannot be lawfully marketed. The FDA probably hasn’t addressed the disclaimer issue with delta-8-THC because it hasn’t been approved as a new drug or been the subject of extensive public clinical scrutiny.
  • The FDA is concerned about the marketing of CBD products to food-producing animals. Finally, in a Warning Letter, the FDA expressed concern about the marketing of CBD products to food-producing animals. The agency expressed concern for the welfare of the animals themselves and for the safety of any human food derived from these animals (e.g. meat, milk and eggs). The agency cites a lack of data on the potential residues of these substances that would reach human consumers.

Go forward

The FDA has requested written responses from companies within 15 business days and failure to promptly address violations in the Warning Letters may result in legal action, including product seizure and/or injunction.

As the agency continues to enforce state 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 on this or any other matter.

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