The relevant Action Item, where citizens can express their views about these bills, and help educate decision makers, is here: http://tinyurl.com/SaveOurSupplements
Current Action items are here:
H. R. 3380
To amend the Federal Food, Drug, and Cosmetic Act
concerning safe dietary ingredients in dietary supplements.
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...
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'.
Actions Against DSHEA Products
H. R. 2044
To amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes.
... In General- The Federal Government may not take any action to prevent use of a claim describing any nutrient in a food or dietary supplement (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless a Federal court in a final order following a trial on the merits finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that--
- (1) the claim is false and misleading in a material respect; and
- (2) there is no less speech restrictive alternative to claim suppression, such as use of disclaimers or qualifications, that can render the claim non-misleading...
H. R. 2045
To amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients.
...EXEMPTIONS FROM REGULATION AS ADVERTISING- No content of any publication shall be considered advertising regulated under this Act unless the content is intended by the seller of a product to promote the sale of that product and the content includes--
- `(A) the name of the product offered for sale;
- `(B) an express offer to sell the named product; and
- `(C) a purchase price for the product.
- No content excerpted in whole or part from a peer-reviewed scientific publication shall be considered advertising regulated 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- 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 ...
H. R. 2908
...Dissemination of Testimonials- Notwithstanding the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Trade Commission Act (15 U.S.C. 41 et seq.), and any other provision of law--
- (1) no Federal official or employee may restrict dissemination of a testimonial containing a consumer's actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer's experience with that food or dietary supplement; and
- (2) if a person disseminating a testimonial reasonably believes that the dissemination is covered by paragraph (1), such dissemination shall not constitute a violation of any Federal law...
* as reported: http://www.nutraingredients-usa.com/Regulation/FDA-silent-on-calls-from-Sen-Hatch-and-Harkin-to-withdraw-NDI-draft-guidance