The Department of Justice reports that a company has pleaded guilty to felony charges of smuggling infant formula from Europe and importing it into the U.S. in violation of the Food and Drug Administration’s prior notice requirements.
Since 2002 the FDA has required the submission of prior notification of food, including animal feed, that is imported or offered for import into the U.S. This advance notice allows the FDA, with the support of U.S. Customs and Border Protection, to target import inspections more effectively and to help protect the U.S. food supply against terrorist acts and other public health emergencies.
According to the DOJ, the company at issue sold infant formulas to consumers throughout the U.S. even though several of them were listed on FDA import alerts due to their failure to meet nutrient or labelling requirements. The company admitted that it attempted to avoid detection and detention of these formulas by failing to comply with prior notice requirements and using false commodity descriptions.
The company pleaded guilty to two felony counts: (1) importing food without providing prior notice with the intent to defraud or mislead in violation of the Federal Food, Drug, and Cosmetic Act, and (2) passing and attempting to pass false and fraudulent documents through customs to defraud the U.S. The DOJ notes that this is the first time a defendant has pleaded guilty to a felony violation for failing to provide prior notice.
A DOJ press release states that the company’s plea agreement includes a proposed forfeiture of $304,640 and that the matter will result in a total recovery by the federal government of approximately $2.3 million.
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