Last Friday, Able Groupe pleaded guilty to a pair of felony charges for smuggling illegal baby formula into the United States.
According to the Justice Department, the company, which also did business as Little Bundle and Huggable, sold European infant formula to U.S. consumers beginning in the spring of 2019 on LittleBundle.com.
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The company imported the formula in violation of the FDA's Prior Notice Requirements. Many of the Able Groupe's infant formulas were listed on FDA Import Alerts because they failed to meet nutrient and labelling requirements, according to court documents.
As part of the plea, Able Groupe admitted that it attempted to avoid detection and detention of its imported formula by failing to comply with the FDA's Prior Notice requirements and by using fake commodity descriptions.
Following an FDA inspection, the company shut its doors and recalled 76,000 units of formula in August 2021.
Able Groupe pleaded guilty to importing food without providing Prior Notice to the FDA with the intent to defraud or mislead in violation of the Federal Food, Drug, and Cosmetic Act (FDCA); and passing and attempting to pass false and fraudulent documents through customs to defraud the U.S.
Under the FDCA, importers must provide prior notice to the FDA when they import food into the U.S. This is the first time a defendant has pleaded guilty to a felony violation for failing to provide such notice. The plea agreement includes a proposed forfeiture of $304,640, and the matter will result in a total recovery of some $2.3 million, according to the DOJ.
In August 2021, Able Groupe announced a slew of recalls, mainly because they didn't provide adequate iron for some infants, particularly those born prematurely. Low iron intake during infancy can lead to iron deficiency anemia, which can lead to irreversible cognitive and functional development issues.
The timing was unfortunate as the recall occurred just before a major formula shortage rocked the U.S. in late 2021 and early 2022 following problems tied to the Covid-19 pandemic and a massive recall and plant shutdown from Abbott Nutrition in February 2022 after a contamination issue led to bacterial infections in infants.
Infant formula has been under an intensifying spotlight of late, as ByHeart infant formula is currently embroiled in a potentially deadly botulism outbreak linked to 31 babies in 15 states.
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