Copycat foods, snacks containing delta-8 THC the focus of regulators — yet again

Selling copycat foods containing delta-8 THC — an intoxicating compound made from hemp-derived CBD — that people could inadvertently consume has incensed the U.S. government. Plain and simple, this practice threatens consumers, especially kids who generally aren’t expecting to get anxious, dizzy or hallucinate from their favorite snack or candy.

So, it’s no wonder that a pair of U.S. regulators have teamed up yet again to target marketers of delta-8 THC products. The U.S. Food and Drug Administration and Federal Trade Commission on Tuesday announced sending joint warning letters to five firms. FDA also sent a letter independently to another company for the same purported violations of the law that it’s charged with enforcing: the Federal Food, Drug & Cosmetic Act (FDCA).

“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,” FDA Principal Deputy Commissioner Namandjé Bumpus, Ph.D., said in a July 16 news release announcing the warning letters. “As accidental ingestion and/or overconsumption of delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety. The FDA 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.”

Related:Experts concerned over unstudied compounds in delta-8 THC products

The move came about a year after FDA and FTC warned six other companies for selling edible food products containing delta-8 THC in packaging that the government said could be easily mistaken for foods sold by national brands. The 2023 letters must have been effective. According to FDA, none of the six firms have the delta-8 THC products (targeted in the letters) in stock anymore.

“Copycat food products containing delta-8 THC are particularly concerning to the FDA as they are extremely easy to purchase and are often available to youth,” FDA explained in the July 16 news release. “The FDA is also concerned about the processes used to synthesize delta-8 THC, as impurities or variations in the composition process can result in products that may be harmful or have unpredictable effects on consumers.”

Indeed, in 2021, I reported on concerns about synthetic compounds in delta-8 THC products that have not been studied to determine whether they are safe or toxic to humans. At the time, one laboratory expert warned that consumers are being used as guinea pigs.

Also of concern to U.S. regulators: packaging that closely resembles popular snacks.

“Several of the companies warned today illegally sell copycat food products containing delta-8 THC, including chips, cookies, gummies or other snacks that mimic well-known snack food brands by using similar brand names, logos or pictures on packaging that consumers, especially children, may confuse with traditional foods,” FDA said in the July 16 news release.

FDA warned consumers in June 2022 about children inadvertently ingesting food containing delta-8 THC. From Jan. 1, 2021, to Dec. 31, 2023, the agency received more than 300 adverse event reports involving children and adults who consumed delta-8 THC products, and nearly half of the reports involved hospitalization or emergency department visits.

FDA reported that two-thirds of the adverse events followed ingestion of food products such as candy or brownies containing delta-8 THC. Adverse events included, but were not constrained to, anxiety, confusion, dizziness, hallucinations, loss of consciousness, tremors and vomiting, the agency said.

Amy Romejko, the owner of Hippie Mood, one of the warning letter recipients, told me in an email that she reached out Tuesday to the FTC, noting that the company does not manufacture the products. She said the delta-8 THC products were removed from the website before the agency was contacted.

“We are just resellers, who purchase the products [wholesale] from a company out of California,” Romejko said, adding her business has been buying the products from the wholesaler for over four years.

She indicated she attempted to get the FTC to remove her company’s name from the list of brands identified in the warning letters, but the agency refused since the products were being sold online. She said she found that inexplicable “since if you Google those products there are tons of websites still selling them.”

None of the other firms targeted in the warning letters immediately responded to emails for this article, and messages to email addresses for one of the companies couldn’t be immediately delivered.

The letters requested that the firms “notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations.” FDA also asks the companies to state their reason for a delay if they cannot complete the corrective actions within the above time frame and specify when they intend to do so. As is standard practice, the letters warned the companies, “Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.”

Editorial view on next steps

FDA does not have a track record of consistently holding companies accountable — at least in a timely manner — when they ignore warning letters or firms are otherwise found in audits and other investigations to be breaking the agency’s rules. This time around, FDA must be prepared to swiftly take the next step, in partnership with the U.S. Department of Justice and/or FTC.

By next step, I mean judicial action to seize the products — in the event the delta-8 THC products targeted in the warning letters continue to be sold and the marketers fail to demonstrate they are following the rules and FDCA.

Otherwise, we should expect FDA critics to lambast the agency once again as a paper tiger. It would be inexcusable for FDA to move sluggishly, especially when it identifies a clear and present danger to America’s children.