Representative Dusty Johnson (R-S.D.) introduced a bill on Monday called the Formula Shortage Reporting Act of 2022 in an effort to prevent future infant formula shortages.
The bill would ensure that manufacturers timely inform the Food and Drug Administration (FDA) about expected disruptions to the infant formula supply. The bill comes after there was a shortage of infant formula after Abbott Nutrition recalled its formula because bacteria was found to be living in the powdered formula.
“Infant formula is medically necessary. The FDA should be informed of any future delays – but currently, that’s not the law of the land,” Rep. Johnson said in a press release. “South Dakota was hit hard during this formula shortage – my bill allows us to be better prepared should an issue at a formula plant ever happen again.”
Abbott has faced several lawsuits about the issues with its formulas, namely the presence of Cronobacter Sakazakii and Salmonella Newport infections connected with the products. These lawsuits were from parents and the U.S. sued over Abbot’s purported role in the nationwide shortage.
The bill provides a framework reporting requirement under the Federal Food, Drug and Cosmetic Act that would require: formula manufacturers to give the FDA at least 72 hours prior notice before an interruption; notice of the reasons for the interruption or discontinuation that is causing the disruption; a 30-day compliance period to provide the necessary information if a manufacturer is not in compliance with the reporting requirement; and manufacturers that fail to comply will violate Section 301 of the Federal Food, Drug, and Cosmetic Act, which is punishable by fine and/or jail time.
The bill is cosponsored by Reps. Stephanie Bice (R-Okla.), Abigail Spanberger (D-Va.) and Kim Schrier, M.D. (D-Wash.).
“With proper warnings and oversight, this formula shortage could have been prevented.” Rep. Spanberger said in a press release. “The FDA needs accurate and timely information about potential shortages of ingredients or supply chain disruptions — and the American people, particularly parents, deserve this information.”
“It seems inconceivable that we could have a baby formula shortage in 2022,” Rep. Schrier, M.D., said in a press release. “This is preventable. Most babies, even those who are primarily breastfed, rely on formula. Baby formula is a little bit different from food in that babies under six months are nearly entirely dependent on it. In some ways, it makes it more like medicine than food. We need an early warning system for when formula supplies may be getting low so we can take the necessary action to prevent such a shortage from happening again.”
Rep. Johnson previously questioned the FDA about the Agency’s knowledge of the impending shortage in May, but right now there is no requirement for the FDA to receive advanced notice with facility issues that could impact the market.
In May, the Federal Trade Commission launched an inquiry into the ongoing infant formula shortage to gather information about the nature and prevalence of any business practices to take advantage of families during this shortage and the issues that have caused this shortage, including supply chain issues.
The FDA has also taken measures to improve infant formula supplies during the shortage, but the introduced bill seeks to get to the root of the problem to prevent this in the future.