The Senate Committee on Health, Education, Labor and Pensions voted to approve a bipartisan deal that includes a policy to respond to the national infant formula crisis.
Its name is the FDA Safety and Excellence Act (FDASLA). “
“Families need accountability from the FDA and formula manufacturers, and they desperately need formula, and I urge them to get both at every opportunity,” said Sen. Patty Murray, D-WA, chair of the committee. HELP.
“The legislation we passed today includes several important steps from myself and my colleagues to deal with this crisis and ensure we never find ourselves in a similar situation again. It requires the FDA to investigate and fix mailbox issues that interfered with its response, requires manufacturers to notify the FDA of problems that could disrupt supply, requires the FDA to put forward a specific plan to get formula on the shelves as soon as possible, and much more. “
The shortage of infant formula is a direct result of food safety concerns that led to the shutdown of an Abbott Nutrition-operated formula plant in Sturgis, Michigan. The closure comes as the company initiated a mass recall of infant formula in mid-February after the FDA found five strains of cronobacteria at a manufacturing facility. Other food safety issues, such as a leaky roof and dirty conditions, have also been found by FDA inspectors.
The FDA, in a federal court order, allowed the plant to reopen on June 4 under strict government oversight, but the formula shortage is expected to last until July. Abbott Nutrition owns 48 percent of the US infant formula market.
The committee took action to address the crisis of the formula in sections 909 and 910 FDASLA..
The Senate bill would:
- Require the FDA to conduct annual audits of every manufacturer of infant formula;
- Require the FDA, in consultation with the Secretary of Agriculture, to develop and publish, within 90 days of adoption, a national infant formula strategy to improve the sustainability of the infant formula supply chain, protect against future contamination and other potential causes of shortages, and ensure parents and caregivers have access to the mixture and information they need;
- Require manufacturers of infant formula to provide a report to the FDA immediately upon initiation of a recall, including a plan of action the manufacturer will take to address the recall issue;
- Require manufacturers of infant formula to notify the FDA of production discontinuations that could result in significant disruption to the supply of infant formula;
- Require FDA to ensure timely communication with manufacturers after inspection and timely re-inspection of facilities;
- Require the FDA to report to Congress on the development and implementation of new or revised policies and procedures to monitor and ensure the effective receipt, tracking, management, and prioritization of complaints;
- Establish a Critical Foods Administration at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN);
- Require the FDA to work with other countries to discuss harmonization of infant formula regulations;
- Require the FDA to submit an annual report to Congress on submissions and reviews of infant formula;
- Require FDA to notify Congress of infant formula recalls and assessment of any supply disruptions
- Allowed importation of special infant formula during current shortages from countries with the same protections as the United States, as well as importation for personal use within 90 days;
- And more.
Section by section FDASLA HERE.
Legislative text HERE.
Amendments adopted HERE.
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