- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameThomas Bross, IV
- Winter Gardens Quality Foods, Inc.
304 Commerce Street
New Oxford, PA 17350-1723
- Issuing Office:
- Division of Human and Animal Food Operations East II
August 5, 2020
Dear Mr. Bross:
The United States Food and Drug Administration (FDA) has determined that your recalled Whole Foods brand Vodka Sauce is 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 (milk). Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). 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 (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov.
On March 20, 2020, after being notified by your customer of the mislabeled product, your firm recalled the Whole Foods brand Vodka Sauce. The Vodka Sauce, which contains milk, was mislabeled with Puttanesca Sauce back panel ingredient labels that do not declare milk. In documentation provided to the Office of Human and Animal Food Operations Division 2 East Recall Coordinator on March 20, 2020, you stated, “The associate that was changing over the label machine did not properly check the new roll of labels.” On June 10, 2020, you provided an updated “Procedure for Proper Packaging and Labeling,” and records of employee training as evidence of corrective actions taken by your firm. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented, and the food manufactured, processed packed or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2). Specifically, you did not identify and implement food allergen controls at the labeling step adequate to significantly minimize or prevent the hazard of undeclared allergens, as evidenced by your firm’s mislabeling the back ingredient label of the Vodka Sauce. This incorrect labeling caused your product to contain an undeclared major food allergen.
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen”. 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 Vodka Sauce is 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 (milk).
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
We will verify implementation of any corrective actions during FDA’s next inspection of your facility. If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter.
If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be directed to Compliance Officer Jessica Weber at the following address: U.S. Food and Drug Administration, Division HAF II East, Baltimore District Office 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, or by e-mail to Compliance Officer Weber by email at firstname.lastname@example.org. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Ms. Weber at (410) 779-5407.
John F. Sheehan
Acting Program Division Director
Acting Division Director
Human & Animal Food Division II East
Baltimore District Office