II 

113TH CONGRESS 

1ST SESSION S. 1425 

To improve the safety of dietary supplements by amending the Federal Food, 

Drug, and Cosmetic Act to require manufacturers of dietary supplements 

to register dietary supplements with the Food and Drug Administration 

and to amend labeling requirements with respect to dietary supplements. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 1, 2013 

Mr. DURBIN (for himself and Mr. BLUMENTHAL) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve the safety of dietary supplements by amending 

the Federal Food, Drug, and Cosmetic Act to require 

manufacturers of dietary supplements to register dietary 

supplements with the Food and Drug Administration 

and to amend labeling requirements with respect to dietary supplements. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Dietary Supplement 

5 Labeling Act of 2013’’. 


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1 SEC. 2. REGULATION OF DIETARY SUPPLEMENTS. 

2 (a) REGISTRATION REQUIREMENTS.— 

3 (1) IN GENERAL.—Section 415(a) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

5 350d(a)) is amended by adding at the end the fol6 lowing: 

7 ‘‘(6) REQUIREMENTS WITH RESPECT TO DIE8 TARY SUPPLEMENTS.— 

9 ‘‘(A) IN GENERAL.—A facility engaged in 

10 manufacturing or processing dietary supple11 ments that is required to register under this 

12 section shall comply with the requirements of 

13 this paragraph, in addition to the other require14 ments of this section. 

15 ‘‘(B) ADDITIONAL INFORMATION.— 

16 ‘‘(i) IN GENERAL.—A facility de17 scribed in subparagraph (A) shall submit a 

18 registration under paragraph (1) that in19 cludes, in addition to the information re20 quired under paragraph (2)— 

21 ‘‘(I) a description of each dietary 

22 supplement manufactured or proc23 essed by such facility; 

24 ‘‘(II) a list of all ingredients in 

25 each such dietary supplement; and 


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1 ‘‘(III) a copy of the label for each 

2 such dietary supplement. 

3 ‘‘(ii) PUBLIC AVAILABILITY.—The 

4 Secretary shall make the information pro5 vided under clause (i) publicly available, in6 cluding by posting such information on the 

7 Internet Web site of the Food and Drug 

8 Administration. 

9 ‘‘(C) REGISTRATION WITH RESPECT TO

10 NEW, REFORMULATED, AND DISCONTINUED DI11 ETARY SUPPLEMENTS.— 

12 ‘‘(i) IN GENERAL.—Not later than the 

13 date described in clause (ii), if a facility 

14 described in subparagraph (A)— 

15 ‘‘(I) manufactures or processes a 

16 dietary supplement that the facility 

17 previously did not manufacture or 

18 process and for which the facility did 

19 not submit the information required 

20 under subclauses (I) through (III) of 

21 subparagraph (B)(i); 

22 ‘‘(II) reformulates a dietary sup23 plement for which the facility pre24 viously submitted the information reVerDate Mar 15 2010 02:16 Aug 07, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.IS S1425

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1 quired under subclauses (I) through 

2 (III) of subparagraph (B)(i); or 

3 ‘‘(III) no longer manufactures or 

4 processes a dietary supplement for 

5 which the facility previously submitted 

6 the information required under sub7 clauses (I) through (III) of subpara8 graph (B)(i), 

9 such facility shall submit to the Secretary 

10 an updated registration describing the 

11 change described in subclause (I), (II), or 

12 (III) and, in the case of a facility described 

13 in subclause (I) or (II), containing the in14 formation required under subclauses (I) 

15 through (III) of subparagraph (B)(i). 

16 ‘‘(ii) DATE DESCRIBED.—The date de17 scribed in this clause is— 

18 ‘‘(I) in the case of a facility de19 scribed in subclause (I) of clause (i), 

20 30 days after the date on which such 

21 facility first markets the dietary sup22 plement described in such subclause; 

23 ‘‘(II) in the case of a facility de24 scribed in subclause (II) of clause (i), 

25 30 days after the date on which such 


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1 facility first markets the reformulated 

2 dietary supplement described in such 

3 subclause; or 

4 ‘‘(III) in the case of a facility de5 scribed in subclause (III) of clause (i), 

6 30 days after the date on which such 

7 facility removes the dietary supple8 ment described in such subclause from 

9 the market.’’. 

10 (2) ENFORCEMENT.—Section 403 of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) 

12 is amended by adding at the end the following: 

13 ‘‘(z) If it is a dietary supplement for which a facility 

14 is required to submit the registration information required 

15 under section 415(a)(6) and such facility has not complied 

16 with the requirements of such section 415(a)(6) with re17 spect to such dietary supplement.’’. 

18 (b) LABELING.— 

19 (1) ESTABLISHMENT OF LABELING REQUIRE20 MENTS.—Chapter IV of the Federal Food, Drug, 

21 and Cosmetic Act (21 U.S.C. 341 et seq.) is amend22 ed by inserting after section 411 the following: 

23 ‘‘SEC. 411A. DIETARY SUPPLEMENTS. 

24 ‘‘(a) DIETARY SUPPLEMENT INGREDIENTS.—Not 

25 later than 1 year after the date of enactment of the DieVerDate Mar 15 2010 02:16 Aug 07, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.IS S1425

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1 tary Supplement Labeling Act of 2013, the Secretary shall 

2 compile a list of dietary supplement ingredients and pro3 prietary blends of ingredients that the Secretary deter4 mines could cause potentially serious adverse events, drug 

5 interactions, or contraindications, or potential risks to 

6 subgroups such as children and pregnant or breastfeeding 

7 women. 

8 ‘‘(b) IOM STUDY.—The Secretary shall seek to enter 

9 into a contract with the Institute of Medicine under which 

10 the Institute of Medicine shall evaluate dietary supplement 

11 ingredients and proprietary blends of ingredients, includ12 ing those on the list compiled by the Secretary under sub13 section (a), and scientific literature on dietary supplement 

14 ingredients and, not later than 18 months after the date 

15 of enactment of the Dietary Supplement Labeling Act of 

16 2013, submit to the Secretary a report evaluating the safe17 ty of dietary supplement ingredients and proprietary 

18 blends of ingredients the Institute of Medicine determines 

19 could cause potentially serious adverse events, drug inter20 actions, or contraindications, or potential risks to sub21 groups such as children and pregnant or breastfeeding 

22 women. 

23 ‘‘(c) ESTABLISHMENT OF REQUIREMENTS.—Not 

24 later than 2 years after the date on which the Institute 

25 of Medicine issues the report under subsection (b), the 


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1 Secretary, after providing for public notice and comment 

2 and taking into consideration such report, shall— 

3 ‘‘(1) establish mandatory warning label require4 ments for dietary supplement ingredients that the 

5 Secretary determines to cause potentially serious ad6 verse events, drug interactions, or contraindications, 

7 or potential risks to subgroups; and 

8 ‘‘(2) identify proprietary blends of ingredients 

9 for which, because of potentially serious adverse 

10 events, drug interactions, or contraindications, or 

11 potential risks to subgroups such as children and 

12 pregnant or breastfeeding women, the weight per 

13 serving of the ingredient in the proprietary blend 

14 shall be provided on the label. 

15 ‘‘(d) UPDATES.—As appropriate, the Secretary, after 

16 providing for public notice and comment, shall update— 

17 ‘‘(1) the list compiled under subsection (a); 

18 ‘‘(2) the mandatory warning label requirements 

19 established under paragraph (1) of subsection (c); 

20 and 

21 ‘‘(3) the requirements under paragraph (2) of 

22 subsection (c).’’. 

23 (2) ENFORCEMENT.—Section 403 of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) 

25 is amended— 


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1 (A) in paragraph (q)(5)(F)(ii), by inserting 

2 ‘‘, and for each proprietary blend identified by 

3 the Secretary under section 411A(c)(2), the 

4 weight of such proprietary blend,’’ after ‘‘ingre5 dients)’’; and 

6 (B) in paragraph (s)(2)— 

7 (i) in clause (A)(ii)(II), by inserting ‘‘, 

8 and for each proprietary blend identified 

9 by the Secretary under section 411A(c)(2), 

10 the weight of each such proprietary blend 

11 per serving’’ before the semicolon at the 

12 end; 

13 (ii) in clause (D)(iii), by striking ‘‘or’’ 

14 at the end; 

15 (iii) in clause (E)(ii)(II), by striking 

16 the period at the end and inserting a semi17 colon; and 

18 (iv) by adding at the end the fol19 lowing: 

20 ‘‘(F) the label does not include information 

21 with respect to potentially serious adverse 

22 events, drug interactions, or contraindications, 

23 or potential risks to subgroups such as children 

24 and pregnant or breastfeeding women, as re25 quired under section 411A(c)(1); or 


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1 ‘‘(G) the label does not include the batch 

2 number.’’. 

3 (c) STRUCTURE AND FUNCTION CLAIMS.—Section 

4 403(r)(6)(B) of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 343(r)(6)(B)) is amended by inserting ‘‘, 

6 and provides such substantiation to the Secretary, as the 

7 Secretary may require’’ after ‘‘misleading’’. 

8 (d) CONVENTIONAL FOODS.—The Secretary of 

9 Health and Human Services, not later than 1 year after 

10 the date of enactment of this Act and after providing for 

11 public notice and comment, shall establish a definition for 

12 the term ‘‘conventional food’’ for purposes of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

14 Such definition shall take into account conventional foods 

15 marketed as dietary supplements, including products mar16 keted as dietary supplements that simulate conventional 

17 foods. 

Æ 


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