,,ii  #aagth ,,congress  #b;d ,session  
,s4 #dbfb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #ai       
7legislative day1 ,may #ag71 #bjbb,mr4  
,lee introduced the following bill2     
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
temporarily allow the importation of    
infant formula free of duty and free of 
quantitative limitation1 and for other  
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,formula ,act of    
#bjbb4  #b4 ,increasing the supply of   
infant formula  7a7 ,in general ,during 
the #ahj day period beginning on the    
date of the enactment of this ,act1     
infant formula classified under heading 
#aija4aj of the ,harmonized ,tariff     
,schedule of the ,united ,states shall  
enter the ,united ,states free of duty  
and free of quantitative limitation1 if 
such formula-- 7#a7 is imported from a  
country on the list published by the    
,secretary of ,health and ,human        

,services under subsection 7c77#a7 or a 
member country of the ,european ,union2 
and  7#b7 is lawfully marketed in the   
country of origin4  7b7 ,guidance  7#a7 
,in general ,the ,secretary of ,health  
and ,human ,services 7referred to in    
this subsection and in subsection 7c7 as
 the ,secretary7 shall1 not later than  
#g days after the date of enactment of  
this ,act1 issue1 and periodically      
update1 as appropriate1 guidance for    
domestic and foreign manufacturers of   
infant formula in order to increase     
availability of such formula in the     
,united ,states that is safe and        
nutritionally adequate4  7#b7 ,elements 
of the guidance ,the guidance under     
paragraph 7#a7 shall address the        
following3 7,a7 ,information to be      
submitted to the ,secretary by foreign  
and domestic manufacturers of infant    
formula for consideration with regard to
 the introduction into interstate       
commerce 7including importation7 of     
infant formula that is safe and         

nutritionally adequate but that may not 
comply with all applicable statutory and
 regulatory requirements4 ,such         
information shall include-- 7i7 safety  
and nutritional adequacy of the infant  
formula2  7ii7 product identification   
information2  7iii7 the quantity of the 
infant formula intended for introduction
 into interstate commerce2  7iv7 a copy 
of the label for the infant formula     
7with information on any allergens      
present on the product label and        
adequate instructions for safe product  
preparation and use7 and description of 
the packaging of the infant formula2 and
  7v7 manufacturing information1        
including test results1 and facility    
compliance and inspection history4  7,b7
 ,information for manufacturers planning
 to increase domestic production of     
infant formula for purposes of          
addressing the ongoing shortage4  7#c7  
,priority ,the guidance under paragraph 
7#a7 shall provide for priority         
consideration for manufacturers that are

 able to produce large volumes of such  
infant formula quickly4  7c7            
,importation from countries meeting     
certain standards  7#a7 ,in general ,not
 later than #g days after the date of   
enactment of this ,act1 the ,secretary  
shall publish a list of countries the   
,secretary determines to have           
manufacturing and safety standards for  
infant formula that are similar1        
equivalent1 or otherwise suitable1 as   
compared to ,united ,states standards4  
7#b7 ,personal and commercial           
importation ,beginning on the date on   
which the list of countries is published
 under paragraph 7#a71 for a period not 
to exceed #ahj days1 the ,secretary     
shall allow personal and commercial     
importation of infant formula from any  
country on such list1 as well as from   
any member country of the ,european     
,union1 without regard to the guidance  
under subsection 7b77#b7 and the        
requirements of section #dab of the     
,federal ,food1 ,drug1 and ,cosmetic    

,act 7#ba ,u4,s4,c4 #cej;a71 section    
#dae of such ,act 7#ba ,u4,s4,c4        
#cej;d71 and parts #ajf and #ajg of     
title #ba1 ,code of ,federal            
,regulations4  7d7 ,definition ,in this 
section1 the term infant formula has the
 meaning given such term in section     
#bja7z7 of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cba7z774  #c4 ,special supplemental    
nutrition program for women1 infants1   
and children  7a7 ,access for ,,wic     
beneficiaries ,notwithstanding any other
 provision of law1 any infant formula   
7as defined in section #b7;d77 imported 
into the ,united ,states pursuant to    
section #b7;c77#b7 is eligible for      
purchase using benefits received under  
the special supplemental nutrition      
program for women1 infants1 and children
 established by section #ag of the      
,child ,nutrition ,act of #aiff 7#db    
,u4,s4,c4 #aghf74  7b7 ,product recalls 
and supply chain disruptions ,section   
#ag of the ,child ,nutrition ,act of    

#aiff 7#db ,u4,s4,c4 #aghf7 is amended--
 7#a7 in subsection 7b71 by adding at   
the end the following3  7#bd7 ,supply   
chain disruption ,the term supply chain 
disruption means a shortage of          
supplemental foods that impedes the     
redemption of food instruments1 as      
determined by the ,secretary4  2 and    
7#b7 by adding at the end the following3
  7r7 ,product recalls and supply chain 
disruptions  7#a7 ,definition of        
qualified administrative requirement ,in
 this subsection1 the term qualified    
administrative requirement means-- 7,a7 
a requirement under this section2 and   
7,b7 any regulatory requirement         
promulgated pursuant to this section4   
7#b7 ,modification or waiver of         
requirements ,notwithstanding any other 
provision of law1 the ,secretary shall  
modify or waive a qualified             
administrative requirement to allow #a  
or more ,state agencies-- 7,a7 to permit
 vendors authorized to participate in   
the program under this section to       

exchange or substitute authorized       
supplemental foods obtained with food   
instruments with food items that are not
 identical 7including in brand and      
size72  7,b7 to modify or waive any     
requirement with respect to medical     
documentation for the issuance of       
noncontract brand infant formula1 except
 the requirements for participants      
receiving ,food ,package ,,iii 7as      
defined in section #bdf4aj7;e77#c7 of   
title #g1 ,code of ,federal ,regulations
 7as in effect on the date of enactment 
of this subsection772  7,c7 to modify or
 waive the maximum monthly allowance for
 infant formula2  7,d7 to modify or     
waive any additional requirement with   
respect to supplemental food products   
provided under the program under this   
section if the modification or waiver-- 
7i7 may facilitate increased access to  
those products2  7ii7 does not          
substantially weaken the nutritional    
quality of those products2 and  7iii7 is
 in accordance with any applicable      

guidance or directive from the          
,administrator of ,food and ,drugs      
determined to be applicable by the      
,secretary4  7#c7 ,duration ,a          
modification or waiver under paragraph  
7#b7-- 7,a7 shall be available for a    
period of not more than #ahj days       
beginning on the date of enactment of   
this subsection2 and  7,b7 may be       
renewed1 subject to the condition that  
the ,secretary shall provide notice of  
the renewal not less than #ae days      
before the renewal shall take effect4  4