[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2117 Introduced in House (IH)]
110th CONGRESS
1st Session
H. R. 2117
To amend the Federal Food, Drug, and Cosmetic Act concerning foods and
dietary supplements, to amend the Federal Trade Commission Act
concerning the burden of proof in false advertising cases, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 2, 2007
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
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act concerning foods and
dietary supplements, to amend the Federal Trade Commission Act
concerning the burden of proof in false advertising cases, 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 ``Health Freedom Protection Act''.
SEC. 2. DEFINITIONS.
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.
Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343(r)) is amended--
(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'';
(2) in subparagraph (2)--
(A) by amending clause (G) to read as follows:
``(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
(B) by amending clause (H) to read as follows:
``(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.'';
(3) in subparagraph (3), by adding at the end the
following:
``(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--
``(i) there is no scientific evidence that
supports the claim; and
``(ii) the claim is inherently misleading
and incapable of being rendered nonmisleading
through the addition of a disclaimer.
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.
``(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).
``(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).
``(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:
``(i) Saw Palmetto may improve urine flow,
reduce nocturia and reduce voiding urgency
associated with mild benign prostatic
hyperplasia (an enlarged prostate).
``(ii) Omega-3 Fatty Acids may reduce the
risk of coronary heart disease.
``(iii) Omega-3 Fatty Acids may reduce the
risk of sudden death heart attack.
``(iv) Glucosamine may reduce joint
stiffness and pain associated with
osteoarthritis.
``(v) Chondroitin Sulfate may reduce joint
stiffness and pain associated with
osteoarthritis.
``(vi) Glucosamine and Chondroitin Sulfate
may reduce joint stiffness and pain associated
with osteoarthritis.
``(vii) Calcium may reduce the risk of bone
fractures.'';
(4) in subclause (i) of subparagraph (4)(A)--
(A) in the first sentence, by striking ``or
(3)(B)'' and inserting ``, (3)(B), or (3)(E)''; and
(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
(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.
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
``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.
Section 5 of the Federal Trade Commission Act (15 U.S.C. 45) is
amended by adding at the end the following:
``(o) Advertising of Dietary Supplements and Dietary Ingredients.--
``(1) Definitions.--In this subsection:
``(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.
``(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.
``(2) Exemptions from regulation as advertising.--
``(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.
``(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.
``(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.
``(4) Notice, opportunity to cure, and burden of proof for
investigation.--
``(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--
``(i) the precise advertising statement
that the Commission suspects may be false or
misleading;
``(ii) the scientific basis for the
Commission's view that any statement of health
benefit may be false or misleading; and
``(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.
``(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.
``(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.''.
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