[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1364 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 1364

   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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 5, 2011

Mr. Chaffetz (for himself and Mr. Polis) 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 the 
   distribution of information on legitimate scientific research in 
 connection with foods and dietary supplements, 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 ``Free Speech About Science Act of 
2011''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Federal regulators have forbidden--
                    (A) cherry growers and food producers to cite 
                independent and respected scientific research on their 
                produce that references health benefits; and
                    (B) a variety of dietary supplement makers to cite 
                independent scientific research on health benefits from 
                supplements from respected, peer-reviewed scientific 
                journals.
            (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.
            (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.
            (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.

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--
            (1) in subparagraph (3)--
                    (A) by redesignating clause (D) as clause (E);
                    (B) by inserting after clause (C) the following:
    ``(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--
            ``(i) the claim is based on legitimate scientific research;
            ``(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);
            ``(iii) the claim is stated in a manner so that the claim--
                    ``(I) is an accurate balanced summary of such 
                research; and
                    ``(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;
            ``(iv) the claim includes a citation to such research; and
            ``(v) the claim identifies each party that funded such 
        research.'';
                    (C) in clause (E), as so redesignated, by striking 
                ``clause (C)'' each place it appears and inserting 
                ``clause (C) or (D)''; and
                    (D) by adding at the end the following:
    ``(F) In this subparagraph, the term `legitimate scientific 
research' means scientific research, whether performed in vitro, in 
vivo, in animals, or in humans, that--
            ``(i) is conducted in accordance with sound scientific 
        principles;
            ``(ii) has been evaluated and accepted by a scientific or 
        medical panel; and
            ``(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--
                    ``(I) a peer-reviewed article or book;
                    ``(II) a recognized textbook;
                    ``(III) a peer-reviewed scientific publication; or
                    ``(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).'';
            (2) by amending subparagraph (6) to read as follows:
    ``(6)(A) For purposes of subparagraph (1)(B), a statement for a 
dietary supplement may be made if--
            ``(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;
            ``(ii) the manufacturer of the dietary supplement has 
        substantiation that such statement is truthful and not 
        misleading;
            ``(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.'; and
            ``(iv) the statement does not claim to diagnose, mitigate, 
        treat, cure, or prevent a specific disease or class of 
        diseases.
    ``(B) Notwithstanding subparagraph (1)(B), a statement for a 
dietary supplement may be made if--
            ``(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));
            ``(ii) the manufacturer of the dietary supplement has 
        substantiation that such statement is truthful and not 
        misleading;
            ``(iii) the statement contains, prominently displayed and 
        in boldface type, the following: `This statement has not been 
        evaluated by the Food and Drug Administration.';
            ``(iv) the claim includes a citation to the research 
        referred to in subclause (i); and
            ``(v) the claim identifies each party that funded such 
        research.
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.''; and
            (3) by adding at the end the following:
    ``(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.''.

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:
    ``(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.
    ``(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.''.
    (b) Definitions.--Section 15 of the Federal Trade Commission Act 
(15 U.S.C. 55) is amended by adding at the end the following:
    ``(g) The term `dietary supplement' has the meaning given to such 
term in section 201 of the Federal Food, Drug, and Cosmetic Act.
    ``(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.''.
                                 <all>