[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3414 Introduced in Senate (IS)]
111th CONGRESS
2d Session
S. 3414
To ensure that the Dietary Supplement Health and Education Act of 1994
and other requirements for dietary supplements under the jurisdiction
of the Food and Drug Administration are fully implemented and enforced,
and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 25, 2010
Mr. Harkin (for himself and Mr. Hatch) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To ensure that the Dietary Supplement Health and Education Act of 1994
and other requirements for dietary supplements under the jurisdiction
of the Food and Drug Administration are fully implemented and enforced,
and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Dietary Supplement Full
Implementation and Enforcement Act of 2010''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Each year, more than 150,000,000 Americans regularly
consume dietary supplements to maintain and improve their
health.
(2) Consumer expenditures on dietary supplements exceeded
$25,000,000,000 in 2008.
(3) Given the growing awareness of the importance of
prevention and wellness in the health care system of the United
States, it is vital that laws governing the safety of, and
education about, dietary supplements be fully implemented and
enforced.
(4) In 1994, Congress approved, and the President signed
into law, the Dietary Supplement Health and Education Act of
1994 (Public Law 103-417) (referred to in this Act as
``DSHEA''). DSHEA balanced the importance of continuing
consumer access to vitamins, minerals, and other dietary
supplements, promoting scientific research on the benefits and
risks of dietary supplements, and fostering public education on
the benefits and risks of supplement use with the need for
regulatory safeguards to protect consumer health, including a
new standard for safety, penalties for mislabeled or
adulterated dietary supplements, rules to ensure scientific
substantiation of the claims made regarding dietary
supplements, and a notification requirement to the Food and
Drug Administration before dietary supplements that contain
certain new dietary ingredients may be marketed.
(5) DSHEA requires that claims made on dietary supplement
labels, packaging, and accompanying material be truthful, non-
misleading, and substantiated. Manufacturers are prohibited
from making claims that products are intended to diagnose,
treat, mitigate, cure, or prevent a disease.
(6) DSHEA requires that dietary supplements comply with
good manufacturing practice (referred to in this section as
``GMP'') requirements, and authorizes the Food and Drug
Administration to establish such requirements.
(7) In 2007, after many years of delay, the Food and Drug
Administration published regulations detailing the GMP
requirements for dietary supplements, including requirements
for identity, purity, strength, sanitary conditions, and
recordkeeping. The Food and Drug Administration began to
enforce those requirements in 2008.
(8) DSHEA requires that, before marketing a dietary
supplement containing certain new dietary ingredients, the
manufacturer or distributor must submit notice to the Food and
Drug Administration that includes information showing that the
dietary supplement will reasonably be expected to be safe.
According to the Food and Drug Administration, the Food and
Drug Administration has raised objections to more than 70
percent of all new dietary ingredient notifications submitted
to the agency.
(9) The Food and Drug Administration has successfully used
the adulteration provisions of DSHEA to remove from the
marketplace dietary supplements that present an unreasonable
risk of injury or illness.
(10) In 2002, Congress passed the Public Health Security
and Bioterrorism Preparedness and Response Act (Public Law 107-
188). This law requires any facility engaged in manufacturing,
processing, packing, or holding food for consumption in the
United States, including dietary supplements, to be registered
with the Food and Drug Administration.
(11) In 2006, Congress supplemented DSHEA by approving the
Dietary Supplement and Nonprescription Drug Consumer Protection
Act (Public Law 109-462). This law requires dietary supplement
manufacturers, packers, and distributors to report promptly to
the Food and Drug Administration any reports the manufacturer
or other responsible person receives of serious adverse events
associated with the use of the products of such manufacturer or
other responsible person. Information the Food and Drug
Administration receives under this reporting requirement may
help the agency detect possible safety problems related to
dietary supplement products or ingredients.
(12) DSHEA created the Office of Dietary Supplements within
the National Institutes of Health to expand research and
consumer information about the health effects of dietary
supplements. The Office of Dietary Supplements has greatly
expanded the number of scientific studies of dietary
supplements and the availability of reliable information to
consumers.
(13) While the Food and Drug Administration has taken some
important steps to implement and enforce DSHEA and the other
laws governing the regulation of dietary supplements, the
agency has not fully implemented and enforced DSHEA and the
other laws governing the regulation of dietary supplements.
(14) Both the public and regulated industry would benefit
from more guidance from the Food and Drug Administration on the
procedures and definitions concerning the regulation of new
dietary ingredients under section 413 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 350b).
(15) If the Food and Drug Administration determines that a
product labeled as a dietary supplement includes an anabolic
steroid or an analogue of an anabolic steroid, the Food and
Drug Administration does not systematically notify the Drug
Enforcement Administration of that determination.
(16) The Food and Drug Administration needs adequate
resources to implement and enforce DSHEA and other laws
governing the regulation of dietary supplements appropriately.
Congress has appropriated additional funds over the last
several years to implement and enforce DSHEA, reaching more
than $14,000,000 for fiscal year 2009.
(17) According to the Food and Drug Administration, full
implementation of DSHEA and the other laws governing the
regulation of dietary supplements would require substantial
additional resources. In 2002, the Food and Drug Administration
reported to Congress in writing that the agency would need
between $24,000,000 and $65,000,000 per year to fully implement
DSHEA.
SEC. 3. SENSE OF CONGRESS.
It is the sense of Congress that:
(1) The Food and Drug Administration should increase
efforts to implement DSHEA more fully and effectively, by--
(A) providing Congress with a professional judgment
estimate of the annual costs during the 5-year period
beginning on the date of enactment of this Act to fully
implement and enforce DSHEA and other dietary
supplement laws and regulations under the jurisdiction
of the Food and Drug Administration;
(B) conducting inspections, using appropriately
trained inspection personnel, of all facilities in
which a dietary supplement is manufactured, processed,
packed, or held to ensure compliance with the new
dietary supplement good manufacturing practices
regulations;
(C) using the authority under DSHEA to protect the
public from unsafe dietary supplement products and
ingredients and to ensure that claims made are
truthful, non-misleading, and substantiated, with
highest regulatory priority given to cases of clear
violations of the law (including the intentional
adulteration and spiking of products);
(D) implementing the recommendations contained in
the January 2009 report of the Government
Accountability Office, entitled, ``Dietary Supplements:
FDA Should Take Further Actions To Improve Oversight
and Consumer Understanding'', (GAO 09-250) that the
Food and Drug Administration--
(i) require all dietary supplement
manufacturers, packers, and distributors to
identify themselves specifically as such under
existing registration requirements and to
update such information annually;
(ii) promptly issue guidance to clarify
when a dietary supplement ingredient is a new
dietary ingredient, the evidence needed to
document the safety of new dietary ingredients,
and appropriate methods for establishing the
identity of a new dietary ingredient; and
(iii) coordinate with stakeholder groups
involved in consumer outreach to identify,
implement, and evaluate the effectiveness of
additional mechanisms for educating consumers
about the safety, efficacy, and labeling of
dietary supplements; and
(E) notifying the Drug Enforcement Administration
if the Food and Drug Administration determines that the
information in a new dietary ingredient notification
submitted under section 413 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350b) is inadequate to
establish that the new dietary ingredient will
reasonably be expected to be safe, because the dietary
supplement may contain an anabolic steroid or an
analogue of an anabolic steroid.
(2) The manufacturers, packers, retailers, and distributors
of dietary supplements and dietary supplement ingredients
should increase efforts to--
(A) comply fully with all requirements of DSHEA and
the Dietary Supplement and Nonprescription Drug
Consumer Protection Act;
(B) cooperate fully and appropriately with the Food
and Drug Administration in implementation and
enforcement of Federal laws and regulations; and
(C) provide the Food and Drug Administration with
appropriate input on known and suspected violations of
such laws and regulations.
SEC. 4. AUTHORIZATION OF APPROPRIATIONS AND ALLOCATION OF RESOURCES.
(a) Authorization of Appropriations.--There are authorized to be
appropriated to carry out the Dietary Supplement Health and Education
Act of 1994, the amendments made by such Act, and other provisions
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
that apply to dietary supplements, $30,000,000 for fiscal year 2011 and
such sums as may be necessary for each of fiscal years 2012 through
2014.
(b) Allocation of Funds for Fiscal Year 2010.--From funds
appropriated to the Food and Drug Administration for fiscal year 2010
for the purpose of enhancing food safety, not less than $20,000,000
shall be expended to effectively and fully implement and enforce the
Dietary Supplement Health and Education Act of 1994, the amendments
made by such Act, and other provisions under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) that apply to dietary
supplements.
(c) Office of Dietary Supplements.--There are authorized to be
appropriated for expanded research and development of consumer
information on dietary supplements by the Office of Dietary Supplements
at the National Institutes of Health--
(1) $40,000,000 for fiscal year 2010; and
(2) such sums as may be necessary for each of the fiscal
years 2011 through 2014.
SEC. 5. ANNUAL ACCOUNTABILITY REPORT ON THE REGULATION OF DIETARY
SUPPLEMENTS.
(a) In General.--Not later than January 31, 2011, and annually
thereafter, the Secretary of Health and Human Services shall submit a
report to Congress on the implementation and enforcement of the Dietary
Supplement Health and Education Act of 1994 and the amendments made by
such Act.
(b) Contents.--The report under subsection (a) shall include the
following:
(1) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to
dietary supplement regulation during the prior fiscal year.
(2) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to
administering adverse event reporting systems, as such systems
relate to dietary supplement regulation, during the prior
fiscal year.
(3) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to
enforcement of dietary supplement labeling and claims
requirements during the prior fiscal year and a brief
explanation of the activities of such personnel.
(4) The total funding and number of full-time equivalent
personnel in the Food and Drug Administration dedicated to the
review and enforcement of good manufacturing practice
requirements with respect to dietary supplements during the
prior fiscal year.
(5) The number of inspections at which the Food and Drug
Administration evaluated or reviewed the compliance of a
manufacturer with good manufacturing practices for dietary
supplements during the prior fiscal year, and the number of
times the Food and Drug Administration issued a warning letter
because it determined that such manufacturer was not in
compliance with some aspect of such requirements.
(6) The number of new dietary ingredient notification
reviews that the Food and Drug Administration performed during
the prior fiscal year and the number of times the Food and Drug
Administration objected to the marketing of the dietary
supplement described in such notification reviews.
(7) The number of times the Food and Drug Administration
issued a warning letter or initiated an enforcement action
against a manufacturer or distributor for failure to file a new
dietary ingredient notification as required under section 413
of the Federal Food, Drug, and Cosmetic Act.
(8) A brief summary and explanation of all enforcement
actions taken by the Food and Drug Administration and the
Department of Health and Human Services related to dietary
supplements during the prior fiscal year, including the number
and type of actions.
(9) The number of times the Food and Drug Administration
requested substantiation of dietary supplement claims from a
manufacturer during the prior fiscal year, the number of times
a manufacturer refused to provide such information, and the
response of the agency in such situations.
(10) The number of dietary supplement claims determined by
the Food and Drug Administration during the prior fiscal year
to be false, misleading, or not substantiated, and a
description of the follow-up action taken by the agency in such
instances.
(11) The research and consumer education activities
supported by the Office of Dietary Supplements of the National
Institutes of Health during the prior fiscal year.
(12) Any recommendations for administrative or legislative
actions to improve the regulation of dietary supplements.
(13) Any other information regarding the regulation of
dietary supplements determined appropriate by the Secretary of
Health and Human Services or the Commissioner of Food and
Drugs.
SEC. 6. NEW DIETARY INGREDIENTS.
(a) Guidelines for Introducing New Dietary Ingredients.--Section
413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is
amended--
(1) by redesignating subsection (c) as subsection (e); and
(2) by inserting after subsection (b) the following:
``(c) Guidelines.--Not later than 180 days after the date of
enactment of the Dietary Supplement Full Implementation and Enforcement
Act of 2010, the Secretary shall publish guidance that clarifies when a
dietary supplement ingredient is a new dietary ingredient, when the
manufacturer or distributor of a dietary ingredient or dietary
supplement should provide the Secretary with information as described
in subsection (a)(2), the evidence needed to document the safety of new
dietary ingredients, and appropriate methods for establishing the
identity of a new dietary ingredient.
``(d) Notification to DEA.--
``(1) In general.--If the Secretary determines that the
information in a new dietary ingredient notification submitted
under this section for an article purported to be a new dietary
ingredient is inadequate to establish that a dietary supplement
containing such article will reasonably be expected to be safe
because the article may be, or may contain, an anabolic steroid
or an analogue of an anabolic steroid, the Secretary shall
notify the Drug Enforcement Administration of such
determination. Such notification by the Secretary shall
include, at a minimum, the name of the product or article, the
name of the person or persons who marketed the product or made
the submission of information regarding the article to the
Secretary under this section, and any contact information for
such person or persons that the Secretary has.
``(2) Definitions.--For purposes of this subsection--
``(A) the term `anabolic steroid' has the meaning
given such term in section 102(41) of the Controlled
Substances Act; and
``(B) the term `analogue of an anabolic steroid'
means a substance whose chemical structure is
substantially similar to the chemical structure of an
anabolic steroid.''.
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