FDA and FTC Crack Down on Delta-8 THC Copycat Products
In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing warnings to companies marketing such products. The packaging of these THC edibles closely resembles that of well-known foods like Double Stuf® Oreos®, Jolly Ranchers®, Froot Loops® cereal, and Chips Ahoy!® cookies, raising significant public health concerns. The FDA has expressed concerns that these products could easily be mistaken for their popular original snack foods, leading to accidental ingestion or overconsumption, especially among children.
Recent FDA and FTC actions are part of an ongoing federal initiative to address growing concerns surrounding certain cannabinoid products. Delta-8 THC is a cannabinoid found in small amounts in the cannabis plant, known for its psychoactive effects that are milder than those of delta-9 THC, the main psychoactive component in cannabis. It is often synthesized from CBD (cannabidiol) and marketed for its potential therapeutic benefits and reduced risk of anxiety compared to delta-9 THC. Delta-8 THC is considered legal in many jurisdictions because it is derived from hemp, which was federally legalized in the United States under the 2018 Farm Bill. This legislation legalized hemp and its derivatives, including cannabinoids like CBD, as long as the delta-9 THC content does not exceed 0.3% by dry weight. Since delta-8 THC can be synthesized from hemp-derived CBD, it falls under the legal framework established by this bill, though its legality can vary by state and is subject to ongoing regulatory scrutiny.
Over the past three years, the FDA has received numerous reports of children being hospitalized after consuming what they believed were ordinary snack foods but were instead delta-8 THC-laced look-alikes. “Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” stated Dr. Namandjé Bumpus, FDA principal deputy commissioner. Adverse effects have included hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness. Nearly half of these cases resulted in hospitalization or emergency department visits.
The FTC and FDA’s cease-and-desist (C&D) letters cite violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FTC Act. These C&D letters emphasize that marketing and selling these products using packaging that appeals to children is illegal and poses significant health risks. The FTC demanded that these companies immediately stop marketing edible delta-8 THC products with child-appealing packaging, review all marketing and packaging for similar THC products, take steps to protect consumers, especially children, and report back within 15 days on the actions taken. If the violations are not promptly addressed, the agency may take legal action. Many states with adult recreational or medical cannabis markets have similar regulations prohibiting packaging that appeals to children.
The FDA and FTC’s efforts highlight the need for regulation and consumer awareness to prevent the dangers posed by improperly labeled delta-8 THC products. Since the enactment of the 2018 Farm Bill, which legalized hemp-derived products, businesses have exploited a loophole by selling products containing psychoactive compounds like delta-8 THC. These products, which mimic the effects of medical and adult-use cannabis, have gained widespread popularity, being sold in shops, gas stations, and online. This is especially true in states with no state-legal adult-recreational or medical-cannabis markets. The FDA advised that it “will continue to work to safeguard the health and safety of U.S. consumers by monitoring the marketplace and taking action when companies sell products that present a threat to public health.”
Recently, an amendment to the new Farm Bill aims to address the legal uncertainties surrounding intoxicating hemp-derived products such as delta-8 THC. Proposed by Rep. Mary Miller of Illinois, the amendment was approved by the U.S. House Committee on Agriculture and seeks to federally ban hemp-derived intoxicating products. This move could disrupt the $28 billion gray market industry. In the absence of federal action on this issue, states will likely look to fill in the gaps. For example, on September 6, 2024 California Governor Newsom proposed emergency regulations to protect children from intoxicating hemp-derived products including delta-8 THC and 32 other cannabinoids. The new regulations require that industrial hemp food, beverage, and dietary products intended for human consumption have no detectable THC or other intoxicating cannabinoids per serving, create a minimum age to purchase hemp products to 21, and limit the number of servings of hemp products to five per package.
The FDA’s and FTC’s recent actions underscore the critical need for regulations and heightened consumer awareness to mitigate the risks associated with improperly labeled delta-8 THC products. Regardless of the outcome of the proposed amendment to the new Farm Bill, companies manufacturing delta-8 THC products should ensure their products do not imitate well-known snack foods or use advertising that is likely attractive to children. In addition to liability under the FDA’s and FTC’s enforcement efforts, companies selling products that mimic actual food products also run the risk of trademark infringement and dilution lawsuits by the brand owners.
