- Delivery Method:
- Certified Mail
- Food & Beverages
Recipient NameJohn Mackey
- Whole Foods Market
550 Bowie St
Austin, TX 78703
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
December 16, 2020
Dear Mr. Mackey:
As part of the U.S. Food and Drug Administration’s (FDA) ongoing efforts to address undeclared allergens as the leading cause of food recalls in the United States, we have analyzed patterns of recalls, and as part of this work, FDA reviewed the history of food recalls for your corporation. These recalls demonstrate that your corporation engaged in a pattern of receiving and offering for sale misbranded food products. For the time period of October 2019 to November 2020, your firm recalled 32 food products due to undeclared allergen(s). We noticed similar patterns of numerous recalls for undeclared allergens in previous years as well. These products were misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the finished product labels failed to declare all major food allergens present in the products, as required by section 403(w)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §343(w)].
The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise is a prohibited act under section 301(c) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §331(c)]. The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded is a prohibited act under section 301(k) of the Act) [21 U.S.C. §331(k)].
You can find the Act and its implementing regulations through links on FDA’s home page at https://www.fda.gov.
Examples of the referenced recalls include:
- F‐0925‐2020 for the recall of Whole Foods Market Minestrone Soup sold in either clear plastic deli‐style containers of various weights, or in clear plastic bags weighing 7 lbs. 12 oz., due to undeclared milk. In documentation included with your April 21, 2020 email to the Office of Human and Animal Food Operations West Division 3 Recall Coordinator, you indicated that the mislabeling occurred because your internal labeling system for the repackaging of food products was not updated to reflect the current ingredient listing for the product.
- F‐0408‐2020 for the recall of Whole Foods Market Raspberry Cheesecake Italian Gelato 1 Pint (473mL) packaged in a clear plastic container, due to undeclared egg. In documentation included with your December 4, 2019 email to the Office of Human and Animal Food Operations West Division 3 Recall Coordinator, you indicated that your contract manufacturer packaged a Butter Cookies & Sweet Cream Italian Gelato product with the incorrect Raspberry Cheesecake Italian Gelato label thereby causing the product to have the incorrect ingredient declaration and undeclared egg.
- F‐0131‐2020 for the recall of Whole Foods Market White Parkerhouse Rolls NET WT. 0 lb 12 oz (340g) packaged in a clear plastic bag, 12 rolls per bag, due to undeclared milk and eggs. In documentation included with your October 28, 2019 email to the Office of Human and Animal Food Operations West Division 3 Recall Coordinator, you indicated that the mislabeling occurred because your retail employees applied a label which did not reflect the ingredient listing on the manufacturer’s label. This caused the product to have undeclared milk and eggs.
- F‐1048‐202 for the recall of Chantilly Key Lime Tartlets Net Wt 1 oz. individually packaged in plastic clamshell containers with Whole Foods Market scale labels, due to undeclared almonds. In documentation included with your July 28, 2020 email to the Office of Human and Animal Food Operations West Division 3 Recall Coordinator, you indicated that the mislabeling occurred because the ingredient statement, which included almond flour, on the master carton was not fully transferred to the scale label used for the individual containers.
- F‐1354‐2020 to F‐1362‐2020 for the recall of Whole Foods Market El Trigal 12 Month Old Manchego, El Trigal 6 Month Old Manchego, Mitica Cordobes, Artequeso Manchego 6 month aged raw Raw Milk ‐ Aged 60 days or more, La Marquesa Herb Manchego Raw Milk ‐ Aged 60 days or More, Mitica La Dama Sagrada Raw Milk ‐ Aged 60 Days or More, Chimay Biere, IL FORTETO Genovese Pesto, Chimay Grand Cru, Lactalis MIMOLETTE Aged 12 Months, Mitica Mahon, and Agriform Piave Vecchio, individually sliced cheese wrapped in plastic wrap with scale label on top. In documentation included with your August 21, 2020 email to the Office of Human and Animal Food Operations West Division 3 Recall Coordinator, you indicated that the mislabeling occurred because not all of your regions had updated their scale ingredient statement to include the egg allergen. This caused the product to have undeclared eggs.
The above violations are not intended to be an all‐inclusive list of violations that exist in connection with the food you manufacture or have manufactured for you, receive, and offer for sale at your retail stores. You are responsible for investigating and determining the causes of the violations identified above 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 and implementing regulations. You should take prompt action to correct all violations noted in this letter, if not already corrected. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include the specific things you are doing to address these violations. You should include in your response documentation and information that would assist us in evaluating your corrections and plans to prevent recurrences. If you believe you have complied with the Act, include your reasoning and any supportive information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written reply should be directed to Ms. Tyra Wisecup, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS‐608), Division of Enforcement, College Park, Maryland 20740‐3835. If you have any questions, you may also contact Ms. Wisecup at Tyra.Wisecup@fda.hhs.gov.
William A. Correll Jr.
Office of Compliance
Center for Food Safety and Applied Nutrition