[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4282 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4282

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

                            November 9, 2005

  Mr. Paul (for himself, Mr. Jones of North Carolina, Mr. Duncan, Mr. 
DeFazio, Mr. Bartlett of Maryland, Mr. Burton of Indiana, Mr. Miller of 
 Florida, and Mr. Bishop of Utah) 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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