The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.

Midwest Foods LLC
Ankeny, IA

The FDA has warned a food firm in Iowa over Acidified Foods Violations, Misbranded Food, and more, including inaccuracies in product labeling.

In a May 21 warning letter, the FDA described a Dec. 11-13, 2023, inspection of Midwest Foods LLC’s ready-to-eat (RTE) food manufacturing facility in Ankeny, IA.

The FDA’s inspection revealed that the firm was not in compliance with federal regulations, which resulted in the issuance of an FDA Form 483. 

Some of the significant violations are as follows:

Acidified Foods Violations 

1. As a commercial processor engaged in the thermal processing of acidified foods, the firm must provide the FDA information as to the scheduled processes, including conditions for heat processing and control of pH, salt, sugar, and preservative level and source and date of the establishment of the process, for each acidified food in each container size, as required. The firm failed to file their scheduled processes with the FDA for each acidified food in each container size. Specifically:

•  They do not have scheduled processes on file with the FDA for 12 or 16 ounce product sizes of Kramer’s Salsa Medium, or for a 16 ounce product size of Kramer’s Salsa Inferno or Kramer’s Habanero Salsa XXXtreme. On Oct. 3, Oct. 17, and Dec. 8, 2023, lots 23276, 23290, and 23342 of Kramer’s Salsa Medium were produced for packaging into 16 ounce product sizes, on Sept. 1, 2023, lot 23244 of Kramer’s Salsa Medium was produced for packaging into a 12 ounce product size, and on April 4 and Nov. 9, 2023, lots 23094 and 23313 of Kramer’s Salsa Inferno and Kramer’s Habanero Salsa XXXtreme were produced for packaging into 16 ounce product sizes.

2. The firm failed to process a food in conformity with at least the scheduled process filed with FDA as required. Specifically, FDA investigators reviewed their scheduled processes filed with the FDA for their 15.5 ounce. and 32 ounce Kramer’s Salsa Medium and Kramer’s Salsa Inferno products, and noted the following deviations from their scheduled processes filed with FDA:

•  The scheduled process for their 32 ounce Kramer’s Salsa Medium product filed with the FDA identifies a process time of (redacted by FDA) at a processing temperature of (redacted by FDA); however, a cook hold time was documented at (redacted by FDA), and fill temperatures were documented as (redacted by FDA) and (redacted by FDA) for Kramer’s Salsa Medium lot 23269, produced on Sept. 26, 2023.
•  The scheduled processes for their Kramer’s Salsa Medium and Kramer’s Salsa Inferno products identify an inversion time of (redacted by FDA). During the inspection, FDA investigators identified that they do not keep track, nor document the number of times cases of product(s) are inverted.

Misbranded Food

1. The firm’s Kramer’s Jalapeno Pepper Jam is misbranded in that the label is false or misleading because the amount of Vitamin C is less than 80 percent of the amount declared on the label. FDA analyzed a sample of the firm’s Kramer’s Jalapeno Pepper Jam to determine whether the nutrition information on their Nutrition Facts Label accurately reflects the nutrient content of the product. The product label at the time of collection states one serving size is 2 tablespoons (30g) and contains 10 percent (9 mg) of the Daily Value for Vitamin C. However, the sample analysis performed by FDA found the product to contain 1.5 mg (16.7 percent of the declared amount) and 0.8 mg (8.9 percent of the declared amount) of Vitamin C.

2. The firm’s Kramer’s Jalapeno Pepper Jam and Gino’s Italian Salad Dressing products are misbranded in that the product labels fail to bear the nutrition information (e.g., Nutrition Facts Label) as required. Specifically:
•  The nutrition information provided for your Kramer’s Jalapeno Pepper Jam and Gino’s Italian Salad Dressing products is not in an appropriate format and fails to declare all of the required nutrients.
•  The firm’s Kramer’s Jalapeno Pepper Jam product and other jam products declare a serving size of “2 Tbsp (30 g),” which is not appropriate for a jam product. The appropriate Reference Amounts Customarily Consumed product category for their jam products is “honey, jams, jellies, fruit butter, molasses, fruit pastes, fruit chutneys” which has a reference amount of 1 tbsp. Therefore, all of the nutrition information is incorrectly declared because it is based on the wrong serving size. The FDA also notes that the servings per container for their 8 ounce Kramer’s Jams do not comply with regulations because of a math error. Specifically, the net weight of 226g divided by 30g serving size equals approximately 7.5 servings per container, but their Kramer’s Jams are labeled as containing 30 servings. The number of servings must be rounded to the nearest whole number for servings above 5. Using the correct serving size of 1 tablespoon (15 g), there are 15 servings per container in their 8 ounce (226 g) jam products.

In addition, the FDA offered the following comments:

Preventive Controls

•  On Dec. 12, 2023, during the manufacture of Gino’s Marinara Sauce, an acid food, FDA investigators observed that they did not document the inversion time for products. For Hot-Filled-Hold Process products, they identify a fill temperature of (redacted by FDA) and inversion time of (redacted by FDA) to (redacted by FDA) as a monitoring parameter for the hazard of pathogens, at their Critical Control Point (CCP) (redacted by FDA), Bottle Pasteurization step. The firm must implement their controls at Critical Control Points.
• The firm must monitor preventive controls with adequate frequency to provide assurance that they are consistently performed, and document monitoring. Record review must be performed by (or under the oversight of) a preventive controls qualified individual, to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decisions were made about corrective actions.

Labeling

•  For the firm’s Kramer’s Jalapeno Pepper Jam, the FDA questions the accuracy of the declared amount of sugars of “1g” in the Nutrition Facts Label because “sugar” is declared as the most predominant ingredient in the ingredient list.
•  The firm’s Gino’s Italian Dressing products are missing the Net Weight in its metric equivalent. If the products are for retail sale, then the net quantity of contents should include the metric equivalent. The Gino’s Italian Dressing products may also provide the net quantity of contents in terms of the metric system.
    o  Of note, “fruit preserves and jams” are a standardized food and their fruit jam products must meet regulation requirements if they contain an applicable fruit ingredient, such as raspberry or peach.

The full warning letter can be viewed here.

Lipari Foods Operating Company LLC
Warren, MI

The FDA has warned a food firm in Michigan over finished product labels that did not declare a major food allergen, resulting in a recall.

In an April 9 warning letter, the FDA informed JLM Manufacturing LLC that it has determined that the following recalled products manufactured by their facility in Warren, MI, are misbranded in that the finished product labels did not declare a major food allergen.

• IO Inspired Organics brand Organic Raw Walnut Halves & Pieces (7ounce plastic tubs 943469, UPC 863669740065) with batch number 21202306A and expiration 6/21/2024 because of undeclared walnuts on the bottom label of the product.
• Filberts/hazelnuts labeled as “JLM brand Roasted Salted Pecan Halves” (10oz clear plastic container UPC 094776110049) with lot number 09202306A because of undeclared filberts/hazelnuts on the principal display panel.
• Cashews labeled as “IO Inspired Organics brand Raw Walnuts” (5 ounce bag, UPC 8 63669 74200 7) with lot number 12202307A because of undeclared cashews on the finished product label.

The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited.

Further, the FDA has determined that their subsidiary did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation. The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions is prohibited.

On Aug. 1, 2023, after being notified of a complaint from a retail store, the firm recalled tubs of the IO Inspired Organics brand Organic Raw Walnut Halves & Pieces. The product was mislabeled with a bottom label identifying the product as cashews in the name, ingredient and contains statements. The bottom label did not declare walnuts in the ingredient statement or the “Contains” statement.

On Sept. 6, 2023, after being notified of a complaint from a retail store, the firm recalled raw filberts/hazelnuts that were mislabeled as “JLM brand Roasted Salted Pecan Halves.” The product was mislabeled with a principal display panel that incorrectly identified the product as Roasted Salted Pecan Halves, while the package contained raw filberts/hazelnuts and the principal display panel did not declare filberts/hazelnuts.

On Sept. 9, 2023, after being notified of a complaint by a retail store, the firm recalled the cashews that were mislabeled as “IO Inspired Organics Raw Walnuts.” The product was mislabeled in the pouch for Raw Walnuts while the package contained cashews. The pouch did not declare cashews.

On Aug. 15, Sept. 14, and Sept.18, 2023, corrective and preventive action documentation was provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator for the three recalls, respectively. This documentation indicates that on Aug. 15, 2023, the firm’s policies were updated, employees were re-trained, and production paperwork was amended to include label retention samples (redacted by FDA). Further, that labels are verified by QA (redacted by FDA). The FDA will verify the implementation of any corrective actions during the FDA’s next inspection of their facility.

Hazard Analysis and Risk-based Preventive Controls
The firm did not identify and implement preventive controls adequate 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 their facility will not be misbranded. Specifically, they did not identify and implement food allergen controls at the packaging/labeling step adequate to significantly minimize or prevent the hazard of undeclared allergens, as evidenced by the three mislabeling occurrences described above. This incorrect labeling resulted in undeclared walnuts, filberts/hazelnuts, and cashews in their Organic Raw Walnut Halves & Pieces, Filberts/hazelnuts labeled as, “JLM brand Roasted Salted Pecan Halves” and Cashews labeled as, “IO Inspired Organics brand Raw Walnuts” respectively.

Misbranding
Walnuts, filbert/hazelnuts, and cashews are considered “major food allergens.” 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 elsewher in the ingredient list (unless the name of the food source that appears elsewher in the ingredient list appears as part of the name of an ingredient that is not a major food allergen).

The firm recalled IO Inspired Organics brand Organic Raw Walnut Halves & Pieces, JLM brand Roasted Salted Pecan Halves, and IO Inspired Organics brand Raw Walnuts are misbranded in that the finished product labels failed to declare major food allergens.

The full warning letter can be viewed here.