Lack of Allergen Labeling Leads to Potential Death

Allergen labeling regulations are important. They help people with severe allergies avoid products that can make them sick or worse. In this example, the company allegedly did not disclose peanuts and eggs, which led to an anaphylactic death.

👉From warning letter. “On January 23, 2024, after being notified of a consumer complaint received by the FDA regarding an anaphylactic death associated with …. your firm recalled the cookies. The products contained peanuts and eggs but your printed label on the package did not contain an allergen statement or ingredient declaration for peanuts or eggs.”

The warning letter goes on to state that there are missing and extra ingredients on the label, which shows that the company’s quality control procedures need a serious review.

Disclosing major allergens is easy. Here are the two options. I always prefer the “Contains” option as it’s more apparent to the consumer.

👉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 U.S.C. § 343(w)(1)(A)]; 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), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].

The Nutrition Facts Panel (NFP) is also not in the correct format. There are differences between a Supplement Fact Panel and an NFP. This FDA reference is pretty good. 

👉From warning letter. “The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii). b. It lacks the declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii) c. It lacks the declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii)”

Here are some examples of compliant NFPs.

Read the warning letter here.

DATE ORIGINALLY POSTED: 11/27/24

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.