From: BSardi@aol.com
Sent: Thursday, December 19, 2002 10:57 PM
To: fdadockets@oc.fda.gov
Subject: Inquiry

TO: Dockets Management Branch HFA-305
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

FROM: Bill Sardi
Knowledge of Health, Inc.
457 West Allen Avenue #117
San Dimas, Ca. 91773 
Bsardi@aol.com

While the Consumer Health Information for Better Nutrition Initiative appears 
to be laudable, obviously it provokes questions.  Previous health claims 
approved by the FDA for folic acid, omega-3 fatty acids and B vitamins are 
not brand-specific claims but rather are authorized claims for dietary 
supplements in general.  The question arises, who will submit a claim to 
obtain a qualified health claim, let's say for vitamin C to prevent 
cataracts?  Since no supplier has exclusive claim to the production of 
vitamin C, an application by one person to obtain a qualified health claim 
for vitamin C would give all suppliers of vitamin C the right to use that 
health claim in their labeling?  I believe the obvious answer is yes, but it 
begs the question, who would have incentive to undergo the costs to prepare 
such an application given that there is no commercial interest that can be 
achieved?  If a food company obtains a qualified claim, let's say for 
potassium in bananas and other fruits for the promotion of healthy blood 
pressure, do all purveyors of bananas then have the right to use that claim 
on their food labeling?  This new direction for the FDA certainly opens 
opportunities for health issues to be driven by the public rather than 
industry or government alone.  I'd certainly like an answer to my questions 
when the FDA has time to mull over the ramifications of this new initiative.