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.
GCHNC LLC dba Hemp XR/Gate City dba Hemp XR/Allaziya Enterprises LLC dba Hemp XR
Greensboro, NC
A food firm in North Carolina is on notice from the FDA over violations of federal regulation for introducing products with cannabidiol (CBD) and Delta-8 Tetrahydrocannabinol (THC) into interstate commerce.
In a Sept. 28, 2023, warning letter the FDA described a September 2023 review of Hemp XR’s website the Internet address hemp-xr.com.
The FDA’s review determined that the firm’s Far Out Candy 500MG Delta 8 Cookies, Not Ya Son’s 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, Hemp XR Delta 8 Honey 500 MG, and Hemp XR CBD Honey 500 MG products offered for sale on their webpages are adulterated because they bear or contain an unsafe food additive.
Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated. Introduction of an adulterated food into interstate commerce is prohibited.
Some of the violations:
Adulterated Human Foods
According to the firm’s product labeling, their Far Out Candy 500MG Delta 8 Cookies, Not Ya Son’s 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 foods to which Delta-8 THC has been added.
The term “food additive” refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated. Introduction of an adulterated food into interstate commerce is prohibited.
There is no food additive regulation that authorizes the use of Delta-8 THC. FDA is not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction. Furthermore, they are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods. FDA’s regulations describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food.
FDA knows of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food before Jan. 1, 1958. Based on FDA review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. FDA review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on FDA review, the use of Delta-8 THC in their products does not satisfy the criteria for GRAS status.
FDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated. Therefore, the firm’s Far Out Candy 500MG Delta 8 Cookies, Not Ya Son’s 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 are adulterated because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited.
Furthermore, according to their product labeling, their Hemp XR CBD Honey 500 MG is a food to which CBD has been added.
There is no food additive regulation which authorizes the use of CBD.
Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act.
The full warning letter can be viewed here.
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