Undeclared Allergens Lead To Recalls

Is major allergen labeling complicated? The answer is maybe sometimes, but it doesn’t have to be. Here, I review recent allergen labeling-related recalls and provide some helpful resource links.

It seems like recall alerts for undeclared allergens happen every week, but even though recalls for undeclared allergens are common, allergen-related warning letters are uncommon, which makes this week’s Warning Letter Wednesday interesting (to me at least).

One company has had four recalls related to undeclared major allergens since 2019, and here’s how the recent mix-up happened. This is, unfortunately, a common mistake and is the reason why GMPs and process control exist.

· From warning letter.  “You indicated that you were scheduled to run “Hamburger Cheeseburger Macaroni Skillet Meal”; however, the line supplier mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used.”

Read this warning letter here.

Another company received a warning letter because of an inadequate FDA communications request response. They are also a conventional food company that had an undeclared allergen recall, which was apparently due to a formulation change without changing the label.

The purpose of Warning Letter Wednesday is to educate, and this is a perfect example of a half-hearted response and no follow-through that led to an avoidable warning letter. Yikes!

· From warning letter. “Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.” ….” FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond.”

Read this warning letter here.

Here are FDA’s comments on major allergen disclosure (from warning letters).

• 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 USC § 343(w)(1)(A)]; or

• The common or usual name of the major food allergen in the list of ingredients is followed in parenthesis 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 USC § 343(w)(1)(B)].”

So how about allergen advisory statements like “This product was manufactured in a facility that handles peanuts, soy, and milk?”

According to this FDA guidance document, “Advisory labeling, such as “may contain [allergen],” is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls.”

Read this FDA’s “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry” document here.

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Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.