The Food and Drug Administration and Federal Trade Commission have joined forces to send warnings to six companies who, according to the agencies, are selling illegal “copycat” Delta-8 THC products packaged in a way that is misleading to mimic popular brands such as Doritos and Cheetos.
In recent years, the market for delta-8 and other novel cannabinoids grew rapidly following the legalization hemp and its derivatives in the 2018 Farm Bill. FDA and FTC generally have discretion when it comes to taking enforcement actions against businesses selling products that contain substances such as CBD or delta-8. They target those whose packaging, or claims of medical benefits are particularly misleading.
The latest warning letters are aimed at two federal laws. First, they allege violations of the Federal Food, Drug and Cosmetic Act (FDCA) because they contain the unapproved “additive” delta-8 tetrahydrocannabinol. They then describe what they refer to as “copycat” brands, which are packaged to look like popular brands and could be appealing to children. This could lead to an accidental ingestion of cannabinoid.
We, along with the @FTC, issued warning letters today to six companies who were selling illegally copycat food products that contained delta-8 THC. https://t.co/LadVXlw2uZ pic.twitter.com/LunMXZSMLK
U.S. FDA July 5, 2020
In a Wednesday press release, FDA Principal Deputy commissioner Janet Woodcock stated that children are more susceptible to THC’s effects than adults. Many have become sick and some even ended up in the hospital after eating “edibles” containing THC. “That’s the reason we are issuing warnings against several companies that sell copycat food products that contain delta-8 THC. These can easily be mistaken as popular foods which are appealing to young children, and can make it very easy for a child to ingest high doses of it without realizing.”
The products that we warn against are designed to mimic popular snack food brands. They use similar logos or images on the packaging so that children and consumers may mistake them for traditional snacks. We are also worried that adults may unintentionally consume them, or take more than they intended and suffer serious side effects. The risk is particularly dangerous for people who drive, work, or have other obligations. The FDA is committed to taking legal action against companies that illegally sell regulated products which could pose a threat to public health.
Smoke LLC, Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC and North Carolina Hemp Exchange LLC are the companies that have received warning letters. Smoke LLC is Exclusive Hemp Farms/Oshipt. Nikte’s Wholesale LLC. North Carolina Hemp Exchange LLC. The Haunted Vapor Room.
FDA has received reports from consumers of delta-8 products describing “serious adverse reactions.” It is also “concerned that some companies may be producing delta-8 THC using methods that could lead to products that contain harmful contaminants.”
Last year, FDA issued a batch of warnings regarding delta-8 THC-containing products to publicize information on what they called unapproved medical claims. FTC has also joined the fray, focusing its attention on alleged violations relating to “copycat marketing.”
Samuel Levine, Director of FTC’s Bureau of Consumer Protection , said that marketing edible THC products which can be mistaken for regular food by children is irresponsible and illegal. Companies must make sure that their products are promoted responsibly and safely, especially in regards to the safety of children.
FTC sent cease and desist letter with @US_FDA, to companies that sell edible products containing Delta-8-THC in packaging similar to the food that children eat. More: https://t.co/y54jsP6Pkg pic.twitter.com/PR9C8I4IWW
FTC (@FTC July 5, 2020
Businesses that receive the letters have 15 days to respond. They can either dispute the claims made or explain what they’re doing to stop selling the products in question and become compliant. FDA warned that failure to address violations promptly could result in legal actions, such as product seizure or injunctions.
The FDA has taken enforcement actions against a small number of companies, but it still faces criticism for its decision to not enact regulations that would allow the legal marketing of CBD as dietary supplements or in food products. The agency stated that such rulemaking would require attention from Congress.
Rep. James Comer, R-KY, chair of the House Oversight and Accountability Committee , sent a letter in April to FDA Commissioner Robert Califf notifying him of an investigation regarding the “insufficient justification for inaction” by the FDA on CBD regulations.
Rep. Andy Harris, R-MD, has also criticized FDA for the lack of regulations on cannabidiol. He told the commissioner at a March hearing that ‘s inaction “disrupts public confidence” .
The Congress has repeatedly attempted to fill the regulatory gaps for non-intoxicating cannabis.
In March , for example, Reps. Morgan Griffith (R-VA), and Angie Craig (D-MN ) reintroduced two bills that were intended to create a regulatory pathway for hemp derivatives such as CBD in dietary supplements or food and beverage additives.
The FDA announced that it would not be regulating CBD just days after released its finalized guidance which focuses on the development of cannabis-based medicines and details the process as well as unique considerations that scientists should take into account when it comes hemp and marijuana.
FDA recently praised its role in helping a state crackdown on a firm selling delta-8 THC gum, which they claimed are linked to serious adverse events.
Five companies selling CBD-containing foods and beverages received warning letters from the agency in November.
The agency did not specify why they targeted these five companies, out of many others that sell similar cannabidiol infused products. However, it stated that the products are “likely to be confused with traditional foods and beverages that may lead to unintentional or excessive consumption of CBD.”
This is all happening in the context of FDA’s major task: Conducted a scientific review of marijuana at the request of President Joe Biden to help in assessing its federal schedule. FDA’s recommendation will not be binding. However, officials expect that the Drug Enforcement Administration (DEA), which is responsible for scheduling marijuana in federal law, will make a recommendation consistent with its findings.
A top DEA official stated in May that will be soon proposing new rules for clarification that synthetically produced cannabinoids such as delta-8 THC is prohibited controlled substances.
Delta-8 THC is found in cannabis naturally, but in very small amounts. The DEA confirmed previously that these natural constituents were uncontrolled. Many products are produced synthetically through a chemical conversion of CBD into delta-8-THC.
FDA also released a draft guidance on “unique” considerations researchers should take into consideration when studying psychedelics. The agency claims that psychedelics show “initial promising” as potential treatments.
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Image courtesy of Pixabay.
The post FDA and FTC Send Warn Letters About ‘Copycats’ Delta-8-THC Products Resembling Popular Food Brands like Doritos first appeared on Marijuana Moment.
