Food companies warn against introducing CBD, Delta-8 THC products into interstate commerce

As part of its enforcement activities, the FDA issues warning letters to entities under its jurisdiction. Some letters are not released for public viewing weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until the company has had months or even years to correct the problem.


GCHNC LLC dba Hemp XR/Gate City dba Hemp XR/Allaziya Enterprises LLC dba Hemp XR
Greensboro, North Carolina

A North Carolina food company received a notice from the FDA for violating federal regulations by introducing products containing cannabidiol (CBD) and delta-8 tetrahydrocannabinol (THC) into interstate commerce.

In a warning letter dated September 28, 2023, the FDA described a September 2023 review of the Hemp XR website (web address hemp-xr.com).

The FDA’s review determined that these companies are Far Out Candy 500MG Delta 8 Cookies, not Ya Sons Weed Bakedies Delta 8 THC 600MG Crispy Bites, Hemp XR Delta 8 Stoner Candy Gummies (including Crawlers, Fruit Smashers, Magic Marbles and Stoner Candy Gummies). including Crawlers, Fruit Smashers, Magic Marbles and Stoner Candy Sour), Lava Rocks 250 MG Delta 8, Delta 8 Rainbow Rope, Pharma Delta 8 Gummies, Hemp XR Delta 8 Honey 500 MG and Hemp XR CBD Honey 500 sold on its web page MG products are adulterated by bearing or containing unsafe food additives.

Any food additive that is not approved for use in food is considered unsafe and can lead to food adulteration. The introduction of adulterated food into interstate commerce is prohibited.

Some violations:

Adulteration of human food

According to the company’s product labels, their Far Out Candy 500MG Delta 8 Cookies, Not Ya Sons Weed Bakedies Delta 8 THC 600MG Crispy Bites, Hemp XR Delta 8 Stoner Candy Gummies (including Crawlers, Fruit Smashers, Magic Marbles and Stoney Headz Sour) , Lava Rocks 250 MG Delta 8, Delta 8 Rainbow Rope, Pharma Delta 8 Gummies, and Hemp XR Delta 8 Honey 500 MG products are edibles fortified with Delta-8 THC.

The term “food additive” means any substance whose intended use causes it to become an ingredient in any food, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or unless the substance meets one of the listed exceptions .

Food additives require premarket approval based on data demonstrating safety. Any food additive that is not approved for use in food is considered unsafe and can lead to food adulteration. The introduction of adulterated food into interstate commerce is prohibited.

There are no food additive regulations authorizing the use of Delta-8 THC. The FDA is not aware of any information indicating that Delta-8 THC was the subject of previous sanctions. Furthermore, they are not aware of any basis for concluding that Delta-8 THC is GRAS for use in conventional foods. FDA regulations describe the eligibility criteria for classifying food ingredients as GRAS. The use of a food substance may be GRAS based on scientific procedures or, for substances used in food before 1958, be considered GRAS based on experience with common uses in food.

The FDA is not aware that prior to January 1, 1958, there was no basis for general recognition of the safety of Delta-8 THC based on scientific procedures or common uses in foods. Based on FDA’s review of published scientific literature, available data and information do not provide any basis for this. There is a strong basis to conclude that the use of Delta-8 THC in food meets GRAS status criteria. Some existing data raises serious concerns about the potential harm of Delta-8 THC. An FDA review of published scientific literature identified potential adverse effects on the central nervous and cardiorespiratory systems. Additionally, animal studies show that exposure to Delta-8 THC during pregnancy can interfere with neurodevelopment. Therefore, according to FDA review, the use of Delta-8 THC in its products does not meet the criteria for GRAS status.

FDA is not aware of any other exceptions to the food additive definition that apply to Delta-8 THC used as a conventional food ingredient. Therefore, Delta-8 THC added to conventional foods is a food additive and is subject to Section 409 of the FD&C Act. Under Section 409, a food additive is considered unsafe unless its intended use is approved by the FDA before being marketed. Delta-8 THC is not approved for use in any conventional foods. Food containing unsafe food additives within the meaning of Section 409 is adulterated. So instead of Ya Sons Weed Bakedies Delta 8 THC 600MG Crispy Bites, the company introduced Far Out Candy 500MG Delta 8 Cookies, Hemp XR Delta 8 Stoner Candy Gummies (including Crawlers, Fruit Smashers, Magic Marbles and Stoney Headz Sour), Lavalers 250 MG Delta 8, Delta 8 Rainbow Rope, Pharma Delta 8 Gummies and Hemp XR Delta 8 Honey 500 MG are adulterated by having or containing unsafe food additives. The introduction of these adulterated foods into interstate commerce is prohibited.

Additionally, according to their product label, their Hemp XR CBD Honey 500 MG is a CBD-infused edible.

There are no food additive regulations authorizing the use of CBD.

Therefore, the introduction or delivery of this product into interstate commerce is a prohibited act.

The full warning letter can be viewed here.

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