Purpose: To amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and dis- ease, to prohibit employees of the Food and Drug Administration from carrying firearms and making arrests without warrants, and to adjust the mens rea of certain prohibited acts under the Federal Food, Drug, and Cosmetic Act to knowing and willful.
IN THE SENATE OF THE UNITED STATES—112th Cong., 2d Sess.
S. 3187
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.
Referred to the Committee on ______ and ordered to be printed
Ordered to lie on the table and to be printed AMENDMENT intended to be proposed by Mr. PAUL
Viz:
At the appropriate place, insert the following:
SEC. 11__. LIMITATION ON SUPPRESSION BY FEDERAL GOVERNMENT OF CLAIMS IN FOOD AND DIETARY SUPPLEMENTS.
(a) 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. (b) DEFINITION.—In this section, the term ‘‘material’’ means that the Food and Drug Administration has identified a competent consumer survey demonstrating that consumers decided to purchase the food or dietary supplement based on the portion of the claim alleged to be false or misleading.
SEC. 11__. DEFINITION OF DRUG.
(a) IN GENERAL.—Subparagraph (1) of section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by striking the second and third sentences and inserting the following: ‘‘A food or dietary supplement for which a claim is made in accordance with section 403(r)(1)(B) is not a drug solely because of such claim.’’.
(b) RULES.—All rules of the Food and Drug Admin- istration in existence on the date of the enactment of this Act prohibiting nutrient-disease relationship claims are revoked.
SEC. 11__. MISBRANDED FOOD.
Section 403(r) (21 U.S.C. 343(r)) is amended—
(1) by striking clause (B) of subparagraph (1) and inserting the following:
‘‘(B) describes any nutrient as mitigating, treating, or preventing any disease, disease symp- tom, or health-related condition if, and only if, the claim has been adjudicated false and misleading in a material respect by final order of a Federal court of competent jurisdiction in accordance with section 1202 of the Health Freedom Act.’’;
(2) by striking subparagraph (3);
(3) in the first sentence of subparagraph (4)(A)(i)—
(A) by striking ‘‘or (3)(B)’’; and
(B) by striking ‘‘or (1)(B)’’;
(4) by striking clause (C) of subparagraph (4); (5) by striking clause (D) of subparagraph (5);
and
(6) in subparagraph (6), in the matter following clause (C), by striking the first sentence.
SEC. 11__. DIETARY SUPPLEMENT LABELING EXEMPTIONS.
Section 403B (21 U.S.C. 343–2) is amended to read as follows:
‘‘FOOD AND DIETARY SUPPLEMENT LABELING ‘‘SEC. 403B. The Federal Government shall take no action to prevent distribution of any publication in connec- tion with the sale of a food or dietary supplement to consumers unless it establishes that a claim contained in the publication—
‘‘(1) names the specific food or dietary supplement sold by the person causing the publication to be distributed;
‘‘(2) represents that the specific food or dietary supplement mitigates, treats, or prevents a disease; and
‘‘(3) proves the claim to be false and misleading in a material respect by final order of a Federal court of competent jurisdiction.’’.
SEC. 11__. PROHIBITIONS ON FDA OFFICIALS CARRYING FIREARMS AND MAKING ARRESTS WITHOUT WARRANTS.
Section 702(e) (21 U.S.C. 372(e)) is amended— (1) by striking paragraph (1);
(2) by redesignating paragraphs (2) and (3) as paragraphs (1) and (2) respectively;
(3) in paragraph (2), as so redesignated, by adding ‘‘and’’ after the semicolon at the end;
(4) by striking paragraph (4); and
(5) by redesignating paragraph (5) as para- graph (3).
SEC. 11__. PROHIBITED ACTS.
Section 301 (21 U.S.C. 331) is amended—
(1) in subsection (a), by inserting ‘‘knowing and willful’’ before ‘‘introduction or delivery’’;
(2) in subsection (b), by inserting ‘‘knowing and willful’’ before ‘‘adulteration’’;
(3) in subsection (c), by inserting ‘‘knowing and willful’’ before ‘‘receipt’’;
(4) in subsection (d), by inserting ‘‘knowing and willful’’ before ‘‘introduction or delivery’’;
(5) in subsection (e), by striking ‘‘The refusal’’ and inserting ‘‘The knowing and willful refusal’’;
(6) in subsection (f), by inserting ‘‘knowing and willful’’ before ‘‘refusal’’;
(7) in subsection (g), by inserting ‘‘knowing and willful’’ before ‘‘manufacture’’;
(8) in subsection (h), by striking ‘‘The giving’’ and inserting ‘‘The knowing and willful giving’’;
(9) in subsection (i)—
(A) in paragraph (1)—
(i) by striking ‘‘Forging’’ and inserting ‘‘Knowingly and willfully forging’’; and (ii) by inserting ‘‘knowingly and willfully’’ after ‘‘proper authority’’;
(B) in paragraph (2), by striking ‘‘Making’’ and inserting ‘‘Knowingly and willfully making’’; and
(C) in paragraph (3), by striking ‘‘The doing’’ and inserting ‘‘The knowing and willful doing’’;
(10) in subsection (j), by striking ‘‘The using’’ and inserting ‘‘The knowing and willful using’’; (11) in subsection (k)—
(A) by inserting ‘‘knowing and willful’’ before ‘‘alteration’’; and
(B) by inserting ‘‘knowing and willful’’ before ‘‘doing’’;
(12) in subsection (m), by striking ‘‘The sale’’ and inserting ‘‘The knowing and willful sale’’;
(13) in subsection (n), by striking ‘‘The using’’ and inserting ‘‘The knowing and willful using’’;
(14) in subsection (o), by inserting ‘‘knowing and willful’’ before ‘‘failure’’;
(15) in subsection (p), by striking ‘‘The failure’’ and inserting ‘‘The knowing and willful failure’’;
(16) in subsection (q)—
(A) in paragraph (1), by striking ‘‘The failure’’ and inserting ‘‘The knowing and willful failure’’; and
(B) in paragraph (2), by inserting ‘‘know- ing and willful’’ before ‘‘submission’’;
(17) in subsection (r), by inserting ‘‘knowing and willful’’ before ‘‘movement’’;
(18) in subsection (s), by striking ‘‘The failure’’ and inserting ‘‘The knowing and willful failure’’;
(19) in subsection (t), by striking ‘‘The importation’’ and inserting ‘‘The knowing and willful importation’’;
(20) in subsection (u), by inserting ‘‘knowing and willful’’ before ‘‘failure’’;
(21) in subsection (v), by striking ‘‘The introduction’’ and inserting ‘‘The knowing and willful introduction’’;
(22) in subsection (w), by inserting ‘‘The making’’ and inserting ‘‘The knowing and willful making’’;
(23) in subsection (x), by inserting ‘‘knowing and willful’’ before falsification;
(24) in subsection (y)—
(A) in paragraph (1), by inserting ‘‘knowing and willful’’ before ‘‘submission’’;
(B) in paragraph (2), by inserting ‘‘knowing and willful’’ before ‘‘disclosure’’; and
(C) in paragraph (3), by inserting ‘‘knowing and willful’’ before ‘‘receipt’’;
(25) in subsection (aa), by inserting ‘‘knowing and willful’’ before ‘‘importation’’;
(26) in subsection (bb), by inserting ‘‘knowing and willful’’ before ‘‘transfer’’;
(27) in subsection (cc), by inserting ‘‘knowing and willful’’ before ‘‘importing’’;
(28) in subsection (dd), by inserting ‘‘knowing and willful’’ before ‘‘failure’’;
(29) in subsection (ee), by inserting ‘‘knowing and willful’’ before ‘‘importing’’;
(30) in subsection (ff), by inserting ‘‘knowing and willful’’ before ‘‘importing’’;
(31) in subsection (gg), by inserting ‘‘and willful’’ after ‘‘knowing’’ each place such term appears; (32) in subsection (hh), by inserting ‘‘knowing and willful’’ before ‘‘failure’’;
(33) in subsection (ii), by inserting ‘‘knowing and willful’’ before ‘‘falsification of a report’’;
(34) in subsection (jj)— (A) in paragraph (1)—
(i) by inserting ‘‘knowing and willful’’ before ‘‘failure’’; and
(ii) by inserting ‘‘and willfully’’ after ‘‘knowingly’’;
(B) in paragraph (2), by inserting ‘‘know- ing and willful’’ before ‘‘failure’’; and
(C) in paragraph (3), by inserting ‘‘know- ing and willful’’ before ‘‘submission’’;
(35) in subsection (kk), by inserting ‘‘knowing and willful’’ before ‘‘dissemination’’;
(36) in subsection (ll), by striking ‘‘The introduction’’ and inserting ‘‘The knowing and willful introduction’’;
(37) in and willful’’ subsection (mm), by inserting ‘‘knowing before ‘‘failure’’;
(38) in and willful’’ subsection (nn), by inserting ‘‘knowing before ‘‘falsification’’;
(39) in and willful’’ subsection (oo), by inserting ‘‘knowing before ‘‘introduction or delivery’’;
(40) in and willful’’ subsection (pp), by inserting ‘‘knowing before ‘‘introduction or delivery’’;
(41) in subsection (qq)—
(A) in paragraph (1), by striking ‘‘Forging’’ and inserting ‘‘Knowingly and willfully forging’’;
(B) in paragraph (2), by striking ‘‘Making’’ and inserting ‘‘Knowingly and willfully making’’; and
(C) in paragraph (3), by inserting ‘‘knowingly and willfully’’ before ‘‘doing’’;
(42) in subsection (rr), by inserting ‘‘knowing and willful’’ before ‘‘charitable’’;
(43) in subsection (ss), by inserting ‘‘knowing and willful’’ before ‘‘failure’’;
(44) in subsection (tt), by striking ‘‘Making’’ and inserting ‘‘Knowingly and willfully making’’;
(45) in subsection (vv), by inserting ‘‘knowing and willful’’ before ‘‘failure’’;
(46) in subsection (ww), by inserting ‘‘knowing and willful’’ before ‘‘failure’’;
(47) in subsection (xx), by inserting ‘‘knowing and willful’’ before ‘‘refusal’’;
(48) in subsection (aaa), as added by section 712, by inserting ‘‘knowing and willful’’ before ‘‘failure’’; and
(49) in subsection (bbb), as added by section 722, by inserting ‘‘knowing and willful’’ before ‘‘violation’’.
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