Online Seller of Infant Formula Pleads Guilty to Smuggling and Violating FDA Prior Notice Requirements

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.

According to court documents, 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. Several of the infant formulas Able Groupe sold were listed on FDA Import Alerts due to their failure to meet nutrient or labelling requirements for infant formula. 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. 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. Under the FDCA, importers are required to provide Prior Notice to FDA when they import food into the United States. 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. U.S. 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 the Department is committed to enforcing the law and protecting our most vulnerable citizens,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The Justice Department will continue to work with our agency partners to investigate and prosecute those who ignore this important legal obligation, attempt to defraud the government, and put the health and safety of infants at risk.”

“U.S. consumers rely on the FDA to ensure that the food products they purchase for their families are safe,” said Special Agent in Charge Christopher Walker, FDA Office of Criminal Investigations’ Kansas City Field Office. “The FDA will continue to work to bring to justice those who would defy its prior notice requirements, defraud the government, and attempt to deceive American consumers, particularly at the potential expense of infants’ health.”

The Food and Drug Administration’s Office of Criminal Investigations Special Agent Chad Medaris investigated the case.

The case is being prosecuted by Assistant Director Patrick Runkle of the Civil Division’s Enforcement and Affirmative Litigation Branch in partnership with the Northern District of Texas U.S. Attorney’s Office.