The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have teamed up to send warning letters to six companies that the agencies say are unlawfully selling “copycat” delta-8 THC products that are misleadingly packaged to mimic popular brands like Doritos, Cheetos and Jolly Ranchers.
The market for delta-8 THC and other novel cannabinoids has rapidly expanded in recent years following the legalization of hemp and its derivatives under the 2018 Farm Bill. FDA and FTC have generally exercised discretion in taking enforcement action against businesses that are selling products containing substances like CBD or delta-8, targeting those whose packaging or claims about medical benefits are especially misleading.
These latest warning letters focus on two areas of federal law. First, they allege violations of the Federal Food, Drug and Cosmetic Act (FDCA) because they contain the unapproved “additive” delta-8 tetrahydrocannabinol. The officials then detail what they call “copycat” products that are packaged in ways that resemble popular brands that could appeal to children and lead to accidental consumption of the intoxicating cannabinoid.
“Children are more vulnerable than adults to the effects of THC, with many who have been sickened and even hospitalized after eating ‘edibles’ containing it,” FDA Principal Deputy Commissioner Janet Woodcock said in a press release on Wednesday. “That’s why we’re issuing warnings to several companies selling copycat food products containing delta-8 THC, which can be easily mistaken for popular foods that are appealing to children and can make it easy for a young child to ingest in very high doses without realizing it.”
“The products we are warning against intentionally mimic well-known snack food brands by using similar brand names, logos, or pictures on packaging, that consumers, especially children, may confuse with traditional snack foods. We’re also concerned that adults could unintentionally take them or take a higher dose than expected and suffer serious consequences. This risk is especially dangerous for those who are driving, working, or have other responsibilities. The FDA remains committed to taking action against any company illegally selling regulated products that could pose a risk to public health.”
The companies that received the warning letters are Delta Munchies, Dr. Smoke LLC, Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC, North Carolina Hemp Exchange LLC and The Haunted Vapor Room.
— U.S. FDA (@US_FDA) July 5, 2023
FDA said it has received reports of “serious adverse events” experienced by people who consumed delta-8 products, adding that it is “also concerned that companies are producing delta-8 THC in ways that could result in products with harmful contaminants.”
FDA sent a first batch of warning letters regarding delta-8 THC products last year, publicizing information about what it described as unsanctioned medical claims about the items. For this round, FTC also weighed in, focusing on alleged violations related to “copycat” marketing.
“Marketing edible THC products that can be easily mistaken by children for regular foods is reckless and illegal,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said. “Companies must ensure that their products are marketed safely and responsibly, especially when it comes to protecting the well-being of children.”
The businesses that received the letters must respond to both agencies within 15 days to either contest the claims or outline what they are doing to cease sales of the specific products and get into compliance. “Failure to promptly address the violations may result in legal action, including product seizure and/or injunction,” FDA said.
While FDA is taking the enforcement action against a limited number of businesses, it continues to face criticism over its decision not to enact regulations to allow for the lawful marketing of CBD in the food supply or as dietary supplements. The agency said that such rulemaking will require congressional attention.
In the meantime, Rep. James Comer (R-KY), chair of the House Oversight and Accountability Committee, sent a letter to FDA Commissioner Robert Califf in April that notified him of an investigation into the agency’s “insufficient rationale for inaction” on CBD regulations.
Another GOP congressman, Rep. Andy Harris (R-MD), has similarly blasted FDA over the lack of cannabidiol regulations, telling the commissioner in a committee hearing in March that the inaction is “disrupting public confidence” in its abilities.
There have been repeated efforts by congressional lawmakers to fill the regulatory gap for the non-intoxicating cannabinoid.
For example, Reps. Morgan Griffith (R-VA) and Angie Craig (D-MN) reintroduced a pair of bills in March meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
FDA’s announcement that it wouldn’t be regulating CBD came days after the agency released finalized guidance that focuses on developing cannabis-based drugs and outlined the process and unique considerations for scientists when it comes to hemp and marijuana.
FDA also recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”
In November, the agency sent warning letters to five companies that sell foods and beverages containing CBD.
The agency didn’t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”
All of this comes in the background of a major task for FDA: Conducting a scientific review into marijuana, at the direction of President Joe Biden, to aid in an assessment of its federal scheduling. FDA’s recommendation won’t be binding, but officials say they expect the Drug Enforcement Administration (DEA) to produce a scheduling recommendation that’s consistent with their findings about its risks and benefits.
Meanwhile, a top DEA official said in May that the agency will soon be proposing new rules to clarify that synthetically manufactured cannabinoids like delta-8 THC are prohibited controlled substances.
Delta-8 THC does occur naturally in cannabis in trace amounts, and DEA has previously confirmed that those natural constituents are uncontrolled. But many products are being produced synthetically, through a chemical process that converts CBD into delta-8 THC.
Separately, FDA released first-of-its-kind draft guidance last month on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.
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