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Infant  Formulas:  Navigating  Marketing  and  Health  Claims

Texas  WIC  Program

The  Texas  WIC  Program

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What  percent   of  Texas  women   do  you  think  initiate  breastfeeding?

What  percent   of  Texas  women   do  you  think  are   exclusively  breastfeeding   at  6  months?  

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Percent  of  Texas  women  who  exclusively  breastfeed  

83%

21%

0%10%20%30%40%50%60%70%80%90%100%

Texas  2012  Initiate* Texas  2012  6  Months*

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Sou rce:   *  National   Immun ization  Su rvey   (NIS),  Cen ters   fo r  Disease   Con tro l  and  P reven tion ,  Departmen t   o f  Heal th  and  Human   Services.   P ro visional  Data,  2 0 1 2  B i rth s.**Texas   WIC ,  Departmen t   o f  State   and  Heal th  Services.   (Augu st  1 9 ,  2 0 1 5 ).  Fin d in g s   from  th e  2 0 1 3  Texa s  WIC   In fa n t  Feed in g  P ra ctices  Su rvey.

55%  of  Texas  WIC  Breastfeeding  Moms  do  NOT  

meet  their  personal  breastfeeding  goals**

Top  Five  Reasons  WIC  Breastfeeding  Moms  Ask  for  Formula

Source:  Texas  WIC  Infant  Feeding  Practices  Survey,  2013,  DSHS

Reasons   for  giving  formula   to  a  baby  who  was  ever  breastfed TexasI  didn’t   think  I  had  enough  milk   46.1%  Breast  milk  alone  did  not   satisfy  my  baby   43.5%  My  baby  had  trouble  sucking  or  latching  on   38.7%  I  could  not  tell  how  much  my  baby  ate   25.6%  I  was  going  back  to  work  or  school  outside  of  the  home 24.2%  

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The  24/7  Texas   Lactation  Support  Hotline:  1  (855)  550-­‐6667.

(Available  to  answer  calls  for  breastfeeding  families.  RN/IBCLCs  are  also  available  to  answer  HCP  calls  about  lactation  management.)

Texas  WIC  Lactation  Support  Centers  are  now  available  for  all  moms.  

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Formulas   in  the  market  

today

Formula  Manufacturers

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Brand  Name  vs.  Generic

Major  Brand  Name Generic

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Infant  Formula

Basic   Infant  Formulas

Routine   Feeding

Formula  Marketed   for  Common   Feeding  Issues

Specialized   Infant  Products  

Nutrient  Compositionof  Basic  Infant  Formula

All  must   meet  the  requirements   of  the  Infant  Formula   Act  of  1980  (FDA).

Breastmilk  &  Infant  FormulaNutrient Breastmilk Cow-­‐Milk  Formula Soy  Formula

Carbohydrate Lactose  Galacto-­‐oligosaccharides  (GOS)

Lactose,  sucrose,  corn  syrup,  maltodextrin,  prebiotic  blend

Corn  syrup, corn  starch  hydrolysate,  tapioca  starch  or  sucrose

Lipid Human  milk  fat Combination  of  vegetable oils:  Palm  olein,   coconut,  soy,  high  oleic  safflower/sunflower  oil

Protein 20-­‐40%casein60-­‐80%  whey

Different ratios  of  casein  and  whey

Soy  protein  isolates  with  L-­‐methionine,   L-­‐Carnitine  &  Taurine

Ballard,   O.,  Morrow,   A.   Human   Milk   Compos ition:   Nutrients   and   Bioactive   Factors .   Pediatr Clin North  Am.   2013.   Feb;   60   (1):   49-­‐74.

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Whey

Casein

Whey  to  Casein  Ratio  by  Brand%  Whey %  Casein

Breastmilk* 60-­‐80 20-­‐40Enfamil  InfantEnfamil  GentleaseEnfamilA.R.

606018

404082

Similac  AdvanceSimilac  TotalComfort

48100

520

Gerber  Good  Start   100 (Hydrolyzed) 0Generic  (varies  by  type)Infant  AdvantageTender

6080100  (Hydrolyzed)

40200

Soy 0 0

*Breast  milk  contains  the  perfect  casein  to  whey  ratio  for  the  growing  infant.   14

Formula  Additives

Prebiotics  &  Probiotics

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DHA  and  ARA• Added  to  most  formulas  since  2002.

• DHA-­‐algae  &  ARA-­‐fungus

• Important  for  eye  and  brain  development.

• Inconsistent  evidence,  produced  endogenously  from  essential  fatty  acids.

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Formula  Can  Marketing

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Formula  Can  Marketing

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Formula  Can  Marketing

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Formula  Can  Marketing

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Controversial  Health  Claim

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“For  healthy  infants   who  are  not   exclusively  breastfed   and  who  have  a  family  history   of  allergy,   feeding  a  100%  whey-­‐protein  partially   hydrolyzed   infant  formula   from   birth  up  to  4  months   of  age  instead  of  a  formula  containing   intact   cow’s   milk  proteins   mayreduce   the  risk  of  developing   atopic  dermatitis   throughout   the  first  year  of  life.”

Calories   in  Infant  Formulas

19  Kcal/Oz 20  Kcal/Oz

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Routine  Feeding  Term  Infant  Formulas

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Term  Infant  Formulas  Marketed  for  Supplementing

• A  generic   for  supplementation  does  not  yet  exist.

• These  formulas  are  problematic  in  the  sense  that  moms  who  are  breastfeeding  think  they  need  them.

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Soy  Formulas• All  are   lactose  free.• Concerns:  Phytoestrogens,  phytates,  aluminum.

• Not  recommended  for  preemies.

• Indicated  for  congenital  lactase  deficiency,  galactosemia or  vegetarian   families.

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Organic  Infant  Formulas

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Formulas  Marketed  for  Common  “Feeding  Issues”

Excessive  Crying,  

Fussiness   &  Gas  

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Comfortable   Stools

• “Helps  baby’s  produce  soft  comfortable  stools”    

• Prebiotics:  Polydextroseand  GOS  

• Easy  to  digest  proteins

Persistent  Feeding   Issues

• “For  discomfort  due  to  persistent  feeding  issues”

• Prebiotic:  GOS• Partially  broken  down  

proteins  for  easy  digestion• Reduced  lactose

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Formulas  Marketed  for  Spit-­‐up

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• Formulas  contain  added  rice  starch• Become  thicker  when  combined  with  stomach  acid• Maybe  effective  for  normal  spit-­‐up

So  which  formula  is  BEST?

• Healthy   babies and  for  supplementing-­‐ cow-­‐milk  based  w/  lactose

• Vegetarian   families,   Galactosemia,   Congenital  lactase   deficiency-­‐ soy  based  infant   formula

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Formula  Preparation

Powder  Formula

• Powdered   formula   is  not sterile.• May  contain   harmful   bacteria   (Cronobacter,  Salmonella).

• Can  become   contaminated   after  opening.• Cronobacter illness   is  very  rare,   but  deadly.• CDC   was  informed   of  13  cases  in  2011  (reporting   is  not  required)

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Centers  for  Disease  Control  and  Prevention.  April  6,  2012.  Cronobacter Illness  and  Infant  Formula.  Retrieved  from  http://www.cdc.gov/features/cronobacter/index.html6  Jan  2016.

CDC  Powder  Infant  Formula  Preparation  Guidelines

1. Bring  water   to  a  boil  on  stovetop  or  kettle   (not  microwave)  

2. Allow   to  cool   to  70° C/  158° F  – not   lower  3. Pour  water   into  bottle   or   feeding   cup4. Mix  with  appropriate   amount   of  formula  

instructed   on  the   label   and  shake  or   swirl  carefully

5. Cool  quickly   to  baby’s   preferred   temperature6. Discard   leftovers   after   2  hours,  discard  prepared  

formula   after   24  hoursWorld  Health  Organization  in  collaboration  with  Food  and  Agriculture  Organization  of  the  United  Nations .(2007)Safe  preparation,  s torage  and  handling  of  powdered  infant  formula  Guidelines .  Retrieved  from  http:/ /www.who.int/ foodsafety/publications/micro/pif_guidelines.pdf

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Formula  Issuance   at  Texas  WICCurrent  Texas  WIC  Contract  Formulas

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Current  Texas  WIC  Contract  Formulas

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Texas  WIC  Formula   Request  Form

• Medical  Request  Form  required  for  all  formulas  except  Similac  Advance  and  Gerber  Good  Start  Soy

• WIC  staff  need  to  approve  requests  form  before  formula  is  issued  to  participants.

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Changes  Coming  October  2016• Non-­‐contract   standard  formula  no  longer  allowed  after  10/1/17.

• Phase  out  will  begin  10/1/16.  The  following  formulas  will  be  affected:– Enfamil   Newborn,   Infant,   A.R.,   Gentlease,   Prosobee– Gerber   Good   Start  Gentle   and   Soothe– Similac Soy  Isomil

• Contract  options  and  therapeutic   formulas  for  medical   reasons  will   continue  to  be  available   by  prescription.

Health  Partners  and  WIC

• WIC  is  your  partner.  • Reach  out  to  WIC  clinic  staff  or  state  WIC  staff  if  you  have  questions

• Call  1-­‐800-­‐942-­‐3678  and  ask  for  a  Formula  Specialist

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QUESTIONS?

Final  Points   and  Wrap-­‐up

• Many  infant  formula   options• Ingredient   variations• All  formulas   meet  FDA  guidelines• No  one  brand   or  formula   type  is  best• Perceived   intolerance   symptoms  are  frequently   normal   baby  behavior

• WIC  is  here  to  support   moms

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Disclosure   to  Learners• Successful   completion   of   this   continuing   education   activity   requires:

– Complete  registration  and  sign   in   sheet– Attend  entire  educational  activity– Participate  in  education  activities  – Complete  participant  evaluation

• This   educational   activity   received   no  commercial   support.  • The  speakers   and  planning   committee   for   this   event  have  disclosed   no  

financial   interests.• Accredited   status   does   not   imply  endorsement   by  the  DSHS,  Continuing  

Education   Service,   Texas  Medical   Association   or  American   Nurse  Credentialing   Center   of  any  commercial   products   or   services.

• The  speakers   did   not  disclose   the  use   of  products   for  a  purpose   other   than  what   it  had  been  approved   for  by   the  Food  and   Drug  Administration.

• Complete   the  attendance   sheet  and   evaluation   by   the  end  of   the  session.

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