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, 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.

SA 2143. Mr. PAUL submitted an amendment intended to be proposed by
him to the bill 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; which was ordered to lie on
the table; as follows:

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 Administration
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 symptom, 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 connection with
the sale of a food or dietary supplement to consumers unless
it establishes that a claim contained in the publication--

[[Page S3453]]

``(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 paragraph (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 ``knowing 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 ``knowing and willful''
before ``failure''; and
(C) in paragraph (3), by inserting ``knowing 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 subsection (mm), by inserting ``knowing and
willful'' before ``failure'';
(38) in subsection (nn), by inserting ``knowing and
willful'' before ``falsification'';
(39) in subsection (oo), by inserting ``knowing and
willful'' before ``introduction or delivery'';
(40) in subsection (pp), by inserting ``knowing and
willful'' 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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