BRIEF-FDA Issues Statement Regarding Baby Formula Imports

U.S. Food and Drug Administration: * FDA ISSUES STATEMENT REGARDING BABY FORMULA IMPORTS

* FDA SAYS IT PROVIDES NEW UPDATES ON ACTIVITIES TO MITIGATE INFANT FORMULA SUPPLY CHALLENGES * FDA - ABBOTT NUTRITION AGREES TO TAKE CORRECTIVE ACTIONS AT FACILITY TO PRODUCE SAFE INFANT FORMULA

* FDA - ALSO CONTINUING TO IMPLEMENT SEVERAL IMPORTANT STEPS TO IMPROVE THE SUPPLY OF INFANT AND SPECIALTY FORMULA PRODUCTS IN THE U.S * FDA - HAS BEEN IN ONGOING DISCUSSIONS WITH ALL INFANT FORMULA MANUFACTURERS WHO ARE REPORTING THAT THEY ARE ALL PRODUCING AT AN EXPANDED CAPACITY

* FDA - TAKING LOOK AT SUPPLY OF INFANT FORMULAS DEVELOPED BY MANUFACTURERS ACROSS U.S. & AROUND WORLD TO DETERMINE IF REALLOCATION OF DISTRIBUTION CAN BE MADE * FDA - PROPOSED CONSENT DECREE OBLIGES ABBOTT TO TAKE ACTIONS THAT ARE EXPECTED TO ULTIMATELY RESULT IN AN INCREASE OF INFANT FORMULA PRODUCTS

* FDA - LOOKING AT WAYS TO MITIGATE FUTURE, POTENTIAL SUPPLY ISSUES INCLUDING BUILDING ON WORK TO DATE WITH ITS 21 FORWARD SUPPLY CHAIN CONTINUITY SYSTEM * FDA - MADE REQUESTS FOR NEW AUTHORITIES FROM CONGRESS TO ALLOW FDA TO REGULARLY COLLECT IMPORTANT SUPPLY DATA FROM BROADER INFANT FORMULA INDUSTRY

* FDA - PROPOSED CONSENT DECREE ENSURES ABBOTT UNDERTAKES CERTAIN ACTIONS THAT WOULD ENSURE SAFE POWDERED INFANT FORMULA PRODUCED AT STURGIS FACILITY * FDA - HAS ALREADY TAKEN STEPS WITH ABBOTT NUTRITION TO MAKE PRODUCT AVAILABLE TO THOSE WITH LIFE-THREATENING CONDITIONS ON A CASE-BY-CASE BASIS

* FDA - AS A RESULT OF RECALL AND WORK WITH THE FDA, OTHER MANUFACTURERS HAVE INCREASED PRODUCTION OF COMPARABLE PRODUCT LINES * FDA - AS A RESULT OF RECALL AND WORK WITH FDA, OTHER MANUFACTURERS HAVE IN SOME CASES EXPEDITED IMPORTATION OF BABY FORMULA PRODUCTS WHERE THEY EXIST

* FDA - EXPECTS SUPPLY OF INFANT FORMULA PRODUCTS TO CONTINUE TO IMPROVE OVER THE NEXT COUPLE OF MONTHS * FDA - GERBER HAS REPORTED THAT IT INCREASED THE AMOUNT OF THEIR INFANT FORMULA AVAILABLE TO CONSUMERS BY APPROXIMATELY 50% IN MARCH AND APRIL

* FDA - RECKITT IS SUPPLYING MORE THAN 30% MORE INFANT FORMULA PRODUCT YEAR TO DATE * FDA - WORKING WITH FEDERAL PARTNERS TO BETTER UNDERSTAND WHERE SHORTAGES OF CERTAIN INFANT FORMULAS EXIST AT A MORE LOCAL LEVEL

* FDA - EXPLORING FURTHER WAYS TO ALLEVIATE MORE IMMEDIATE AND GEOGRAPHICAL SUPPLY CHALLENGES THROUGH BETTER DISTRIBUTION OF INFANT FORMULA PRODUCTS Source text for Eikon: [https://bit.ly/3sFhZQl] Further company coverage:

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