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.

Ventura Foods LLC
Brea, CA

A food firm in California is on notice from the FDA for not declaring major food allergens on finished product labels.

According to an Oct. 28 warning letter, the FDA determined that the firm’s recalled garlic parmesan sauce labeled as “Garlic Sauce,” which was manufactured by their Birmingham, AL, facility, is misbranded. Misbranding is a food safety concern because undeclared allergens and other labeling problems are a serious threat to public health.

Preventive Controls
The firm did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control such as undeclared allergens will be significantly minimized or prevented. Specifically, they did not identify and implement food allergen controls at the labeling step adequate to significantly minimize or prevent the hazard of undeclared allergens. This was evidenced by using the garlic sauce label on a product that contains cheese, which is a dairy product and officially designated as a major allergen. 

Further, they did not implement effective corrective action procedures that must be taken if preventive controls are not properly implemented. Specifically, their corrective actions did not ensure that all affected product was evaluated for safety and prevented from entering commerce when their product was misbranded, as evidenced by mislabeled “Garlic Parmesan Sauce” that reached customers.

Misbranding

Milk and wheat are considered “major food allergens” under U.S. regulations. 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 firm’s recalled “Garlic Parmesan Sauce” labeled as “Garlic Sauce” is misbranded, in that the finished product label fails to declare the major food allergens of milk and wheat.

The full warning letter can be viewed here.

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