Docket Management
Docket: 91N-384H - Food Labeling; Nutrient Content Claims, Define Sodium Levels - Term Healthy
Comment Number: EC -2

Accepted - Volume 13

Comment Record
Commentor Mr. Richard Hanneman Date/Time 2002-05-31 18:46:36
Organization Salt Institute
Category Association

Comments for FDA General
Questions
1. General Comments May 31, 2002 Dockets Management Branch (HFA-305) Food and Drug Administration 5360 Fishers Lane, rm 1061 Rockville, MD 20857 RE: Docket No. 91N-384H and 96P-0500 (RIN 0910-AA19) The Salt Institute, on behalf of the nation’s salt producers, strongly supports FDA’s final rule extending until at least January 1, 2006 any imposition of the second tier sodium requirements for foods to be labeled “healthy.” We are pleased that FDA is reexamining the question of whether sodium content should be considered, at all, as a disqualifying consideration for a “healthy” food to bear that label claim. Following what we hope is a final decision to remove the current disqualification, food manufacturers will need time to adjust their labels and move their inventory; your timeframe seems entirely reasonable. With the effective date of the new Data Quality Act fast approaching on October 1, 2002, we hope and expect that FDA will be reviewing more broadly the quality of the science underlying its health claims labeling program. As an example, the sodium “health claim” relies primarily on affirmation by NHLBI that no significant controversy surrounds the notion that low-salt diets confer general health benefits. Recent medical research belies that claim as explained in the award-winning article in Science magazine “The (Political) Science of Salt.” We are confident that FDA’s guidelines will open the way for reconsideration of the quality of the data upon which the agency’s “Sodium and Hypertension” health claim is founded and that, by 2006, there may not be even a “first tier” sodium number to determine a “healthy” food. Our attached comments, submitted today to NIH, explain our rationale. Thank you for your timely and effective decision on this matter. Sincerely, Richard L. Hanneman President TA7153




EC -2