July 20, 2007
Office of Nutritional Labeling and Dietary Supplements
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
Re: Docket No. 2007D-0125
Dear Sir or Madam:
The Salt Institute submits these comments to the Office of Nutritional Labeling and Dietary Supplements of the Food and Drug Administration in reference to the Draft Guidance for Industry: Evidence-based Reviewed System for the Scientific Evaluation of Health Claims (Docket No. 2007D-0125).
The Salt Institute is the trade association representing virtually all United States food salt producers. For many years, the Salt Institute has closely monitored developments in the scientific evaluation of health claims, as well as food labeling.
We support this Guidance for Industry and welcome its application to the future evaluation of health claims. We would further like to provide comments and suggestions to this document, which we feel will strengthen it and its eventual application.
The Salt Institute particularly applauds the clearly stated assertion that the scientific evaluation of claims will be based upon publicly available data. This lends weight to the importance of having a fully transparent process which everyone can trust and buy in to an issue of great importance when dealing with any matter related to health. We would also suggest that whenever any claims are rejected, the decision and its supporting information should be made public. This will add to the transparency of the process and will also present the added benefit of imparting knowledge of the decision-making process to others who are contemplating submission of a claim.
We believe that surrogate or proxy endpoints must be considered with extreme caution. What FDA is, and should be, most concerned with is health outcomes, in our modern vernacular, the bottom line. If a surrogate end point does not accurately predict the health outcome, we are faced with a dilemma and have little choice but to reconsider the use of that surrogate endpoint. Without doubt, a health outcome is multifactorial and is the result of a great many events working simultaneously. Reducing or eliminating the divide between a surrogate and the actual health outcome generally calls for a reconsideration of the surrogate.
Usually, FDA accords the greatest weight to the conclusions of federal government scientific bodies as opposed to the judgments of outside experts or expert panels. The purpose of this is to ensure that conclusions meet the highest standards of objectivity a principle that no one could or should object to. However, sometimes federal agencies themselves develop an institutional interest that may cloud the objectivity of their judgments on certain claims and if they do not recuse themselves, they should not be invited to evaluate such claims.
The Salt Institute congratulates the Food and Drug Administration for this initiative and is grateful for the opportunity to comment upon it.
Sincerely,
Morton Satin
Director, Technical and Regulatory Affairs
Salt Institute
700 North Fairfax St.
Alexandria, VA 22314
Phone: (703) 549-4648
morton@saltinstitute.org
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