HR 3380 the Dietary Supplement Protection Act will reinforce the congressional intent of the Dietary Supplement Health
and Safety Act of 1994 (DSHEA) by including all safe dietary supplement ingredients on the market as of January 1, 2007 under the DSHEA protections. The FDA is proposing to require pre-market approval of dietary ingredients it claims are new to the market since October 1994, which, under FDA definitions, would remove tens of thousands products from sale despite an impeccable safety record.
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
Mr. BURTON of Indiana introduced the following bill; which was referred to the Committee on (TBD)
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 SupplementProtection 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 con sumption. FDA regulatory policy, industry practices, and consumer marketplace paradigms have dras tically 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 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’’.
