Emerging Science and Health Claims

Introduction: FDA Food Advisory Committee Action

The major points of Committee comment, in addition to addressing use of the words, "possibly" and "probably" in the definition of emerging science, were about:

  - The difficulty in setting "lower limits" to the amount, type and quality of studies that would be acceptable in support of an emerging science statement on food labeling;

  - The interpretation of science for a food substance and how that relates to consumption of foods containing the substance; and

  - The limits of substance intake encompassed by the phrase "a reasonable amount over a reasonable period," taking into consideration intake by consumption of conventional foods and dietary supplements.

The ESWG report, as edited by the Committee, forms the main body of this Committee report.

Submission of this Committee report discharges the responsibilities of the FDA Food Advisory Committee with respect to its charge regarding emerging science for health claims.

Report of the FDA Food Advisory Committee
Emerging Science Working Group (ESWG) (as amended)

The final report of The Keystone National Policy Dialogue on Food, Nutrition, and Health was released in March, 1996 by The Keystone Center, Keystone, CO and Washington, DC. The report addressed issues on conveying dietary information to consumers. It focused largely on the use of health claims on the labels or in labeling of food products. The Keystone Dialogue (hereafter, Keystone) advanced 17 recommendations in its final report, directed toward the private, academic and public sectors.

FDA was the primary focus of most of the Keystone recommendations. The agency sought advice from its Food Advisory Committee (FAC) on options for implementing several of the recommendations. An FAC subgroup, the Emerging Science Working Group (ESWG), was asked to consider the following two Keystone recommendations:

The FDA charges to the FAC and the ESWG were:

ESWG Members

FAC members and participants were: Dr. Susan Harlander, Chair; Dr. Stephen E. Benedict, Dr. Bruce Chassy, Dr. Owen Fennema, and Dr. Patricia Rodier. Consultants, guest experts and liaisons were: Ms. Sue Borra, International Food Information Council (IFIC); Ms. Marsha Cohen, Hastings College of the Law, University of California; Mr. John Cordaro, President, and Dr. John Hathcock Council for Responsible Nutrition; Ms. Nancy Ernst and Dr. Peter Greenwald, National Institutes of Health; Ms Melanie Fairchild, Nestle; Dr. Ken Fisher, Executive Director, White House Commission on Dietary Supplement Labels; Ms. Anne Maher, Federal Trade Commission; Dr. Donna Porter, Library of Congress; and Mr. Mark Silbergeld, Consumers Union of the U.S. FDA participants were: Dr. Lynn Larsen, Executive Secretary, FAC; Dr. Christine Lewis, Office of Special Nutritionals; Dr. Camille Brewer, Office of Food Labeling; and Dr. Brenda Derby, Dr. Ken Falci and Dr. Alan Levy, Office of Scientific Analysis and Support.

ESWG meetings and other relevant activities

The first ESWG meeting was held February 11, 1997, to gather information and begin discussion of the issues.

Ms. Borra and Dr. Derby presented results from recent IFIC and FDA consumer surveys, respectively. Together, the surveys suggested that while printed and electronic media are significant sources of diet and health information, the general public is dissatisfied with conflicting and inconsistent reports, "headlining" without supporting context, and portrayal of new data as being well-established. The public is also concerned about the reliability of nutrient information because of a perception that diet and health experts readily change nutrition guidance. Perception of the food label as a credible source of diet and health information has risen. However, consumers note little beyond the existence and plausibility of label claims, i.e., communication of detailed risk/benefit information is limited. Consumers also appear unable to distinguish between nutrient content claims and health claims as signals of product health effects.

Dr. Brewer briefed the ESWG on the provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA), and Dr. Fisher commented on the progress of the White House Commission on Dietary Supplement Labels which was empaneled in response to a DSHEA mandate. As a lead-in to ESWG discussion of its charge, working group participants who also were members of the Keystone Dialogue provided their views of the Keystone discussions.

A wide range of issues, concerns and proposals were addressed during the course of the ESWG discussion. A distillation of the discussion is contained in the minutes of the meeting and in the conclusions of the working group provided below.

The second ESWG meeting was held September 25-26, 1997, in conjunction with the FAC meeting. The discussion outline for this meeting included: defining emerging science, the potential impact of emerging science on label credibility, handling of emerging science in areas other than diet and health, the potential research incentive derived from allowing emerging science on food labels, and options/criteria relative to the unregulated (by FDA) communications arena (printed and electronic media). A variety of mechanisms were suggested as means of providing consumers and the media with accurate information. It was noted that the FDA Home Page on the World Wide Web is playing an increasing role. The ESWG began to develop a definition for "emerging science," and to outline arguments both in support of and in opposition to including emerging science on food labels.

The third ESWG meeting was held February 12, 1998, following the FAC meeting. The members continued their debate on whether emerging science was appropriate on food labels or on off-package labeling, and the role FDA could or should play in the unregulated arena. The ESWG came to a tentative general agreement on a draft definition for "emerging science."

Subsequent to the third ESWG meeting, reports based on the deliberations of an advisory group convened by the Harvard School of Public Health and the International Food Information Council Foundation were made available. These reports outlined guidelines suggested by the advisory group for communicating emerging science on nutrition, food safety and health. Copies of the related reports were distributed to the ESWG for consideration in conjunction with its charge.

ESWG findings and conclusions

Consumers as skeptics. The ESWG charge was to address FDA's role in communicating, and regulating communication of, emerging science to consumers. However, the discussions recognized that consumers must understand how to interpret and utilize the information that is provided to them. The phrases "healthy skeptic" and "healthy skepticism" have been used by several authors to describe the approach consumers should take when reading and evaluating information on emerging science. One example reviewed by the ESWG was the brochure "Quackery ...The Billion Dollar Miracle Business" published over a decade ago by the FDA, the Federal Trade Commission, the U.S. Postal Service, and the Pharmaceutical Advertising Council (HHS Publication No. 85-4200).

The ESWG generally agreed that FDA's role is not only to ensure that "healthy skeptics" get truthful and not misleading information, but also to educate and encourage consumers to be "healthy skeptics." To this end, the ESWG concludes that it would be useful for FDA to develop a new brochure, similar to the one on quackery, that focuses on teaching consumers to be "healthy skeptics" about emerging science issues. In addition to printed form, this document should be prominently available on the FDA Web site.

Statements about diet and health. Any discussion about allowing emerging science statements on labels or in labeling must begin with an understanding of the types of claims that currently are permitted.

The Food, Drug, and Cosmetic Act (FDCA), as amended by the Nutrition Labeling and Education Act of 1990 (NLEA), is the statute under which FDA may authorize a nutrient content claim or a health claim for use on food labels or in labeling. The Food and Drug Administration Modernization Act of 1997 (FDAMA) further amended FDCA to permit food manufacturers to utilize health claims and nutrient content claims based upon authoritative statements by certain scientific bodies of the U.S. government. Guidance for the use of authoritative statements as the basis for nutrient content or health claims is available from FDA (http://www.cfsan.fda.gov/~dms/guidance.html.) The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended FDCA to provide the legal basis for dietary supplement manufacturers to make statements of nutritional support - more commonly referred to as structure/function claims.

Nutrient content claims. Regulations in Title 21 of the Code of Federal Regulations, section 101.13 (21 CFR 101.13) define direct nutrient content claims as "...any direct statement about the level (or range) of a nutrient in the food..." Implicit nutrient content claims are also defined, e.g., claims that suggest a nutrient is absent or present.

Health claims. A health claim is defined in 21 CFR 101.14 as "any claim made on the label or in labeling of a food...that expressly or by implication...characterizes the relationship of any substance to a disease or health-related condition." The validity requirement for such a claim includes the provision that there must be significant scientific agreement among qualified experts that the totality of publicly available evidence supports the claim.

Structure/function statements. FDA has proposed regulations for codification in 21 CFR 101.93(f) that would govern permitted structure/function statements. (Federal Register, vol. 63, no. 82, April 29, 1998, pp. 23623-23632) Such statements would be those "...that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function..." Excluded would be "disease claims" as would be defined in 21 CFR 101.93(g).

The task of the ESWG was to consider information on diet and health that cannot fit within the three statutorily permitted types of claims or statements, and to consider whether a fourth category of statements - "emerging science" - might be appropriate for food labels or labeling.

Definition of emerging science. The ESWG began its consideration of a definition by agreeing that "emerging science is any evidence that does not meet the level of significant scientific agreement." Consequently, the parameters of "significant scientific agreement" will set the upper bound on "emerging science."

The members had difficulty in defining a lower limit on the definition for the purposes of labeling and for general dissemination by the media to consumers. In other words, it is difficult to set the amount and quality of data needed to move something that is a tantalizing bit of new scientific information to reach a level of knowledge where it is truly "emerging science" and might be beneficially communicated to consumers.

The ESWG attempted to set criteria for a definition, despite the absence of established parameters for the upper bound and lack of agreement on what might constitute a lower bound. Members agreed that supporting studies should meet scientific standards and be published in a reputable peer-reviewed journal. The number of supporting studies was considered to be of less importance than the quality of the research work. Although there would be less than "significant scientific agreement" about the potential health benefits described in the studies, the ESWG nevertheless concluded that an appropriately qualified panel of experts would need to judge that health benefits were "probable" and that adverse effects were "not probable." Criteria relating to consumption patterns were also discussed.

An initial definition was crafted incorporating elements based on the above criteria and was further debated, refined and expanded. The definition finally agreed upon as a suitable working definition was:

The ESWG discussed various mechanisms for convening the expert panel envisioned in this definition. One proposal was for FDA to have a non-governmental scientific organization such as the Life Sciences Research Office (LSRO) of the American Society for Nutritional Sciences convene an expert panel. Another proposal envisioned FDA preparing "state of the science" monographs on selected emerging science subjects. A third suggestion was to utilize the review mechanism currently used by the U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (DHHS) to approve dietary guidance prepared by federal agencies. While ESWG members could not agree on a particular expert panel mechanism, they did agree that FDA must have a direct role in whatever process is used. Only with FDA involvement could manufacturers feel confident that their use of emerging science information in product marketing and labeling would be consistent with the Agency's policies.

Emerging science in the regulated arena (labels, advertising).

ESWG members held widely differing views about placing statements based upon emerging science on food labels. Some members felt that it was inappropriate to place information about emerging science on food labels. Concern was expressed that the uncertainty in such information and the lack of space to fully explain it would detract from consumer confidence in the credibility of food labels.

One member gave "qualified support" for such information on the food label as an effective means of providing educational messages to consumers, particularly less literate ones, who likely would not obtain the information from other written sources. One suggestion was that consumers could be educated to understand the value or legitimacy of diet and health information on food labels, and to be suspicious of information that does not appear on food labels, regardless of the prominence such information might receive elsewhere.

Other members were quite positive in their support of placing emerging science information on food labels. These members generally felt that adequate safeguards could be imposed to protect label credibility. One suggested that conclusions about a specific link between diet and health be reserved for authorized health claims. Emerging science information would be presented as an accurate and balanced "description of the scientific support" (sans conclusions) for a potential diet-health link. This suggestion would require FDA to provide guidance on determination of "accuracy" and "balance." Mechanisms to assist consumers in distinguishing a "preliminary claim" from an authorized health claim were discussed. The ESWG did not have an opportunity to explore whether such distinctions could be made under FDA statutory authorities. However, the group was informed that under Federal Trade Commission (FTC) law, it is presumed that consumers do not distinguish among various levels of claims, and manufacturers are liable for all statements.

ESWG members were less divided on whether emerging science information should be allowed in off-package labeling. Most members agreed that this is an appropriate means of informing the public about this type of information. Because more space would be available, additional information and qualifiers could be supplied to consumers to help them distinguish the level of scientific validity of health statements. Such information would, of course, have to be conveyed in a manner that was truthful, substantiated, and properly qualified. One member felt, however, that if there was strongly opposing evidence (in addition to the supporting evidence) the statement should not be allowed in off-package labeling. The implication was that for an emerging science statement to be allowed in off-package labeling, there should be a discernable trend of data in support of the statement, with every expectation that future research results would firmly establish the diet-health relationship. One member opposed allowing emerging science information in off-package labeling. This member felt that diet and health information on labels and labeling and in advertising should be regulated in the same way.

Most ESWG members did agree that if FDA should decide to permit emerging science information in off-package labeling, criteria are needed to guide how statements are developed. The statements need to be placed in proper context with existing supportive, and perhaps conflicting, science. Statements should be reviewed by a panel of "marketing experts" for effective communication. There should be adequate research to ensure that the message perceived by consumers is the public health message that is intended.

FDA has statutory authority to regulate advertising that may cause a food product to be misbranded. However, this authority is shared with FTC. By agreement between the two agencies, regulation of advertising is primarily handled by FTC. Consequently, the ESWG did not address the issue of emerging science information being used in product advertising.

Emerging science in arenas not regulated by FDA (e.g., news media).

FDA has authority to provide consumers with truthful information through education. The agency has public affairs specialists throughout the country who provide communities and consumers with factual and educational information on the products FDA regulates. FDA publishes a monthly magazine entitled "FDA Consumer" that contains articles in lay language about food and health topics. The agency is expanding the amount of information available through the Internet and the World Wide Web.

The ESWG members supported current FDA efforts to disseminate truthful and educational information. It was suggested that FDA develop closer ties to academic nutrition programs and professional organizations. It was also suggested that FDA consider reinstituting regular meetings with food editors. However, members were very divided on significant expansion of agency efforts, particularly with respect to the news media.

Other groups, besides the Keystone Dialogue, have examined this issue. The Harvard School of Public Health and the International Food Information Council Foundation (IFIC) convened an advisory group that included nutrition and food scientists, journal editors, academic press officers, broadcast and print reporters, and representatives of consumer groups and the food industry. After holding a series of roundtable discussions, the advisory group developed a set of science communication guidelines entitled "Improving Public Understanding: Guidelines for Communicating Emerging Science on Nutrition, Food Safety, and Health. For Journalists, Scientists, and Other Communicators." These guidelines are available in booklet form from IFIC, and were also published in the Journal of the National Cancer Institute (JNCI, 90(3):194-199, 1998). The ESWG applauds the development of the guidelines and encourages FDA to refer others to these guidelines as a sound basis for communicating emerging science in the public media.

Emerging science and research incentives.

The ESWG recognized that the ability of manufacturers to publicly associate a marketed food product with health benefits suggested by emerging science can provide an incentive for diet-health research. However, some members also suggested that the ability to place emerging science information in direct association with a product (e.g., on the label or in labeling) might also be a disincentive for further research that would move the science beyond the "emerging" status. The ESWG did not engage in extensive discussions about this issue, and offers no conclusions or recommendations in this regard.

ESWG summary recommendations and prioritized options

The views and recommendations of the ESWG are:

• The ESWG could reach no consensus on allowing statements with less than "significant scientific agreement" on food labels or in labeling. Consequently, as a group, the ESWG offers no recommendation on this question. FDA may wish to consider the variety of suggestions and comments offered by individual ESWG members, as recorded in this report and the minutes of group meetings.
• The ESWG recommends that FDA use the following working definition of "emerging science" when policy decisions are needed on emerging science issues:

Emerging science is one or more research findings pertaining to a food substance's consumption by humans that are judged, by a panel of appropriately qualified experts, to indicate, after consideration of all valid reports pertaining to the substance, that the general population, or some specific segment of the population, will possibly achieve a significant health benefit(s) without significant adverse effects when the substance is consumed in a reasonable amount over a reasonable period.

• The ESWG recommends the following with respect to FDA activities in the "unregulated arena" --

• FDA should continue to expand the availability of information for consumers about emerging science issues on the agency's World Wide Web site.
• FDA should consider restarting its "food editors" meetings, and should consider holding similar public meetings for other groups, e.g., focusing on ties to academic nutrition programs and professional organizations. The Harvard/IFIC guidelines should be publicized at these meetings, and use of the guidelines should be encouraged.
• FDA is encouraged to reissue an updated and retitled version of its "quackery" informational brochure, encouraging consumers to be "healthy skeptics" about all diet-health information, and helping them to understand the strength of the scientific foundation on which statements found on food labels, in labeling, and elsewhere are based.

Hypertext updated by cjm/kwg 2000-NOV-22