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Today, the US Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally selling and marketing copycat food products containing delta-8 THC in violation of the Federal Food Federation, Medicines and Cosmetics. Act (FD&C Act). Warning letters were issued to: Hippy Mood, Earthly Hemps, Shamrockshrooms.com, Mary Janes Bakery Co. LLC and Life Leaf Medical CBD Center. The FDA also independently issued a warning letter to the company GrowGod LLC for the same violations of the FD&C Act.
These warnings serve as part of the FDA’s and FTC’s ongoing joint efforts to take action against companies selling illegal copycat food products containing delta-8 THC. In July 2023, the two agencies worked together to warn six other companies for selling edibles containing delta-8 THC in packaging that could easily be confused with edibles sold by nationally recognized brands. All six of these companies no longer have such products in stock.
“Inadequate or confusing labeling can result in unsuspecting children or adults consuming products that closely resemble popular foods and sweets that contain delta-8 THC without realizing it,” said FDA Principal Deputy Commissioner Namandjé Bumpus, Ph. .D. “Since accidental ingestion and/or overconsumption of products containing delta-8 THC can pose significant health risks, companies selling these illegal products are demonstrating complete disregard for consumer safety. The FDA will continue to work to protect the health and safety of American consumers by monitoring the market and taking action when companies sell products that pose a threat to public health.
In June 2022, the FDA warned consumers about children accidentally ingesting food products containing delta-8 THC. From January 1, 2021 to December 31, 2023, the FDA received over 300 reports of adverse events involving children and adults who consumed delta-8 THC products. Almost half of these reports involved hospitalization or emergency department visits, and approximately two-thirds of these adverse events followed ingestion of food products containing delta-8 THC, such as candy or brownies. Adverse events included, but were not limited to, hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness.
Counterfeit edibles containing delta-8 THC are of particular concern to the FDA as they are extremely easy to purchase and are often available to young people. The FDA is also concerned about the processes used to synthesize delta-8 THC, as impurities or changes in the compounding process could result in products that could be harmful or have unpredictable effects on consumers.
In addition, packaging that is almost indistinguishable from many popular foods can be confusing to consumers. Some of the companies warned today that they illegally sell counterfeit food products containing delta-8 THC, including chips, cookies, gum or other foods that imitate popular snack food brands, using similar brand names, logos or pictures on packaging that consumers, especially children, may be confused with traditional foods. Watch below:
Hippy Mood “Trips Ahoy!”
Ground hemp “slushers”.
Mary Jane’s Bakery Co. LLC “Infused Sour Slizzles”
Life Leaf Medical CBD Center “Double Stuff Stoneo”
GrowGod LLC “Flamin’ Hot Cheetos”
“Companies that market and sell THC edibles that are easily mistaken for snacks and candy are not only operating illegally, but are also putting the health of young children at risk,” said Samuel Levine, director of the Consumer Protection Bureau. to the FTC. “Those who prioritize profits over the safety of children are at serious risk of legal action.”
FDA encourages healthcare providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested written responses from the companies within 15 business days indicating how they will address these violations and prevent their recurrence. Failure to promptly address violations may result in legal action, including product seizure and/or ban.
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The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s supply of food, cosmetics, dietary supplements, products that emit electronic radiation, and for the regulation of tobacco products.