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                                                                                                 U.S. NEWS Wednesday 25 May 2022
             U.S. safety, savings rules set stage for baby formula shortage



            By MATTHEW PERRONE                                                                                                  with the FDA before selling
            WASHINGTON  (AP)  —  A                                                                                              a new formula, altering in-
            massive  recall  is  getting                                                                                        gredients in an existing one
            most  of  the  blame  for  the                                                                                      or making major manufac-
            U.S.  baby  formula  short-                                                                                         turing changes. The result is
            age,  but  experts  say  the                                                                                        only the biggest manufac-
            products  have  long  been                                                                                          turers have plants and pro-
            vulnerable  to  this  type  of                                                                                      cedures  that  comply  with
            crisis  due  to  decades-old                                                                                        federal  rules.  And  would-
            policies that have allowed                                                                                          be  competitors  have  little
            a handful of companies to                                                                                           incentive to enter the field,
            corner the market.                                                                                                  given  the  declining  U.S.
            Those  government  rules                                                                                            birth rate.
            —  aimed  at  assuring  safe,                                                                                       "You have to have a lot of
            affordable  formula  —  are                                                                                         expertise, a lot of resources
            getting  renewed  scrutiny                                                                                          and  a  lot  of  research  dol-
            as President Joe Biden's ad-                                                                                        lars," White said.
            ministration rushes to import                                                                                       There  are  other  hurdles
            formula from Europe.                                                                                                for  foreign  manufactur-
            "There's perfectly good and                                                                                         ers  looking  to  compete.
            safe  baby  formula  avail-                                                                                         The  U.S.  has  long  imposed
            able around the world. We                                                                                           tariffs and quotas on dairy
            just  don't  have  access  to   Shelves typically stocked with baby formula sit mostly empty at a store in San Antonio, Tuesday,   imports  from  abroad,  in-
            it,"  said  Bindiya  Vakil,  CEO   May 10, 2022.                                                                    cluding  Canada,  in  order
            of  Resilinc,  a  supply  chain                                                                    Associated Press  to shield American milk pro-
            analytics  firm.  "We've  cre-                                                                                      ducers from competition.q
            ated  this  problem  by  not  part  of  a  Biden  adminis-
            setting up an infrastructure  tration  initiative  last  year
            for imports."                spotlighting   dangerously
            Federal  regulators  are  ex-  concentrated industries, in-
            pected  to  soon  allow  Ab-  cluding  prescription  drugs,
            bott Nutrition to reopen the  airlines,  hearing  aids  and
            Michigan plant that's been  internet services.
            closed  since  February  due  The Federal Trade Commis-
            to  contamination  prob-     sion  announced  Tuesday
            lems. The factory is the larg-  that it has launched an in-
            est of its kind in the U.S. and  quiry into the formula short-
            its  shutdown  —  combined  age,  seeking  information
            with     pandemic-related  on any deceptive or fraud-
            supply  chain  problems  —  ulent business practices re-
            hobbled  supplies  of  popu-  lated to it. The agency said
            lar  formulas  and  specialty  it also aims to shed light on
            formulas  for  children  with  what led to the concentra-
            rare medical conditions.     tion  in  the  baby  formula
            Lawmakers  will  hold  three  market and the weak sup-
            hearings  on  the  issue  this  ply chains.
            week, calling on company  Food  experts  say  strict  for-
            executives,    government  mula regulations set by the
            regulators  and  outside  ex-  Food and Drug Administra-
            perts  to  testify.  The  atten-  tion have long limited com-
            tion  could  spur  changes  petition.
            to  government  safety  and  Beginning  in  1980,  Con-
            contracting rules that have  gress gave the FDA author-
            been  in  place  since  the  ity to rigorously enforce the
            1980s  and  favor  big  U.S.  nutritional  content  of  all
            manufacturers  that  are  formula sold in the U.S., im-
            capable of navigating the  posing  extra  research  and
            complex requirements.        manufacturing  standards
            Baby formula is one of the  that  have  few  equivalents
            few American products es-    worldwide.  The  changes
            sentially unaffected by glo-  came  after  some  babies
            balization,  with  98%  of  the  were sickened by deficient
            supply  manufactured  do-    formulas in the 1970s.
            mestically. Four companies  "They  are  pretty  much  the
            account for roughly 90% of  strictest food safety guide-
            the market: Abbott, Reckitt,  lines in the U.S. and Amer-
            Nestle and Perrigo, accord-  ica  has  some  of  the  strict-
            ing to industry figures. That  est guidelines in the world,"
            consolidation mirrors similar  said  Wendy  White,  a  food
            trends  across  the  food  in-  safety  expert  at  Georgia
            dustry.                      Tech.
            But  infant  formula  wasn't  Companies  must  consult
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