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 upd...