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FDA and FTC continue crack down on delta-8 THC copycat products
In July, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued warning letters to five manufacturers of products containing delta-8 tetrahydrocannabinol (THC)—a psychoactive substance in cannabis. The regulators alleged that the products’ packaging illegally resembled popular food brands. The concern is that the nearly identical labeling could result in consumers—especially children—unknowingly eating the THC products. The warning letters are part of an ongoing joint effort by the two agencies to crack down on companies selling copycat delta-8 THC products in violation of federal laws.
This isn’t the first time the FDA and FTC have warned companies about this issue. In July 2023, the agencies issued warning letters to six companies “for selling edible food products containing delta-8 THC in packaging that could easily be confused for foods sold by popular national brands.”
What’s driving the increased enforcement
According to the FDA, between January 1, 2021 and December 31, 2023 the agency received more than 300 adverse event reports involving children and adults who consumed delta-8 THC products. Almost half of these reports involved hospitalization or emergency department visits.
The FDA had previously noted that national poison control centers received 10,448 single substance exposure cases involving edible products containing THC between January 1, 2021, and May 31, 2022. Of these, the exposure to THC was unintentional in 65% of the cases and 77% involved patients 19 years old or younger. Pediatric patients were impacted in 91% of the unintentional exposure events. The agency had previously issued a warning to consumers about the dangers of children accidentally ingesting food products containing delta-8 THC.
The FDA is particularly strict when it comes to protecting children from potentially harmful or unsafe products. We’ve seen this recently with recalls for applesauce pouches due to lead contamination. Children’s safety consistently tops the FDA’s list of priority topics each year.
Details of the warning letters
In many cases, the copycat delta-8 THC products so closely resemble those sold by popular national brands that it can be easy to confuse the two, especially for children who may not be able to understand the text on product labels. In the latest action, the FTC determined that the five companies’ advertising “may violate the FTC Act’s prohibition against unfair or deceptive acts in the marketplace, including practices that present unwarranted health or safety risks.”
The FDA claims that the companies are in violation of the Federal Food, Drug, & Cosmetic Act (FD&C Act) for illegally selling copycat food products containing delta-8 THC and introducing them into the marketplace. Specifically, the FDA cites section 402(a)(2)(C)(i) in asserting that the companies’ products are adulterated because they “bear or contain an unsafe food additive.” The companies are also in violation of section 301(a) of the FD&C Act, which prohibits the introduction of adulterated food into interstate commerce.
The five companies were given 15 days to provide a written response outlining how they would address the violations and prevent them in the future. The FTC also ordered the companies to immediately stop marketing these copycat products. In addition, the agency recommended that manufacturers review of all their marketing and product packaging for similar edible THC products to ensure there are no other products that don’t comply.
Looking ahead
The FDA’s scrutiny of delta-8 THC products is expected to continue, especially given these products may be accidentally consumed by children. The agency has also raised concerns about the processes used to synthesize delta-8 THC, noting that impurities or variations in composition can lead to products that may be harmful to consumers.
These warning letters do not carry any immediate legal repercussions. Instead, they offer companies an opportunity to bring their products into compliance or remove them from the market. In the rare cases where companies fail to comply, we are seeing regulators take more aggressive action, such as unilateral press releases, to protect consumer safety.
It is more important than ever for companies to establish and practice their recall and crisis plans, so they are prepared for any regulatory action regarding their products. A swift response is important not just for maintaining a positive relationship with regulators and staying in compliance with law, but also for retaining consumer trust and protecting a brand’s reputation.
Trusted by the world’s leading brands, Sedgwick brand protection has managed more than 7,000 of the most time-critical and sensitive product recalls in 100+ countries and 50+ languages, over 30 years. To find out more about our product recall and remediation solutions, visit our website here.
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