Catherine M. DeRoever
Center for Food Safety and Applied Nutrition (HFS-22)
Food and Drug Administration
200 C St. S.W.
Washington, D.C. 20204

Re: Food Advisory Committee Working Group Report on "Significant Scientific Agreement in Review of Health Claims"

Dear Ms. DeRoever:

The Salt Institute submits these comments in response to the Food and Drug Administration’s ("FDA") implementation of section 303 of the Food and Drug Administration Modernization Act of 1997 ("FDAMA") regarding establishment of a "significant scientific agreement" standard. These comments specifically address the final working group draft report "Interpretation of Significant Scientific Agreement in the Review of Health Claims" ("Working Group Report") considered by the Food Advisory Committee ("FAC") at the committee meeting held on June 24-25, 1999. Although the Salt Institute agrees with the basic principles regarding scientific evidence discussed in the Working Group Report, we believe that the FAC must address three considerations:

1. First, the reevaluation or revocation of previously approved health claims,
2. the need to assess the timeliness of scientific data and expert opinions for approval or continued approval of a health claim, and
3. the importance of considering the biases of certain investigators and institution’s research which support a health claim.

The Salt Institute believes that the principles in the Working Group Report, if modified consistent with these recommendations, will result in well-substantiated health claims that are consistent with Congressional intent in enacting the Nutrition Labeling and Education Act of 1990 ("NLEA") and FDAMA.

I. Background

Congress intended NLEA to give consumers more scientifically valid information about food. NLEA authorizes FDA to permit statements describing the relationship between food substances and disease or health-related conditions (i.e., health claims) to be placed on food labels. NLEA requires FDA to use a "significant scientific agreement" standard to evaluate health claims and to ensure their validity. In 1996, the Keystone National Policy Dialogue on Food, Nutrition, and Health ("Keystone") released a final report to FDA regarding the health claim authorization process and its interpretation of the "significant scientific agreement" standard. Following the release of this report, FDA sought advice from the FAC regarding the implementation of several of Keystone’s recommendations. Specifically, Keystone recommended, inter alia, that FDA use the "significant scientific agreement" standard in an objective, flexible, and responsive manner and that FDA should base its decisions to authorize health claims on the totality of the evidence relating to the proposed relationship.

FDA established the Significant Scientific Agreement Working Group ("Working Group") to develop principles to review health claims. In addition, although the Working Group was not requested to specifically address the opinion of the Circuit Court of Appeals for the District of Columbia in Pearson v. Shalala, this decision required FDA to "explain what it means by significant scientific agreement or, at a minimum what it does not mean" with respect to the use of health claims on dietary supplements. Finally, FDA must use the Working Group Report to implement FDAMA, which requires FDA to allow more scientifically sound nutrition information to be released to consumers in a more timely manner.

II. FDA Should Supplement the Principles from the Working Group Report Regarding the Significant Scientific Agreement Standard

Although the Working Group Report has identified many of the basic principles necessary to meet the "significant scientific agreement" standard, the Salt Institute recommends that the FAC, or the Center for Food Safety and Applied Nutrition ("CFSAN"), also specifically address the need to periodically review, or timely revoke, previously-approved health claims, the need to consider the timeliness (i.e., currency) of scientific data and expert opinions supporting the approval, or continued approval, of a health claim, and the importance of considering the biases of investigators or institutions associated with the science supporting a health claim.

Through NLEA and subsequently in FDAMA, Congress intended to expand and improve consumer access to important new dietary information and "scientifically sound" nutritional information, in part, by streamlining the approval process for health claims. As stated in the Working Group Report, FDA can continue to authorize health claims only after significant scientific agreement exists among qualified experts. It naturally follows that FDA can authorize the use of such claims only as long as significant scientific agreement continues to exist.

The Salt Institute generally agrees with the Working Group’s conclusions about the quality and quantity of evidence needed to show "significant scientific agreement." The Salt Institute, however, also believes that this evidentiary showing must reflect emerging science and its relationship to previously-approved claims. Moreover, FDA must consider the timeliness and bias of the science supporting a claim. Only those health claims that meet, or continue to meet, this strict standard should be allowed on food labels.

A. The Principles of the Standard Must Apply to the Review of Previously-Approved Health Claims

The Salt Institute agrees with the Working Group’s conclusion that in order to evaluate the evidence properly, FDA must determine whether significant scientific agreement exists based on an objective and disinterested analysis of scientific information from a variety of sources, including: multiple well-designed studies with consistent and strong results; publications, such as authoritative review articles, textbooks, and compendia, which critically summarize data and information in the secondary scientific literature; expert panels’ views; and the opinion or recommendations of an authoritative body such as the National Academy of Sciences, the American Society of Hypertension, the American Heart Association, NIH task forces, and others. However, the existence of significant scientific agreement necessarily may change as the strength and consistency of the evidence changes and, thus, FDA should objectively evaluate new claims and reevaluate previously-approved claims using these key elements. There is no reason to exclude previously-approved claims from this review process. Moreover, failure to reevaluate claims in the face of new science is an abdication of FDA’s responsibility under NLEA and FDAMA.

B. FDA Must Consider the Timeliness of Evidence Supporting Health Claims

In enacting FDAMA, Congress implied that information should be removed from the market when it becomes scientifically unsound nutritional information because health claims based on such information are no longer accurate representations of authoritative statements. Although the Working Group Report does not specifically address timeliness of the evidence and expert opinions, consistent with Congressional intent, FDA must periodically review the evidence supporting previously-approved health claims to ensure that the health claims reflect current evidence and that expert opinions and recommendations supporting claims are current. Unsubstantiated claims should be revoked or appropriately modified. A decision not to provide consumers with information about emerging science that contradicts a health claim, or not to revoke an unsubstantiated claim, runs contrary to Congress’ intent to provide timely, accurate, non-misleading and scientifically sound nutritional information to consumers.

C. FDA Must Account for Research and Other Biases in Consensus Views

In reviewing the conclusions of authoritative bodies or consensus views, FDA must be willing to scrutinize the political and social agendas of institutions and scientific groups to ensure that their conclusions, recommendations, or views are balanced and represent the spectrum of scientific thinking on the relevant topic before FDA accepts them as validation for a health claim. Those claims that are not supported by current, objective scientific data or objective expert opinions should not be approved, and previously-approved opinions should be revoked absent sufficient current, objective data and opinions.

FDA has recognized the necessity of understanding such biases in reviewing drug and medical device applications and should apply the same principles to health claims. For example, FDA requires sponsors of drug and medical device applications to submit financial disclosure forms which provide financial information about investigators or institutions that conducted clinical studies relied on in the application. FDA regulations also have required financial disclosure by certain investigators and disclosure by companies or speakers sponsoring medical symposia. Similarly, FDA policies, guidance, or regulations for the approval of health claims should address the financial, political or other influences of the experts, institutions or organizations that conducted the investigations, collected data, or rendered consensus views in support of a particular health claim because of the potential impact on the soundness of the scientific data and expert opinions. In fact, the potentially more widespread influence of a health claim arguably makes it more important for FDA to consider such biases.

D. The Working Group’s Principles, as Modified by the Salt Institute’s Recommendations, Mandate the Revocation of the Sodium Claim

The sodium health claim should be revoked because significant scientific agreement, as evidenced by recent peer-reviewed scientific articles, no longer exists to support it, continued use misleads consumers into believing that the health claim is still accepted by experts and supported by strong, consistent and quality scientific data, and that the dietary advice in the claim will actually enhance their health. Significant new evidence rejects the hypothesized sodium-hypertension relationship and, thus, by definition, "significant scientific agreement" does not support the sodium health claim. Moreover, the principal supporters of the hypertension sodium hypothesis have recognized research biases that must be considered. Accordingly, under the Working Group’s principles, as modified, the sodium health claim should be significantly modified or revoked.

IV. Summary

The Salt Institute respectfully requests that the FAC and CFSAN supplement their principles to incorporate the elements of timeliness and sponsor/institutional bias and influence and that the guidelines also discuss the applicability of the principles to the revocation of outdated health claims. Only by ensuring that there is a reliable, independent, current and scientifically valid consensus can FDA ensure that its approved health claims will reflect the Congressional intent of promoting the public health and providing current and accurate nutritional information to consumers. In addition, the Salt Institute respectfully requests that FDA revoke the sodium health claim based on emerging science and the lack of "significant scientific agreement" in support of the claim.

Thank you for your consideration.

Sincerely,

Richard L. Hanneman