Requires the Secretary of Health and Human Services, within 100 days of receiving such a claim, to promulgate regulations authorizing such claims in a form that accurately reflects the degree of scientific evidence supporting the claim, unless the Secretary determines that no scientific evidence supports such claim and that the claim is inherently misleading. Allows judicial review of claims denied by the Secretary. Allows on such labeling statements made by a scientific body of the U.S. Government about the relationship between a nutrient and a health-related condition. Prohibits the Secretary from denying claims based on such statements.
Approves the health claims references in the decision of the U.S. Court of Appeals for the District of Columbia in Pearson v. Shalala. Directs the Secretary to publish a notice granting each of such claims with the following disclaimer: "The Food and Drug Administration has determined that the evidence supporting this claim is inconclusive." Makes null and void: (1) the interim final rules concerning health claims based on the authoritative statement published in the Federal Register of June 22, 1998; and (2) all orders issued by the FDA after April 20, 1999, and before this Act, that have denied health claims. Requires reevaluation of claims included under such orders.
[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4604 Introduced in House (IH)]
106th CONGRESS
2d Session
H. R. 4604
To amend the Federal Food, Drug, and Cosmetic Act to compel Food and
Drug Administration compliance with the first amendment to the United
States Constitution and to protect freedom of informed choice in the
dietary supplement marketplace consistent with the decision of the
United States Court of Appeals for the District of Columbia Circuit in
Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g denied en
banc, 172 F.3d 72 (D.C. Cir. 1999).
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 8, 2000
Mrs. Chenoweth-Hage (for herself, Mr. Paul, Mr. Stump, Mr. McIntosh,
and Mr. Doolittle) introduced the following bill; which was referred to
the Committee on Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to compel Food and
Drug Administration compliance with the first amendment to the United
States Constitution and to protect freedom of informed choice in the
dietary supplement marketplace consistent with the decision of the
United States Court of Appeals for the District of Columbia Circuit in
Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g denied en
banc, 172 F.3d 72 (D.C. Cir. 1999).
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE.
(a) Short Title.--This Act may be cited as the ``Consumer Freedom
Protection Act''.
(b) References.--Each amendment to or repeal of a section or other
provision of law that is made by this Act shall be considered to be an
amendment to or repeal of, respectively, that provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), unless another
public law is specified as being the subject of the amendment or
repeal.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The Food and Drug Administration has only authorized
three health claims for dietary supplements since enactment of
the Nutrition Labeling and Education Act of 1990 despite the
publication of tens of thousands of peer reviewed scientific
journal articles on the effect of nutrients on disease and
health-related conditions.
(2) Scientific information on the nutrient-disease
relationship contained in peer reviewed scientific journals is
indispensable to the exercise of informed choice in the food
and dietary supplement marketplaces.
(3) The Food and Drug Administration's failure to authorize
health claims has violated the first amendment rights of health
claimants and American consumers alike and is injurious to
public health because it denies consumers access to information
necessary to exercise informed choice at the point of sale.
(4) Contrary to the will of Congress, on repeated occasions
the Food and Drug Administration has denied and suppressed
health claims that would otherwise convey to consumers
important information on the association between nutrients and
diseases.
(5) Contrary to the will of Congress, the Food and Drug
Administration's treatment of dietary supplements and its
implementation of the Nutrition Labeling and Education Act of
1990 and the Food and Drug Administration Modernization Act of
1997 health claims provisions has hindered, rather than
fostered, the dissemination of truthful and nonmisleading
information about the nutrient-disease relationship.
(6) The Food and Drug Administration has failed to
implement faithfully and fully the first amendment mandate in
Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), and
continues to suppress, rather than authorize, health claims.
SEC. 3. FOOD AND DIETARY SUPPLEMENT CLAIMS.
(a) Conforming Amendments.--Section 403 (21 U.S.C. 343) is
amended--
(1) in paragraph (r)(1), by inserting ``or a dietary
supplement'' after ``food'' but before ``intended'' and by
inserting ``or dietary supplement'' after ``food'' but before
``which'';
(2) in paragraph (r)(1)(A), by inserting ``or dietary
supplement'' after ``food'';
(3) in paragraph (r)(1)(B), by inserting ``or dietary
supplement'' after ``food'' and by adding at the end of the
paragraph the following: ``For purposes of this subparagraph, a
claim that characterizes such a relationship includes claims to
diagnose, cure, mitigate, treat, or prevent any disease or
health-related condition.'';
(4) in paragraph (r)(2)(G), by inserting ``or dietary
supplement'' after ``food'';
(5) in paragraph (r)(2)(G)(iii), by inserting ``or dietary
supplement'' after ``food'';
(6) by striking subclause (iv) of subparagraph (r)(2)(G);
(7) by striking paragraph (r)(2)(H);
(8) in paragraph (r)(3)(A)(ii), by inserting ``or dietary
supplement'' after ``food'' but before ``for'';
(9) in paragraph (r)(3)(C), by inserting ``or dietary
supplement'' after ``food'';
(10) in paragraph (r)(3)(C)(iii), by inserting ``or dietary
supplement'' after ``food'';
(11) by striking subclause (iv) of paragraph (r)(3)(C);
(12) by striking subclause (A)(i) of paragraph (r)(4);
(13) by striking subclause (D) of paragraph (r)(5); and
(14) by striking subparagraph (7) of paragraph (r).
(b) Health Claims in General.--Section 403 (21 U.S.C. 343) is
amended in paragraph (r)(3) by amending clause (B) to read as follows:
``(B)(i) The Secretary shall promulgate no later than 100 days
after the Secretary receives a claim of the type described in
subparagraph (1)(B) regulations authorizing the claim in a form that
accurately reflects the degree of scientific evidence supporting the
claim unless the Secretary determines based on all publicly available
scientific evidence that no scientific evidence supports the claim and
that the claim is inherently misleading. The Secretary may require that
the claim be accompanied by a disclaimer disclosing the absence of
conclusive evidence, the presence of conflicting evidence, or such
other information about the claim as is needed to avoid a misleading
connotation.
``(ii) If within 100 days after the Secretary receives a claim, the
Secretary promulgates neither regulations authorizing the claim nor a
final decision denying the claim, the claim shall be deemed authorized
and shall be accompanied by the following disclaimer until such time as
the Secretary complies with the requirements of subparagraph (3)(B)(i):
`The Food and Drug Administration has not evaluated the scientific
evidence concerning this claim.'.
``(iii) If the Secretary denies a claim of the type described in
subparagraph (1)(B) and the claimant informs the Secretary in writing
that the claimant objects to the Secretary's denial, no later than 30
days after the Secretary receives the objection, the Secretary shall
file a petition to review the order with the United States Court of
Appeals for the D.C. Circuit, naming the claimant as a defendant and
seeking a declaratory judgment on whether the Secretary's denial
complies with subparagraph (3)(B)(i) and the first amendment to the
United States Constitution. For purposes of subparagraph (3)(B) the
United States Court of Appeals for the D.C. Circuit has exclusive
jurisdiction and venue. If the United States Court of Appeals for the
D.C. Circuit declares the Secretary's denial invalid, the Court shall
order the Secretary to pay the claimant from funds appropriated by
Congress to the Food and Drug Administration no later than 60 days
after the Court's decision is filed with the Clerk of the Court the
actual costs and fees incurred by the claimant for participating in the
proceedings before the United States Court of Appeals, exclusive of all
other recompense to which the claimant would otherwise be entitled
under Federal law.''.
(c) Health Claims Based on Government Statements.--Section 403 (21
U.S.C. 343) is amended by striking subclauses (i) and (ii) of paragraph
(r)(3)(C) and inserting the following:
``(i) the claim is a verbatim quotation of a statement
published by a scientific body of the United States Government
about the relationship between a nutrient, including a dietary
supplement, and a disease or health-related condition and
includes a citation to the author, the title of the
publication, the date of publication, and the page on which the
statement appears, provided that the claimant submits to the
Secretary a written notice of the exact words used in the claim
and of the citation at least 30 days before first introducing
the food or dietary supplement into interstate commerce with
the claim; or
``(ii) the claim paraphrases in a nonmisleading manner a
statement published by a scientific body of the United States
Government about the relationship between a nutrient and a
disease or health-related condition and includes a citation to
the author, the title of the publication, the date of
publication, and the page on which the statement appears,
provided that the claimant submits to the Secretary a written
notice of the exact words used in the claim and of the citation
at least 30 days before first introducing the food or dietary
supplement into interstate commerce with the claim; and''.
(d) Disclaimers for Health Claims Based on Government Statements.--
Section 403 (21 U.S.C. 343) is amended by adding at the end of
subclause (iii) of paragraph (r)(3)(C) the following: ``The Secretary
may not deny authorization of a claim made in compliance with the
provisions of subclause (i) or (ii) of clause (C) but may require that
the claim be accompanied by a disclaimer disclosing the absence of
conclusive evidence, the presence of conflicting evidence, or such
other information about the claim as is needed to avoid a misleading
connotation. The Secretary shall authorize use of the claim no later
than 100 days after the date it is submitted to the Secretary. If the
Secretary does not act to authorize the claim within 100 days after it
is submitted to the Secretary, the claim shall be considered
authorized.''.
(e) Nutrient Content Claims Based on Government Statements.--
Section 403 (21 U.S.C. 343) is amended by striking subclauses (i) and
(ii) of paragraph (r)(2)(G) and inserting the following:
``(i) the claim is a verbatim quotation of a statement published by
a scientific body of the United States Government which identifies the
nutrient level to which the claim refers and includes a citation to the
author, the title of the publication, the date of publication, and the
page on which the statement appears, provided that the claimant submits
to the Secretary a written notice of the exact words used in the claim
and of the citation at least 30 days before first introducing the food
or dietary supplement into interstate commerce with the claim; or
``(ii) the claim paraphrases in a nonmisleading manner a statement
published by a scientific body of the United States Government which
identifies the nutrient level to which the claim refers and includes a
citation to the author, the title of the publication, the date of
publication, and the page on which the statement appears, provided that
the claimant submits to the Secretary a written notice of the exact
words used in the claim and of the citation at least 30 days before
first introducing the food or dietary supplement into interstate
commerce with the claim; and''.
(f) Disclaimers for Nutrient Content Claims Based on Government
Statements.--Section 403 (21 U.S.C. 343) is amended by adding at the
end of subclause (iii) of paragraph (r)(2)(G) the following: ``The
Secretary may not deny authorization of a claim made in compliance with
the provisions of subparagraph (G)(i) or (G)(ii) but may require that
the claim be accompanied by a disclaimer containing such information
about the claim as is needed to avoid a misleading connotation.''.
(g) Definition of Published Statement.--Section 403 (21 U.S.C. 343)
is amended by adding at the end of paragraph (r)(2)(G) the following:
``For purposes of this clause, a statement published by a scientific
body of the United States is any statement contained in a document
available to the public published by any one or more United States
Government offices, departments, commissions, agencies, institutes,
centers, divisions, academies, or other subdivisions thereof.''.
SEC. 4. STATEMENTS OF NUTRITIONAL SUPPORT.
Section 403 (21 U.S.C. 343) is amended by striking the last
sentence of paragraph (r)(6).
SEC. 5. WITHDRAWAL OF ORDERS AND RULES; AUTHORIZATION OF SPECIFIC
CLAIMS.
(a) The health claims references in Pearson v. Shalala, 164 F.3d
650 (D.C. Cir. 1999) are approved. No later than 30 days after the
effective date of this Act, the Secretary of Health and Human Services
shall publish a notice in the Federal Register granting each of the
health claims referenced in that decision with the following
disclaimer: ``The Food and Drug Administration has determined that the
evidence supporting this claim is inconclusive.''.
(b) The interim final rules concerning health claims based on
authoritative statement published in the Federal Register of June 22,
1998 (63 Fed. Reg. 34084; 63 Fed. Reg. 34092; 63 Fed. Reg. 34097; 63
Fed. Reg. 34101; 63 Fed. Reg. 34104; 63 Fed. Reg. 34107; 63 Fed. Reg.
34110; 63 Fed. Reg. 34112; and 63 Fed. Reg. 34115) are null and void
and of no further force or effect. The health claims referenced therein
are approved. No later than 30 days after the effective date of this
Act the Secretary of Health and Human Services shall publish a notice
in the Federal Register revoking the interim final rules, declaring
them null and void and of no further force or effect, and granting each
of the health claims referenced therein with the following disclaimer:
``The Food and Drug Administration has determined that the evidence
supporting this claim is inconclusive.''.
(c) All orders issued by the Food and Drug Administration after
April 20, 1999, but before the effective date of this Act, that have
denied health claims are hereby null and void. The Food and Drug
Administration shall reevaluate those claims in accordance with the
provisions of this Act and the amendments made by this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Commerce.
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