2006D-0066
  

  
Guidance for Industry and FDA Staff: Whole Grains Label Statements
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC8
  



  

  
Submitter : 
  

  
Mr. Ernesto Martinez
  

  
Date & Time: 
  

  
05/08/2006 01:05:05
  



  

  
Organization : 
  

  
Bimbo Bakeries USA, Inc.
  



  

  
Category : 
  

  
Food Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 April 17, 2006 







Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland  20852





Re: Whole Grains Label Statements

 Docket No. 2006D-0066

 71 Fed. Reg. 8597 (February 17, 2006) 





These comments are submitted on behalf of Bimbo Bakeries USA Inc., (BBU)



We appreciate this opportunity to comment on FDAs Draft Guidance for Whole Grain Label Statements (Draft Guidance), to help ensure that such guidance does not restrict lawful claims and that it reflects definitions consistent with accepted industry standards.

Toward this end, BBU strongly urges FDA to eliminate from the Draft Guidance the apparent  prohibition on claims that imply a particular level of the ingredient, i.e., high or excellent source.. Whole grain claims are not nutrient content claims, and we believe the FDA lacks legal authority to regulate the use of terms such as high or excellent source in whole grain claims.



FDAs legal authority with respect to whole grain claims is limited to prohibiting claims that are false or misleading and would need to be evaluated on a case-by-case basis in the overall context of the individual package.  



Similarly, while the Draft Guidance does not address claims that a product is made with whole grains, BBU notes that such claims may also be made where they are truthful and nonmisleading.  Again, this is necessarily a case-by-case determination, and BBU believes that such claims are supportable where the product contains a meaningful amount of whole grains.  We suggest this meaningful threshold to be 4.8 grams per serving, which is 10% of the whole grains suggested to be consumed daily by the USDA U.S. Dietary Guidelines. This would be significant in helping consumers reach the goals set by these Guidelines.



It is important that we do not send a message to consumers that ONLY 100% whole grain products are acceptable. Several studies have show that the decrease in some diseases risk reduction is not significantly affected by the whole grain content of the foods consumed, but by the total

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 combined amount. The apparent  prohibition on claims that imply a particular level of the ingredient, i.e., good or excellent source., might send such a negative message.





BBU appreciates this opportunity to provide comments on this Draft Guidance, which is of substantial importance to the baking industry.  

  Respectfully submitted,



Ernesto Martinez-Franco       

R&D Director     

Bimbo Bakeries USA, Inc.



  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006D-0066-EC8-Attach-1.PDF
  



  

  
2006D-0066-EC8-Attach-2.PDF