Infant Formula Pleads Guilty, Prior Notice Requirements Friday, Share Facebook — Online Seller of Infant Formula Pleads Guilty to Smuggling and Violating FDA Prior Notice Requirements | United States Justice Department.
Following an FDA inspection, the company ceased operations and recalled 76,000 units of formula in August 2021.Able Groupe pleaded guilty to two felony counts: (1) importing food without providing Prior Notice to FDA with the intent to defraud or mislead in violation of the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) passing and attempting to pass false and fraudulent documents through customs to defraud the United States. announcement Online Seller of Infant Formula Pleads Guilty to Smuggling and Violating FDA Prior Notice Requirements Friday, November 21, 2025 Share Facebook X
LinkedIn Email For Immediate Release Office of Public Affairs Able Groupe Inc., a company that sold infant formula on the website LittleBundle.com, pleaded guilty today to two felony charges for smuggling European infant formula and importing it into the United States in violation of FDA’s Prior Notice Requirements.court filings state, Able Groupe, which also did business as Little Bundle and Huggable, Inc., sold European infant formula to consumers throughout the United States beginning in the spring of 2019. In pleading guilty, Able Groupe admitted that it attempted to avoid detection and detention
of its imported formula by failing to comply with FDA’s Prior Notice requirements for imported food and by using false commodity descriptions for the imported formula. This is the first time a defendant has pleaded guilty to a felony violation for failing to provide such notices to FDA. The company’s plea agreement includes a proposed forfeiture of $304,640, and the matter will result in a total recovery by the Government of approximately $2.3 million. Magistrate Judge Toliver presided over the company’s guilty plea.“FDA’s Prior Notice requirements help safeguard consumers as well as the nation’s food supply, and