September 19, 1996

Dockets Management Branch

Food and Drug Administration

Department of Health and Human Services

Room 1-23

12420 Parklawn Drive

Rockville, MD 20857

CITIZEN PETITION

The undersigned submits this petition on behalf of the Salt Institute pursuant to 21 C.F.R. § 10.30, under sections 201(f), (m), 403(a) and 403(r) of the Federal Food, Drug, and Cosmetic Act ("FFDCA" or "the Act") to request the Commissioner of Food and Drugs to revoke and amend the regulations specified below.

I. Action Requested

A. The Salt Institute requests that the Commissioner of Food and Drugs ("the Commissioner") revoke the regulation approving a health claim for sodium (21 C.F.R. § 101.74 (1995)), based on the current absence of statutorily required significant scientific agreement about the relationship between sodium and hypertension. (See Appendix A, section I, infra for the text of the current regulation.)

B. The Salt Institute requests that the Commissioner revoke the disqualifying nutrient levels for sodium (21 C.F.R. § 101.14(a)(5) (1995)), because sodium does not increase "to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of" sodium-containing foods in the daily diet. (See Appendix A, section II, infra, for the text of the current regulation and for the proposed changes.)

C. The Salt Institute requests that the Commissioner revoke the nutrient disclosure levels for sodium (21 C.F.R. § 101.13(h) (1995)), because sodium does not increase "to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of" sodium-containing foods in the daily diet. (See Appendix A, section III, infra, for the text of the current regulation and for the proposed changes.)

II. Statement of Grounds

A. Introduction

In 1990, Congress passed the Nutrition Labeling and Education Act ("NLEA") in part to address the problems of inadequately substantiated or exaggerated health claims on food labeling. One of the principal objectives of the NLEA is to ensure that the health claims and nutrient content claims on which Americans make food purchasing and dietary decisions are based on sufficient scientific evidence. Congress recognized that many consumers are interested in regulating their nutrient intake to improve their health. The NLEA is designed to assist these consumers by converting health claims from a form of advertising puffery into useful nutritional information.

A principal component of the NLEA is the standard of scientific support and agreement required to support each permissible health claim. No health claim may appear on a food label until the Commissioner of FDA determines, based on all publicly available scientific evidence, that there is significant expert scientific agreement supporting the health claim. As a result, consumers need not cull purely speculative from scientifically substantiated nutritional information and, thus, reasonably can rely on health claims in making purchasing and/or consumption decisions.

Two other components of the NLEA are the nutrient disclosure level and the nutrient disqualifying level. These values are intended to prevent misleading use of nutrient content claims and health claims respectively. The label of a food that bears a nutrient content claim (e.g., reduced fat) must also disclose the presence of other nutrients which are present at certain designated levels. Specifically, the NLEA requires disclosure of specific nutrients present in the food at levels which, in the context of the daily diet, increase to persons in the general population the risk of a disease or health-related condition. Analogously, a food containing a nutrient in such an amount is prohibited from bearing a health claim on its label.

Like health claims, the disclosure and disqualifying levels are based on the Commissioner's assessment of the available scientific data and information. All three of these NLEA regulatory devices therefore must be reassessed in response to significant new scientific information concerning a nutrient. Health claims and disclosure and disqualifying levels that are no longer supported by current science, and yet continue to be maintained as regulations, undermine the purpose of the NLEA by allowing inadequately supported, yet governmentally-approved, nutrition information to be provided to consumers, on which they will rely to make consumption decisions. At some point, such information becomes meaningless or may even cause some consumers to suffer adverse health effects, undermining consumer confidence in all approved claims.

The health claim, disclosure level and disqualifying level for sodium have reached this point.

When FDA first promulgated the health claim for sodium, nutrition experts disagreed about the relationship between sodium and hypertension. Since then, research from diverse sources and experts have cast significant additional doubt on the health benefits and safety to the general public of reducing sodium consumption. Indeed, recent scientific evidence demonstrates that reduction of sodium, perhaps via increased plasma renin activity levels, may have consequent adverse health effects in some people. Scientific understanding has evolved such that many experts now believe: 1) there is no relationship between sodium consumption and hypertension in the general population, 2) reduction of sodium consumption is of no health benefit to the overwhelming majority of Americans, and 3) low-sodium diets may have detrimental effects for selected individuals. For these reasons, the Commissioner no longer has the basis of significant scientific agreement among qualified experts required under the NLEA to support the current rule and, consequently, must revoke the current sodium health claim.

Similarly, current science regarding sodium and health no longer supports the disclosure and disqualifying levels for sodium. Therefore, the inclusion of such levels is misleading to consumers because it suggests, without sufficient basis, the likelihood of a benefit from reduced sodium consumption. Moreover, the unsupported disqualifying level for sodium prevents consumers from receiving useful nutrition information through well-substantiated health claims about other nutrients in food. Therefore, consistent with the requirements of the NLEA and the First Amendment protection of such information, the Salt Institute also requests the Commissioner to revoke the nutrient disclosure level and nutrient disqualifying level for sodium to allow consumers access to accurate and important nutrition information.

The actions requested by the Salt Institute in this citizen petition will result in labeling that will better enable the American public to make informed nutritional decisions. These changes are required by the letter and spirit of the NLEA, the Federal Food, Drug, and Cosmetic Act ("FFDCA"), and the First Amendment, and are fundamental to the maintenance of good public health. To refuse to make these changes would, as Justice Breyer has observed in his recent discussion of risk assessment, simply "freeze old rules in place," to the detriment of consumers.

B. The Commissioner Must Revoke The Regulation Permitting a Health Claim Linking Sodium and Hypertension.

The NLEA requires FDA to ensure that health claims on foods reflect current scientific knowledge about the role of nutrients in a healthful diet. When scientific understanding of a nutrient's relationship to health develops significantly, FDA must alter any approved health claim concerning that nutrient accordingly. To fail to make such a change undermines the goals of the NLEA and violates its statutory standards.

The publication of new data relating to sodium's dietary effects has continually and significantly eroded agreement by the relevant experts in hypertension research about the role of sodium in hypertension. Indeed, there is significant reason to feel that the health-related condition, hypertension, is not a reliable indicator of risk of cardiovascular events. As the attached expert affidavit demonstrates, there is no longer a basis of significant scientific agreement for the current sodium health claim. The current sodium health claim no longer presents accurate, non-misleading nutrition information, as intended by the NLEA. Because the currently approved health claim for sodium no longer accurately characterizes the relationship between sodium and hypertension, labeling of a food with the sodium health claim, even though the claim is currently approved, renders the food misbranded within the meaning of the FFDCA. For all of these reasons, FDA must revoke the regulations permitting the sodium health claim.

1. The Sodium Health Claim is Inconsistent with the Stated Purpose of the NLEA to Protect the Public Health by Ensuring that Health Claims Are Scientifically Substantiated.

The NLEA emerged from a food marketing environment in which FDA exhibited growing concern about unfounded health claims. Marketers, realizing that consumers respond to claims about the health benefits of particular foods or diets, increasingly used such claims on food labels. Some of these claims relied on preliminary findings, while others promoted the health benefits of a nutrient without regard to the quantities of the nutrient in the labeled food.

To protect consumers from unfounded, misleading, or otherwise meaningless health claims, Congress acted "to establish the circumstances under which claims may be made about nutrients in foods." Health claims based on sufficient scientific substantiation can "help Americans to maintain a balanced and healthful diet." Congress' intent in regulating health claims is to protect and improve U.S. public health by providing well-substantiated nutrition information on food. Congress did not intend that a health claim with only some support be permitted on food labeling. Rather, it concluded that only health claims about which there is substantial scientific agreement would contribute to the overall health of the U.S. population.

As discussed below, the current health claim for sodium is not based on well-founded, consistent nutrition science regarding the role of sodium in health which is accepted by the relevant scientific community. The current sodium health claim therefore violates Congress' legislative intent in permitting health claims. Consequently, the Commissioner of FDA must revoke the regulation permitting a health claim for sodium on food labeling.

2. The Health Claim Linking Sodium and Hypertension Does Not Meet the NLEA's Statutory Standard for Significant Scientific Agreement and, Therefore, Must be Withdrawn.

Congress intended FDA to regulate health claims by requiring that all claims meet a strict standard of scientific substantiation. Only those health claims meeting the standard may be used on food labeling. The scientific and logical corollary is that a claim that once met, but no longer meets, the standard should be eliminated. To do otherwise is to ignore Congress' intent by creating a class of approved, but scientifically-unsupported, health claims. Failing to revoke the regulation also facilitates the marketing of misbranded foods which continue to use the unsubstantiated health claim.

Congress chose a stringent standard of scientific support for health claims to assure that consumers do not make nutrition choices based on either preliminary or outdated research but, rather, on current science which is accepted by the community of relevant scientific experts. In the case of the sodium health claim, recent studies relating to dietary sodium and health demonstrate that earlier conclusions about sodium and health are now outdated and invalid. Consequently, there is no longer adequate scientific support for continued approval of the sodium health claim and it must be revoked.

a. The NLEA Requires "Significant Scientific Agreement" for Authorization of a Health Claim.

The standard for approval of a health claim under the NLEA is:

[Determination by FDA based] on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by training and experience to evaluate such claims, that the claim is supported by such evidence.

Congress meant this to be a strong standard. It requires that FDA have a high degree of confidence that the claim is valid based on a "review [of] all the scientific evidence that is pertinent to [the] claim."

Congress provided little guidance as to the exact meaning of "significant scientific agreement" other than to say that it is a high standard and that it does not constitute unanimity. FDA echoed this position by rejecting the proposition that Congress intended only a "substantial evidence" standard requiring "more than a scintilla and less than a preponderance" of evidence in support of a health claim. Both Congress and FDA anticipated that many potential health claims would fail to meet this standard. The difficulty of establishing significant scientific agreement for a health claim was exemplified most recently y FDA’s denial of a petition for a health claim on dietary calcium and hypertension. FDA applied a high standard by requiring that there be clinical, not merely statistical, significance to data submitted in support of a health claim and in finding that the data were too inconsistent and equivocal to support a calcium health claim.

Similarly, it would hardly be remarkable for a health claim that once met the standard of substantiation to lose the necessary scientific support in light of publication and acceptance of new scientific findings. As FDA has itself recognized, knowledge about "the role of nutrients and food components in reducing the risk of disease is in an evolving state." The history of science is replete with examples of advancing knowledge overturning previously accepted scientific conclusions. In light of the ongoing active research on hypertension and the continuing controversy concerning the hypothesized relationship of sodium to hypertension, it is not surprising that there has been a significant scientific rejection of the hypothesis and, thus, of the necessary scientific support for the sodium health claim.

b. There Is Currently a Lack of Necessary "Significant Scientific Agreement" Among Experts About a Causal Relationship Between Sodium Consumption and Hypertension in the General Population.

At most, the available scientific evidence at the time that the sodium health claim was approved by FDA only narrowly met the standard of significant scientific agreement. New studies have undermined this agreement in two ways. First, for the first time, one recent study has directly assessed the cardiovascular morbidity and mortality outcomes of dietary sodium restriction rather than simply measuring blood pressure -- a surrogate for cardiovascular health outcomes. This study provides evidence of serious health risks associated with low sodium diets for some people, and therefore not only challenges the usefulness of reducing sodium intake, but questions the safety. Second, reanalyses of earlier data on the relationship between sodium intake and hypertension, the health effect surrogate, have questioned the validity of earlier conclusions that lowered sodium intake actually results in lowered blood pressure. As a result, scientists are not in significant agreement on either the relationship between sodium and hypertension or the link between dietary sodium and the risk of cardiovascular events.

i. Public Health Impact Study of Low Sodium Diets

In enacting the NLEA's standard of scientific substantiation for health claims, Congress anticipated that FDA would accord different weight to different scientific studies. FDA similarly expressed its view that,

the evidence relating to a particular claim may vary in its usefulness, and that some types of studies may be more probative than others in establishing the validity of particular nutrient-disease relationships. . . . [Consequently t]he agency will evaluate the strengths and weaknesses of each individual study and weight it accordingly in reaching a decision about the validity of a particular claim.

In approving the sodium health claim, FDA had available to it only data on the relationship between sodium and the surrogate endpoint – blood pressure. As the only data available, they were accorded great weight in evaluating the sodium health claim.

Since FDA's approval of the sodium health claim, a new study has become available which directly examines the relationship between sodium restriction intervention and changes in cardiovascular disease state, such as incidence of heart attacks. The study demonstrates that a reduction in sodium consumption, the objective promoted by the current sodium health claim, can have serious adverse cardiovascular effects for a significant segment of the population -- hypertensives. This is the group previously thought most likely to benefit from attaining the sodium health claim's goal of reduced sodium consumption. FDA has received no data affirming the beneficial cardiovascular health effects of low sodium diets for the general population.

The prospective study of 3,000 mild and moderate hypertensive subjects has revealed an inverse, linear relation of sodium intake to cardiovascular disease and particularly heart attack during a follow-up period of up to 8 years. Sodium intake was measured as 24 hour urine excretion in unmedicated patients prior to entry into a standardized treatment program. Neither patients nor therapists in the study were informed of sodium excretion levels. Blood pressure control was similarly good in all patients in each quartile grouped by sodium excretion. After control for all known risk factors associated with the occurrence of heart attack (e.g., personal and family history of hypertension, left ventricular hypertrophy, etc.), the independent relationship of low sodium to increased heart attack remained significant. Statistical analysis revealed that, as hypothesized, much, but not all, of the relationship of sodium to heart attack was explained by variation in plasma renin activity. Significantly, there was no biochemical marker for determining which of the patients on the low sodium diet were at increased risk for myocardial infarction. This is analogous to the "potential safety concern" that FDA cited in its denial of the calcium-hypertension health claim.

FDA is interested in hypertension primarily as a risk factor for mortality from heart attack and stroke. Its intent in permitting the sodium health claim was to effect a decrease in blood pressure in the population generally in order to reduce the risk of both heart attack and stroke. This new study demonstrates clearly that FDA needed to consider more the safety of encouraging reduced sodium diets. A reduction in blood pressure may not result in improved cardiovascular health. Additionally, the study calls into question the continuing usefulness of hypertension as a surrogate endpoint for heart attack and stroke. Because the study directly examines the effect of sodium on human health end points rather than on a surrogate measure, like earlier studies on which FDA relied, the new study should be accorded more weight than the earlier studies in assessing scientific agreement about a relationship between sodium and disease or health-related conditions. When considered in the context of the maturing data on sodium and health, this study demonstrates serious questions in the scientific community about the continuing validity of the sodium health claim.

Under these circumstances it would violate both the intent and meaning of the NLEA to continue permitting the use of the sodium health claim on food. In addition, in light of the risks involved with reduced sodium diets, it is irresponsible from a public health perspective to continue categorically encouraging decreased consumption of sodium until further information is provided on the morbidity associated with lower sodium diets.

ii. Recent Studies of Sodium and Hypertension Demonstrate That Sodium Has No Significant Effect on Blood Pressure in the General Population

Other scientific evidence that has become available since the publication of the final health claim regulation for sodium erodes the scientific (and, thus, the legal) basis for the continued use of the sodium claim. Indeed, by further weakening the earlier, marginal scientific basis, it profoundly undermines the current scientific, and hence legal, basis for maintaining the sodium claim as an authorized health claim. Observational studies have suggested the hypothesis that lowering sodium intakes will reduce population blood pressure. This hypothesis has now been tested in numerous, high quality randomized clinical trials. A recent meta-analysis of fifty-six previously published randomized clinical trials on the effect of sodium on blood pressure demonstrates that low sodium diets do not lower the blood pressure of normotensives. The very small blood pressure reductions identified were limited to the hypertensive population, especially in older hypertensives. Although there has been at least one criticism of this study, it is generally recognized that properly conducted clinical studies, as analyzed, for example, in the Midgley article, provide better and more reliable health data than observational studies, such as INTERSALT, on which FDA originally relied in approving the sodium health claim.

The National Heart, Lung and Blood Institute recognizes the importance of using meta-analyses of randomized clinical trial data when available; indeed, it has produced its own meta-analysis of the sodium and hypertension literature. FDA has also recognized the usefulness of meta-analyses in overcoming statistical problems with other types of studies or with smaller studies. Clinical trial data are very important. Because of the inherent limitations of observational data, there has been growing concern over and criticism of their use as the basis for public health policy, particularly when more reliable types of evidence are available. This concern is reflected in recent effectiveness assessments by the U.S. Preventive Services Task Force and its counterpart Canadian organization.That newer and more reliable studies such as Midgley refine and, in selected ways, contradict earlier analyses strongly undermines support for the previous conclusion that sodium reduction is beneficial for the general population.

Similarly, results from Phase II of the Trials of Hypertension Prevention (TOHP II) also support the conclusion that sodium reduction has little long-term benefit. As reported by Dr. Paul Whelton, the principal investigator, at the 1995 American Heart Association Scientific Sessions, TOPH II found that the blood pressure lowering effect of sodium reduction, while significant at six months and, diminished, at 18 months, had virtually disappeared when measured at 36 months and again at the 48-months termination of the trial, even though the reduction in dietary sodium remained significant The TOHP II results thus confirm that sodium restriction has no long term effect on the blood pressure of the large normotensive population (in fact, the TOHP II population was "high normal" which would be expected to have an above-average response to restriction of dietary sodium).

Two recent review chapters and a review article acknowledge the significant continuing controversy over the usefulness of universal sodium restriction. One chapter stated:

Some authorities have recommended that dietary sodium and chloride intake should be curtailed…in the hope that the development of hypertension, increased of blood pressure with age, and cardiovascular disease morbidity and mortality may thus be alleviated. The wisdom of such an approach in terms of a public health strategy for nonhypertensive normal individuals is currently under debate and is not yet thoroughly established.

The other chapter also noted the great controversy over the relationship between sodium and hypertension and observed that:

If dietary sodium were a major factor in the development of hypertension in industrialized countries,… one would expect that increased intake would increase blood pressure in normotensive subjects, especially those with strong family histories of hypertension, who are at increased risk of developing hypertension themselves. However, this has not been found to be the case. In addition, the fact that strict vegetarians or thin nondrinkers can have a low prevalence of hypertension and a high sodium intake has suggested that sodium by itself has a minor role in the development of hypertension.

Similarly, the review article on the "Role of Dietary Salt in Hypertension," which focused on papers published since 1991, concluded:

sodium intake, as judged by 24-hour urinary excretion, is not clearly related to arterial pressure within adult communities. For example, it is difficult to demonstrate a relation between NaCl intake and arterial pressure within the United States, perhaps because most normotensive members of the population have a high NaCl intake but only a few are sensitive to NaCl.

In a concluding section on prevention, the authors state that "a number of investigators have advocated a reduction in the dietary intake of NaCl for the prevention of hypertension." "However," they continue, "an equally large number of investigators do not share this view and feel that such a recommendation for the general public is premature based on the available data."

The lack of expert scientific agreement about the usefulness of dietary sodium restriction is also demonstrated by the views of those experts who actually counsel patients on issues of diet -- primary care physicians. A recent study documented that between 1981 and 1994 the portion of primary care physicians who believed that decreasing salt consumption was "very important" "in promoting the health of the average person" decreased from forty to thirteen percent. During this period, the government has engaged in continued efforts to promote universal sodium restriction. In like manner, the lack of scientific agreement about the usefulness of sodium restriction is further demonstrated by the number of articles in the popular press that either give contrary advice about sodium restriction, or note the current scientific controversy over sodium restriction’s usefulness for the general population.

If a significant number of researchers expert in the field reject the usefulness of dietary sodium restriction as a general health measure to lower cardiovascular risk, it makes no sense, and bad public health policy, for FDA to continue advocating such restrictions. More importantly, continuing to authorize a health claim embodying such advice violates the NLEA. It cannot accurately be said that there is currently significant scientific agreement that available evidence supports the sodium health claim. At best, scientists are equally divided on the point. The FDA has acknowledged this divided level of support does not meet the standards set by the NLEA.

There appear to be no other recent studies on the relationship between sodium and blood pressure in humans. One study measured the effect of salt on chimpanzee blood and found that increased salt consumption correlated with increased blood pressure. The authors suggested that these results can be applied to human populations. However there are serious flaws in the study that undermine the validity of the results even in chimpanzees.

When combined with the pre-existing body of scientific literature, the newly available science demonstrates the current absence of significant scientific agreement among qualified experts about the relationship between sodium and hypertension.

iii. There is Significant Scientific Disagreement Over the Continuing Validity and Relevance of Older Data Suggesting a Link Between Sodium and Hypertension.

This controversy is evident from recent published exchanges relating to the INTERSALT data published in 1988. A recent article from the Salt Institute published in the British Medical Journal reexamined the statistical analysis of the original INTERSALT data and demonstrated that the originally-reported correlation of sodium intakes with increasing blood pressure with age was a statistical artifact. When the INTERSALT analysis corrects for the non-zero y-intercept, rather than arbitrarily setting that value at zero, the significant association of sodium excretion with the slope of blood pressure with age disappears. At least one other commentator has focused on the statistical anomaly of setting all the Y-intercepts at zero. Forty-seven percent of the postulated "slope with age" is created by the failure to make this critical statistical adjustment; less than five percent, by sodium excretion.

The INTERSALT group replied in the same issue of the British Medical Journal, attacking the Salt Institute’s statistical methods and attempting to buttress its own analyses. BMJ also published further reanalyses of the original 1988 data on which FDA relied in adopting the sodium health claim.

More recently, another independent critique of the INTERSALT statistical methods was published in the British Medical Journal, along with another response by the INTERSALT group. Non-prospective data, like that collected in INTERSALT, does not provide an adequate basis on which to develop prospective statistical models. Using inadequate data, or analyzing them using flawed assumptions, produces inherently unreliable conclusions. The vigorous and continuing debate over the validity of conclusions first published eight years ago indicates that scientists are far from agreement about the validity of INTERSALT results on sodium and hypertension. Moreover, FDA’s reliance both on the INTERSALT study, and on studies which rely on INTERSALT data as evidence of significant scientific agreement was clearly misplaced.

Data from observational studies, such as INTERSALT, do not provide adequate evidence to support a major population intervention such as sodium restriction. This is particularly true when there are clinical data contradicting the observational evidence. As described above, in 1991, a scientist at the National Heart, Lung and Blood Institute prepared a meta-analysis of human experimental evidence, consisting of 28 trials, including only six of normotensive populations, on the relationship between sodium and blood pressure. This meta-analysis, which was relied on by FDA when it enacted the sodium and hypertension health claim, found a small but statistically significant reduction in blood pressure from sodium restriction. However, the NHLBI meta-analysis has since been superseded by Midgley’s meta-analysis of a significantly larger amount of data from 56 trials, involving significantly more normotensive patients on sodium and blood pressure. Midgley found that sodium restriction reduced blood pressure only in hypertensives. This newer meta-analysis of clinical data which conflicts with the INTERSALT observational data significantly undermines any previous evidence of significant scientific agreement among experts on the validity of the sodium health claim.

iv. There is Significant Disagreement in Scientific and Medical Groups about the Relationship Between Sodium and Hypertension.

The absence of significant scientific agreement about the role of sodium in hypertension is further demonstrated by the increasing inability of scientific and medical associations to issue consistent statements on the subject. For example, some groups have simply stated that they are unable to agree on sodium's role in health. For example, the Dietary Guidelines Advisory Committee (DGAC), recognized the controversy over the sodium/hypertension question in the scientific literature. In fact, at the Committee's public hearing, the President of the American Dietetic Association testified on behalf of that group of 64,500 dietetic professionals against maintaining a Guideline for sodium/hypertension stating: "Research is accumulating that questions the appropriateness of sodium restriction for the healthy adult population." The National Kidney Foundation, a professional organization of nephrologists and hypertension researchers and the largest voluntary health organization in the U.S., specifically advised the Committee that it opposed restrictions on sodium intakes: "We urge the Committee to recognize that science documents no benefits from universal sodium restriction for the general population" and urged elimination of the sodium Dietary Guideline. The American Heart Association testified at the same hearing that a sodium consumption level 25% greater than the government's recommended limit would be preferable. Several members of the DGAC believed that "evidence that sodium plays a big part in hypertension was not that strong" and that it is "'difficult to be convinced that for a normotensive population,' sodium is that important."

A 1989 NHLBI Salt and Blood Pressure Workshop notably lacked expert consensus, as attested to in the 1990 Report of the Dietary Guidelines Advisory Committee. Another NHLBI workshop, in August 1994, focused on devising strategies to implement sodium restriction, yet experts challenged the assertions of the keynote speaker that there is significant scientific expert agreement that sodium restriction confers public health benefits. In December 1994, the International Life Sciences Institute (ILSI) sponsored a comprehensive review of the salt/hypertension relationship; the experts were clearly unable to reach significant agreement.

The U.S. Departments of Agriculture and Health and Human Services have recently been able to agree about one aspect of hypertension -- that many different factors contribute to its development. The most recent Dietary Guidelines place an increased emphasis on the non-sodium factors involved in hypertension. The guidelines contain a new section entitled "Other Factors Affect Blood Pressure" and add lack of exercise and low potassium intakes to the list of other factors, like alcohol consumption and obesity, that may affect blood pressure.

v. Experts' Evaluation

As further evidence of the absence of significant scientific agreement about the relationship between sodium and hypertension, the Salt Institute has sought and attached an Experts' Evaluation of the data on the sodium-hypertension relationship and the sodium health claims on food labeling signed by sixteen eminent national and international hypertension and nutrition experts. This statement reflects the view of each expert that: (1) the sodium health claim is not supported by current science, and (2) that there is not significant expert scientific agreement in support of the sodium health claim. In view of such a large group of peer-recognized experts stating that the sodium health claim is not well-substantiated, it simply cannot be said that there is currently significant agreement in favor of the claim.

For all of these reasons, it is apparent that the sodium health claim no longer meets the NLEA's legal standard. FDA must therefore revoke the sodium health claim.

3. A Food Labeled with a Health Claim Not Supported by Significant Scientific Agreement is Misbranded Within the Meaning of Section 403(a) of The Federal Food, Drug, and Cosmetic Act.

When there is no longer significant scientific agreement to support a health claim, use of the health claim on food labeling becomes misleading. As a result, the food is rendered misbranded under Section 403(a) of the FFDCA. FDA is consequently authorized to proceed against the food, even though the regulation permitting the health claim has not been revoked. To avoid creation of such an anomalous regulatory status, FDA must promptly withdraw approval for the sodium health claim.

The FFDCA provides that a food is misbranded if among other things "its labeling is false or misleading in any particular." Thus, use of a health claim that no longer has appropriate scientific support renders the labeled food misbranded.

The sodium health claim is misleading in that it fails to meet three criteria established for health claims under the NLEA: (1) that the claim is supported by significant scientific agreement, (2) that the claim has relevance to the general population or an identified subgroup, and (3) that the claim has relevance in the context of the total daily diet. A health claim that is not supported by significant scientific agreement is misleading because consumers rely on FDA to authorize only those health claims currently supported by significant scientific agreement among qualified experts. The consumer who reads and relies on a health claim is justified in assuming that the health claim has met this high standard of substantiation.

Consumers are knowledgeable about and reliant on nutrition labeling information -- particularly information about sodium. Additionally, purchasers of products making health claims are often particularly motivated to buy a food that they believe has beneficial health effects. Such purchasers are especially susceptible to improperly substantiated statements that appear to have a scientific basis, particularly if they appear to be government-approved.

The approved model health claim for sodium also is misleading because it improperly suggests that it is applicable to the general population or an identified subgroup in the context of the total daily diet. The NLEA requires that health claims be stated in a way that "enables the public to comprehend the information provided in the claim and to understand the significance of such information in the context of a total daily diet." FDA has stated that,

for this requirement to be satisfied, the general U.S. population or some identified subgroup must be at risk with respect to the particular diet-related disease or condition, or, if that is not the case . . . any claim approved by FDA [must] otherwise explain[] the prevalence of the disease or health-related condition in the U.S. population and the relevance of the claim in the context of the total daily diet.

From this statement of FDA intent with respect to health claims, consumers can reasonably expect: (1) that a health claim applies to them as a member of the general U.S. population or that it identifies the subgroup to which it applies, and (2) that the health claim, without more elaboration, provides sufficient information on which to make consumption and diet decisions.

In fact, there is no sodium health claim which can meet either of these criteria. First, there is currently no significant scientific agreement that normal intakes of sodium have relevance to the health of the general population. Second, it is virtually impossible to draft a claim which can adequately explain the effect of sodium on the health of the affected subpopulations -- salt-sensitive hypertensives. Furthermore, there is new evidence, currently not included in the sodium health claim, that a reduction of sodium intake can have significant adverse health effects in the form of increased myocardial infarctions for some consumers or increased toxicity of commonly used drugs including those sold without a doctor’s prescription.

Concern with "excess" sodium consumption in the American diet is appropriate only for salt-sensitive hypertensives who comprise a small portion of the public. For these people, especially in light of the new findings on adverse health effects from low sodium diets, dietary sodium can be understood and controlled only with the assistance of a physician or other health care practitioner (e.g., dietitian). A sodium health claim cannot provide them with safe, useful advice.

The sodium health claim fails to meet several justified and reasonable consumer expectations and consequently misleads consumers. Foods labeled with the health claim are therefore misbranded. To prevent confusion to food manufacturers, approval for the sodium health claim should therefore be revoked.

C. The Commissioner Should Revoke both the Disqualifying Nutrient Level and the Disclosure Level for Sodium.

The disqualifying nutrient level and the nutrient disclosure level are intended to promote a balanced presentation of a food's health benefits and risks on the food's labeling. The disqualifying nutrient level prohibits labeling a food with a health claim regarding one nutrient when a second nutrient is present in the food at a level that can increase some other health risk. The nutrient disclosure level requires that when a nutrient content claim appears on a label, so does a reference to any other nutrients that are in the food at a level that may increase the risk of illnesses related to those nutrients. In both cases, the risk of illness which may be increased must be one that is of potential concern to the general population.

As discussed above, the current scientific evidence does not support the proposition that the general population will suffer an increased risk of illness from increased sodium consumption. The disqualifying levels and disclosure levels for sodium therefore exceed the authority granted to FDA in the NLEA and consequently must be revoked.

Further, in view of the current status of the science on sodium and health, the prohibition on labeling with otherwise approved non-sodium health claims or content claims constitutes an unlawful restraint on commercial speech in violation of the First Amendment of the U.S. Constitution.

1. The Standard for Creating Both a Disqualifying Nutrient Level and a Nutrient Disclosure Level is Increased Risk of Nutrient-Related Illness in the General Population.

The circumstances under which FDA is permitted by the NLEA to set either a disqualifying nutrient level or a nutrient disclosure level are the same. A food labeled with a nutrient content claim must disclose the presence of any other nutrient contained in the food,

at a level which increases to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of the food in the total daily diet . . .

Virtually identically, the NLEA requires that a food may not be labeled with a health claim if the food contains any nutrient,

in an amount which increases to persons in the general population the risk of a disease or health-related condition which is diet related, taking into account the significance of the food in the total daily diet . . . .

One essential element of both standards is that any nutrient-related disease or condition on which a disqualifying level or disclosure level is based must be of concern to the general population. A disease or health-related condition such as salt-sensitive hypertension that is pertinent only to a small unidentified subgroup of the general population does not provide the necessary statutory basis to prohibit labeling of food with a health claim or to require disclosure of nutrient content. Establishing a disqualifying level or disclosure level only on the basis of such a limited effect conflicts with the mandate of sections 343(r)(2)(B)(ii) and 343(r)(3)(A)(ii) of the FFDCA. In addition, promulgation of such regulations violates the Administrative Procedure Act, which holds unlawful agency actions which are in excess of statutory authority. Therefore, these two regulations must be revoked.

2. Sodium Consumption Within Normal Intake Ranges Does Not Increase the Risk of Any Disease or Health-Related Condition That Affects Members of the General Population.

As is described in detail above, based on the currently available data, consumption of sodium in amounts greater than the current disclosure and disqualifying levels should be a concern only to salt-sensitive hypertensives. Current scientific literature does not support the conclusion that normotensives and salt-resistant hypertensives are at any demonstrable increased risk of disease or health-related condition from "high" sodium consumption. Because salt-sensitive hypertensives comprise only a small part of the general population (less than ten per cent), sodium consumption is not linked to an increased risk of any disease or health-related condition in the general population. Consequently, disclosure and disqualifying levels for sodium are unsupported and unwarranted and regulations effecting such levels must be revoked.

3. The Disqualifying and Disclosure Levels for Sodium Violate the First Amendment of the U.S. Constitution by Restricting Truthful, Accurate and Non-Misleading Health Claims.

Non-misleading health claims and nutrient content claims on food labeling constitute commercial speech that FDA can regulate only after demonstrating that: 1) the government has a substantial interest, 2) that is advanced in a direct and material way by the proposed regulation, 3) which regulation is not more extensive than necessary to serve the interest. Although the last element does not require a "least restrictive alternative" analysis, there must be a "fit between the legislature's ends and the means chosen to accomplish those ends;" the means must be "narrowly tailored to achieve the desired objective."

In the absence of significant scientific support for the usefulness of current disqualifying and disclosure levels for sodium, prohibiting or limiting health claims for nutrients other than sodium ("non-sodium health claims") and content claims for nutrients other than sodium ("non-sodium content claims") constitutes a restraint on truthful, non-misleading commercial speech that does not directly and materially advance a government interest and is not narrowly tailored to accomplish a government interest. Continued application of the levels by the Agency in its regulations is therefore unconstitutional.

a. Regulation of Commercial Speech.

Identification of speech as commercial speech rests on a consideration of three characteristics of the speech: (1) whether it is advertising, (2) whether it refers to a specific product, and (3) whether it is motivated by economic interest. A health claim or nutrient content claim that appears on a food label is characterized by all three of these elements. Both are intended to advertise the food, both refer to the specific food to which they are attached, and use of both is motivated by the economic interest of the food producer. Recent case law is entirely consistent with the conclusion that food labeling and the contents of food labeling such as health claims and nutrient content claims constitute commercial speech.

Central Hudson Gas establishes the framework under which restrictions of commercial speech are analyzed, as confirmed recently by the Supreme Court in the Rubin v. Coors Brewing Co. decision. The opinions in the recent case, 44 Liquormart, Inc. v. Rhode Island, indicate that in assessing the constitutionality of complete bans on speech, Central Hudson Gas continues to establish the minimum standard that the government must meet. The government can restrict commercial speech that is misleading or that promotes or furthers an unlawful activity, but:

[if] the communication is neither misleading, nor related to an unlawful activity, the government's power is more circumscribed. . . . First, the restriction must directly advance the state interest involved . . . . Second, if the governmental interests could be served as well by a more limited restriction on commercial speech, the excessive restrictions cannot survive.

In a more recent case, the Court clarified that the restriction must both materially and directly advance the relevant state interest. The burden of demonstrating the constitutionality of a proposed restriction on commercial speech lies with the government.

b. Non-Sodium Health Claims and Non-Sodium Nutrient Content Claims are Neither Misleading Nor Related to an Unlawful Activity As a Result of High Sodium Content in The Labeled Food.

Labeling can mislead either through actual statements or by the omission of material information. FDA's intent in establishing disqualifying and disclosure levels for sodium is to ensure that consumers are not misled by non-sodium health claims and content claims on products with a high sodium content. However, information about sodium content is not material to non-sodium health and content claims. As discussed in detail above, neither the disqualifying level nor the disclosure level for sodium is supported by the relevant scientific literature or by qualified hypertension experts; reduced sodium consumption has not been shown to be of benefit to the general population. Furthermore, even if sodium content information were material, such information is already disclosed in the nutrition facts panel required to be on almost all foods.

Information on potential adverse health effects from high sodium consumption is not material to the general population in assessing non-sodium health claims or non-sodium nutrient content claims. Those to whom such information is material -- salt sensitive hypertensives who are following medically-supervised low-sodium diets -- are likely to inspect all foods for sodium content regardless of health claims and nutrient content claims. Such consumers thus will avail themselves of the nutrient content information on the food package which will provide clear and ample disclosure of sodium content.

Promoting the consumption of "high" sodium foods is not unlawful. Consequently, because high sodium content in a food renders non-sodium health and content claims neither misleading nor unlawful, FDA may not regulate such claims constitutionally unless it can to show that the regulation is narrowly tailored to advance directly and materially a government interest.

c. Regulation of Non-Sodium Health Claims Based on the Current Disqualifying Nutrient Level for Sodium Does Not Advance The Government's Interests in a Direct and Material Way.

FDA's motivation for regulating health claims and content claims ultimately is the government's interest in maintaining and promoting good health in the general population. However, the disqualifying and disclosure levels for sodium neither directly nor materially advance this interest and, in fact, likely impede it.

Sodium disqualifying and disclosure levels advance the government's interest in maintenance and promotion of good public health, only if: (1) sodium consumption would differ in the absence of such levels, and (2) this difference in sodium consumption can be expected to affect the public health adversely. FDA cannot show that either of these conditions is met for sodium.

As discussed above, there is not significant scientific support for the proposition that increased sodium consumption has a negative effect on the health of members of the general population. Although there is some evidence that for a small portion of the population -- salt-sensitive hypertensives -- high sodium consumption can be unhealthy, there is also evidence that, for others, low sodium consumption can be dangerous. Based on the current state of scientific knowledge, FDA cannot claim that its goal of universal sodium restriction will result in any measurable general public health benefit if successful.

Similarly, FDA is unable to demonstrate that the absence of sodium disqualifying and disclosure levels would change sodium consumption patterns. In fact, Federal Trade Commission (FTC) studies establish the contrary conclusion, that health claims and content claims unqualified by disclosure and disqualifying levels do not encourage the consumption of foods that contain otherwise "unhealthy" levels of some nutrients. The disqualifying and disclosure levels for sodium may have no effect on U.S. sodium consumption patterns of any segment of the population. In large part, this may be because sodium sensitive hypertensives would use the nutrition facts panel to avoid sodium containing foods regardless of the presence or absence of sodium disqualifying or disclosure levels.

FDA cannot show either: (1) that disclosure and disqualifying levels for sodium affect sodium consumption in the U.S., or (2) that decreased sodium consumption would result in improved public health. FDA is therefore unable to show that use of the disclosure and disqualifying levels for sodium advances at all a significant government interest. For this reason, the disclosure and disqualifying levels for sodium are restrictions on commercial speech that violate the First Amendment of the U.S. Constitution.

d. The Restrictions on Commercial Speech Imposed by the Disqualifying and Disclosure Levels for Sodium are More Extensive than Necessary to Serve A Governmental Interest.

Although not decisive, the existence of less burdensome regulatory alternatives to a broad restriction on commercial speech is substantial evidence that the restriction is more extensive than necessary to serve the Government's interest. This principle is reflected in the Supreme Court's invalidation of prior, general prohibitions of potentially misleading speech which could effectively be examined case-by-case, for example, in enforcement actions against individual food products. The Court is especially skeptical of government efforts to "protect" consumers or to affect purchasing decisions by keeping consumers ignorant of accurate information through advertising bans.

There are obvious, less burdensome regulatory alternatives available to FDA for regulating health and nutrient content claims on foods than through use of disqualifying and disclosure levels. The methods used by the Federal Trade Commission and state attorneys general to enforce statutes prohibiting false or deceptive advertising do not include pre-approval of individual commercial label statements. Instead, these laws are enforced by post-market surveillance of advertising and labeling materials. The FTC has, for example, not indicated any concern regarding its ability to undertake effective enforcement of food advertising through such post-market surveillance.

Similarly FDA's enforcement of the FFDCA's prohibition of false or misleading labeling relies generally on post-market review to prevent misleading statements. These alternatives demonstrate that the complete bans embodied by the disclosure and disqualifying levels are unnecessary.

FDA has not demonstrated that the disqualifying and disclosure levels for sodium are not more extensive regulation on non-sodium health claims and content claims than is necessary to further the Government's public health goals. As a result, the disqualifying and disclosure levels for sodium violate the First Amendment to the U.S. Constitution and should consequently be revoked.

D. Conclusion

Since FDA first approved the sodium health claim, there has been a continual decrease in scientific support for the claim. New studies have further called into question the usefulness of universal sodium restriction and have undermined the findings on which FDA relied for approving the sodium claim. Additionally, at least one study suggests that in the population for which sodium restriction is most strongly recommended -- hypertensives -- there may be serious adverse consequences associated with significantly reducing sodium consumption. All of these data demonstrate that there is not significant scientific agreement that the sodium health claim is warranted. Because the claim no longer meets the statutory standard of the NLEA, and because it no longer serves the health interests of the American public, the sodium health claim must be revoked.

Just as recent science has undermined support for the sodium health claim, it justifies rejecting the current disqualifying and disclosure levels for sodium. Those levels are not related to diseases or health-related conditions that affect the general population. Additionally, the levels prohibit truthful, accurate, non-misleading health claims on foods in violation of the First Amendment. Consequently, the sodium disqualifying and disclosure levels must also be revoked. All of these changes will contribute to the improved health and nutrition of the American public.

III. Environmental Impact

The actions requested in this petition are not within any of the categories for which an environmental assessment is required pursuant to 21 C.F.R. § 25.22. Additionally, the actions requested in this petition are exempt from the requirement of an environmental assessment pursuant to 21 C.F.R. § 25.24(a)(11).

IV. Economic Impact

None requested.

V. Certification

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

Respectfully submitted,

Richard L. Hanneman

President

AND SODIUM HEALTH CLAIMS ON FOOD LABELING

The undersigned scientists, who are familiar with the evolving understanding of the relationship between sodium and hypertension and having considered the current FDA-authorized sodium health claim, subscribe to the following statement to be conveyed to the FDA.

I. Introduction

The critical role of salt in human survival has been known since antiquity. The involvement of sodium in the maintenance of blood pressure has been recognized for nearly a century. More recently, the impact on blood pressure of varied sodium diets has been investigated. Specifically, it has been hypothesized that sodium intake is positively related to blood pressure, which in turn is positively related to the incidence of fatal and non-fatal cardiovascular disease. The relevant hypothesis is that reduced sodium increases health. Built on the belief that a low sodium diet will reduce blood pressure, it has been hypothesized that a lower sodium diet will translate into a human health benefit. We do not believe that there continues to be significant scientific agreement among qualified experts supporting this conclusion.

Evidence to support this line of reasoning was derived from several sources. There are cross sectional data within and between populations which, while not uniform, have been interpreted to support the notion that a large difference in sodium intake is associated with significant differences in blood pressure. There is also experimental evidence, in animals and humans, demonstrating a direct influence of changes in sodium intake on blood pressure. There is little direct evidence relating sodium intakes to health outcomes.

II. The 1993 Health Claim

We are aware that the Food and Drug Administration ("FDA") permits the labeling for some food products to state that diets low in sodium may reduce the risk of high blood pressure. The FDA authorized this statement in 1993 based on its conclusion from scientific evidence at that time. FDA interpreted this evidence as demonstrating that 1) populations with lower sodium intakes have lower prevalence of hypertension, 2) populations can lower average blood pressure by reducing dietary sodium which can aid in both treating and preventing hypertension, 3) populations with higher sodium intakes experience a rise in blood pressure with age , a phenomenon which does not occur in lower sodium-ingesting populations, and 4) populations with lower sodium intakes have lower risks of cardiovascular incidents. Among the studies cited by FDA, three illustrate these findings: INTERSALT, the meta-analysis of Cutler et al and the Trials of Hypertension Prevention..

1. INTERSALT was a large cross-sectional survey of individuals in 52 diverse communities. While unable to identify an association between dietary sodium intake, as reflected by urinary sodium excretion, and either mean blood pressure or the prevalence of hypertension, the published INTERSALT results posited that sodium excretion was predictive of the rise in blood pressure with increasing age.
2. The meta-analysis performed by Cutler et al provided an overview of 28 randomized controlled trials of dietary sodium manipulation, including only six enrolling only normotensive individuals. The analysts concluded that sodium reduction lowers systolic and diastolic blood pressure in both hypertensive and normotensive subjects.
3. The Trials of Hypertension Prevention was a reasonably large study of middle-aged men and women with high normal blood pressure. The investigators reported that reduction of dietary sodium during the first six months of intervention had a small but significant blood pressure lowering effect and showed a tendency towards preventing the onset of hypertension.

We believe that new scientific evidence has now called into question the relationship between dietary sodium, blood pressure and cardiovascular outcomes (and overall health status in the general population) and that significant gaps in understanding of the complex relationship still exist. This new evidence similarly undermines earlier recommendations for universal reduced-sodium diets and the appropriateness of the sodium and hypertension health claim on food labels.

III. New Scientific Evidence

Since the closure of the record for FDA's current rule, a number of important new studies and analyses have been published which raise serious questions about the health benefits and safety of dietary sodium restriction and the appropriateness of advising the general population to restrict sodium intake. Among these studies are the following:

• A review of 56 randomized controlled clinical trials concluded that, although dietary sodium restriction for older hypertensive individuals was justified, based on the finding that a 100 mmol reduction in sodium intake is associated with a 6.3 mmHg reduction in systolic and 2.2 mmHg reduction in diastolic blood pressures, evidence of benefit was much less in trials of younger hypertensive subjects (reductions of 2.4 mmHg systolic and -0.1 mmHg diastolic respectively). There was little or no blood pressure benefit in trials of normotensive persons (reductions of 1.0 mmHg systolic and 0.1 mmHg diastolic). Significantly, this meta-analysis evaluated twice as many trials (principally new publications in normal subjects) as that earlier analysis by Cutler et al and employed more stringent statistical procedures in the primary analysis. While the two studies share much more than they differ, their different conclusions derive from the larger data base and more powerful analytical methodology. This more recent study also identified evidence of publication bias in favor of trials with a positive outcome, i.e., those in which sodium reduction reduced blood pressure. Furthermore, the expanded data base permitted an important observation that the degree of sodium reduction did not predict blood pressure response, thus raising the possibility that some as-yet unidentified variable, not dietary sodium, which may be responsible for the blood pressure variations.
• A recent cohort study has challenged the widely-held view that a low-sodium diet poses little adverse health risk. In this report of nearly 3,000 free-living persons with mild and moderate hypertension drawn from the general community and receiving treatment for their condition, those consuming the lowest sodium diet had a four-fold greater likelihood of a myocardial infarction than did those with the highest sodium intakes. Thus, the safety of restricting dietary sodium is now questionable.
• The long-term results of the Trials of Hypertension Prevention have documented that no significant blood pressure benefit derives from sodium restriction even for those individuals with above-average blood pressures who have had extensive nutrition counseling and were able to maintain the intervention over three or four years. The results confirm the difficulty of maintaining compliance even among these motivated volunteers, but the results indicate that even compliant subjects experience diminishing effectiveness of lowered sodium intakes to the point that virtually no blood pressure benefit remains three years after the low-sodium diet begins.

4. Continuing Significant Scientific Disagreement Over Existing Science

One of the studies on which FDA relied to justify the sodium health claim was the INTERSALT study. Although the INTERSALT authors have published enormous volumes of data, controversy continues with regard to both its interpretation and utility. Recently published analyses in the British Medical Journal identify errors in statistical technique and challenge conclusions as presented by the Intersalt Consortium. One of these analyses was based on newly-obtained INTERSALT data, not previously made available to FDA or the scientific community. These data bear directly on the INTERSALT authors’ asserted blood pressure "rise with age." Te analysis presented by the Salt Institute demonstrated that the adjustment of initial blood pressure explained more than nine times the variance in rising blood pressure with age accounted for by sodium excretion. This analysis showed no significant relationship between urinary sodium excretion and the rate of blood pressure increase with age. The second analysis criticizes the INTERSALT "corrections" of the data as leading to an "inflation in epidemiology," and warns: "Confusion may be increased by the presentation of a set of ‘updated’ corrected estimates, to replace the already corrected estimates given in the initial Intersalt report." The INTERSALT authors have defended their conclusions and the authors have produced new reanalyses, attempting to meet the objections of their critics. Without question, there is a lack of significant agreement in the scientific literature concerning the analyses and interpretation of the INTERSALT data as put forward by the investigators, the basic statistical approach used throughout the INTERSALT analyses and the public policy implications of the findings. The INTERSALT authors themselves have produced three distinct analyses of their data in an attempt to defuse this controversy.

Equally importantly, there is significant scientific controversy over the use of a cross-sectional observational study, such as INTERSALT as the basis for a public health policy promoting universal sodium restriction and, specifically, for a determination that a sodium health claim on food labeling is necessary. The absence of confirmatory evidence of the efficacy of universal sodium restriction from intervention studies as reported by Midgley and the significant adverse health effects found in the only study linking sodium intake levels to overall health outcomes (Alderman) undermines the wisdom of this policy.

Indeed, the usefulness of a cross-sectional observational study for determination of health policy is particularly doubtful when a higher level of evidence (controlled clinical trials as compared to a cross-sectional observational study), such as the Midgley study, directly contradict the observational study. We disagree with those who argue that a "weight of evidence" or "preponderance of evidence" approach is appropriate and, instead, agree with the many health policy-makers who support a graded-evidence or "progression of evidence" approach recognizing that certain types of studies should be given greater weight in policy-making. In this, we support the approach advocated by the U.S. Preventive Services Task Force and its Canadian counterpart.

In short, because of new studies and analyses that have appeared since the 1993 health claim was approved, there is no significant scientific agreement about the value of sodium restriction for lowering blood pressure and preventing cardiovascular events.

V. No Significant Scientific Agreement

As evidenced by the attached curricula vitae, the undersigned are all qualified experts in the field of hypertension research or nutrition research and have personally contributed to the scientific literature relating to the sodium-hypertension relationship or the literature relating diet to cardiovascular disease. In view of our assessment of the current status of the scientific evidence, it is now clear that there is no significant scientific agreement among qualified experts that the general population should be advised to restrict dietary sodium intake through a health claim on food labeling.

The experts signing this statement are health-care professionals who are qualified to assess whether universal sodium dietary restriction is appropriate advice for the general population. We agree that the evidence available is no longer sufficient to justify a recommendation on dietary sodium intake for the general population. Specifically, we concur that there is no significant scientific agreement among qualified experts that universal sodium dietary restriction and the sodium and hypertension health claim on food labels are appropriate advice for the general public. Therefore, the sodium health claim should not be permitted.

We believe the consensus views of these experts reflect a body of expert opinion that, in and of itself, demonstrates that there is no significant scientific agreement among the general community of qualified experts in support of universal sodium dietary restriction.

//signed//

Michael H. Alderman, Albert Einstein College of Med./Montefiore Med. Center, New York City

Sharon Anderson, Oregon Health Sciences University, Portland

William M. Bennett, Oregon Health Sciences University, Portland

Tilman B. Druëke, Hôpital Necker, Paris, France

R. Brian Haynes, McMaster University Medical Centre, Canada

Priscilla S. Kincaid-Smith, University of Melbourne/Epworth Hospital, Australia

Theodore W. Kurtz, University of California-San Francisco Medical Center

John H. Laragh, New York Hospital-Cornell Medical Center, New York City

Stuart L. Linas, University of Colorado/Denver General Hospital

Alexander G. Logan, University of Toronto, Canada

Friedrich C. Luft, Humboldt University of Berlin/Klinikum Buch (General Hospital), Germany

Giuseppe Mancia, University of Milan School of Medicine

David A. McCarron, Oregon Health Sciences University, Portland

Suzanne Oparil, University of Alabama-Birmingham School of Medicine

Jan A.H. Staessen, University of Leuven, Belgium