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):
o 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.
o 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.
o 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 breastfeeding
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 nearunanimous
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.
