Warning letter · FDA Warning Letters

GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya…: FDA Warning Letter 656057 (Sep 28, 2023)

Agency action: Sep 28, 2023Record ID: fda_warning_-512c5bba9070ed10
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What happened

Original notice title

GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya Enterprises, LLC dba Hemp XR MARCS-CMS 656057, September 28, 2023

From the archived source record

FDA has determined that your 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 are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. It is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. This letter is to inform you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers. Adulterated Human Foods According to your product labeling, your 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. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Some of the available data raise serious concerns about potential harm from Delta-8 THC.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
07057eb5e450

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
Delta-8 THC-containing products; Hemp XR CBD Honey 500 MG; Hemp XR CBD Honey 500 MG product
Company
GCHNC LLC dba Hemp XR/Gate City Hemp dba Hemp XR/Allaziya Enterprises, LLC dba Hemp XR
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.