Health Freedom Protection Act (Introduced in House)
The Library of Congress
May 2, 2007
HR 2117 IH
Mr. PAUL (for himself, Mr. BURTON of Indiana, Mr. SHAYS, Mr. BARTLETT of Maryland, and Mr. DUNCAN) introduced the following bill; which was referred to the Committee on Energy and Commerce
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Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
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This Act may be cited as the `Health Freedom Protection Act'.
SEC. 2. DEFINITIONS.
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The second sentence of subparagraph (1) of section 201(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended
by inserting `including a claim to cure, mitigate, treat, or prevent
disease,' after `for which a claim,'.
SEC. 3. MISBRANDED FOOD.
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Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(r)) is amended--
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(1) in subparagraph (1)(B), by striking `to a disease or a
health-related condition' and inserting `to the cure,
mitigation, treatment, or prevention of any disease or any
health-related condition';
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(2) in subparagraph (2)--
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(A) by amending clause (G) to read as follows:
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`(G) Publications of the United States Government shall not
be subject to this subparagraph, subparagraph (3), or
subparagraph 5(D). The Secretary shall take no action under
this Act to restrict, limit, or impede the reprinting and
distribution or sale of any publication of the United States
Government (including ones published by or at the request of
any department, agency, institute, center, or academy and
including content characterizing the relationship of any
nutrient to the cure, mitigation, treatment, or prevention
of any disease). The Secretary shall not construe the
distribution or sale of a publication of the United States
Government in connection with the sale of a food or dietary
supplement as evidence of an intent to sell that food or
dietary supplement as a drug.'; and
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(B) by amending clause (H) to read as follows:
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`(H) Accurate quotations from a publication of the United
States Government referred to in clause (G) shall not be
subject to this subparagraph, subparagraph (3), or
subparagraph 5(D). The Secretary shall take no action under
this Act to restrict, limit, or impede the use of accurate
quotations from a United States Government publication that
characterize the relationship of any nutrient to the cure,
mitigation, treatment, or prevention of any disease. The
Secretary shall not construe accurate quotations from a
United States Government publication used in connection with
the sale of a food or dietary supplement as evidence of an
intent to sell that food or dietary supplement as a drug.';
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(3) in subparagraph (3), by adding at the end the following:
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`(E) The Secretary shall allow with reasonable and concise
disclaimers not to exceed three sentences claims of the type
described in subparagraph (1)(B) not authorized under this
subparagraph or subparagraph (5)(D) unless the Secretary
determines that--
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`(i) there is no scientific evidence that supports the
claim; and
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`(ii) the claim is inherently misleading and incapable
of being rendered nonmisleading through the addition of
a disclaimer.
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The Secretary shall not use tests of consumer perception of
product health benefits as a basis for a determination under
subclause (ii). The Secretary shall bear the burden of proof
by clear and convincing evidence on each element of this
clause.
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`(F) The Secretary shall not exclude studies concerning the
treatment effects of nutrients on disease from the
evaluation of any health claims under this subparagraph or
subparagraph (1)(B) or (5)(D).
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`(G) Notwithstanding any other provision of law, a member of
an advisory committee under this Act may not, with respect
to service on a committee evaluating a claim of the type
described in subparagraph (1)(B), be granted an exemption
under section 208(b) of title 18, United States Code
(relating to personal financial interests).
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`(H) Notwithstanding any prior decisions of the Secretary
concerning the relationship of saw palmetto to benign
prostatic hyperplasia, the relationship of omega-3 fatty
acids and coronary heart disease, the relationship of
omega-3 fatty acids and sudden death heart attack, the
relationship of glucosamine or chondroitin sulfate and
osteoarthritis, or the relationship of calcium and bone
fractures, the following health claims are authorized for
use on labels and in the labeling of all foods and dietary
supplements containing those nutrients:
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`(i) Saw Palmetto may improve urine flow, reduce
nocturia and reduce voiding urgency associated with mild
benign prostatic hyperplasia (an enlarged prostate).
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`(ii) Omega-3 Fatty Acids may reduce the risk of
coronary heart disease.
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`(iii) Omega-3 Fatty Acids may reduce the risk of sudden
death heart attack.
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`(iv) Glucosamine may reduce joint stiffness and pain
associated with osteoarthritis.
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`(v) Chondroitin Sulfate may reduce joint stiffness and
pain associated with osteoarthritis.
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`(vi) Glucosamine and Chondroitin Sulfate may reduce
joint stiffness and pain associated with osteoarthritis.
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`(vii) Calcium may reduce the risk of bone fractures.';
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(4) in subclause (i) of subparagraph (4)(A)--
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(A) in the first sentence, by striking `or (3)(B)' and
inserting `, (3)(B), or (3)(E)'; and
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(B) by striking `Not later than 100 days' and all that
follows through the end of subclause (i) and inserting `The
Secretary shall promulgate regulations authorizing or
denying claims under subparagraph (3)(B), shall publish
notice of claims allowed or disallowed under subparagraph
(3)(C) or (3)(E) no later than 100 days after the petition
for such claims is received by the Secretary, and shall not
seek or grant any extensions of that deadline. Any failure
by the Secretary to act within the 100-day period described
in the preceding sentence shall result in authorization or
allowance, as applicable, of the petitioned claim by
operation of law.'; and
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(5) in the matter following clause (C) in subparagraph (6), by
adding at the end the following `A statement for a dietary
supplement under this subparagraph may include words that are
recognized as signs or symptoms of disease or that among their
commonly understood meanings imply the cure, mitigation,
treatment, or prevention of disease so long as the statement
does not include the name of a specific disease and is made in
compliance with the requirements of clause (C). A statement for
a dietary supplement under this subparagraph may in support of
the statement refer to or cite a scientific publication that has
a title or contents that include the name of a specific disease
or a sign or symptom of a specific disease.'.
SEC. 4. DIETARY SUPPLEMENT LABELING EXEMPTIONS.
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Section 403B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343-2) is amended to read as follows:
`FOOD AND DIETARY SUPPLEMENT LABELING EXEMPTION
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`Sec. 403B. A truthful and nonmisleading scientific publication
reprinted in its entirety and used in connection with the sale of a
food or dietary supplement to consumers shall not be defined as
labeling and shall not be deemed evidence of an intent to sell a
drug. The Secretary shall not restrict in any way whatsoever the
distribution of any publication exempt from labeling under this
section.'.
SEC. 5. HEALTH INFORMATION.
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Section 5 of the Federal Trade Commission Act (15 U.S.C. 45) is
amended by adding at the end the following:
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`(o) Advertising of Dietary Supplements and Dietary Ingredients-
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`(1) DEFINITIONS- In this subsection:
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`(A) DIETARY SUPPLEMENT- The term `dietary supplement' has
the meaning given to that term in section 201(ff) of the
Federal Food, Drug, and Cosmetic Act.
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`(B) DIETARY INGREDIENT- The term `dietary ingredient' means
an ingredient listed in clause (A) through (F) of section
201(ff)(1) of the Federal Food, Drug, and Cosmetic Act that
is included in, or that is intended to be included in, a
dietary supplement.
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`(2) EXEMPTIONS FROM REGULATION AS ADVERTISING-
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`(A) Insofar as a publication is exempt pursuant to Section
403B of the Federal Food, Drug, and Cosmetic Act, the
publication is also exempt from regulation as `advertising'
under this Act.
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`(B) A truthful and accurate summary of the findings of a
peer-reviewed medical, nutritional, or other scientific
publication shall not be subject to regulation as
`advertising' under this Act.
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`(3) NO IMPLIED CLAIMS- In any investigation commenced by the
Commission and in any adjudicative proceeding in which the
Commission is a party, the Commission shall not attribute to an
advertiser accused of false advertisement any advertising
statement not actually made by that advertiser.
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`(4) NOTICE, OPPORTUNITY TO CURE, AND BURDEN OF PROOF FOR
INVESTIGATION-
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`(A) Before the Commission authorizes an investigation of
false advertisement by an advertiser of a dietary supplement
or a dietary ingredient, the Commission shall send the
advertiser a written `Notice of Suspected Violation and
Opportunity to Cure' informing the advertiser of--
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`(i) the precise advertising statement that the
Commission suspects may be false or misleading;
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`(ii) the scientific basis for the Commission's view
that any statement of health benefit may be false or
misleading; and
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`(iii) a date certain, not less than 30 days after the
date of the advertiser's receipt of the notice, by which
the advertiser may voluntarily discontinue further use
of the statement the Commission suspects may be false or
misleading and, upon so doing, the advertiser shall not
be subject to an investigation of false advertisement by
the Commission for the statement.
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`(B) The Commission shall not commence any investigation of
an advertiser of a dietary supplement or a dietary
ingredient to determine whether the advertiser has
disseminated a false advertisement unless it possesses
before the commencement of such investigation proof by a
preponderance of the evidence that the advertisement is
false and misleading.
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`(5) BURDEN OF PROOF FOR FALSE ADVERTISEMENT CASES- In any
proceeding before a Court or the Commission in which an
advertiser of a dietary supplement or a dietary ingredient is
charged with deceptive advertising, the burden of proof shall be
on the Commission to establish that the advertisement is false
and misleading and that the advertisement actually causes
consumers to be misled into believing to be true that which is
demonstrably false. No order adverse to the advertiser shall be
entered except upon the Commission satisfying that burden of
proof.'.