FDA Issues Warning for Dollar Tree Over Recall

(LibertyInsider.org) – On October 31 and November 9, 2023, WanaBana issued voluntary recalls for its Apple Cinnamon Fruit Puree and Cinnamon Apple Sauce pouches sold under the WanaBana, Schnucks, and Weis brands, citing concerns over elevated lead levels found in some units. On June 11, the FDA sent a warning letter to one big-box vendor regarding its alleged failure to heed the recall.

Despite the voluntary recall and several FDA follow-up calls and emails, federal and state investigators found that many Dollar Tree stores failed to remove adulterated batches of WanaBana Cinnamon Fruit Puree and Cinnamon Apple Sauce products from store shelves even more than 45 days after the recall notification.

FDA Sends Warning Letter to Dollar Tree for Selling Lead-Tainted Product After Recall

The federal health regulator then noted that the selling of “adulterated food” violates the Federal Food, Drug, and Cosmetic Act of 1938.https://t.co/wzH5ZbZoG1

— The Epoch Times (@EpochTimes) June 19, 2024

In the letter, Ann Oxenheim, the agency’s food safety and applied nutrition compliance Director, noted that the FDA had called Dollar Tree to discuss compliance issues on November 22, 2023, asking how the chain would ensure the removal of recalled products from its stores’ shelves.

However, despite company assurances on November 27 that it had removed and destroyed adulterated products, the FDA continued to receive reports from consumers and state regulators who found recalled products still on store shelves. Based on continued reports that recalled products remained available in stores, the FDA initiated another call on December 1, 2023, to notify Dollar Tree of a Recall Audit Check (RAC).

As of December 7, the FDA continued receiving reports “from various state partners” about contaminated WanaBana products remaining on store shelves. More than 45 days after the initial recall notifications, the FDA held follow-up calls with Dollar Tree on December 18, 20, and 21, relaying concerns that the chain had still failed to remove adulterated products from consumers’ reach.

The June 11 letter allowed Dollar Tree 15 working days to respond with steps the company has taken to address the company’s violations of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)]. Moreover, the agency demanded a step-by-step action plan to prevent a recurrence or an explanation and supporting documentation as to why the company believed it was not in violation. If Dollar Tree can’t complete the requirements in the given timeframe, it must provide a letter of explanation and state when it will comply.