The Dietary Supplement Health and Education Act (DSHEA or the Act) of 1994 was enacted by Congress following public debate concerning the importance of dietary supplements in leading a healthy life, the need for consumers to have current and accurate information about supplements, and controversy over the Food and Drug Administration's (FDA) regulatory approach to dietary supplements. President Clinton, in signing the legislation into law on October 25, 1994, said:

After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.

This legislation defines dietary supplements, places the responsibility for ensuring their safety on manufacturers, identifies how literature may be used in connection with sales, specifies types of statements of nutritional support that may be made on labels, specifies certain labeling requirements, and provides for the establishment of regulations for good manufacturing practices. The legislation creates an Office of Dietary Supplements (ODS) in the National Institutes of Health (NIH), with a mandate to coordinate scientific research relating to dietary supplements within NIH and to advise Federal agencies on issues relating to dietary supplements.

DSHEA also directs the President to appoint a Commission on Dietary Supplement Labels to consider several issues needing clarification when the Act was passed. The Act indicates that the Commission is to:

. . . conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims.

In making its recommendations, 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.

A seven-member Commission was appointed by President Clinton in October 1995, and its charter was approved by the Secretary of the Department of Health and Human Services (HHS) on February 13, 1996. The Commission convened its first meeting in February 1996. In the course of its deliberations, the Commission held public meetings at several sites around the United States and received oral and written testimony from interested organizations and individuals who presented views on issues related to the Commission's charge.

Reflecting the charge to the Commission in DSHEA and in the Commission's charter, this report is addressed to the President, Congress, and the Secretary of HHS. The organization of the report is as follows:

• Chapter I summarizes the major provisions of DSHEA and the charge to the Commission.

   

• Chapter II reviews the legislative and regulatory context surrounding DSHEA and summarizes information related to consumer use of dietary supplements and the supplement industry.

   

• Chapters III and IV present findings, guidance, and recommendations related to the key issues identified by the Commission during its deliberations. The conclusions of the Commission are presented in each section of these two chapters in this manner (See Executive Summary Endnote 1):

   

  • Findings are the conclusions reached by the Commission during its deliberations and are based on the information and data received and reviewed by the Commission.

     

  • Guidance represents advice to specific agencies, groups, or individuals. Guidance should be considered by the identified recipients as they develop or implement activities related to the availability of dietary supplements in the marketplace.

     

  • Recommendations are indicated as such and identify the intended recipients. Recommendations that call for consideration of changes in existing regulations, development of new regulations, or legislative action are so indicated.

The Commission on Dietary Supplement Labels was aware of the public interest in its work and desired to have an additional public comment period. Therefore, a draft report was released for public comment on June 24, 1997.

This executive summary highlights the findings, guidance, and recommendations made by the Commission in the areas of safety, health claims, statements of nutritional support, notification letters, substantiation files, publications used in connection with sales, and some special considerations regarding botanical products. The Commission also addressed consumer and health professional information needs; industry expert advice on safety, label statements, and claims; research issues; and the Office of Dietary Supplements.

SAFETY OF DIETARY SUPPLEMENTS

The Commission considers it axiomatic that all marketed dietary supplements should be safe. Congress, in reflecting on the issues associated with safety, concludes in DSHEA that dietary supplements "are safe within a broad range of intake, and safety problems with the supplements are relatively rare." Congress emphasizes in the Act that the government should take swift action when safety problems arise but should not impose unreasonable barriers or limit access to safe products.

Guidance

Manufacturers and the industry as a whole must fully accept the responsibility for assuring the safety of dietary supplements and must take any action necessary to meet the expectation expressed in DSHEA that dietary supplements are and will continue to be safe for use by the consuming public.

• The Commission urges FDA, the industry, the scientific community, and consumer groups to work together voluntarily to improve passive postmarketing surveillance systems, including adverse reaction reporting systems, to ensure that any safety problems that may arise are identified and corrected promptly.

   

• Ensuring the safety of supplements includes the need to provide adequate information and warnings to consumers. The Commission strongly suggests that dietary supplement manufacturers include appropriate warnings in product information where necessary, as specifically permitted by DSHEA. In addition, manufacturers should recognize the need to advise women who are pregnant or breast-feeding to consult a health professional about supplement use during the pre- and postnatal periods.

   

• The Commission urges FDA to use its authority under DSHEA to take swift enforcement action to address potential safety issues such as those posed recently by products containing ephedrine alkaloids. While it is expected that a responsible industry will avoid marketing unsafe products and that the industry will react promptly to remove products shown to be associated with significant or serious adverse reactions, in the final analysis there must be a strong and reliable enforcement system to back up the safety provisions of DSHEA. Failure by FDA to act when strong enforcement is needed undermines public confidence in the ability of not only the Federal government but also the dietary supplement industry to ensure safety and avoid harm to the public.

   

• FDA and, within many states, certain agencies have the responsibility in enforcement actions to develop, affirmatively, the evidence that shows an unreasonable risk from using existing supplements. FDA and appropriate agencies in some States may need additional resources to develop the necessary evidence, and these agencies need to be given the resources necessary to meet this important responsibility in the context of their overall public health priorities.

NLEA CLAIMS IN DIETARY SUPPLEMENT LABELING

In enacting DSHEA, Congress implicitly intended the Commission to determine whether any changes should be made in the requirements for health claims allowed by the Nutrition Labeling and Education Act of 1990 (NLEA) for dietary supplements. Current FDA rules require the same type of scientific evidence and support and the same process for approval of NLEA health claims on dietary supplements as are required for conventional foods.

Guidance

• The process for approval of health claims as defined by NLEA should remain the same for dietary supplements and conventional foods.

   

• The standard of significant scientific agreement is appropriate and serves the public interest. The standard of significant agreement should not be so strictly interpreted as to require unanimous or near-unanimous support.

   

• FDA should ensure that broad input is obtained to ascertain the degree of scientific agreement that exists for a particular health claim. The use of appropriate panels of qualified scientists from outside of the agency is encouraged, and the views of other government agencies should be given considerable weight in determining whether significant scientific agreement exists.

SCOPE OF STATEMENTS OF NUTRITIONAL SUPPORT

DSHEA allows dietary supplement labeling to bear statements of nutritional support without preauthorization by FDA. FDA has received notification letters regarding more than 1,000 such statements. Review of the letters and consideration of testimony presented to the Commission indicate that clarification of the scope of a nutritional support statement may be helpful to manufacturers.

Guidance

• While the Commission recognizes that the context of a claim has to be considered on a case-by-case basis, the Commission proposes the following general guidelines:

  1.	Statements of nutritional support should provide useful information to consumers about the intended use of a product.
  2.	Statements of nutritional support should be supported by scientifically valid evidence substantiating that the statements are truthful and not misleading.
  3.	Statements indicating the role of a nutrient or dietary ingredient in affecting the structure or function of humans may be made when the statements do not suggest disease prevention or treatment.
  4.	Statements that mention a body system, organ, or function affected by the supplement using terms such as "stimulate," "maintain," "support," "regulate," or "promote" can be appropriate when the statements do not suggest disease prevention or treatment or use for a serious health condition that is beyond the ability of the consumer to evaluate.
  5.	Statements should not be made for products to "restore" normal or "correct" abnormal function when the abnormality implies the presence of disease. An example might be a claim to "restore" normal blood pressure when the abnormality implies hypertension.
  6.	Health claims are specifically defined under NLEA as statements that characterize the relationship between a nutrient or a food component and a specific disease or health-related condition. Statements of nutritional support should be distinct from NLEA health claims in that they do not state or imply a link between a supplement and prevention of a specific disease or health-related condition.
  7.	Statements of nutritional support are not to be drug claims. They should not refer to specific diseases, disorders, or classes of diseases and should not use drug-related terms such as "diagnose," "treat," "prevent," "cure," or "mitigate."

• To the extent resources permit, FDA should continue to provide guidance to manufacturers by responding to letters of notification when the agency deems a proposed statement to be inappropriate as a statement of nutritional support.

NOTIFICATION LETTERS FOR STATEMENTS OF NUTRITIONAL SUPPORT

DSHEA requires that the manufacturer of a dietary supplement bearing a statement of nutritional support notify the Secretary no later than 30 days after the first marketing of the dietary supplement that such a statement is being made. The law also states that the manufacturer must have substantiation that such a statement is truthful and not misleading. The law does not provide that the evidence supporting a statement be reviewed by a regulatory agency prior to marketing of the product. The Commission agreed that guidelines are needed for standardizing the format and content of the notification letters.

Guidance

• Notification letters should continue to be available in the public dockets.

   

• While the rulemaking process need not be reopened at this time, the Commission suggests that notification letters should include the following information:
  

  1.	A statement that the purpose of the letter is to provide notification of a statement of nutritional support, including the exact wording that appears on the product label.
  2.	The name, address, and telephone number of the manufacturer or distributor, and if available, the address and/or toll-free telephone number for consumer inquiries.
  3.	The name and description of the product. The name of the product should include the trade name and the common or usual name. A copy of the product label or label copy, if labels are not yet printed, should be included.
  4.	The identity of specific individual ingredients or combinations of ingredients for which the statement of nutritional support is made. For botanicals, ingredients should be identified by the common or usual name, the Latin binomial and its scientific authority, and the part(s) of the plant(s) used.
  5.	A statement of intended use, including the recommended dosage and appropriate contraindications or warnings.

• In the notification letter or in a separate public notice manufacturers should provide statements of affirmation that they have substantiation for the statement of nutritional support and that the product does not represent a significant or unreasonable risk of illness under conditions of use recommended or suggested in labeling.

   

• Although some of the information indicated in the above guidelines is not required by FDA, the Commission suggests that manufacturers use these guidelines in preparing their notification letters.

SUBSTANTIATION FILES FOR STATEMENTS OF NUTRITIONAL SUPPORT

The Commission discussed how a statement of nutritional support can be adequately substantiated when it is based solely on historical use without supporting experimental or clinical data. At a minimum, such a statement of nutritional support would have to be carefully qualified to prevent misleading consumers. Some Commission members believe that, in some circumstances, qualified statements based solely on historical use would be recognized by experts as being adequately substantiated. Other Commissioners believe that experts would want more scientific support for substantiation and especially so in the case of statements that have particular health importance. One Commissioner believes that scientific support for substantiation is needed for all statements with health importance.

DSHEA does not require that substantiation files be made available to FDA, and the majority of the Commission members are not recommending a change in legislation regarding the availability of these files. However, one member believes that FDA needs to be able to obtain access to the relevant files of a manufacturer to enforce effectively the manufacturer's obligation to substantiate statements of nutritional support and the obligation to substantiate safety. That member believes the authority to obtain access to substantiation files should be provided either through a rule similar to that proposed by FDA on nutrient content claims based on new technology for food ingredients or through legislative action.

The Commission provides the following guidance regarding the information a responsible manufacturer should have in a substantiation file for a statement of nutritional support and product safety. While the Commission's guidance on substantiation files is directed to statements of nutritional support and safety, other types of label statements may be made for dietary supplements. The Commission's guidance on substantiation file content may also be helpful in identifying what a responsible manufacturer would do for substantiation of other types of label statements.

Guidance

• Substantiation files for statements of nutritional support and safety should include the following information:

1.	A copy of the notification letter.
2.	The identity and quantity of the dietary ingredient(s) that is (are) the subject of the statement of nutritional support.
3.	The key evidence to substantiate statements of nutritional support, including an interpretive summary of the evidence by an individual(s) or group qualified by training and experience.
4.	Evidence substantiating the safety of the product.
5.	Assurance that good manufacturing practices were followed in the manufacture of the product.
6.	The qualifications of the individual(s) or group who reviewed the evidence for safety and efficacy.

PUBLICATIONS EXEMPT FROM CLASSIFICATION AS LABELING WHEN USED IN CONNECTION WITH SALES

DSHEA directs the Commission to study and make recommendations on the regulation and evaluation of the use of literature in connection with the sale of dietary supplements. DSHEA exempts publications used in connection with the sale of dietary supplements from being defined as labeling under certain conditions.

The Commission finds that the requirements of Section 5 of DSHEA may be difficult to apply, especially the requirement that an article provide (or be displayed with other publications that provide) a balanced view of the available information. Although this provision of DSHEA seems to have been written with scientific articles in mind, the term publication has a broader meaning. Also, the Commission recognizes that scientific articles may not be consumer friendly. Therefore, it appears likely that the bulk of the literature used in accordance with this provision may be in the form of publications specifically prepared for this purpose and written for the consumer.

Guidance

• Because more experience with the implementation of this provision may provide additional information about the use of publications in connection with a sale, the Commission suggests that proactive monitoring of practice in this area be undertaken by FDA as resources permit and that regulatory guidance be developed if necessary.

BOTANICAL PRODUCTS

Botanical products represent a major category of dietary supplements. The Commission observes that many botanical products sold as dietary supplements are used for prevention or treatment purposes. The scientists on the Commission noted that, in some cases, there is current scientific evidence to support such use. Most Commissioners believe that, in some cases, the consumer would be better served by clear information regarding preventive and therapeutic uses than by the limited statements of nutritional support permitted by DSHEA.

The Commission believes it would be logical and desirable for the U.S. over-the-counter (OTC) drug system to include preventive or therapeutic claims for botanicals, at least for those having a long history of use and general recognition of safety and efficacy based on adequate studies. The Commission also recognizes that there are botanical products used as remedies by some segments of the U.S. population that may not meet standards of evidence needed for OTC approval. In many other industrialized countries in the world, claims for botanical remedies and medicines are permitted, often with specific disclaimers, as a unique category of nonprescription products within the drug regulatory system. The types of disclaimers that are used and that may be needed are described in this report. The appropriate regulation of these products as remedies was considered to be outside of the Commission's charge and expertise but deserving of further study.

Guidance

• More study is needed regarding the establishment of some alternative system for regulating botanical products that are used for purposes other than to supplement the diet, but that cannot meet OTC drug requirements. The study should include the types of disclaimers that might apply and the appropriateness of such a system within the U.S. regulatory framework. Such a comprehensive study would go beyond the mandate of this Commission, which is limited to dietary supplement uses of these products.

   

• The Commission concluded that a comprehensive evaluation of regulatory systems used in other countries for botanical remedies is needed. Such an evaluation should consider the scope of products covered, the means of assuring safety and preventing deception, the effect of such systems on overall medical care, the definition of appropriate drug uses of products, and the appropriateness and applicability of the different types of disclaimers.

Recommendations

• The Commission recognizes that, under DSHEA, botanical products should continue to be marketed as dietary supplements when properly labeled.

   

• The Commission strongly recommends that FDA promptly establish a review panel for OTC claims for botanical products that are proposed by manufacturers for drug uses. The panel should have appropriate representation of experts on such products.

INFORMATION FOR CONSUMERS AND HEALTH PROFESSIONALS

DSHEA charged the Commission to determine how best to provide truthful, scientifically valid, and not misleading information to consumers so that they may make informed and appropriate health care choices for themselves and their families. The Commission believes additional research is needed on the type of label information that would be most useful to consumers. Other avenues of consumer information, including advice from health professionals, could be critical in assisting consumers in making appropriate decisions relative to supplement use.

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 required 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

Dietary supplements are eligible for a variety of label statements and claims, each of which has unique regulatory requirements. Despite the diverse regulatory provisions, in a practical sense, the messages conveyed to consumers by label statements of nutritional support, NLEA health claims, and OTC drug claims may be similar. The Commission believes that the dietary supplement industry and consumers would benefit from an increased level of scientific input into decisions regarding label statements for dietary supplements. An expert advisory panel on dietary supplements could be a valuable source of increased scientific input.

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 establishing ODS within NIH, Congress wished to promote the scientific study of the benefits of dietary supplements. In considering the scientific evidence for the benefits of supplements, the Commission has made a number of observations relative to support of research on dietary supplements, the constraints to such research, and the incentives to the industry to invest in research in this area. The Federal government has been a major supporter of research on the health benefits of dietary supplements in some areas.

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 such 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

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.

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.

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