I. Introduction
Mr. Chairman, and Members of the Committee, my name is Jane Henney. I am honored to
address you as the Commissioner of Food and Drugs and pleased to be here today to discuss
implementation of the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Since this is my first appearance before this Committee as the Commissioner, I would
like to take this opportunity to share with you my priorities for the Food and Drug
Administration (FDA or the Agency). They will give you context for our dialogue on
specific matters today and in the future. My priorities are:
- Full and effective implementation of the FDA Modernization Act (FDAMA). I intend to
build on this collaborative, constructive model by working closely with Congress, the
regulated industry, patients, consumers, and health care professionals. This means not
just implementing the letter of the law but the spirit of the law.
- Enhancing the Agency’s science base. It should be a concern to us all that, at the
very time the public and private research enterprise in this country is flourishing, the
FDA, an essential science-based regulatory Agency, may have difficulty recruiting and
retaining strong scientists. If we are to meet our statutory obligations to regulate
cutting-edge scientific discovery and development, we must have comparable cutting-edge
expertise in our staff.
The remaining three priorities are not only priorities of the Agency but of the
Administration:
- The safety of the Nation’s food supply;
- The safety of the Nation’s blood supply; and,
- Reducing young people’s use of tobacco products.
These priorities are limited in number but encompass many activities. We need to
allocate our finite resources wisely and when we undertake activities beyond these
priorities we need to do so with deliberation and intention and in the areas of highest
public health promotion and protection. This is the perspective from which we approach our
implementation of DSHEA.
I understand that this statute was passed with bipartisan support and by the hard work
of you and others in Congress in developing an appropriate regulatory scheme that would
facilitate consumers’ access to dietary supplements. It is important that the
Agency’s implementation of the statute be true to Congressional intent. As I stated
during my confirmation process, I am aware that many Americans place great faith in
dietary supplements to help them maintain and improve their health and that the scientific
evidence documenting the benefits of a number of supplements is increasing. The challenge
to FDA is to strike the right balance between preserving consumers’ access to both
products and information and assuring the safety and proper labeling of all of these
products. It is clear, with the benefit of hindsight, that we still have a way to go both
in achieving full implementation of DSHEA and in developing a workable regulatory
framework. I want to take the opportunity to acknowledge our progress, shortcomings,
remaining challenges, and commitment to fully implement the statute.
II. Changes Since DSHEA
There have been many changes in the size and scope of the industry and the consumers
using dietary supplements, since 1994. Let me briefly outline some of these changes. The
dietary supplement industry has grown exponentially since the passage of DSHEA. Surveys
show that more than half of the U.S. adult population uses dietary supplement products.
Annually, consumers spend approximately $12 billion on dietary supplements,
according to Nutrition Business Journal in their 1998 Annual Industry Overview.
Just as the industry and consumption have grown, access also has changed. In the past,
except for vitamin and mineral products, dietary supplements, particularly botanical
products were available mainly in health food stores. These products were marketed
principally to adults. Now such products are available in supermarkets and other retail
stores, and even via the Internet. This makes dietary supplements readily available to
children and adolescents, as well as to adults. While many of these changes would appear
to be consistent with the expectations and intent of DSHEA, they nevertheless present new
regulatory challenges.
- DSHEA
DSHEA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to define the
term "dietary supplement" and establish a regulatory framework for
dietary supplements. In doing so, Congress made 15 significant findings that emphasize the
importance of diet and nutrition, including dietary supplement use, in promoting health
and reducing the risk of disease. FDA acknowledges these findings. DSHEA provides for
broad access to dietary supplements for consumers and also recognizes that there is a need
for a rational regulatory framework that provides FDA authority to remove from the market
products that pose a "significant or unreasonable" risk to consumers or that are otherwise adulterated and to require that labeling for dietary supplements be accurate.
Congress defined "dietary supplement" to mean products that are intended to supplement the diet that contain one or more of certain dietary ingredients, such as:
- a vitamin or a mineral,
- an herb or other botanical,
- an amino acid,
- a dietary substance for use by man to supplement the diet by increasing the total
dietary intake, or
- a concentrate, metabolite, constituent, extract, or
- combination of the preceding ingredients, and, that meet other criteria specified in
Section 201(ff)(2)-(3).
Since Congress considered dietary ingredients marketed prior to passage of DSHEA to be
generally safe, dietary supplements containing these ingredients are permitted to be
freely marketed, just like regular foods (e.g., fresh fruits and vegetables). If a
supplement contains a new dietary ingredient that has not been in the food supply,
however, Congress required the manufacturer to notify FDA at least 75 days before
marketing, and to include in the notification the manufacturer’s basis for its
conclusion that a dietary supplement containing the ingredient will reasonably be expected
to be safe. There is no requirement that the firm wait for a safety determination from FDA
before marketing the product.
Should safety problems arise after marketing, DSHEA makes "adulterated" any
dietary supplement that creates a "significant or unreasonable" risk to
consumers, thereby subjecting it to FDA enforcement action. Further, in particularly
compelling cases, DSHEA allows the Secretary to ban a dietary supplement if she finds it
to be an "imminent hazard."
Finally, as a preventive measure, DSHEA grants FDA explicit authority to establish good
manufacturing practice (GMP) regulations for dietary supplements. Such regulations would
be intended to establish a mechanism to help assure purity and consistency in dietary
supplement products.
Regarding labeling, DSHEA seeks to provide consumers with information to help guide
personal choice. This includes specially tailored requirements for ingredient labeling and
nutrition labeling.
DSHEA also provides for use of claims to affect the structure or function of the body,
claims of general well-being from consumption of a nutrient or dietary ingredient, and
claims of benefits related to classical nutrient deficiency diseases. These claims require
notification to FDA within 30 days after marketing, must be substantiated, and must be
accompanied by the disclaimer: "This statement has not been evaluated by the FDA.
This product is not intended to diagnose, treat, cure, or prevent any disease."
Finally, DSHEA contains ground rules for publications used in connection with the sale
of dietary supplements.
IV. FDA’s Role in Implementation of DSHEA
In its initial efforts under DSHEA, the Agency concentrated on promulgating the many
regulations mandated by DSHEA and began a number of other regulatory actions to establish
the framework for implementation of the new statute. Since passage of DSHEA, FDA has
published 25 Federal Register notices regarding dietary supplements (see Appendix).
Let me briefly discuss a few specific DSHEA regulatory actions we have taken.
- Supplement Facts: On September 23, 1997, FDA published a final rule in the Federal
Register implementing the nutrition labeling provisions of DSHEA. As of March 23,
1999, the effective date of the regulation, all dietary supplements must bear nutrition
information entitled "Supplement Facts." This labeling is similar to nutrition
content labeling for conventional foods but is tailored to the special characteristics of
dietary supplements.
- Good Manufacturing Practice: On February 6, 1997, FDA published in the Federal
Register an Advance Notice of Proposed Rulemaking requesting comment on whether FDA
should institute rulemaking to develop current GMP regulations for dietary supplements and
dietary ingredients. In February 1998, we asked our Food Advisory Committee to establish a
working group to assist us in defining GMP for dietary supplements. While we have not
moved as rapidly on this rulemaking as we might have, the Agency is committed to
accelerating the development and implementation of GMP regulations. I have made it one of
my priorities. The general view we have received is that GMP regulations would be a useful
tool for both the industry and the Agency. By including GMP regulations in the overall
priority-setting strategy, we recognize the importance of such regulations as an effective
mechanism for consumer protection. As noted earlier, such regulations would help assure
the purity and consistency of dietary supplement products.
- Structure/Function: On April 29, 1998, FDA published in the Federal Register, and
sought public comment on, a proposed rule defining the types of statements that can be
made concerning the effect of a dietary supplement on the structure or function of the
body. This action is intended to implement the provisions of DSHEA that permit
structure/function claims but prohibit claims to treat or prevent disease. The comment
period closed on September 28, 1998, and the Agency received over 100,000 comments, many
of which addressed the proposed definition of disease. The Agency currently is reviewing
each of the comments, and we will re-evaluate each of the elements of the proposed rule in
light of these comments.
- Authoritative Statement Health Claims: On January 21, 1999, FDA published a proposed
rule in the Federal Register to permit the use of health claims based on
authoritative statements for dietary supplements under the notification procedures
established in FDAMA. This proposal tracks the language of Section 303 of FDAMA and would
place dietary supplements on an equal footing with conventional foods with respect to
health claims based on authoritative statements. On May 11, 1999, a public meeting is
planned to gather stakeholder input on the proposal and other issues relating to the
Agency’s implementation of Sections 303 and 304 of FDAMA.
Many of the proposals referenced in the Appendix, or above, are open rulemakings that
are still in progress.
Mr. Chairman, notwithstanding our actions to date, I want to acknowledge that FDA still
has a long way to go to achieve full implementation of DSHEA. I assure you that as the new
Commissioner of Food and Drugs, I am focusing attention on dietary supplements, an issue
that is currently a priority for FDA’s Center for Food Safety and Applied Nutrition
(CFSAN).
Last month, CFSAN published a 1999 program priorities document which includes on its
"A" list completion of an overall dietary supplement strategy by the end of the
year. The Agency is committed to developing an overall strategy for achieving effective
regulation of dietary supplements under DSHEA, and in doing so, to provide ample
opportunity for stakeholder input. In developing its strategy for implementing DSHEA, the
Agency will be guided not only by the basic tenets of DSHEA, but also by the priorities I
articulated earlier that include commitment to the Agency’s mission for promoting and
protecting the public health and basing our regulatory decisions on sound science.
The dietary supplement strategy will address all elements of the dietary supplement
program, including:
- definitional boundaries between dietary supplements and conventional foods, between
dietary supplements and drugs, and between dietary supplements and cosmetics;
- claims;
- good manufacturing practice regulations;
- adverse event reporting, review, and follow-up;
- laboratory capability;
- research needs;
- enforcement; and
- resource needs.
CFSAN also is committed to enhancing outreach efforts to stakeholders to assure
effective communication as we move forward with the development and implementation of this
strategy.
Mr. Chairman, I think important progress has been made towards achieving the central objective of DSHEA: that of assuring consumer access to safe dietary supplements. At the same time, none of us could have
foreseen the great increase in products claiming to be dietary supplements promoted on the
Internet and elsewhere. A small but disturbing number of these products have a potential
for harm or bear unsupported claims. In this context, a rapidly expanding industry and a
changing demographic of consumers eager to manage their own health care needs provide a
significant regulatory challenge.
Just as the Agency is committed to implementing DSHEA fully and ensuring consumers have
access to dietary supplements, FDA also is committed to quickly removing unsafe products
from the market or taking other timely actions to protect consumers. FDA has tools at its
disposal to take enforcement actions against dietary supplements found to have safety,
labeling, or other violations of the FD&C Act, as amended by DSHEA. The Agency has
used a variety of regulatory tools from enforcement actions to rulemaking, when it has found dietary supplements that cause safety concerns. A good example is digitalis-contaminated plantain.
After being notified of a young woman with life-threatening abnormal heart function who
required hospitalization for six days, FDA conducted an investigation. The Agency detected
the botanical Digitalis lanata in samples of raw material labeled
"plantain" that was an ingredient in one of the dietary supplement products used
by this young woman. Digitalis is a powerful heart stimulant whose effects may include
nausea, vomiting, dizziness, headache, confusion, hypotension (low blood pressure), vision
disturbances, and abnormal heart rate and rhythm.
FDA then traced all uses of the contaminated ingredient and asked manufacturers and
retailers to recall these products from the market. FDA issued several press releases in
May and June 1997 warning consumers not to purchase or ingest certain dietary supplement
products labeled as containing plantain because these products might contain Digitalis
lanata, a plant that can cause life-threatening heart reactions, including cardiac
arrest, if ingested. In the press releases, FDA listed the names of distributors,
manufacturers, and retailers, as well as the products involved, and urged consumers to
obtain updates from FDA’s Consumer Hotline and FDA’s "Foods" website.
Fast and effective actions by FDA prevented serious adverse effects, which would likely
have occurred if these contaminated products had remained in the marketplace.
IV. Challenges
A. Boundaries
Before Congress passed DSHEA, dietary supplements (including vitamins and minerals)
were regulated either as foods or as drugs, depending on their intended use. If a product
was used primarily for its taste, aroma, or nutritive value, it was regulated as a food.
This meant that the ingredients used in such dietary supplements were subject to the food
additive provisions of the FD&C Act, which require the safety of an ingredient to be
demonstrated before it can be marketed. The supplement was subject to regulation as a drug
if therapeutic claims were made, i.e., claims to treat or prevent disease; if claims were
made to affect the structure or function of the body through a non-nutritive mechanism; or
if there was other evidence that the intended use of the product was as a drug. The
supplement, with such claims, would have to meet the rigorous drug safety and efficacy
requirements of the FD&C Act, including, in the great majority of cases, premarket
approval.
When Congress passed DSHEA, it created a regulatory framework for dietary supplements
that previously did not exist. The purpose of creating this new framework was to strike
the right balance between providing consumers access to both products and truthful
information about the products while retaining authority for FDA to take action against
products that present safety problems or are improperly labeled. We are now engaged in the
difficult task of delineating boundaries between drugs, dietary supplements, and
conventional foods. This is a task that requires great care if the Agency is to fulfill
Congressional intent with regard to the availability of dietary supplements while
preserving the established food additive and drug regulatory frameworks for products that
fall outside the dietary supplement boundaries.
For example, Congress has permitted dietary supplements to be intended to affect the
structure or function of the body, but it has not permitted dietary supplements to be
intended to treat, prevent, mitigate, cure, or diagnose disease, except that dietary
supplements may bear authorized health claims. DSHEA required FDA to draw a line between
two types of intended use that the Agency never needed to distinguish previously. Congress
also drew a line between conventional foods and dietary supplements by saying that a
dietary supplement may not be represented for use as a conventional food. This boundary,
too, raises many complex issues that the Agency is responsible for clarifying.
Aspects of DSHEA’s dietary supplement definition that have proven especially
problematic to implement are the statute’s limitation of dietary supplements to
products that are intended to supplement the diet and its inclusion of dietary
substance[s] for use by man to supplement the diet as dietary ingredients that may be used
in dietary supplements. It is clear that the dietary ingredients specifically listed in
DSHEA (vitamins, minerals, herbs or other botanicals, and amino acids) were intended by
Congress to be broadly available under DSHEA, and many of these have a long history of
safe use. Products are now being positioned as dietary supplements, however, by purporting
to fall within the "dietary substance" language. The terms "dietary
substance" and "intended to supplement the diet" are broad, but they must
not allow the inclusion of ingredients never intended to fit within the universe of
dietary supplements. Now, products that contain substances similar to those found in
prescription drugs are marketed for children as dietary supplements. Likewise, products
with ingredients that simulate illicit street drugs are marketed as dietary supplements to
adolescents via the Internet and shops specializing in drug paraphernalia. FDA is working
toward a solution that will be consistent with the intent of DSHEA.
B. Claims
DSHEA also amended the FD&C Act to permit certain types of claims for dietary
supplements that formerly would have made them drugs, including claims to affect the
structure or function of the body through a non-nutritive mechanism. Congress recognized
that if foods and dietary supplements were permitted to make disease treatment and
prevention claims without premarket review, the burden would have been on consumers to
evaluate the validity of a myriad of claims about products marketed for serious and
life-threatening conditions. In addition, dietary supplements would be given an unfair
advantage over prescription and over-the-counter drugs in the marketplace.
Thus, as I have noted above, the Agency issued a proposed rule intended to provide
direction to the industry as to the types of statements that can be made concerning the
effect of a dietary supplement on the structure or function of the body and to clarify the
line between disease and structure/function claims. This is important because disease
claims for drugs as well as for conventional foods and dietary supplements continue to
require pre-market authorization by FDA.
For foods, including dietary supplements, disease claims are "health claims."
These claims describe the relationship between a food substance and a disease. The claim
is usually in the context of risk reduction of the disease. Any person or firm may
petition FDA to authorize a health claim. FDA then reviews the scientific evidence for or
against the claim. If the Agency finds that the claim is supported by significant
scientific agreement among qualified experts, it will issue a regulation authorizing the
claim. Recently, FDAMA authorized a second method for streamlined review of health claims.
This involves the use of authoritative statements made by certain federal scientific
bodies and the National Academy of Sciences in their publications. With this latter
method, an interested party notifies FDA of its intent to make a health claim based on an authoritative statement and provides information as to the source of the statement.
C. Safety
With the passage of DSHEA, dietary supplements are deemed to be foods, except for
purposes of the drug definition. In addition, Congress specifically excluded "dietary
ingredients" in dietary supplements from the definition of "food additive."
As a result, dietary ingredients used in dietary supplements no longer require premarket
documentation of safety for submission to FDA unless they are new dietary ingredients
subject to the notification requirement in Section 413(a)(2) of the FD&C Act. The
notification requirement stipulates that the manufacturer or distributor of the dietary
supplement submit to FDA information which is the basis on which the manufacturer or
distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably
be expected to be safe at least 75 days before marketing.
Because in most cases dietary supplement manufacturers are not required to provide
safety information to FDA before marketing a product, FDA has the responsibility for
gathering information before the Agency can take action to restrict the sale of a dietary
supplement product for safety reasons. This means that the Agency must rely on adverse
event reports, product sampling, information in the scientific literature, and other
sources of evidence. The Agency’s scientists have to determine whether a safety
problem exists, and evidence adequate to support a regulatory action has to be gathered
and assembled. As is the case whenever the Agency considers regulatory action against a
product, it must take care to ensure that statutory requirements for an action against a
dietary supplement are met. This process is often complex and warrants being thoughtful
but timely.
VI. Conclusion
Mr. Chairman, I share the goal of making safe products available to consumers who want
to make informed personal choices about using dietary supplements to improve their health.
DSHEA was enacted to ensure access to those products. I also believe DSHEA provides FDA
with the necessary legal authority to protect the public health. We will do our best to
marshal the scientific information and expertise necessary to exercise that authority when
the public health is threatened.
The dietary supplement industry sells products on which millions of Americans rely. I
am aware that in the past the relationship between FDA and some in the dietary supplement
industry has been at times antagonistic and counterproductive. FDA is committed to
developing a positive working relationship with the industry so we may together meet our
goals of providing safe products to the American public.
The statute is still in the early stages of implementation, and I look forward to
working with Congress and other interested parties to ensure that resource constraints or
other issues do not impede FDA’s ability to use this statutory authority most
effectively.
I would be happy to respond to any questions the Committee may have.
