Senate bill dictates solution for infant formula

The Senate Committee on Health, Education, Labor and Pensions voted to approve a bipartisan agreement, which includes policies to address the nation’s infant formula crisis.

Its title is “FDA Safety and Landmark Advancements (FDASLA) Act”. “

“Families need accountability from the FDA and formula makers, and they desperately need formulas — and I’m pushing to get them both at every opportunity I can,” said Senator Patty Murray, D-WA, who chairs the HELP committee.

“The legislation we passed today includes several valuable steps from me and my colleagues to address this crisis and ensure that we never find ourselves in a situation like this again. It requires the FDA to investigate and address mailroom issues that have impeded its response, requires manufacturers to notify the FDA of issues that may disrupt supply, requires the FDA to come up with a concrete plan to get the formula on the shelves as soon as possible, and more. “

The infant formula shortage is the direct result of food safety concerns that led to the closure of an infant formula production facility operated by Abbott Nutrition in Sturgis, MI. The shutdown came when the company launched a massive infant formula recall in mid-February after the FDA found five strains of cronobacter in the production plant. Other food safety issues such as a leaky roof and dirty conditions were also uncovered by FDA inspectors.

The FDA, through a federal court consent decree, allowed the plant to reopen on June 4 under strict government controls, but the formula shortage is expected to last through July. Abbott Nutrition holds 48% of the infant formula market in the United States.

The Committee has taken steps to address the formula crisis in the sections 909 and 910 from FDASLA.

The Senate bill:

  • Require the FDA to conduct annual inspections of every infant formula manufacturer;
  • Require the FDA, in consultation with the Secretary of Agriculture, to develop and publish within 90 days of promulgation a National Infant Formula Strategy to increase the resilience of the formula supply chain formulas, to protect against future contamination and other potential causes of shortages, and to ensure parents and caregivers have access to the infant formula and the information they need;
  • Require infant formula manufacturers to submit a report to the FDA promptly after initiating a recall, including a plan of actions the manufacturer will take to address the recall;
  • Require infant formula manufacturers to notify the FDA of manufacturing disruptions that could cause a significant disruption in the supply of infant formula;
  • Require the FDA to provide prompt communication with manufacturers following an inspection and to re-inspect facilities in a timely manner;
  • Require 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 the Office of Critical Foods at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN);
  • Require the FDA to work with other countries to discuss harmonization of regulatory requirements for infant formula;
  • Require the FDA to submit an annual report to Congress on infant formula submissions and inspections;
  • Require the FDA to notify Congress of an infant formula recall and an estimate of any supply disruptions
  • Allows importation of specialty infant formula during the current shortage from countries with similar protections to the United States, as well as importation for personal use for 90 days;
  • And more.

FDASLA Section by Section HERE.

Legislative text HERE.

Amendments adopted HERE.

(To sign up for a free subscription to Food Safety News, Click here.)

Norman D. Briggs