Six marketers of products containing delta-8 THC have received warnings from the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) over snacks the agencies say appeal to children.
The letters include stop-sale orders regarding the intoxicating cannabinoid products, which the agencies say are packaged and advertised in motifs that mimic well-known brands.
Producers and marketers of the hemp-derived products have developed brisk business in gummies and other treats that include delta-8 and other psychoactive substances by exploiting a loophole in the 2018 Farm Bill, historic legislation that removed industrial hemp from the U.S. dangerous drugs list.
‘Confusing labeling’
The federal agencies said the “copycat” products are particularly concerning because they are easy to purchase by youth, and because processes used to produce them result in impurities that can be harmful and lead to unpredictable effects in users.
“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,” said FDA Principal Deputy Commissioner Namandjé Bumpus.
“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,” Bumpus said.
Delta-8 and most other synthetic, “high”-producing compounds that have emerged are made in the lab from hemp-derived CBD. Products containing them are widely available in convenience stores, hemp shops, bodegas and other common retail outlets.
Companies warned
The warnings, for violations of the Food, Drug and Cosmetics Act (FD&C Act) were sent to:
- Emmett Hill and Amy L. Romejko, Hippy Mood, Levittown, Pennsylvania;
- Spencer Willis, Life Leaf Medical CBD Center, Murrells Inlet, South Carolina;
- Robert Waring, Earthly Hemps, Cape Coral, Florida;
- Michael A Callahan, Miami Rave LLC/Mary Janes Bakery Co. LLC, Miami, Florida;
- Shamrockshrooms.com, no principal person or headquarters indicated;
- Jamiel Gustafson and Rhonda V. Edior-Gustafson, GrowGod LLC, San Bernadino, California, (letter from FDA only)
Products that drew warnings from the federal agencies mimic well-known brands.
A flourishing gray market has developed for the products, which the 2018 Farm Bill, a historic measure that removed hemp from the dangerous drugs category, failed to anticipate. Many of the synthetic, “high”-producing products, which are marketed as an alternative to marijuana, have been found to be a threat to public health. They remain unregulated, which has led to a multi-billion dollar market.
Second round of warnings
In addition to delta-8 THC – the most popular of the compounds – others commonly available are delta-10 THC, THC-O-acetate, HHC, and THCP.
This is the second time the FDA and FTC have issued joint warning letters to hemp companies over “copycat” marketing of intoxicating hemp products. Similar letters were sent to six other companies one year ago.
Separately, the FDA in June 2022 warned consumers about children accidentally ingesting snack products containing delta-8 THC. Also, the agency said it recorded 300 “adverse event” reports involving children and adults from Jan. 1, 2021, to Dec. 31, 2023. Half of those incidences resulted in hospitalization or emergency room visits due to hallucinations, vomiting, tremors, anxiety, dizziness, confusion, and loss of consciousness, the FDA said.
