TESTIMONY for the March 24, 2004 HEARING:

"10 Years after the Implementation of DSHEA: The Status of Dietary
Supplements in the United States"

Subcommittee on Human Rights and Wellness

#### Committee on Government Reform

2157 Rayburn House Office Building

Washington, DC 20515-6143

Prepared by:

Annette Dickinson, Ph.D.

President

Council for Responsible Nutrition

1828 L Street, N.W., Suite 900

Washington, DC 20036-5114

Mr. Chairman and members of the Committee, thank you for the opportunity
to testify before the Committee on Government Reform, Subcommittee on
Human Rights and Wellness - 10 Years After the Implementation of DSHEA:
The Status of Dietary Supplements in the United States. My name is
Annette Dickinson and I am the president of the Council for Responsible
Nutrition (CRN).

CRN represents the mainstream core of the dietary supplement industry,
including suppliers of dietary supplement ingredients as well as
manufacturers and marketers of branded and private label products
available to consumers through all distribution channels \-- mass
market, health food stores, mail order, and direct sales. CRN members
adhere to a strong code of ethics, comply with dosage limits and
manufacture dietary supplements to high quality standards under good
manufacturing practices.

**[Introduction]{.underline}**

The Dietary Supplement Health and Education Act was passed in 1994 for
two primary reasons: to ensure that consumers would continue to have
access to a wide variety of safe dietary supplements and to provide
consumers with more information about the dietary supplements they
purchase.

The past 10 years have demonstrated that these purposes are being
fulfilled, as are other goals established by the law.

# Access to Products

In 1993, FDA published an Advance Notice of Proposed Rulemaking
suggesting numerous restrictions that might be placed on dietary
supplements, including

-   Limiting the dosage of vitamins and minerals to a small multiple of
    the RDA,

-   Not permitting the sale of dietary supplements containing amino
    acids,

-   Treating most herbs and botanicals as inherently therapeutic and
    restricting them to sale as drugs.

DSHEA was passed in part to avoid these arbitrary restrictions, by
establishing a broad and specific definition listing several classes of
permissible dietary supplement ingredients. Today, consumers have access
to a wide variety of safe dietary supplements, and category sales have
continued the steady rate of increase they have enjoyed since at least
the 1970s. Thus, DSHEA has been successful in assuring broad consumer
access.

# Access to Information

In order to provide consumers with more information about the uses of
dietary supplements, DSHEA permitted marketers to make Statements of
Nutritional Support, including structure/function statements \-- that
is, statements describing how a product affects the structure or
function of the body. These statements may be used in labeling, subject
to the following provisions:

-   The marketer must have substantiation that the statement is truthful
    and not misleading.

-   FDA must be notified within 30 days that the statement is being
    made.

-   The product label must include a disclaimer that distinguishes the
    statement from FDA-approved health claims and from FDA-approved drug
    claims.

Companies began using Statements of Nutritional Support as soon as DSHEA
was passed, and FDA issued extensive rules on structure/function
statements in January 2000. As of today, more than 10,000 letters of
notification have been submitted to FDA, and the agency has responded to
about 10% of the statements with "courtesy letters" advising companies
that the claim submitted was not appropriate, either because FDA viewed
it as a disease claim or because the product involved was not in fact a
dietary supplement.

The ten most commonly utilized types of structure/function statements in
the marketplace have to do with immune function, heart health,
antioxidant effects, gastrointestinal function, healthy joints,
cognitive function, men's health issues, weight loss or metabolism,
energy or endurance, and women's health issues. Consumers have a vital
interest in receiving more information about these topics, and DSHEA was
successful in devising a means of providing that information in product
labeling.

# Nutrition Labeling

In its implementation of the Nutrition Labeling and Education Act, FDA
initially proposed to require companies to label dietary supplements as
though they were conventional foods. Under this proposal, herbal
products for example would have been required to show the amount of
protein, fat, and carbohydrate in the product, even though all three
values would almost always be zero. Further, those herbal products would
not have been permitted to list any of their active components, but
would have been required to show the amount of vitamins A and C and the
amount of calcium and iron they contained. A product like glucosamine
and chondroitin sulfate would have been subject to similar requirements.
Since this approach would not have provided consumers with useful
information about dietary supplements other than vitamin and mineral
products, DSHEA required FDA to reconsider its approach to nutrition
labeling for dietary supplements and to develop a more appropriate
system. DSHEA further specified that the new system must permit the
inclusion in the Facts Box of components other than vitamins and
minerals.

FDA developed a revised approach, as required by DSHEA, and published
final regulations on nutrition labeling for dietary supplements in
September 1997. These regulations permit all relevant components to be
listed in the "Supplement Facts" box, following the list of
macronutrients and micronutrients, if any are present. Thus, DSHEA
succeeded in the goal of creating a nutrition labeling format
appropriate to the types of ingredients and components utilized in
dietary supplements.

# Good Manufacturing Practices

DSHEA authorized FDA to establish Good Manufacturing Practices (GMPs)
for dietary supplements, modeled after GMP regulations for foods. Until
such regulations are finalized, dietary supplements are subject to the
same GMPs that apply to conventional foods. The Council for Responsible
Nutrition (CRN) had earlier established GMP guidelines for its
membership, and those GMPs had formed the basis for the guidelines
adopted by the U.S. Pharmacopeia for nutritional supplements. After the
passage of DSHEA, CRN approached FDA officials and inquired whether they
intended to establish dietary supplement GMPs. They indicated they would
like to do so, but lacked in-house expertise and would appreciate input
from the industry. CRN convened a working group to draft appropriate
GMPs and invited other trade associations to join in this effort. In
November 1995, just over a year after the passage of DSHEA, the trade
associations submitted a comprehensive draft that FDA published in
February 1997 as an Advance Notice of Proposed Rulemaking. The proposal
languished until the current administration published an extensive and
problematic Proposed Rule in March 2003. Numerous comments were
submitted during the official comment period, and even after the comment
period several trade associations continued to work toward GMP language
that could be jointly supported. On January 30, 2004, CRN, the American
Herbal Products Association, and the National Nutritional Foods
Association submitted a joint proposal that included specific
recommended language for the GMPs. This document was also endorsed by
the Consumer Healthcare Products Association. FDA is currently
evaluating all the comments and is expected to issue a final rule in the
near future. The new GMPs will provide a strong framework for ensuring
the purity, identity, quality, strength and composition of dietary
supplements, and CRN is pleased to have been able to contribute to this
outcome by getting the ball rolling in 1995 and by submitting extensive
comments and participating in development of the joint submission in
2003 and 2004.

# New Ingredients

DSHEA "grandfathered" dietary supplement ingredients already on the
market as of October 1994, in the same way the 1958 food additive
amendments to the Food, Drug and Cosmetic Act "grandfathered" hundreds
of substances already being used in foods at the time those amendments
were adopted. DSHEA established a procedure that would be required for
new ingredients used in dietary supplements in the future. Companies are
now required to provide a notification to FDA regarding any new
ingredient at least 75 days before marketing it, setting forth the basis
for considering the ingredient to be "reasonably expected to be safe."
FDA has been receiving these notifications on a regular basis since the
passage of DSHEA and has been giving them serious attention. A recent
analysis by the American Herbal Products Association indicated that
there have been 138 unique notifications filed, of which FDA has
rejected 65, or almost half. The rejections are generally due to a
company's failure to sufficiently establish the identity of the
ingredient or a failure to provide sufficient information to provide a
basis for concluding that the ingredient is reasonably expected to be
safe.

# Commission on Dietary Supplement Labels

DSHEA mandated the appointment by the President of a Commission on
Dietary Supplement Labels, to provide advice to FDA on a number of
issues. The Commission was appointed in 1995, met for a period of two
years, and published its final report in November 1997. That report,
unfortunately, has been largely ignored but it provides useful guidance
that could still be helpful in defining, for example, the level of
substantiation that should be required for structure/function
statements. Among the seven members of the Commission were two highly
respected professors of nutrition (including the Chairman), the
country's leading professor of pharmacognosy, a prominent professor of
law who had previously served as an FDA counsel, and three persons
directly or indirectly associated with the industry, including myself.

# NIH Office of Dietary Supplements

DSHEA required the establishment within the National Institutes of
Health of an Office of Dietary Supplements (ODS), to encourage
additional research and to serve as a source of expertise for FDA on
issues relating to dietary supplements. This year, under the leadership
of Dr. Paul Coates, ODS has a budget of \$20 million to support an
aggressive research agenda relating to safety, benefits, and analytical
methods. ODS also supports six botanical research centers at leading
academic institutions and has sponsored numerous research conferences
highlighting the evidence available regarding dietary supplements for
specific populations such as women or the elderly or for particular
purposes such as performance enhancement. Thus, DSHEA succeeded in
creating a powerful mechanism within NIH for increasing research
attention to dietary supplements and for engaging leading academic
institutions in the task.

# Problem Ingredients

The biggest problems for the industry in the decade since the passage of
DSHEA are only two in number, but these two have led to criticism so
widespread as to undermine consumer confidence in the dietary supplement
category as a whole. These are:

-   The failure to resolve the issues surrounding ephedra until just
    this year, and

-   The absence of action restricting the marketing of steroid hormone
    precursors until just this year.

FDA has recently finalized a regulation declaring ephedra products to be
adulterated, using new authority provided under DSHEA to declare a
product adulterated if it poses a "significant or unreasonable" risk of
illness or injury. A legal challenge has been filed against the rule,
and the courts will soon decide whether FDA's rule is appropriate. Also,
legislation has been introduced in both the Senate and the House that is
expected to pass this year and that will classify androstenedione and a
number of related substances as controlled substances. It is to be hoped
that these actions will bring these issues to a resolution.

**[What Remains to be Done?]{.underline}**

DSHEA brought about a meaningful change in the way dietary supplements
were regulated. Dietary supplements have always been regulated as a
subcategory of foods, and DSHEA reaffirmed the appropriateness of this
classification, but within the food category specific provisions were
created for dealing with the unique aspects of dietary supplement
regulation. FDA has implemented some of the provisions of DSHEA through
extensive regulations on nutrition labeling for dietary supplements, on
structure/function statements used for dietary supplements, and on GMPs
for dietary supplements. It cannot be said, however, that DSHEA has been
fully implemented as of this tenth year following its passage.

DSHEA requires that companies submit notifications before marketing new
ingredients, and those notifications must include information about the
safety of the ingredients. FDA has been evaluating these submissions in
a meaningful way, but there is no indication that the agency is
monitoring the marketplace to ensure that new ingredients are not
introduced without the filing of such notifications. This is an area
that needs additional attention.

DSHEA permits marketers to use structure/function statements to describe
the effects of dietary supplements, but also requires the companies to
have substantiation that the statements are truthful and not misleading.
The industry and the agency need to pay more attention to establishing
guidance about the kind of substantiation needed. The Commission on
Dietary Supplement Labels suggested that the substantiation be made
public, in order to provide health professionals and consumers with more
information about the basis of the claims, and this is a proposal worthy
of further consideration.

One serious remaining challenge for the industry and for FDA is to put a
stop to the marketing of street-drug knockoffs masquerading as dietary
supplements. The agency has taken a number of actions against such
products, but no sooner is one challenged than another emerges. There is
a need for the industry and the agency to develop a highly visible
partnership to attack this problem, in order to protect young people
from unscrupulous marketers.

It is to be ardently hoped that the industry's second decade under DSHEA
will be more peaceful than the first. With a few very difficult issues
now resolved or about to be brought to closure, the industry should have
an opportunity as it moves forward to focus on the good news about the
safety and benefits of most dietary supplements as positive components
of a healthy lifestyle.