II 

112TH CONGRESS 

1ST SESSION S. 1310 

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 supplement products with the Food and Drug Administration and to amend labeling requirements with respect to dietary 

supplements. 

IN THE SENATE OF THE UNITED STATES 

JUNE 30, 2011 

Mr. DURBIN 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 

supplement products 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 2011’’. 


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1 SEC. 2. REGULATION OF DIETARY SUPPLEMENTS. 

2 (a) REGISTRATION.— 

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 dietary supplements that is re11 quired to register under this section shall com12 ply with the requirements of this paragraph, in 

13 addition to the other requirements of this sec14 tion. 

15 ‘‘(B) ADDITIONAL INFORMATION.—A facil16 ity described in subparagraph (A) shall submit 

17 a registration under paragraph (1) that in18 cludes, in addition to the information required 

19 under paragraph (2)— 

20 ‘‘(i) a description of each dietary sup21 plement product manufactured by such fa22 cility; 

23 ‘‘(ii) a list of all ingredients in each 

24 such dietary supplement product; and 

25 ‘‘(iii) a copy of the label and labeling 

26 for each such product. 


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1 ‘‘(C) REGISTRATION WITH RESPECT TO

2 NEW, REFORMULATED, AND DISCONTINUED DI3 ETARY SUPPLEMENT PRODUCTS.— 

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

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

6 described in subparagraph (A)— 

7 ‘‘(I) manufactures a dietary sup8 plement product that the facility pre9 viously did not manufacture and for 

10 which the facility did not submit the 

11 information required under clauses (i) 

12 through (iii) of subparagraph (B); 

13 ‘‘(II) reformulates a dietary sup14 plement product for which the facility 

15 previously submitted the information 

16 required under clauses (i) through 

17 (iii) of subparagraph (B); or 

18 ‘‘(III) no longer manufactures a 

19 dietary supplement for which the fa20 cility previously submitted the infor21 mation required under clauses (i) 

22 through (iii) of subparagraph (B), 

23 such facility shall submit to the Secretary 

24 an updated registration describing the 

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


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

2 in subclause (I) or (II), containing the in3 formation required under clauses (i) 

4 through (iii) of subparagraph (B). 

5 ‘‘(ii) DATE DESCRIBED.—The date de6 scribed in this clause is— 

7 ‘‘(I) in the case of a facility de8 scribed in subclause (I) of clause (i), 

9 30 days after the date on which such 

10 facility first markets the dietary sup11 plement product described in such 

12 subclause; 

13 ‘‘(II) in the case of a facility de14 scribed in subclause (II) of clause (i), 

15 30 days after the date on which such 

16 facility first markets the reformulated 

17 dietary supplement product described 

18 in such subclause; or 

19 ‘‘(III) in the case of a facility de20 scribed in subclause (III) of clause (i), 

21 30 days after the date on which such 

22 facility removes the dietary supple23 ment product described in such sub24 clause from the market.’’. 


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1 (2) ENFORCEMENT.—Section 403 of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) 

3 is amended by adding at the end the following: 

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

5 is required to submit the registration information required 

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

7 with the requirements of such section 415(a)(6) with re8 spect to such dietary supplement.’’. 

9 (b) LABELING.— 

10 (1) ESTABLISHMENT OF LABELING REQUIRE11 MENTS.—Chapter IV of the Federal Food, Drug, 

12 and Cosmetic Act (21 U.S.C. 341 et seq.) is amend13 ed by inserting after section 411 the following: 

14 ‘‘SEC. 411A. DIETARY SUPPLEMENTS. 

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

16 later than 1 year after the date of enactment of the Die17 tary Supplement Labeling Act of 2011, the Secretary shall 

18 compile a list of dietary supplement ingredients and pro19 prietary blends of ingredients that the Secretary deter20 mines could cause potentially serious adverse events, drug 

21 interactions, contraindications, or potential risks to sub22 groups such as children and pregnant or breastfeeding 

23 women. 

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

25 into a contract with the Institute of Medicine under which 


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1 the Institute of Medicine shall evaluate dietary supplement 

2 ingredients and proprietary blends of ingredients, includ3 ing those on the list compiled by the Secretary under sub4 section (a), and scientific literature on dietary supplement 

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

6 of enactment of the Dietary Supplement Labeling Act of 

7 2011, submit to the Secretary a report evaluating the safe8 ty of dietary supplement ingredients and proprietary 

9 blends of ingredients the Institute of Medicine determines 

10 could cause potentially serious adverse events, drug inter11 actions, contraindications, or potential risks to subgroups 

12 such as children and pregnant or breastfeeding women. 

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

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

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

16 Secretary, after providing for public notice and comment 

17 and taking into consideration such report, shall— 

18 ‘‘(1) establish mandatory warning label require19 ments for dietary supplement ingredients that the 

20 Secretary determines to cause potentially serious ad21 verse events, drug interactions, contraindications, or 

22 potential risks to subgroups; and 

23 ‘‘(2) identify proprietary blends of ingredients 

24 for which, because of potentially serious adverse 

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1 tential risks to subgroups such as children and preg2 nant or breastfeeding women, the weight per serving 

3 of the ingredient in the proprietary blend shall be 

4 provided on the label. 

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

6 providing for public notice and comment, shall update— 

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

8 ‘‘(2) the mandatory warning label requirements 

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

10 and 

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

12 subsection (c).’’. 

13 (2) ENFORCEMENT.—Section 403 of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) 

15 is amended— 

16 (A) in subsection (q)(5)(F)(ii), by inserting 

17 ‘‘, and for each proprietary blend identified by 

18 the Secretary under section 411A(c)(1)(B), the 

19 weight of such proprietary blend,’’ after ‘‘ingre20 dients)’’; and 

21 (B) in subsection (s)(2)— 

22 (i) in subparagraph (A)(ii)(II), by in23 serting ‘‘, and for each proprietary blend 

24 identified by the Secretary under section 

25 411A(c)(1)(B), the weight of each such 


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1 proprietary blend per serving’’ before the 

2 semicolon at the end; 

3 (ii) in subparagraph (D)(iii), by strik4 ing ‘‘or’’ at the end; 

5 (iii) in subparagraph (E)(ii)(II), by 

6 striking the period at the end and inserting 

7 a semicolon; and 

8 (iv) by adding at the end the fol9 lowing: 

10 ‘‘(F) the label or labeling does not include 

11 information with respect to potentially serious 

12 adverse events, drug interactions, contraindica13 tions, or potential risks to subgroups such as 

14 children and pregnant or breastfeeding women, 

15 as required under section 411A(c); or 

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

17 number.’’. 

18 (c) CONVENTIONAL FOODS.—The Secretary of 

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

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

21 public notice and comment, shall establish a definition for 

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

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

24 Such definition shall take into account conventional foods 

25 marketed as dietary supplements, including products marVerDate Mar 15 2010 23:11 Jul 05, 2011 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1310.IS S1310

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1 keted as dietary supplements that simulate conventional 

2 foods. 

Æ 


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