such as the Committee on Nutrition of the American Academy of Pediatrics (AAP), the American Heart Association (AHA), American Cancer Society (ACS), or task forces or other groups assembled by the National Institutes of Health (NIH);
review publications that critically summarize data and information in the secondary scientific literature.
FDA accords the greatest weight to the conclusions of federal government scientific bodies, especially when the evidence for the validity of a substance/disease relationship has been judged by such a body to be sufficient to justify dietary recommendations to the public. When the validity of a substance/disease relationship is supported by the conclusions of federal government scientific bodies, FDA typically finds that significant scientific agreement exists. Conclusions of other expert bodies may also be relevant to support a determination of SSA. Although reviews by individual outside experts are considered in assessing SSA, evidence from such reviews alone would not necessarily support a conclusion that the standard has been met, especially if the conclusions of such reviews were not supported by available assessments of the same body of evidence from federal scientific bodies, expert panels, or independent expert bodies. Reviews by outside experts or expert panels are most useful when there is a reasonable basis to conclude that they represent the larger group of qualified experts in the field. Most importantly, the relevance of an outside expert review depends on whether the evidence examined applies to the claim in terms of considerations such as specification and measurement of the substance and the disease.
When conclusions from qualified experts are not available (for instance, if the data supporting a proposed health claim are relatively new and have not yet been reviewed by an independent expert panel or body), a compelling and relevant body of evidence may nonetheless cause the agency to conclude that significant scientific agreement exists. Because each situation may differ with the nature of the claimed substance/disease relationship, it is necessary to consider both the extent of agreement and the nature of the disagreement on a case‐by‐case basis. If scientific agreement were to be assessed under arbitrary quantitative or rigidly defined criteria, the resulting inflexibility could cause some valid claims to be disallowed where the disagreement, while present, is not persuasive.
Application of the significant scientific agreement standard is intended to be objective, in relying upon a body of sound and relevant scientific data; flexible, in recognizing the variability in the amount and type of data needed to support the validity of different substance/disease relationships; and responsive, in recognizing the need to re‐evaluate data over time as research questions and experimental approaches are refined….
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NOTES
1 5.9. Significant scientific agreement. In response to the court of appeals holding in Pearson, FDA announced the issuance of GUIDANCE FOR INDUSTRY: SIGNIFICANT SCIENTIFIC AGREEMENT IN THE REVIEW OF HEALTH CLAIMS FOR CONVENTIONAL FOODS AND DIETARY SUPPLEMENTS on Dec. 22, 1999 (64 Fed. Reg. 17494).
2 5.10 Evidence‐based scientific review. While the basic principles of significant scientific agreement have not changed, the above 1999 document was superseded by FDA, GUIDANCE FOR INDUSTRY: EVIDENCE-BASED REVIEW SYSTEM FOR THE SCIENTIFIC EVALUATION OF HEALTH CLAIMS (Jan. 2009) www.fda.gov.
Not everyone agrees with the decision of the U.S. Court of Appeals in Pearson v. Shalala.43 It has been argued that disclaimers thwart the purpose of Congress when it enacted the NLEA to ensure that consumers would no longer be subjected to unreliable and unverifiable health claims for dietary supplements—that disclaimers will relegate consumers to a marketplace rife with unproven and unreliable health claims. It has also been argued that the reasoning of Pearson misconceives basic First Amendment commercial speech principles because the Supreme Court has never directed a government agency to permit potentially misleading speech so long as it is accompanied by a disclaimer.44
5.6.8 Guidance for Qualified Health Claims
In the Federal Register of October 6, 2000,45 the FDA issued guidance on qualified health claims in the labeling of conventional foods and dietary supplements. FDA also republished this information as a guidance document for industry and expanded to include conventional foods along with dietary supplements.46 The document sets forth criteria for when the agency allows a qualified health claim in labeling. In addition, FDA states that the agency will use the “reasonable consumer” standard in evaluating food labeling claims. Use of this standard makes the FDA’s regulation of food labeling consistent with the FTC’s regulation of advertising for these products.
FDA noted that consumers are more likely to respond to health messages in food labeling if the messages are specific with respect to the health benefits associated with particular substances in the food. According to the Bureau of Economics Staff of the Federal Trade Commission (FTC),47 “consumers are not as responsive to simple nutrient claims” as they are to health claims. FDA stated that in the aggregate, decisions by individual consumers to incorporate beneficial foods into their diets improve public health, “By making clear the lawfulness of conventional foods labeled with truthful and non‐misleading health claims, FDA believes that this guidance will precipitate greater communication in food labeling of the health benefits of consuming particular foods, thereby enhancing the public’s health.”48
In its “Better Nutrition Information for Consumer Health Initiative,” FDA has “acknowledged that consumers will benefit from more information on food labels concerning diet and health and this, in turn, has prompted the agency to establish interim procedures whereby ‘qualified’ health claims can be made not only for dietary supplements but for conventional foods as well… . FDA began considering qualified health claims under its interim procedures September 1, 2003.”49
To sum up key provisions for use of qualified health claims:
All health claims must undergo review by FDA.
All unqualified health claims must meet the Significant Scientific Agreement standard.
Qualified health claims must be accompanied by a disclaimer or otherwise “qualified” in a way as to not mislead consumers.
Proposed new qualified claims must be submitted by petition to the FDA. (The procedures for submitting a proposed qualified health claim petition are available on the FDA website.)
FDA review of qualified health claim petitions results in an FDA letter concerning the use of enforcement discretion for a qualified health claim or denying the qualified health.
All letters of enforcement discretion are posted on the FDA website, and once posted, all manufacturers receive the same enforcement discretion on the use of the qualified health claim.
Qualified claims must follow any limits and conditions specified in the FDA letter of enforcement discretion.
Did FDA Go Too Far After Pearson? 50
