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. The FDA frequently redacts parts of warning letters posted for public view.
Frito-Lay Inc.
Plano, TX
Frito-Lay, a food firm headquartered in Texas, is on notice from the FDA after an inspection of its manufacturing facility. The FDA inspection was triggered by a recall after a consumer complained of a bag of “Ruffles Original Potato Chips” containing “Ruffles Cheddar & Sour Cream Potato Chips.” Mislabeling and undeclared allergens can be a serious threat to public health, according to U.S. regulations.
Their firm has had a total of five Class I recalls involving undeclared allergens in the past five years.
In a Nov. 24 warning letter, the FDA described a Sept. 21 through Sept. 25, 2020, inspection at Frito-Lay Inc’s manufacturing facility in Bakersfield, CA, and a Sept. 16 through Sept. 29, 2020, inspection at its Vancouver, WA, manufacturing facility. The FDA’s inspections revealed that the firm was not in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulations. As a result, the FDA issued an FDA Form 483.
Violations:
Hazard Analysis and Risk-Based Preventive Controls:
- The firm did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated, as evidenced by the following:
- The firm did not adequately implement food allergen controls at the packaging step at their Vancouver, WA facility to significantly minimize or prevent the hazard of undeclared allergens when they packaged Ruffles Cheddar & Sour Cream Potato Chips in Ruffles Original bags on June 24, 2020. This incorrect labeling caused their product to contain an undeclared major food allergen, milk. Specifically:
- They did not implement their roll change procedure while manufacturing the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips. At that time, they were manufacturing Ruffles Cheddar & Sour Cream Potato Chips and intended to change the bagmaker to 1.5oz size Ruffles Cheddar & Sour Cream; however, their bagmaker operator incorrectly used the Ruffles Original film. Their allergen control procedure, “Film Splice Tracking,” indicates that at roll change they will log the time, the identifying labeling film code, and attach the labeling film splice to the “Film Splice Verification” form, and a second person will verify the labeling film code. These splice operations were not documented on the form. Also, the form indicates that the product should be identified, but on June 24, 2020, the product was not identified on this form. Further, they discontinued attaching the labeling film splice to the form in June of 2020.
- The firm did not implement their procedure for “Job Aid for Package Quality & Regulatory Certification/Weaklink.” This procedure has the stated objective to “verify the correct product is in the correct package and bag coding/case coding information is accurate.” The procedure also requires that the “Product” and “Flavor” be documented and that “Product Tasted / Correct Product in Bag?” is assessed and given a “GO or NO-GO.” On June 24, 2020, during the production of the recalled bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, “Product Tasted / Correct Product in Bag?” was given a “GO” even though the product documented on the form was Ruffles Cheddar & Sour Cream, and the label was “Ruffles Original.” Further, two employees signed the form, indicating that they verified the activities performed, and the discrepancy was not noted.
- They did not adequately implement their Bakersfield, CA “(redacted) for Seasoning Allergens SSOP” and PSM (Product Safety Management) Procedure, which are allergen preventive control procedures to significantly minimize or prevent allergen cross-contact. These procedures indicate that they will verify that all visible evidence of prior seasoning is removed (redacted) cleaning. On September 23, 2020, (redacted) cleaning of packaging line (redacted) in preparation for production of Lay’s Limón Flavored Potato Chips, orange residue, which was the same color as the seasoning used in milk-containing Ruffles Queso made immediately (redacted) cleaning, was observed by FDA investigator. In particular, three orange residues approximately one millimeter in size were observed on the (redacted) feeder (food contact surface), and two orange residues approximately one millimeter in size were observed on the interior surface of an unsealed finished product label for Lay’s Limón Flavored Potato Chips on the bagmaker of packaging Line (redacted). These residues were observed after they conducted a (redacted) clean-out and documented on their “(redacted)” form that “the line has no visible evidence of previous products/seasoning run.” Further, a post-sanitation verification audit was conducted by their PSM auditor, and this area was determined to be ready for production and packaging of Lay’s Limón Flavored Potato Chips. Lay’s Limón Flavored Potato Chips do not contain milk.
In their Nov. 16 response to the Bakersfield, CA, inspection and their Nov. 20 response to the Vancouver, WA, inspection, Frito-Lay officials indicated that the new seasoning application preventive control and the film splice verification preventive control should be implemented by Dec. 31, 2020, at these facilities. The responses include updated hazard analyses, their “Seasoning Allergen” and “(redacted) Packing Film Splice” preventive control procedures, examples of associated monitoring records, preventive control master plans, and training materials.
Their Oct. 16 and Nov. 16 Bakersfield, CA, responses include materials on the proper method of inspecting the equipment under their inspection program, updated inspectional checklists, and training records. Also, they indicate that, by Jan. 31, 2021, they will institute the seasoning application preventive control across their entire company and the (redacted) film splice verification preventive control across their entire company with the exception of the facilities that have deployed their “(redacted).” Their (redacted).” Their responses also indicate that by mid-2021 they intend to complete deployment of their “(redacted)” across their entire company.
Class I Recalls
The firm recalled Lay’s Barbecue Flavored Potato Chips on Aug. 24, 2020, after receiving a consumer complaint that the chips were extremely spicy and recalled bags of chips labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips on Aug.21, 2020, after receiving a consumer complaint.
Their firm has had a total of five Class I recalls involving undeclared allergens in the past five years. On Oct. 2, 2019, Frito-Lay met with the FDA to discuss the recent inspections that had occurred at Frito-Lay’s Irving, TX, and Lynchburg, VA, facilities. The Irving, TX facility inspection was conducted in response to the Class I recall of Lay’s Lightly Salted Barbeque Potato Chips. During the meeting, as a major part of their corrective actions to prevent future allergen issues, company officials described plans to implement technology advancements to their seasoning and packaging steps that would ensure that the correct seasoning is added to the formula and that their products are correctly labeled, preventing future allergen issues similar to those described.
Misbranding
- Their bags labeled “Ruffles Original Potato Chips” but containing Ruffles Cheddar & Sour Cream Potato Chips, lot 34631762, are misbranded, in that the finished product label fails to declare a major food allergen (milk).
Milk is considered a “major food allergen.” A food is misbranded 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; 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).
The full warning letter can be viewed here.
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