[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3380 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 3380

   To amend the Federal Food, Drug, and Cosmetic Act concerning safe 
              dietary ingredients in dietary supplements.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 4, 2011

Mr. Burton of Indiana 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 safe 
              dietary ingredients in dietary supplements.

    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 ``Dietary Supplement Protection Act of 
2011''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Improving the health status of United States citizens 
        ranks at the top of the national priorities of the Federal 
        Government. The importance of nutrition and the benefits of 
        dietary supplements to health promotion and disease prevention 
        are well known and have been documented in scientific studies.
            (2) Since enactment of the Dietary Supplement Health and 
        Education Act of 1994 (DSHEA), dietary supplements have had an 
        exemplary public health safety record. Based on national 
        surveys, in 1994, 50 percent of the 260,000,000 Americans 
        regularly consumed dietary supplements. In 2006, 232,000,000 
        adults over the age of 18 alone consumed dietary supplements, 
        53 percent of the United States adult population.
            (3) There were 4,000 dietary supplements in the marketplace 
        in 1994, and in 2006 an estimated 29,000 dietary supplements 
        were being consumed daily by Americans. Since the enactment of 
        DSHEA, there has been 17 years of additional historical use-
        safety experience conducted by millions of Americans. Over 17 
        years, approximately 25,000 new supplements with new dietary 
        ingredients have been approved by the Food and Drug 
        Administration (FDA) under DSHEA and have and are being safely 
        consumed by Americans.
            (4) Since January 2007, FDA regulations governing dietary 
        supplement manufacturer good manufacturing practices, dietary 
        supplement adverse event reporting, and private sector 
        voluntary testing and auditing for supplement quality and 
        purity have improved postmarketing consumer safety. Before 
        DSHEA, these mechanisms did not exist.
            (5) There are DSHEA ``grandfathered'' supplements, dietary 
        ingredients, and classified products which were on the market 
        before October 15, 1994, and ``generally recognized as safe'' 
        for human consumption. FDA regulatory policy, industry 
        practices, and consumer marketplace paradigms have drastically 
        changed over 17 years, but this policy has not.
            (6) The definition of a new dietary ingredient in section 
        413 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 350b) 
        does not recognize the current safe market in supplements, nor 
        how intensively supplements have been regulated over the 17 
        years since enactment of DSHEA to protect public health and 
        safety, and should be updated to reflect this reality.

SEC. 3. NEW DIETARY INGREDIENT DEFINITION.

    Section 413(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350b(d)) is amended by striking ``October 15, 1994'' each place 
it appears and inserting ``January 1, 2007''.
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