INFORMATION FOR CONSUMERS AND HEALTH PROFESSIONALS

The Commission devoted considerable attention to the need for assessment of consumer understanding and to the use of dietary supplement labeling. The information needs of consumers and health professionals must be met appropriately to ensure that the purposes of labeling are achieved.

The principle of using food labels to communicate messages that encourage a healthful diet and inform consumers of foods that may meet various nutritional objectives is well established (126). The emphasis has been on ensuring that the message on any given food label is of high quality, understandable, based on sound scientific information, and consistent with national nutrition policy. A review of issues related to consumer understanding of conventional food label claims is instructive because it is potentially analogous to the understanding of dietary supplement label claims.

Ippolito & Mathios (76) provide evidence that in the ready-to-eat cereal market, producer advertising and labeling are a significant source of information and reach consumers who are not being as well informed by government and general information sources. They confirm the ability of producer advertising and labeling to effectively communicate the link between diet and health to the public. However, it is important to note that the investigators evaluated consumers' changes in cereal choices during a time (1985 and 1986) when cereal manufacturers promoted their products using fiber-related health claims and that, at that time, there was no significant agreement in the scientific community on the relationship between dietary fiber and cancer. Another economic analysis of the regulation of health claims addresses the credibility of these claims on labels (10). Citing studies by Deighton in 1983 and 1984 (16,17), these authors assert that consumers tend to base their decisions on a "portfolio" of health information rather than on marketing information alone. That is, they tend to treat advertising claims with skepticism and check the truthfulness of claims against neutral sources of information, such as newspapers, magazines, books, physicians, and government sources.

A recent review on communication of food, nutrition, and health messages did not include dietary supplement labeling specifically but did address consumer understanding of nutrient content and health claims on food labels (80). In an appendix to this report, Levy (83) indicates that consumers in focus groups were interested in having information about the relationship between diet and disease. Some Commissioners interpret this study as suggesting that consumer research has not yet established a "mandate" for having health information on food labels as opposed to obtaining such information from health care providers, books, or the print and telecommunications media. Moreover, considering that food labels are viewed by consumers as reflective of the manufacturer's interest in selling the product, consumers are skeptical about the veracity of health messages on food labels.

This skepticism may be exacerbated by the prevailing climate in which many consumers have a sense that they are constantly being bombarded with conflicting information about nutrition. In this context, the study (83) may suggest that the precautions taken to make nonmisleading food label claims involving any aspect of the diet-health relationship may satisfy policy makers but may be ineffective in reassuring consumers that label statements are reliable. In addition, while nutrient content claims can be verified by reference to the Nutrition Facts panel on the label, most other types of claims cannot be verified without further information, which by its very nature is too extensive to include on a label.

After several years of deliberations, FDA approved a number of health claims for use in food labeling and set forth "model health claims" to guide manufacturers. Recent research on consumer understanding of food label claims suggests that perceptions formed from label claims may differ from those intended in setting regulatory criteria. In focus groups conducted by FDA relating to health claims on food products, consumers did not discriminate between health claims and nutrient content claims when asked about statements on food packages that described possible health benefits of particular products (83). This conclusion was confirmed in a subsequent quantitative study of consumers' perceptions when exposed to food packages with various health claims and claim formats (84). When asked which food packages contained any "health" information, more than 90 percent of respondents identified products with only nutrient content claims. Further, at least four times as many respondents described the health benefits of the product in terms of its nutrient characteristics as in terms of its effects in alleviating disease. When asked closed-ended questions about the possible health benefits of the products, consumers generalized positive impressions conveyed by a nutrient content or health claim to benefits other than those explicitly identified in the message (sometimes referred to as a "halo" effect). However, fewer of them did so in response to open-ended questions (84). As was also evident in FTC studies (10,76), consumers do not tend to look at label claims or advertising claims in isolation.

In contrast to the situation with food labels, in which policy makers seemed to be leading the public, support by consumers and industry for passage of DSHEA suggested that consumers want more flexibility in label claims for dietary supplements (136). The interest of policy makers in meeting this consumer need is reflected in DSHEA's provision for the establishment of the Commission on Dietary Supplement Labels to address "how best to provide truthful, scientifically valid, and not misleading information to consumers." Among the findings identified by Congress in DSHEA was the concern that "although the Federal government should take swift action against products that are unsafe or adulterated, the Federal government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers." In the view of those who promote dietary supplements, the interest in allowing flexibility in making label claims for supplements seems to be more urgent than for foods. One reason for this is that while foods are consumed for many reasons, including health, anticipated health benefits are the only reason for consuming supplements. Thus, labeling with respect to potential health benefits may be more important in supplement choice than in food choice.

A syndicated study of 2,010 men and women (71) indicated that 58 percent of vitamin and/or mineral supplement users read the supplement label always, almost always, or most of the time. Of these, 33 percent looked for an explanation of benefits to be gained from taking supplements and 23 percent looked for scientific findings supporting use of the supplement (e.g., health claims). However, 78 percent of regular users believed that scientific information on package labels was very or somewhat important. The study indicated that scientific information and/or functional or health claims on product labels are important to and wanted by consumers. However, the study pointed out that this information is viewed by consumers in the context of information from other sources and their own knowledge and experience. The effective use of scientific information on labels may require a certain amount of education and personal experience on the part of the consumer (71).

Findings

The Commission recognizes that evaluation of consumer information needs relating to dietary supplements is an important issue and makes several recommendations intended to provide more useful label information to consumers. Recent studies of consumer perceptions of food label claims illustrate the potential for miscommunication despite the efforts of policy makers to establish clear labeling guidelines and of manufacturers to comply with them. The Commission believes that there is value in providing information about nutrition and health to consumers on the product label, as authorized by NLEA and DSHEA. Reports on consumer research indicate that adequate effort must go into providing information that consumers understand. Clear, nonmisleading communication of dietary supplement attributes may pose unique challenges. The understanding by older adults of information relating to dietary supplements merits particular attention because older adults represent a substantial proportion of the users of dietary supplements (142).

Consumer comprehension of the uses of dietary supplements may be hampered by a lack of attention to dietary supplements by the traditional sources of consumer information about diet and health. Although surveys show that substantial numbers of Americans consume dietary supplements, the Commission believes that guidance provided by some scientific, health, and nutrition societies on supplement use is often limited. Evidence suggests that the American public obtains more information about diet and health from the media than from physicians and dietitians (85,127). Also, nutritional guidance by the Federal government provides limited discussion of supplements that may help consumers make appropriate decisions about supplement use (135). Current policy statements say that conventional foods should provide needed nutrients and that supplements are largely unnecessary in the context of a well-chosen diet.

The Commission believes that some professionals in medicine and nutrition devote more effort to refuting unsubstantiated and unrealistic claims than to providing sound information on appropriate, scientifically valid uses of dietary supplements. Research is needed on the attitudes of health and nutrition professionals toward supplements and the extent to which these attitudes are sufficiently specific (i.e., differentiating among different types and uses of dietary supplements) and informed. Such research may reveal ways in which health and nutrition professionals can better help the public interpret label information and scientific literature on dietary supplements. Health professionals need to take into account scientific developments that demonstrate the benefits of dietary supplements. There now are scientific studies and significant scientific agreement to support health claims on some dietary supplements. Dietary supplements are also permitted under DSHEA to make statements of nutritional support when the claims are substantiated and not misleading. To enable health professionals to evaluate these uses of dietary supplements, and to advise consumers about the uses, the health professionals need to have access to adequate information about the scientific basis for the statements.

In Chapter III of this report, the Commission suggests that manufacturers affirm in the notification letter, or in a separate public notice, that they have evidence to document statements of nutritional support and that the product is safe for its intended use. The Commission also concludes that some synopsis of the scientific evidence regarding statements of nutritional support and product safety should be available to potential buyers of dietary supplements. This conclusion is based primarily on the mandate in DSHEA which indicates that a major role of the Commission is to "evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families." Thus, the Commission concludes that the dietary supplement industry has a responsibility not only to affirm that such evidence exists, but also to make summaries of information about the scientific evidence for statements of nutritional support and product safety available to the public. The Commission is suggesting that these summaries include evaluation of evidence from observational and experimental scientific studies on the effects of the specific dietary supplement or its active ingredient(s), if known.

Further, the dietary supplement industry should be responsive to requests for such summaries of evidence by interested parties. These summaries could be provided by manufacturers or independent organizations. A publicly accessible database might be a more efficient means of communication. Summaries or the database could be developed and maintained by a government agency such as ODS, a trade association, a consumer organization, or a partnership of such organizations. Criteria for inclusion of data should be stated in each summary. Data summaries on specific dietary supplements themselves, or a database, would help consumers, health professionals, and health care organizations in evaluating the extent of scientific evidence that supports label statements. In addition, publicly available data summaries on specific dietary supplements or a publicly accessible database of these would have considerable educational value to all users.

For example, it would be important for consumers and health professionals to know whether a statement of nutritional support for a dietary supplement relating to a structure or function of the body is based on clinical data or on a long history of use of the supplement for the purpose mentioned in the statement of nutritional support. Similarly, it would also be important to know whether a statement relating to a biochemical mechanism is based primarily on in vitro studies of the physiological function of active compounds in the supplement or whether observational or experimental animal and human data are available to support the reputed effects.

The Commission recognizes that the summaries would need to be prepared with care in order to provide consumers and health professionals with responsible information. Summaries should be balanced and not misleading. Because statements of nutritional support cannot, under the provisions of DSHEA, claim to prevent or treat a disease or disorder, the summaries should similarly not make these types of claims.

The Commission believes that consumers and health professionals should have full access to the information supporting statements of nutritional support. The summaries should also indicate how health professionals can obtain access to the studies and evidence that support the statements. Full access would facilitate the ability of health professionals and consumers to evaluate these statements.

There may be a need to clarify whether these summaries are labeling or are publications exempt from classification as labeling. Currently, experience with such publications is quite limited, and any legislative or regulatory determination of this sort should be made on the basis of adequate experience. If the summaries are classified as labeling, they should bear the same disclaimer required by DSHEA for statements of nutritional support.

As indicated previously, Congress made it clear, in passing DSHEA, that these products and information about these products should be available so that consumers could make "informed and appropriate health care choices for themselves and their families." The Commission believes that providing consumers and health professionals with appropriate and nonmisleading summaries of scientifically valid evidence regarding substantiation of statements of nutritional support and product safety for specific dietary supplements would support this goal.

Guidance

• The Commission urges that dietary supplement labeling be evaluated in additional consumer research to determine whether consumers actually want and can utilize the information provided by existing FDA regulations, by the requirements of DSHEA, and in the recommendations of this Commission. The Commission recognizes that consumer understanding of statements of nutritional support and health claims, as well as consumer perception of dietary supplement use based on literature at the point of sale, are important aspects of the use of information that require additional and continued assessment.
• The Commission believes that it is important for health and nutrition professionals to become more knowledgeable about all types of dietary supplements and to assist the consumer in making appropriate health care choices with respect to use of dietary supplements.
• The Commission urges manufacturers to make available publicly balanced and nonmisleading summaries of the evidence substantiating statements of nutritional support and product safety for the intended use at the stated dosage. The summary should not claim use for prevention or treatment of disease.

NEED FOR INDUSTRY EXPERT ADVICE ON SAFETY, LABEL STATEMENTS, AND CLAIMS

The Commission believes the industry should be more proactive in incorporating scientific input to its decision-making regarding the safety and benefits of dietary supplements. The establishment of one or more expert advisory committees could be a productive way of obtaining such scientific input for the industry. Such committees might serve in an advisory role to individual companies, to members of specific trade associations, or to the industry as a whole, depending on the nature of the support available and the mechanism used for establishing such committees. Public comments received on the Commission's draft report expressed concern that these advisory committees might take over the role of reviewing NLEA health claims, but that was not the Commission's intent. The outside expert review that the Commission urges FDA to seek when evaluating health claims is an entirely separate topic from the industry's internal need for more scientific guidance, and the two topics are treated separately in this report. This section of the report addresses the need for industry to develop one or more mechanisms for strengthening its scientific basis for making label statements.

Dietary supplements are eligible for a variety of label statements and claims, each of which is subject to unique regulatory requirements. Despite differing regulatory provisions, in a practical sense, messages conveyed to consumers by label statements of nutritional support, NLEA health claims, and OTC drug claims are often similar. Manufacturers of dietary supplements have several options in determining which type of statement or claim is appropriate for a given product, in evaluating the degree of substantiation required for the statement or claim, and in deciding whether the evidence is sufficient to substantiate a statement of nutritional support under DSHEA or to justify a petition to FDA for approval of an NLEA health claim or an OTC drug claim.

The Commission believes the dietary supplement industry and consumers alike would benefit from an increased level of scientific input into decisions regarding label statements for dietary supplements. In addition, as emphasized elsewhere in this report, the Commission considers it axiomatic that dietary supplements must be safe for their intended uses, and scientific input is essential in making such determinations. Accordingly, the Commission recommends that the industry consider establishing an expert advisory committee on dietary supplements to provide scientific review of label statements and claims and to provide guidance to the industry regarding the safety, benefit, and appropriate labeling of specific products. Such a committee might be supported by one or more industry trade associations or might be established as an independent entity funded by extramural grants and/or fees for services.

A number of models illustrate the value and reliability of expert outside review as a means of helping to resolve issues relating to the safety and/or benefits of specific products or groups of products. The Flavor and Extract Manufacturers Association (FEMA) has conducted its own GRAS review of flavor compounds and the Cosmetic, Toiletry and Fragrance Association, Inc. (CTFA) has conducted its own Cosmetic Ingredient Review. In these two instances, the reviews are organized and funded by industry but involve extramural scientists with appropriate expertise and experience who conduct quality reviews that are made available publicly.

AHPA proposed a botanical ingredient review to FDA as an alternative mechanism for approving NLEA health claims for botanical ingredients. Although the agency declined to incorporate such an outside review into its procedures for approving health claims, the Commission believes there would be value in the industry's undertaking such reviews in the spirit of self-regulation and with the goal of increasing consumer confidence in both the safety and the efficacy of dietary supplements. Some Commissioners believe that an expert outside review would also enhance the quality of petitions submitted to FDA for approval of an NLEA health claim or an OTC drug claim for a product.

To assure the credibility of an expert advisory committee, any such committee should be composed of scientific experts with appropriate specialties in nutrition, pharmacognosy, pharmacology, health promotion and disease prevention, medicine, and toxicology. Some Commissioners believe it would be desirable to include participation by the U.S. Pharmacopeial Convention, Inc., FDA, the National Academy of Sciences, and international bodies such as WHO. Regardless of the composition of the committee, procedures should be in place to avoid conflict of interest.

The Commission recognizes that the support of an expert advisory committee in the pursuit of a comprehensive review of dietary supplement ingredients would be a major and costly undertaking. However, the success of the CTFA and FEMA reviews indicates that the value of the undertaking might be well worth the investment.

Guidance

• The Commission recommends that the dietary supplement industry consider establishing an expert advisory committee on dietary supplements to provide scientific review of label statements and claims and to provide guidance to the industry regarding the safety, benefit, and appropriate labeling of specific products. Such a committee might be supported by one or more industry trade associations or might be established as an independent entity funded by extramural grants and/or fees for services.

RESEARCH ISSUES

DSHEA recognizes the importance of research in relation to dietary supplements. In the findings section of the legislation, Congress indicated that the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been increasingly documented in scientific studies. The Commission endorses the continuation of these types of studies. DSHEA establishes ODS within NIH to promote scientific studies of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions. Thus, it seems clear that Congress recognized that use of dietary supplements should be based on a strong foundation of scientific research.

As discussed elsewhere in this report, the Commission considered the availability of scientific evidence supporting the benefits of dietary supplements and deliberated on the type of evidence that may be used to substantiate health claims and statements of nutritional support. In the course of these deliberations, it became evident that the research base for supporting various types of statements for dietary supplements is highly variable.

Over the past several decades, the Federal government has supported a significant body of basic research on ingredients used in dietary supplements, specifically vitamins, minerals, and amino acids. In addition to the basic work on most of the vitamins and minerals, in recent years large clinical or epidemiologic studies have been carried out dealing with the relationship between nutrients and diseases (e.g., vitamins E and C and cardiovascular disease and cancer, selenium and cancer, ß-carotene and cancer, calcium supplements and osteoporosis).

The Commission is unable to ascertain with certainty the magnitude of federally supported basic and applied research associated with dietary supplements due to difficulties in retrieving such data. However, some estimates can be derived from existing information.

According to data provided from the Human Nutrition Research and Information Management System (HNRIMS), in fiscal year 1995, expenditures by Federal agencies on human nutrition, research, manpower development training, and education totaled about $540 million (82) (Table 4). Comparison of data from 1986 to 1995 (Table 5) suggests a progressive increase in Federal funding for nutrition research and training (74,82). However, the portion of research directly applicable to dietary supplements cannot be determined. ODS is defining a series of codes for dietary supplements to allow inclusion of data on dietary supplement research expenditures in the HNRIMS databases. This effort will be completed later this year or in 1998.

There has been relatively little Federal support of basic research dealing with the mechanism of action of botanical products. In view of the public's interest in dietary supplements, the Commission believes that additional Federal funding should be directed toward evaluation of the potential health benefits and safety of a wide range of dietary supplements, including botanical products. Such research results can provide information that consumers can use to make informed decisions about their health.

Support for research from the private sector depends to a considerable degree on the economic return that may be expected from investments in research. While some companies make grants and donate products for research studies, the Commission was unable to obtain any reliable information on the dietary supplement industry's overall investment in research on product efficacy and safety. Public testimony to the Commission indicated that many of the products marketed as dietary supplements do not have patent protection, thus marketing advantages obtained through research are difficult to maintain because the research results would be available to competitors as well as the company supporting the research. The Commission took note of the discussion of research issues related to health claims in the recent Keystone report (80) and believed that the discussion was particularly relevant to consideration of mechanisms for support of research on dietary supplements.

Findings

The Commission reached the following conclusions about research issues related to dietary supplements:

• The dietary supplement industry is diverse, with a number of large companies and several hundred relatively small companies manufacturing and/or marketing dietary supplements. The small size of many companies contributes to limited investment by individual companies in research on product efficacy. These companies have been able to market products either with no label claims or now, under DSHEA, with statements of nutritional support without heavy research investment. It may be difficult for such companies to envision increased economic return on greater research investment. In lieu of investment in research, substantiation of statements of nutritional support has been based on extension of publicly available research, research conducted overseas, or a history of use.
• The Commission heard testimony in its public hearings that most dietary supplements, being natural or generic products, cannot be given effective patent protection. Therefore a manufacturer lacks incentive to expend resources for research that might benefit competitors as well as itself.
• Conducting clinical research to assess the validity of statements of nutritional support could be difficult. A statement that a product provides a feeling of well-being may be confounded with the placebo effect, thus double-blind studies using placebo would be essential to assessing such statements. A statement that a product enhances immune function requires an appropriate challenge using acceptable clinical and biochemical methodology to determine whether the product actually improves resistance to common conditions such as colds and flu. Such research is resource intensive.
• Many dietary supplements claim to improve or optimize the functioning of the human body and do not result in immediate drug-like effects. The "soft" end points of research supporting such claims can make clinical research results ambiguous. The cost of research to prove moderate benefits is significantly higher than that of research to prove immediate relief of disease symptoms. In addition, identification of benefits for particular segments of the population will require either multiple trials involving each group or large studies that involve several population subgroups.
• For a health claim to be made under NLEA, a considerable body of research must demonstrate that a food or dietary supplement ingredient will reduce risk for a specific disease or condition. The research base must be sufficient to permit significant scientific agreement among qualified scientists. Existing health claims generally have not been based on research supported by a single company, but have relied on research funded by both government and industry. For example, the recently approved health claim that soluble fiber from whole oats reduces the risk of coronary heart disease was based on research supported by NIH and the petitioner over a period of many years.

• Determination of prevention in the general population, or even in a population at risk for developing a specific disease, is more expensive and difficult than determination of an effect in a population with a disease. Determining any relationship between dietary ingredients and disease or risk of developing a disease may require numerous expensive, large-scale clinical trials.

Guidance

• The Commission believes that the public interest would be served by more research that assesses the relationships between dietary supplements and maintenance of health and/or prevention of disease.
• Incentive mechanisms should be developed to encourage the dietary supplement industry to invest in research on products offered to the consumer. FDA might consider a mechanism for review of research conducted to validate a statement of nutritional support so that the label disclaimer mandated by DSHEA could be modified or removed. More consideration is needed of ways to provide sufficient resources to FDA to make it possible for the agency to take on such an additional responsibility.
• The Commission recommends that Federal agencies continue to support research on the health benefits and safety of dietary supplements. Research should be expanded beyond the traditionally supported areas associated with vitamin and mineral supplements and include research on some of the more promising botanical products used as dietary supplements.

NIH OFFICE OF DIETARY SUPPLEMENTS

DSHEA established the Office of Dietary Supplements within NIH for the purpose of exploring the potential role of dietary supplements as a significant part of the efforts of the United States to improve health care, and to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease.

Most of the duties outlined by DSHEA for ODS are related to conducting, coordinating, or compiling the results of scientific research. ODS is directed by the Act to conduct and coordinate scientific research relating to dietary supplements within NIH, to coordinate funding for such research, to collect and compile the results of scientific research on dietary supplements, and to compile a database of such research. In addition, DSHEA directs ODS to "…serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and provide advice to the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs on issues…" relating to safety, benefits, and labeling of dietary supplements.

The Commission observes that ODS has so far not been provided with sufficient staffing or funds to achieve these goals. While an annual budget of $5 million was authorized by DSHEA in 1994, the Commission notes that currently, ODS has an annual budget of about $1 million. Much of its work over recent months has focused on assessment of priorities among several mandated tasks; collection and organization of information concerning research activities, both within NIH and throughout other Federal agencies; and gathering information on research needs.

The development of a strategic plan has been a major activity of ODS. A draft plan has been developed with the assistance of industry, the scientific community, and others. The final plan will probably not be available until after the Commission completes this report. Nevertheless, the Commission believes that critical evaluation of the ODS strategic plan for research will be essential if the intent of DSHEA is to be realized fully.

ODS has great potential, but has so far been unable to reach that potential due to inadequate staffing and funding. If adequate resources can be provided, the Commission believes ODS could play a valuable role in providing consumers with information about dietary supplements. In this report, the Commission is urging manufacturers to provide consumers and health professionals with more information regarding the substantiation for statements of nutritional support and regarding the safety of products. ODS could serve as a depository for that information, which could be compiled into a useful database.

Findings

The Commission recognizes a need for ODS to be more proactive in fulfilling its purposes, including promotion of scientific studies on potential roles of dietary supplements in health promotion and disease prevention. Appropriations as authorized by DSHEA are essential if ODS is to meet these mandates of the Act.

Recommendations

• ODS should strive to be an effective focal point for research on and understanding of the health effects of dietary supplements.
• ODS should place greater emphasis on its assigned role of advising other government agencies on a broad range of issues relating to dietary supplements.
• Congress should fund ODS at the level authorized by DSHEA.

Commission on Dietary Supplement Labels