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.
Koi CBD, LLC
Norwalk, CA
In a June 18 warning letter, the FDA described a review of Koi CBD, LLC’s website at the internet address koicbd.com from June 2023 through July 2023.
The FDA determined that the firm’s products, Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks,” are adulterated because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce.
The 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 that include:
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 containing 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; and
5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children.
Adulterated Human Foods
According to the firm’s product labeling, their Koi brand “Delta 8 Gummies” and Hemp Living brand “Pot Rocks” are foods to which Delta-8 THC has been added.
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 generally recognized as safe (GRAS) for use in conventional foods. FDA’s regulations describe the criteria for eligibility for the 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.
The FDA knows of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to 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 of Delta-8 THC 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 the products does not satisfy the criteria for GRAS status.
The full warning letter can be viewed here.
Northland Vapor Company, LLC
Fargo, ND
In a July 7 warning letter, the FDA described an inspection of the firm’s Wonky Confections, LLC facility, which manufactures ready-to-eat (RTE) human food products containing Delta-8 tetrahydrocannabinol (THC) in Nov. 8-9, 16, 28, and Dec. 7, 2022
Based on the inspection, a review of the product labels collected during the inspection, and laboratory analysis of the firm’s products, the FDA has determined the “Death by Gummy Bears” and “Wonky Weeds” gummy bear products they manufactured in their facility are adulterated because they bear or contain an unsafe food additive. Additionally, the FDA has determined that the RTE food products manufactured in their facility are adulterated, in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
At the conclusion of the inspection FDA issued a Form FDA-483, Inspectional Observations, listing the deviations found at the facility.
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 that include:
1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk;
2) FDA has received adverse event reports involving Delta-8 THC containing 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; and
5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children.
Adulterated Human Foods
According to the firm’s product labeling, their “Death by Gummy Bears” and “Wonky Weeds” gummy bear products are foods to which Delta-8 THC has been added. In addition, the FDA confirmed through laboratory analysis that samples of these products contain Delta-8 THC.
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.
Adulterated Human Foods
The firm’s RTE food products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby the food products may have become contaminated with filth, or whereby they may have been rendered injurious to health. During FDA inspection of their establishment, FDA investigators found violations of the Current Good Manufacturing Practice regulations for human foods. The significant violations are as follows:
1. The firm did not take reasonable precautions and measures to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) after each absence from the workstation and at any other time when hands may have become soiled or contaminated. Specifically, on Nov. 8 and Nov. 9, 2022, (redacted) employees were observed not washing and sanitizing hands prior to donning gloves before separating by hand the RTE gummy candy products from excess sugar and hand-packing the products into finished product packaging.
2. The firm did not provide (redacted) facilities designed to ensure that an employee’s hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. Specifically, their facility is equipped with only one (redacted) sink, located in the employee restroom, which is inaccessible during bathroom occupancy and shared by approximately (redacted) employees. This (redacted) sink is in a separate area that is approximately (redacted) feet away from the production area.
3. The firm did not clean food-contact surfaces in a manner that protects against allergen cross-contact and contamination. Specifically, on Nov. 9, 2022, employees were observed washing equipment and utensils used in the production of the RTE gummy candy products with detergent but not sanitizing them. Cleaned utensils are placed onto a metal drying rack; however, a measuring pitcher was observed on the drying rack not inverted and containing pooled water. The pitcher also contained residual material that they identified as THC distillate.
The full warning letter can be viewed here.
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