[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.
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