FDA WARNING_LETTER - Stew Leonard's Holdings LLC - February 12, 2024

The FDA conducted an inspection of Stew Leonard’s facility in Danbury, CT, from January 26 to February 12, 2024, following a consumer complaint and an anaphylactic death linked to Florentine Cookies. The firm recalled the cookies on January 23, 2024.

The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The Florentine Cookies were misbranded under section 403(w) of the Act [21 U.S.C. § 343(w)] because their labels failed to declare major food allergens, specifically peanuts and eggs, which were ingredients.

Both Florentine Cookies and Rainbow Cookies were misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] and 21 CFR 101.4, as they are fabricated from multiple ingredients, but the common or usual name of each ingredient, including sub-ingredients, was not declared on the label.

Additionally, the Rainbow Cookies product was misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] because its Nutrition Facts label (NFL) did not comply with 21 CFR 101.9. Specific NFL deficiencies included: the calorie declaration not being bolded and in