Statement of the Salt Institute to the European Food Safety
Authority regarding its proposed scientific standard guideline for food label
health claims.
Submitted June 5, 2007.
The Salt Institute represents the major producers of sodium chloride used for human consumption. We write in general support of the draft opinion, “Scientific and Technical Guidance for the Preparation and Presentation of the Application for Authorization of A Health Claim.” and strongly urge the EFSA to retain and refine its core principles in the final regulations governing food label health claims. These principles require that the medical literature be considered in its entirety and with regard to the quality of the evidence; that evidence must demonstrate the safety and efficacy of the intervention for the general population, not for sensitive sub-populations; and that the intervention produce improved outcomes for chronic disease and not simply affect intermediate variables, ignoring unintended changes in other intermediate variables.
We salute EFSA for its pledge to base health claims on a systematic review of the evidence. We believe EFSA should amend the draft to explicitly embrace the review procedures of the Cochrane Collaboration whereby all evidence meeting pre-established quality standards is required to be included in the analysis. The draft requires a clear cause-and-effect relationship be established in humans.
The draft Guidance would permit health claims only when the benefit is population-wide. Thus, foods for diabetics will not bear general health claims. This will eliminate the potential for miscommunication to food purchasers who might think their choice addresses their health concerns when the recommendation might apply only to sensitive sub-groups. The draft would rule out the practice of extrapolating to whole populations the observed effects on various sub-populations.
Likewise, the draft’s explicit recognition that health claims be made only for foods shown to produce improved human “health outcomes” is a strength of the proposal. Too often have health claims been authorized for health conditions which are only intermediate variables affecting health outcomes. Hard outcomes like mortality or, at least, incidence of a medical event such as a stroke or heart attack, are the proper target, not such intermediate “risk factors” as insulin resistance, blood pressure, plasma renin activity or other variables affecting the final health outcome (e.g. a heart attack).
There are two aspects to the draft which we recommend be addressed in the final rule: first, broad language suggesting that a claim might be possible for a food that “significantly reduces a risk factor” for disease, and, second, news that European member states are compiling lists of “well established” claims even in advance of finalization of the rules that will determine whether those claims should be allowed, even if authorized in the past.
The final Guidelines should not permit health claims for individual disease risk factors; they should be authorized when evidence shows that the net health outcome effect is positive. An intervention often affects multiple risk factors and the same intervention can increase some risks even while reducing others. It is the net effect of the intervention that should be the subject of the health claim. While it is appropriate that an application demonstrate the validity of the relationship between a food and a single health outcome, the Guideline must ensure against authorizing a claim about the relationship of a food with a single risk factor.
Compiling lists of “well established” claims is problematic. Advent of these new rules should supersede older claims since EFSA’s newer, higher standard should be pre-emptive. There should be no “grandfather” acceptance of claims that were based on older evidence which has, in some cases been impeached, and, in other cases, has been directed towards intermediate variables (e.g. blood pressure) and not health outcomes (e.g. cardiovascular events).
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