|2004Q-0180 - Qualified Health Claim (QHC): Lutein and Eye Disease|
|FDA Comment Number :||EC12|
|Submitter :||Dr. Alberto Davidovich||Date & Time:||06/29/2004 06:06:45|
|Organization :||DSM Nutritional Products, Inc.|
| Dockets Management Branch (HFA-305) June 25, 2004
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Reference: Docket: 2004Q-0180 - Qualified Health Claim (QHC): Lutein and Eye Disease
To Whom It May Concern:
This letter contain comments to the qualified health claim petition - Xangold? Lutein Esters and development of certain eye diseases, docket 2004Q-0180.
DSM Nutritional Products, Inc. believes that there is sufficient data to justify the use of a qualified health claim on conventional foods and detary supplements regarding the relationship between lutein and zeaxanthin and certain eye diseases.
We have all the references cited in these comments, and they are available at your request.
Please feel free to call me, at your convenience if we can be of any assistance in the evaluation of these comments.
DSM Nutritional Products, Inc
Alberto Davidovich, DVM, PhD
Associate Director Regulatory Affairs
45 Waterview Boulevard
Parsippany, NJ 07054
Telephone 973 257 8325
Fax 973 257 8414