As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Companies selling products containing Delta-8 tetrahydrocannabinol (THC) in California, Missouri, New Mexico, New Jersey and North Carolina are on notice by the FDA.
The FDA has determined that the companies are selling adulterated products because they bear or contain an unsafe food additive. In addition, the products are sold in forms that are appealing to children and could be deceptive.
FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC.
In June 2022, FDA warned consumers about the accidental ingestion by children of food products containing THC. The agency received over 125 adverse event reports from Jan. 1, 2021, through May 31, 2022, related to children and adults who consumed edible products containing THC. Ten reports specifically mention the edible product as a copycat of popular foods.
The FDA is particularly concerned that the companies’ products are in forms that are appealing to children, mimic well-known snack food brands by using similar brand names, logos or pictures on the packaging, and that consumers may confuse with traditional foods. Therefore, with these products, there is a risk of unintended consumption of the Delta-8 THC ingredient by consumers.
In a series of June 29, 2023, warning letters, the FDA reviewed companies’ websites and determined that the firms sell various human products represented as containing Delta-8 THC.
1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put public health at risk
2) FDA has received adverse event reports involving Delta-8 THC products
3) Delta-8 THC has psychoactive and intoxicating effects
4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace
5) FDA is concerned about Delta-8 THC products that children may consume, as some packaging and labeling may appeal to children
Companies that have received warnings and products under scrutiny:
Delta Munchies LLC
Los Angeles, CA
Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:
- Sour Worms – 625mg Delta-8 THC
- Gummy Bears – 450mg Delta-8 THC
- Strawberry Sour Belts – 3000mg Delta-8 THC
- Peach Rings – 450mg Delta-8 THC
- Berry Blue Sour Belts – 3000mg Delta-8 THC
- Green Apple Sour Belts – 3000mg Delta-8 THC
- Watermelon Gummies – 450mg Delta-8 THC
- Sour Bites – 450mg Delta-8 THC
The full warning letter can be viewed here.
North Carolina Hemp Exchange, LLC dba NC Hemp Shoppe
Raleigh, NC
Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:
- Stoner Patch Delta-8 Gummies Watermelon 500 mg,
- Stoneo Oreo Cookies Delta-8 THC,
- Delta-8 THC Flamin Hot Cheetos
- Stoney Patch 500mg
The full warning letter can be viewed here.
Exclusive Hemp Farms/Oshipt.com
Gilroy, CA
Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:
- Oreo Stoneo – Medicated 500mg
- Cannaa Banana Delta 8 – Rope Candy 600mg – 7 Flavors
- Pot Tarts Strawberry 1000mg – Medicated, Tropical Sour Patch – Delta-8 500mg
- Trips Ahoy Medicated – Real Chocolate Chip Cookies – 600mg Medicated
- Trips Ahoy Medicated – Real Chocolate Chunky Cookies – 600mg Medicated
- Medicated Cheddar Snack Crackers 600mg – Medicated
The full warning letter can be viewed here.
The Haunted Vapor Room
Franklin, NJ
Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:
- Rope 500mg Delta 8 Nerds Candy,
- Medicated Dope Rope Bites, Packwoods x Coned Delta-8 Edible Cones – 600mg
- Cake 500mg Delta 8 Gummy Pack
- Candy’s D8 Chocolate Bars 500mg
The full warning letter can be viewed here.
Dr. Smoke, LLC aka Dr. S, LLC
Kansas City, MO
Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:
- Cheetos Crunchy Flamin’ Hot THC Infused Chips
- Doritos Nacho Cheese THC Infused Chips
The full warning letter can be viewed here.
Nikte’s Wholesale, LLC
Albuquerque, NM
Products are all in forms that may be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children:
- Delta 8 THC Gushers
- Delta 8 THC Lemonade 500mg
- Medicated Jolly Rancher Gummies Sour
- Delta 8 THC Hot Cheetos THC
The full warning letter can be viewed here.
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