May  2019    Re:  Gluten-­‐free  claims  on  restaurant  menus    Dear  [names  of  FDA  staff  redacted],    There  appears  to  be  a  growing  trend  among  restaurants  of  labeling  menu  items  gluten-­‐free  based  solely  on  the  ingredients  used  in  the  menu  item  without  regard  to  potential  cross  contact  that  may  occur  in  the  kitchen.  This  is  evidenced  by  various  disclaimers  on  restaurant  menus,  including  those  stating  that  items  marked  gluten-­‐free  are  not  intended  for  people  with  celiac  disease.  It  is  also  evidenced  by  the  use  of  gluten-­‐free  claims  even  when  there  is  a  known  source  of  gluten  cross  contact  (e.g.,  a  shared  restaurant  fryer).        What  FDA  has  stated  online  about  restaurants  and  gluten-­‐free  claims    

“FDA’s  regulation  established  a  federal  definition  of  the  term  “gluten-­‐free”  for  food  manufacturers  that  voluntarily  label  FDA-­‐regulated  foods  as  “gluten-­‐free.”  The  definition  was  intended  to  provide  a  reliable  way  for  people  with  celiac  disease  to  avoid  gluten,  and,  given  the  public  health  significance  of  gluten,  restaurants’  use  of  gluten-­‐free  labeling  should  be  consistent  with  the  federal  definition.”    “Some  restaurants  use  the  term  “gluten-­‐free”  in  their  menus.  The  gluten-­‐free  final  rule  applies  to  packaged  foods,  which  may  be  sold  in  some  retail  and  food-­‐service  establishments  such  as  some  carry-­‐out  restaurants.  However,  given  the  public  health  significance  of  gluten-­‐free  labeling,  restaurants  making  a  gluten-­‐free  claim  on  their  menus  should  be  consistent  with  FDA’s  definition.”    “State  and  local  governments  play  an  important  role  in  oversight  of  restaurants.  FDA  will  continue  to  work  with  partners  in  state  and  local  governments  with  respect  to  gluten-­‐free  labeling  in  restaurants.”  

 Excerpt  of  a  statement  provided  by  FDA  to  me  for  public  posting      In  the  strict  sense,  FDA  requirements  for  gluten-­‐free  claims  apply  to  only  packaged  foods  that  are  subject  to  FDA  labeling  regulations.  However,  FDA  stated  the  following  

in  regards  to  restaurants  in  the  preamble  to  its  final  rule  on  gluten-­‐free  labeling  (see  78  FR  47153  at  47173,  issued  8/5/13):  “with  respect  to  restaurants,  FDA  guidance  suggests  that  any  use  of  an  FDA-­‐defined  food  labeling  claim  (e.g.,  “fat-­‐free”  or  “cholesterol-­‐free”)  on  restaurant  menus  should  be  consistent  with  the  regulatory  definitions.”    Further,  both  FDA  regulations  at  21  CFR  101.13(q)(5)  (see  http://tinyurl.com/lfvknn7)  and  Chapter  IV  of  FDA’s  guidance  document  titled  Guidance  for  Industry:  A  Labeling  Guide  for  Restaurants  and  Other  Retail  Food  Establishments  Selling  Away-­‐From-­‐Home  Food  initially  issued  April  2008  (see  http://tinyurl.com/mngrt4j)  reiterate  the  agency’s  position  that  restaurants  should  not  use  an  FDA-­‐defined  nutrient  content  claim  for  foods  sold  in  restaurants  unless  those  foods  meet  regulatory  requirements  for  the  claim.  A  gluten-­‐free  claim  is  an  avoidance  claim  and  FDA  has  publicly  expressed  its  opinion  (in  the  Federal  Register  and  in  a  guidance  document)  that  it  takes  a  similar  approach  to  gluten-­‐free  claims  made  for  foods  sold  in  restaurants.    Consequently,  if  restaurants  or  other  retail  food  establishments  wish  to  make  “gluten-­‐free”  claims  (or  the  synonymous  claims  “no  gluten”  “free  of  gluten”  or  “without  gluten”)  for  any  of  their  menu  items,  these  foods  should  meet  all  of  the  requirements  FDA  has  established  for  a  food  labeled  gluten-­‐free,  including  not  containing  20  parts  per  million  or  more  gluten,  whether  or  not  the  presence  of  gluten  is  due  to  accidental  cross-­‐contact  occurring  in  the  kitchen.  If  restaurants  cannot  ensure  that  the  foods  they  prepare  fully  comply  with  FDA’s  definition  of  gluten-­‐free,  restaurants  should  not  refer  to  their  foods  as  being  “gluten-­‐free.”      Problems    Based  on  information  on  restaurant  menus  and  restaurant  websites  provided  to  Gluten  Free  Watchdog  by  members  of  the  community,  many  restaurants:    

1.  Appear  unaware  that  foods  designated  as  gluten-­‐free  on  a  menu  should  be  gluten-­‐free  when  served  to  the  customer.  

 2.  Lack  an  understanding  that  the  designation  gluten-­‐free  pertains  to  both  the  actual  ingredients  used  to  prepare  a  meal  and  the  presence  of  gluten  due  to  accidental  or  even  intentional*  cross-­‐contact  in  the  kitchen.    

*Some  restaurants  mark  menu  items  as  gluten-­‐free  even  though  said  items  are  cooked  in  a  shared  fryer  with  wheat-­‐containing  products.  This  may  or  may  not  be  disclosed  on  a  menu.  See  restaurant  7  below.    

 3.  Include  disclaimers  regarding  potential  cross  contact  on  gluten-­‐free  menus  and  meals  designated  as  gluten-­‐free.  

 

4.  Include  wording  in  their  disclaimers  stating  that  gluten-­‐free  meals  are  not  safe  for  customers  with  celiac  disease.  

 5.  Lack  an  understanding  that  the  term  “gluten-­‐free”  was  defined  to  help  people  with  celiac  disease  avoid  gluten.    6.  Have  not  been  subject  to  any  state  or  federal  oversight  regarding  gluten-­‐free  claims.  

 Recommendation    Many  people  with  celiac  disease  greatly  appreciate  when  restaurants  identify  meals  that  are  free  of  or  can  be  made  without  gluten  ingredients.  This  provides  them  with  a  good  starting  point  to  ask  questions  of  restaurant  staff  about  cross  contact  precautions.  Customers  do  not  want  restaurants  to  stop  this  practice.    An  FDA  guidance  document  directed  to  restaurants  on  how  to  accurately  represent  menu  items  would  be  very  helpful.  This  guidance  could  include  information  on:    

A.  Proper  use  of  a  gluten-­‐free  claim  (i.e.,  meal  is  gluten-­‐free  when  served  to  a  patron  as  may  occur  in  a  dedicated  gluten-­‐free  restaurant  or  a  restaurant  with  well-­‐trained  staff  who  are  well  versed  in  the  steps  necessary  to  prevent  cross  contact  in  the  kitchen).    B.  Recommendations  for  the  use  of  an  alternative  claim  when  a  restaurant  can  provide  meals  made  with  no  gluten-­‐containing  ingredients  and  take  precautions  to  prevent  cross  contact  but  can’t  ensure  that  cross  contact  won’t  occur  (e.g.,  NG=no  gluten-­‐containing  ingredients).      C.  Disallowance  of  the  use  of  a  gluten-­‐free  claim  when  it  applies  to  ingredients  only  with  little  to  no  regard  for  the  potential  for  cross  contact.    

 Community  Input  Gluten  Free  Watchdog  recently  asked  the  community  to  submit  photos  of  restaurant  menus  containing  both  a  gluten-­‐free  claim  and  a  precautionary  statement  pertaining  to  cross  contact  and  lack  of  suitability  for  patrons  with  celiac  disease.  What  follows  on  the  next  page  is  a  sampling  of  these  submissions.  The  Gluten  Free  Watchdog  community  is  more  than  happy  to  provide  FDA  with  additional  examples.    Hopefully  the  information  provided  in  this  letter  helps  to  increase  FDA  awareness  about  the  current  use  of  gluten-­‐free  claims  by  restaurants.    Thank  you.    Tricia  Thompson,  MS,  RD  Founder,  Gluten  Free  Watchdog,  LLC  

Restaurant  1:  Gluten-­‐Free  Pizza;  Disclaimer  includes  “…  our  gluten-­‐free  items  are  not  recommended  for  guests  with  celiac  or  any  other  gluten  sensitive  disorders.”    

       

Restaurant  2:  Gluten-­‐free  Menu;  Disclaimer  includes,  “…  we  cannot  guarantee  hospital  pureness  for  customers  who  have  a  strict  celiac  diet.  We  do  offer  our  gluten-­‐free  menu  for  customers  who  prefer  a  diet  without  gluten.”      

 

Restaurant  3:  Gluten-­‐Free  Menu;  Disclaimer  reads,  “[restaurant  name]  does  not  recommend  them  for  customers  with  celiac  disease.”    

     Restaurant  4:  Circular  advertises  gluten-­‐free  pizza;  There  is  no  disclaimer  on  the  circular;  Website  disclaimer  states,  “Customers  with  gluten  sensitivities  should  exercise  judgment  in  consuming  these  items.”    

   

 

Restaurant  5:  Designates  menu  items  gluten-­‐free;  Disclaimer  states  “[Restaurant]  does  not  recommend  these  items  for  guests  with  celiac  disease.”    

     Restaurant  6:  Designates  menu  items  gluten-­‐free:  Disclaimer  states,  “Cross-­‐contact  with  other  food  items  that  contain  gluten  is  possible.”    

       

Restaurant  7:  Gluten  Free  Menu;  Appears  to  use  shared  fryer.  Disclaimer  states,  “There  may  be  trace  amounts  of  flour  in  fry  oil”    

     Restaurant  8:  Designates  menu  items  as  gluten-­‐free;  Disclaimer  states,  “We  do  not  recommend  it  for  those  with  celiac  disease.”    

     

Restaurant  9:  National  Park  Service  restaurant.  Offers  gluten-­‐free  options;  Disclaimer  states  we  “cannot  ensure  the  (sic)  cross  contamination  will  never  occur.”    

         

Restaurant  10:  Gluten-­‐Free  Menu;  Disclaimer  states  “there  may  be  a  chance  of  cross  contamination.”    

   Restaurant  11:  Gluten-­‐Free  Menu;  Disclaimer  states,  “Our  fries  are  gluten  free,  but  are  prepared  in  a  fryer  that  is  used  for  foods  containing  gluten.”    

     Additional  restaurant  menu  of  interest:  Items  marked  “G”  to  mean  “Contains  Gluten.”