HR 1364 IHCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

H. R. 1364CommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act concerning the distribution of information on legitimate scientific research in connection with foods and dietary supplements, and for other purposes.CommentsClose CommentsPermalink

IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink

April 5, 2011CommentsClose CommentsPermalink

Mr. CHAFFETZ (for himself and Mr. POLIS) introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act concerning the distribution of information on legitimate scientific research in connection with foods and dietary supplements, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Free Speech About Science Act of 2011’.CommentsClose CommentsPermalink

SEC. 2. FINDINGS.

The Congress finds the following:CommentsClose CommentsPermalink





(1) Federal regulators have forbidden--CommentsClose CommentsPermalink





(A) cherry growers and food producers to cite independent and respected scientific research on their produce that references health benefits; andCommentsClose CommentsPermalink





(B) a variety of dietary supplement makers to cite independent scientific research on health benefits from supplements from respected, peer-reviewed scientific journals.CommentsClose CommentsPermalink





(2) Americans want access and have a right to access legitimate scientific information about foods and dietary supplements to ensure informed decisions about diet and health care. While the American public is inundated daily with advertisements about prescription drugs for health conditions, many of which could be prevented through lifestyle changes, proper nutrition, and informed use of dietary supplements, Americans are denied access to the very information that assists in making informed lifestyle and health care decisions.CommentsClose CommentsPermalink





(3) Providing access to scientific information promotes self-responsibility, thereby empowering Americans to exercise independent judgment in caring for themselves and ultimately reducing health care costs and improving quality of life.CommentsClose CommentsPermalink





(4) The United States has a long commitment to the free dissemination of scientific research with the exception of limited extreme situations for national security. This commitment goes back to the First Amendment to the Constitution and has contributed vitally to the Nation’s economic progress.CommentsClose CommentsPermalink

SEC. 3. MISBRANDED FOOD AND DIETARY SUPPLEMENTS.

Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)) is amended--CommentsClose CommentsPermalink





(1) in subparagraph (3)--CommentsClose CommentsPermalink





(A) by redesignating clause (D) as clause (E);CommentsClose CommentsPermalink





(B) by inserting after clause (C) the following:CommentsClose CommentsPermalink





‘(D) Notwithstanding the provisions of clauses (A)(i) and (B), a claim of the type described in subparagraph (1)(B) which is not authorized by the Secretary in a regulation promulgated in accordance with clause (B) shall be authorized and may be made with respect to a food if--CommentsClose CommentsPermalink





‘(i) the claim is based on legitimate scientific research;CommentsClose CommentsPermalink





‘(ii) the claim and the food for which the claim is made are in compliance with clause (A)(ii) and are otherwise in compliance with paragraph (a) and section 201(n);CommentsClose CommentsPermalink





‘(iii) the claim is stated in a manner so that the claim--CommentsClose CommentsPermalink





‘(I) is an accurate balanced summary of such research; andCommentsClose CommentsPermalink





‘(II) enables the public to comprehend the information provided in the claim and the relative significance of such information in the context of a total daily diet;CommentsClose CommentsPermalink





‘(iv) the claim includes a citation to such research; andCommentsClose CommentsPermalink





‘(v) the claim identifies each party that funded such research.’;CommentsClose CommentsPermalink





(C) in clause (E), as so redesignated, by striking ‘clause (C)’ each place it appears and inserting ‘clause (C) or (D)’; andCommentsClose CommentsPermalink





(D) by adding at the end the following:CommentsClose CommentsPermalink





‘(F) In this subparagraph, the term ‘legitimate scientific research’ means scientific research, whether performed in vitro, in vivo, in animals, or in humans, that--CommentsClose CommentsPermalink





‘(i) is conducted in accordance with sound scientific principles;CommentsClose CommentsPermalink





‘(ii) has been evaluated and accepted by a scientific or medical panel; andCommentsClose CommentsPermalink





‘(iii) has been published in its entirety, or as an accurate, balanced summary or scientific review including a citation to the research in its entirety, in--CommentsClose CommentsPermalink





‘(I) a peer-reviewed article or book;CommentsClose CommentsPermalink





‘(II) a recognized textbook;CommentsClose CommentsPermalink





‘(III) a peer-reviewed scientific publication; orCommentsClose CommentsPermalink





‘(IV) any publication of the United States Government (including ones published by or at the request of a Federal department, agency, institute, center, or academy).’;CommentsClose CommentsPermalink





(2) by amending subparagraph (6) to read as follows:CommentsClose CommentsPermalink





‘(6)(A) For purposes of subparagraph (1)(B), a statement for a dietary supplement may be made if--CommentsClose CommentsPermalink





‘(i) the statement claims a benefit related to a classical nutrient deficiency condition and discloses the prevalence of such condition in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient;CommentsClose CommentsPermalink





‘(ii) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading;CommentsClose CommentsPermalink





‘(iii) the statement contains, prominently displayed and in boldface type, the following: ‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.’; andCommentsClose CommentsPermalink





‘(iv) the statement does not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.CommentsClose CommentsPermalink





‘(B) Notwithstanding subparagraph (1)(B), a statement for a dietary supplement may be made if--CommentsClose CommentsPermalink





‘(i) the statement claims to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases, based on legitimate scientific research (as defined in subparagraph (3)(F));CommentsClose CommentsPermalink





‘(ii) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading;CommentsClose CommentsPermalink





‘(iii) the statement contains, prominently displayed and in boldface type, the following: ‘This statement has not been evaluated by the Food and Drug Administration.’;CommentsClose CommentsPermalink





‘(iv) the claim includes a citation to the research referred to in subclause (i); andCommentsClose CommentsPermalink





‘(v) the claim identifies each party that funded such research.CommentsClose CommentsPermalink





If the manufacturer of a dietary supplement proposes to make a statement described in clause (A) or (B) in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.’; andCommentsClose CommentsPermalink





(3) by adding at the end the following:CommentsClose CommentsPermalink





‘(8) Subject to subparagraph (1) (relating to claims in the label or labeling of food), the Secretary shall take no action to restrict in any way the distribution of information that is not false or misleading on legitimate scientific research (as defined in subparagraph (3)(F)) in connection with the sale of food.’.CommentsClose CommentsPermalink

SEC. 4. FALSE ADVERTISING.

(a) Dissemination of Legitimate Scientific Research in Connection With Sale or Distribution of Food or Dietary Supplement- Section 12 of the Federal Trade Commission Act (15 U.S.C. 52) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(c)(1) The dissemination of legitimate scientific research in connection with the sale or distribution of a food or dietary supplement to consumers shall not be determined to be false advertising by virtue of the fact that the research does not directly correlate to the type of food or dietary supplement (including any component thereof) being sold or distributed if the dissemination includes a clear disclosure that the research does not directly correlate to such type of food or dietary supplement.CommentsClose CommentsPermalink





‘(2) In any proceeding under section 13, the burden of proof shall be on the Commission to establish that the literature being disseminated is not legitimate scientific research.’.CommentsClose CommentsPermalink





(b) Definitions- Section 15 of the Federal Trade Commission Act (15 U.S.C. 55) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(g) The term ‘dietary supplement’ has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act.CommentsClose CommentsPermalink





‘(h) The term ‘legitimate scientific research’ has the meaning given to such term in section 403(r) of the Federal Food, Drug, and Cosmetic Act.’.CommentsClose CommentsPermalink