FDA warns Stew Leonard’s Holdings over misbranded cookie products following anaphylactic death

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.

Stew Leonard’s Holdings LLC
Norwalk, CT

The Food and Drug Administration has issued a warning letter to Stew Leonard’s Holdings LLC for significant misbranding violations tied to undeclared allergens in its cookie products. The letter, dated Nov. 18, 2024, was recently made public. It was prompted by a consumer complaint about the company’s Florentine Cookies, which contained peanuts and eggs not listed on the label. The undeclared allergens caused an anaphylactic reaction resulting in a death, leading to the recall of the product on Jan. 23, 2024.

Following the consumer’s death on April 26, 2023, a wrongful death lawsuit was filed against Stew Leonard’s Holdings LLC and related parties, including employees and the cookie manufacturer, Cookies United LLC. The estate of Órla Ruth Baxendale, who died from consuming the mislabeled Florentine Cookie, alleges gross negligence and reckless indifference. The suit claims that 11 Stew Leonard’s employees were informed six months before the incident that the cookies contained peanuts but failed to update the labels or warn customers. Baxendale, a 25-year-old with a severe peanut allergy, relied on the incorrect labeling, leading to her fatal reaction.

The FDA’s inspection of the company’s Danbury, Connecticut facility, conducted from Jan. 26 to Feb. 12, 2024, revealed that the Florentine Cookies violate the Federal Food, Drug, and Cosmetic Act for failing to declare major allergens.

The investigation also identified labeling deficiencies in Stew Leonard’s Rainbow Cookies, which omitted essential ingredient details and sub-ingredients like rice flour, fruit juice color, and xanthan gum. Additionally, the company’s nutrition facts panel for the Rainbow Cookies failed to meet federal requirements, lacking information on added sugars, vitamin D, and potassium, among other violations.

The FDA issued Form 483 after the inspection, noting that the company’s inadequate labeling practices posed severe public health risks. The letter also highlighted discrepancies between bulk ingredients and final product labels, emphasizing that the sodium benzoate listed as an ingredient in the Florentine Cookies was not part of the original bulk ingredients.

The full warning letter can be found here.

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