Regal Health Food International, Inc.

WARNING LETTER
CMS 662089

November 29, 2023

Dear Mr. Piatigorsky:

The United States Food and Drug Administration (FDA) has determined that your recalled Regal Gourmet Snacks Milk Chocolate Raisins (16oz., UPC #028744201002) with best by date “04/07/24” are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, peanuts. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. You may find the Act through links in FDA's home page at http://www.fda.gov.

On June 6, 2023, your firm recalled your product labeled Regal Gourmet Snacks Milk Chocolate Raisins after being notified by your consignee of a consumer complaint regarding milk chocolate peanuts being found in containers labeled as milk chocolate raisins. Your firm indicated in documentation provided to the Human and Animal Food Operations (OHAFO) East Division 6 Recall Coordinator that milk chocolate peanuts were packed into tubs labeled “Milk Chocolate Raisins” due to an error in the packing process by (b)(4) packers. This documentation also described your proposed corrective actions to prevent reoccurrence including: retraining employees on packing procedures, additional labeling of work in progress products, additional product and label confirmation steps and using an (b)(4) line which will have less opportunities for this type of error. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.

Misbranding

Peanuts are considered a “major food allergen” under section 201(qq) of the Act [21 U.S.C. § 321(qq)]. A food is misbranded under section 403(w) of the 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 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 Act [21 U.S.C. § 343(w)(1)(B)].

Your recalled “Regal Gourmet Snacks Milk Chocolate Raisins”, which contained chocolate covered peanuts are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (peanuts).

Additional Comments

Your facility is subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (subparts A, C, D, E, F, and G) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].

The violations cited in this letter are not intended to be an all‐inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and/or injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.

Your firm’s response should be sent to Lauren Sexton, Compliance Officer, via e-mail at Lauren.Sexton@fda.hhs.gov. If you have any questions about this letter, please contact Lauren Sexton at (313) 393-8179 or via e-mail.

Sincerely,
/S/

William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6

Dear Mr. Piatigorsky:

The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS #662089 issued on November 29, 2023. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Clarice J. Ahn, Acting Branch Chief
Division of Conventional Foods Enforcement
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program