I
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 Representa-
tives 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 amend-
ment or repeal.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The Food and Drug Administration has
only authorized three health claims for dietary sup-
plements since enactment of the Nutrition Labeling
and Education Act of 1990 despite the publication
of tens of thousands of peer reviewed scientific jour-
nal articles on the effect of nutrients on disease and
health-related conditions.
(2) Scientific information on the nutrient-dis-
ease relationship contained in peer reviewed sci-
entific journals is indispensable to the exercise of in-
formed choice in the food and dietary supplement
marketplaces.
(3) The Food and Drug Administration’s fail-
ure to authorize health claims has violated the first
amendment rights of health claimants and American
consumers alike and is injurious to public health be-
cause it denies consumers access to information nec-
essary to exercise informed choice at the point of
sale.
(4) Contrary to the will of Congress, on re-
peated occasions the Food and Drug Administration
has denied and suppressed health claims that would
otherwise convey to consumers important informa-
tion on the association between nutrients and dis-
eases.
(5) Contrary to the will of Congress, the Food
and Drug Administration’s treatment of dietary sup-
plements 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 nonmis-
leading information about the nutrient-disease rela-
tionship.
(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 sup-
press, 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 die-
tary 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 die-
tary supplement’’ after ‘‘food’’;
(3) in paragraph (r)(1)(B), by inserting ‘‘or di-
etary 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-re-
lated condition.’’;
(4) in paragraph (r)(2)(G), by inserting ‘‘or di-
etary 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 die-
tary 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 Sec-
retary 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 dis-
closing 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 au-
thorizing the claim nor a final decision denying the claim,
the claim shall be deemed authorized and shall be accom-
panied 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 de-
scribed 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 Sec-
retary receives the objection, the Secretary shall file a peti-
tion 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 Sec-
retary’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 claim-
ant 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 be-
tween a nutrient, including a dietary supplement,
and a disease or health-related condition and in-
cludes a citation to the author, the title of the publi-
cation, 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 relation-
ship between a nutrient and a disease or health-re-
lated 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, pro-
vided 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 in-
troducing the food or dietary supplement into inter-
state 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 Sec-
retary. 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 GOV-
ERNMENT 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 Govern-
ment 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 supple-
ment into interstate commerce with the claim; or
‘‘(ii) the claim paraphrases in a nonmisleading man-
ner 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 publica-
tion, and the page on which the statement appears, pro-
vided 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.—Sec-
tion 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 docu-
ment available to the public published by any one or more
United States Government offices, departments, commis-
sions, 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; AUTHORIZA-
TION 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 dis-
claimer: ‘‘The Food and Drug Administration has deter-
mined that the evidence supporting this claim is inconclu-
sive.’’.
(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 Sec-
retary of Health and Human Services shall publish a no-
tice 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 ref-
erenced therein with the following disclaimer: ‘‘The Food
and Drug Administration has determined that the evi-
dence supporting this claim is inconclusive.’’.
(c) All orders issued by the Food and Drug Adminis-
tration 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 re-
evaluate those claims in accordance with the provisions of
this Act and the amendments made by this Act.
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