2006D-0066
  

  
Guidance for Industry and FDA Staff: Whole Grains Label Statements
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC14
  



  

  
Submitter : 
  

  
Mrs. Terri Long
  

  
Date & Time: 
  

  
05/08/2006 02:05:01
  



  

  
Organization : 
  

  
North American Millers' Association
  



  

  
Category : 
  

  
Food Association
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 April 18, 2006



<P>Division of Dockets Management (HFA-305)

Food and Drug Administration<br>

5630 Fishers Lane, Rm. 1061<br>

Rockville, MD 20852



<P>Re: Docket No. 2006D-0066



<P>Dear Sirs:



<P>The North American Millers' Association is pleased that FDA recognizes the importance of whole grains and is seeking to provide guidance to the industry. We appreciate the opportunity to provide comments to FDA on this subject.



<P>NAMA is the trade association of the wheat, corn, oat and rye milling industries. Members include milling companies operating mills in the United States and companies representing the industries providing products and services to the mills. The aggregate production capacity of NAMA milling members is more than 160 million pounds of product daily, which is about 95% of the total U.S. capacity. 



<P>As a milling industry trade association, we would like to comment on two specific aspects of the draft Guidance.  First, NAMA agrees with FDA's answer to Question 1: 'Cereal grains that consist of the intact, ground, cracked or flaked caryopsis, whose principal anatomical components -- the starchy endosperm, germ and bran -- are present in the same relative proportions as they exist in the intact caryopsis -- should be considered a whole grain food.' Second, we believe that the last sentence in the answer to Question 4 requires additional clarification to be accurate and informative. Question 4 asks: 'Should a corn flour or corn meal made from corn grain to which the pericarp has been removed be considered whole grain?' The last sentence in FDA's Guidance answer reads: 'Because the rest of the meal standards allow removal of some of the hull, these also should not be considered whole grain products.'



<P>The meal standards for corn meal allow removal of the hull, however, such removal is not required by the standards.  While we agree that removal of the corn hull in a manner that changes the relative proportions of the principal anatomical components of the corn results in a product that is not a whole grain, where a processor chooses not to remove the hull, the resulting corn or corn meal should properly be considered a whole grain product. We believe, therefore, that the last sentence to Answer 4 should be revised to reflect this distinction.



<P>Thank you for the opportunity to provide these comments on the FDA Guidance on Whole Grain for Manufacturers. As the agency considers various aspects of this subject, we look forward to providing input where appropriate.




  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 <P>Sincerely,



<P>Terri Long<br>

Director of Communications <br>

North American Millers' Association<br>

202.484.2200 ext. 11<br>

ttodd@namamillers.org



  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006D-0066-EC14-Attach-1.DOC