WARNING LETTER
Northland Vapor Company, LLC
MARCS-CMS 648568 —
July 07, 2023
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Brett T. Erpelding
Recipient Title
Chief Executive Officer
Northland Vapor Company, LLC
201 Fifth Street North, 16th Floor
Fargo
,
ND
58102
United States
Issuing Office:
Division of Human and Animal Food Operations West I
United States
July 7, 2023
WARNING LETTER
Refer to CMS 648568
Bradley E. Erpelding, President and Chief Financial Officer
Cody Townsend, Executive Vice President of Retail
Dear Messrs. Erpelding and Townsend:
The United States Food and Drug Administration (FDA) conducted an inspection of your Wonky Confections, LLC facility, which manufactures ready-to-eat (RTE) human food products containing Delta-8 tetrahydrocannabinol (THC), located at 2721 20th Avenue South, Unit J, Moorhead, Minnesota, on November 8-9, 16, 28, and December 7, 2022.
Based on the inspection, a review of the product labels collected during the inspection, and laboratory analysis of your products, FDA has determined that your “Death by Gummy Bears” and “Wonky Weeds” gummy bear products you manufactured in your facility 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. Additionally, we have determined that the RTE food products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), 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 (FDA-483), Inspectional Observations, listing the deviations found at your facility. We also received your response dated December 19, 2022, which included a summary of corrective actions taken or planned by your firm. Based on our review of the inspectional findings and the response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility.
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov. You can find specific information about how FDA regulates cannabis-derived products at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.
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 puts 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. See
https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc. This letter informs you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers.
Adulterated Human Foods (section 402(a)(2)(C)(i) of the FD&C Act)
According to your product labeling, your “Death by Gummy Bears” and “Wonky Weeds” gummy bear products are foods to which Delta-8 THC has been added. In addition, FDA confirmed through laboratory analysis that samples of these products contain Delta-8 THC.
As defined in section 201(s) of the FD&C Act, 21 U.S.C. § 321(s), the term "food additive" refers to any substance the intended use of which results in it 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.
1
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 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).
There is no food additive regulation that authorizes the use of Delta-8 THC. We are not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) 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 (see 21 CFR 170.30).
We know of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to January 1, 1958. Based on our 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. Our 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 our review, the use of Delta-8 THC in your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
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 under section 201(s) of the FD&C Act 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 within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Therefore, your “Death by Gummy Bears” and “Wonky Weeds” gummy bear products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).
Adulterated Human Foods (section 402(a)(4) of the FD&C Act)
Your RTE food products are adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), 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 our inspection of your establishment, FDA investigators found violations of the Current Good Manufacturing Practice regulations for human foods under 21 CFR Part 117, subpart B. The significant violations are as follows:
1. You 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, as required by 21 CFR 117.10(b)(3). Specifically, on November 8 and November 9, 2022,
(b)(4)
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.
In your response you stated you have implemented a
(b)(4)
procedure that instructs employees to wash hands in a number of situations, including but not limited to, the following situations: before starting work, before putting on or changing gloves, and after any time the hands may become contaminated. You state you have begun training employees in the new procedure, including posting signs with a step-by-step
(b)(4)
procedure by each
(b)(4)
sink. You state the process will be implemented by January 31, 2023. We will verify the adequacy of this corrective action during a future inspection.
2. You did not provide
(b)(4)
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, as required by 21 CFR 117.37(e). Specifically, your facility is equipped with only one
(b)(4)
sink, located in the employee restroom, which is inaccessible during bathroom occupancy and shared by approximately
(b)(4)
employees. This
(b)(4)
sink is in a separate area that is approximately
(b)(4)
feet away from the production area.
In your response you stated you will begin drafting plans for the installation of a new
(b)(4)
sink, which will be in the same room where manufacturing operations occur. Additionally, you stated you have contacted a plumber and discussed plans for the following services: installation of motion sensor operated faucets on both the current and the new
(b)(4)
sink and the installation of automatic soap dispensers at both
(b)(4)
stations. You also state that until these operations have been completed, employees will be instructed to use paper towels to turn off the faucet and open the door, if necessary. You did not provide in your response an update on the installation process or a timeline for completion, nor did you include invoices or other records demonstrating that you have been in contact with a plumber. We will verify the adequacy of this corrective action during a future inspection.
3. You did not clean food-contact surfaces in a manner that protects against allergen cross-contact and contamination, as required by 21 CFR 117.35(a). Specifically, on November 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 you identified as THC distillate.
In your response you stated you would prepare, implement, and train employees on a new SOP on appropriate dishwashing and sanitizing practices. You also said the SOP will include signage placed above the three-compartment sink to remind employees to wash with detergent, rinse with warm clean water, and then sanitize and soak dishes. You stated you will also employ the use of test strips to double-check the concentration of sanitizer in the water. We will verify the adequacy of this corrective action during a future inspection.
Misbranded Food
Under section 201(qq) of the FD&C Act, 21 U.S.C. § 321(qq), soy is considered a “major food allergen.” A food is misbranded under section 403(w) of the FD&C Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the FD&C Act, 21 U.S.C. § 343(w)(1)(A); or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, e.g., “Whey (Milk),” except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the FD&C Act, 21 U.S.C. § 343(w)(1)(B).
FDA’s inspection found that during the manufacturing of your gummy products, you use Pam spray as a releasing agent, which contains the allergen “soy.” Your “Wonky Weeds” and “Death by Gummy Bears” gummy bear products are misbranded within the meaning of section 403(w) of the FD&C Act, 21 U.S.C. § 343(w), in that the finished product label fails to declare a major food allergen (soy).
In your response you stated that you are exploring alternatives to the use of Pam spray and that, should you continue to use Pam spray, you will ensure the use of such product and its inclusion of soy will be referenced on product labels. However, you did not provide a copy of a revised label declaring the allergen soy and, therefore, we are unable to determine the adequacy of your corrective action.
Failure to Register Food Facility
In addition, FDA has determined that your facility located at 2721 20th Avenue South, Unit J, Moorhead, Minnesota, 56560, is subject to the food facility registration requirement in section 415 of the FD&C Act, 21 U.S.C. § 350d, and our implementing regulation at 21 CFR Part 1, Subpart H. Our records indicate that as of the date of this letter your facility has not been registered with FDA. The failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act, 21 U.S.C. § 331(dd).
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute comply with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility's owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the cause(s) of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days from your receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration, Attention: Compliance Officer Boun Xiong, 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976 or via email at boun.xiong@fda.hhs.gov.
Sincerely,
/S/
CAPT Chris van Twuyver
Program Division Director, West Division 1
Office of Human and Animal Food Operations
___________________________
1
Under section 201(s) of the FD&C Act, 21 U.S.C. § 321(s), the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction,” i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.
Content current as of:
07/25/2023
Regulated Product(s)
Food & Beverages