[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2352 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 2352

To amend the Federal Food, Drug, and Cosmetic Act to ensure that health 
claims for foods and dietary supplements include accurate statements of 
    the curative, mitigation, treatment, and prevention effects of 
   nutrients on disease or health-related conditions, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 12, 2005

   Mr. Paul 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 to ensure that health 
claims for foods and dietary supplements include accurate statements of 
    the curative, mitigation, treatment, and prevention effects of 
   nutrients on disease or health-related conditions, 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 ``Consumers' Access to Health 
Information Act''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) When the Congress included health claims provisions in 
        the Nutrition Labeling and Education Act of 1990, amending the 
        Federal Food, Drug, and Cosmetic Act (``FDCA'' or ``Act''), the 
        Congress intended for those provisions to permit use of 
        accurate label and labeling claims of the curative, mitigation, 
        treatment, and prevention effects of foods and dietary 
        supplements on disease and health-related conditions.
            (2) In the 2004 decision, Whitaker v. Thompson, 353 F.3d 
        947 (2004), rehearing den. 2004 U.S. App. LEXIS 4617 (D.C. Cir. 
        March 9, 2004), the United States Court of Appeals for the D.C. 
        Circuit erroneously construed the health claims provisions of 
        the FDCA to prohibit accurate curative, mitigation, and 
        treatment health claims.
            (3) The health claims provisions of the Act should be 
        amended to clarify their meaning and ensure that accurate 
        health claims are not suppressed; that consumers are given 
        truthful and full information about the disease curative, 
        mitigation, treatment, and prevention effects of foods and 
        dietary supplements; that the intent of the Congress is 
        honored; and that the erroneous construction of the health 
        claims provisions of the Act by the United States Court of 
        Appeals for the D.C. Circuit in such 2004 decision does not 
        remain the law.

SEC. 3. HEALTH CLAIMS; EXCEPTION FROM DRUG DEFINITION.

    (a) Health Claims.--The Federal Food, Drug, and Cosmetic Act is 
amended--
            (1) in section 403(r)(1)(B) (21 U.S.C. 343(r)(1)(B))--
                    (A) by striking ``the relationship of any nutrient 
                which'' and inserting ``the curative, mitigation, 
                treatment, or prevention effect of any nutrient (which 
                ''; and
                    (B) by striking ``the food to a disease or a 
                health-related condition'' and inserting ``the food) on 
                any disease or health-related condition''; and
            (2) in section 403(r)(3)(B)(ii)(I) (21 U.S.C. 
        343(r)(3)(B)(ii)(I))--
                    (A) by striking ``the relationship between a 
                nutrient'' and inserting ``the curative, mitigation, 
                treatment, or prevention effect of a nutrient''; and
                    (B) by striking ``and a disease'' and inserting 
                ``on any disease''.
    (b) Exception From Drug Definition.--Section 201(g)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)) is amended 
by striking the second and third sentences and inserting the following: 
``A claim on the label or in the labeling of a food or dietary 
supplement, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 
403(r)(1)(B) and 403(r)(5)(D), made in accordance with the requirements 
of section 403(r), shall not cause the food or dietary supplement to be 
a drug. A truthful and not misleading statement on the label or in the 
labeling of a food or a dietary supplement made in accordance with 
section 403(r)(6) shall not cause the food or dietary supplement to be 
a drug.''.
                                 <all>