II 

111TH CONGRESS 

2D SESSION S. 3002 

To amend the Federal Food, Drug, and Cosmetic Act to more effectively 

regulate dietary supplements that may pose safety risks unknown to 

consumers. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 4, 2010 

Mr. MCCAIN (for himself and Mr. DORGAN) introduced the following bill; 

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

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

more effectively regulate dietary supplements that may 

pose safety risks unknown to consumers. 

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 Safety Act of 2010’’. 


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1 SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

2 COSMETIC ACT. 

3 (a) DEFINITIONS.—Section 201 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 

5 adding at the end the following: 

6 ‘‘(ss) DIETARY SUPPLEMENT FACILITY.—The term 

7 ‘dietary supplement facility’ means any business or oper8 ation engaged in manufacturing, packaging, holding, dis9 tributing, labeling, or licensing a dietary supplement for 

10 consumption in the United States.’’. 

11 (b) REGISTRATION OF DIETARY SUPPLEMENT FA12 CILITIES.— 

13 (1) ADULTERATED FOOD.—Section 402 of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 342) is amended by inserting at the end the fol16 lowing: 

17 ‘‘(j) If it is a dietary supplement that is manufac18 tured, packaged, held, distributed, labeled, or licensed by 

19 a dietary supplement facility that is not registered with 

20 the Secretary.’’. 

21 (2) REGISTRATION OF FOOD FACILITIES.—Sec22 tion 415 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 350d) is amended— 

24 (A) in the section heading, by striking 

25 ‘‘FACILITIES’’ and inserting ‘‘AND DIETARY

26 SUPPLEMENT FACILITIES’’; and 


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1 (B) in subsection (a)— 

2 (i) in paragraph (2)— 

3 (I) by striking ‘‘An entity’’ and 

4 inserting the following: 

5 ‘‘(A) FOOD FACILITIES.—An entity’’; and 

6 (II) by adding at the end the fol7 lowing: 

8 ‘‘(B) DIETARY SUPPLEMENT FACILI9 TIES.— 

10 ‘‘(i) IN GENERAL.—A dietary supple11 ment facility (referred to in the section as 

12 a ‘dietary supplement registrant’) shall 

13 submit a registration under paragraph (1) 

14 to the Secretary containing information 

15 necessary to notify the Secretary of the 

16 name and address of each facility at which, 

17 and all trade names under which, the die18 tary supplement registrant conducts busi19 ness. At the time of registration, the die20 tary supplement registrant shall also file 

21 with the Secretary a list of all dietary sup22 plements manufactured, packaged, held, 

23 distributed, labeled, or licensed by the fa24 cility. Such list shall be prepared in such 

25 form and manner as the Secretary may 


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1 prescribe, and shall be accompanied by a 

2 full list of the ingredients contained in 

3 each dietary supplement, and a copy of the 

4 labeling used by the facility for each die5 tary supplement. 

6 ‘‘(ii) UPDATES.—Each dietary supple7 ment registrant shall update the reg8 istrant’s registration annually on or before 

9 the anniversary date of the registrant’s ini10 tial registration. Each dietary supplement 

11 registrant shall also update the registrant’s 

12 registration to include information regard13 ing any new dietary supplement, or refor14 mulation of an existing dietary supplement, 

15 on or before the date such dietary supple16 ment is marketed for consumption in the 

17 United States.’’; and 

18 (ii) in paragraph (3), by inserting ‘‘or 

19 dietary supplement registrant’’ after ‘‘no20 tify the registrant’’. 

21 (c) NEW DIETARY INGREDIENTS.—Section 413 of 

22 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

23 350b) is amended— 

24 (1) by striking subsection (a) and inserting the 

25 following: 


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1 ‘‘(a) IN GENERAL.—A dietary supplement which con2 tains a new dietary ingredient shall be deemed adulterated 

3 under section 402(f) unless there is a history of use or 

4 other evidence of safety establishing that the dietary ingre5 dient when used under the conditions recommended or 

6 suggested in the labeling of the dietary supplement will 

7 reasonably be expected to be safe and, at least 75 days 

8 before being introduced or delivered for introduction into 

9 interstate commerce, the manufacturer or distributor of 

10 the dietary ingredient or dietary supplement provides the 

11 Secretary with information, including any citation to pub12 lished articles, which is the basis on which the manufac13 turer or distributor has concluded that a dietary supple14 ment containing such dietary ingredient will reasonably be 

15 expected to be safe. The Secretary shall keep confidential 

16 any information provided under this subsection for 90 

17 days following its receipt. After the expiration of such 90 

18 days, the Secretary shall place such information on public 

19 display, except matters in the information which are trade 

20 secrets or otherwise confidential, commercial informa21 tion.’’; 

22 (2) in subsection (c), by striking ‘‘was not mar23 keted in the United States before October 15, 1994 

24 and does not include any dietary ingredient which 

25 was marketed in the United States before October 


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1 15, 1994’’ and inserting ‘‘is not included on the list 

2 of ‘Accepted Dietary Ingredients’, to be prepared, 

3 published, and maintained by the Secretary’’; and 

4 (3) by adding at the end the following: 

5 ‘‘(d) MAINTAINING SUBSTANTIATION FILE.—Any 

6 person submitting information to the Secretary under sub7 section (a) shall create and maintain a scientifically rea8 sonable substantiation file relating to the claim that the 

9 dietary ingredient or dietary supplement will reasonably 

10 be expected to be safe. The substantiation file shall be pre11 pared and maintained in such form and manner as the 

12 Secretary may prescribe and shall be available for review 

13 and inspection by the Secretary upon request. 

14 ‘‘(e) EVIDENCE OF COMPLIANCE.—A dietary supple15 ment facility or retailer shall, prior to manufacturing, 

16 packaging, holding, distributing, labeling, or licensing the 

17 dietary supplement, obtain adequate written evidence from 

18 the preceding responsible entity in the chain of commerce 

19 that the product is registered as required by section 415 

20 and that the requirements of subsection (a) have been 

21 met. Such facility or retailer shall maintain such evidence 

22 of compliance for review and inspection by the Secretary 

23 upon request.’’. 

24 (d) CIVIL MONETARY PENALTY FOR NON-COMPLI25 ANCE.—Section 303 of the Federal Food, Drug, and CosVerDate Nov 24 2008 22:35 Feb 08, 2010 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3002.IS S3002

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1 metic Act (21 U.S.C. 333) is amended by adding at the 

2 end the following: 

3 ‘‘(h) CIVIL MONETARY PENALTY FOR NON-COMPLI4 ANCE.—Notwithstanding the provisions of subsection (a), 

5 any person who manufacturers, packages, holds, distrib6 utes, labels, or licenses a dietary supplement in violation 

7 of section 301, 402, 413, 415, 501, 502, 505, or 761, may, 

8 in addition to other penalties imposed in this section, be 

9 fined not more than twice the gross profits or other pro10 ceeds derived from the manufacture, packaging, holding, 

11 distribution, labeling, or license of such dietary supple12 ment.’’. 

13 (e) ADVERSE EVENT REPORTING FOR DIETARY SUP14 PLEMENTS.—Section 761 of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 379aa–1) is amended— 

16 (1) in the section heading, by striking ‘‘SERI17 OUS ADVERSE’’ and inserting ‘‘ADVERSE’’; 

18 (2) in subsection (a), by adding at the end the 

19 following: 

20 ‘‘(4) ADVERSE EVENT REPORT.—The term ‘ad21 verse event report’ means a report of non-serious ad22 verse events that is required to be submitted to the 

23 Secretary under subsection (b).’’; 

24 (3) in subsection (b)(1)— 


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1 (A) by striking ‘‘The manufacturer’’ and 

2 inserting the following: 

3 ‘‘(A) SERIOUS ADVERSE EVENTS.—The 

4 manufacturer’’; and 

5 (B) by adding at the end the following: 

6 ‘‘(B) NON-SERIOUS ADVERSE EVENTS.— 

7 The manufacturer, packer, holder, distributor, 

8 labeler, or licensee of a dietary supplement, 

9 whose name appears on the label of a dietary 

10 supplement marketed in the United States, 

11 shall submit to the Secretary, in such form and 

12 manner as the Secretary shall determine, a 

13 compilation report of all non-serious adverse 

14 events associated with such dietary supplement 

15 when used in the United States, accompanied 

16 by a copy of the label on or within the retail 

17 packaging of such dietary supplement.’’; 

18 (4) in subsection (c)(1), by adding at the end: 

19 ‘‘The responsible person shall annually submit to the 

20 Secretary a compilation report of all non-serious ad21 verse events received during the preceding year.’’; 

22 (5) in subsection (e)(1), by adding at the end: 

23 ‘‘The responsible person shall maintain records re24 lated to each annually submitted adverse event re25 port for a period of 3 years.’’; and 


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1 (6) in subsection (f), by striking ‘‘or an adverse 

2 event report voluntarily submitted’’ and inserting 

3 ‘‘or a non-serious adverse report submitted annu4 ally’’. 

5 (f) RECALL AUTHORITY FOR DIETARY SUPPLE6 MENTS.— 

7 (1) IN GENERAL.—Chapter IV of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 341 et 

9 seq.) is amended by adding at the end the following: 

10 ‘‘SEC. 418. RECALL AUTHORITY FOR DIETARY SUPPLE11 MENTS. 

12 ‘‘(a) RECALL AUTHORITY.— 

13 ‘‘(1) CEASE DISTRIBUTION AND NOTIFICATION

14 ORDER.— 

15 ‘‘(A) IN GENERAL.—If the Secretary finds 

16 there is a reasonable probability that a dietary 

17 supplement or a product marketed or sold as a 

18 dietary supplement would cause serious, adverse 

19 health consequences or death, or is adulterated 

20 or misbranded, the Secretary shall issue a cease 

21 distribution and notification order requiring the 

22 person named in the order to immediately— 

23 ‘‘(i) cease distribution of such dietary 

24 supplement or a product marketed or sold 

25 as a dietary supplement; 


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1 ‘‘(ii) notify distributors, importers, re2 tailers, and consumers of the order; and 

3 ‘‘(iii) instruct those distributors, im4 porters, retailers, and consumers to cease 

5 distributing, importing, selling, and using 

6 the dietary supplement. 

7 ‘‘(B) INFORMAL HEARING.—An order de8 scribed in subparagraph (A) shall provide the 

9 person subject to the order with an opportunity 

10 for an informal hearing, to be held not later 

11 than 10 days after the date of the issuance of 

12 the order, on the actions required by the order 

13 and on whether the order should be amended to 

14 require a recall of the dietary supplement or the 

15 product marketed or sold as a dietary supple16 ment. The person subject to the order shall 

17 have 5 days to notify the Secretary of the per18 son’s intent to challenge the order. If, after pro19 viding an opportunity for such a hearing, the 

20 Secretary determines that inadequate grounds 

21 exist to support the actions required by the 

22 order, the Secretary shall vacate the order. 

23 ‘‘(2) RECALL.— 

24 ‘‘(A) IN GENERAL.—If, after providing an 

25 opportunity for an informal hearing under 


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1 paragraph (1), the Secretary determines that 

2 the order should be amended to include a recall 

3 of the dietary supplement or the product mar4 keted or sold as a dietary supplement with re5 spect to which the order was issued, the Sec6 retary shall, except as provided in subpara7 graphs (B) and (C), amend the order to require 

8 a recall. The Secretary shall specify a timetable 

9 in which the dietary supplement recall will 

10 occur and shall require periodic reports to the 

11 Secretary describing the progress of the recall. 

12 The Secretary shall have the authority to ini13 tiate the action prescribed in this subparagraph 

14 regardless of whether or not the person subject 

15 to the order elects to exercise the right to chal16 lenge the initial order as permitted under para17 graph (1). 

18 ‘‘(B) CONTENT OF AMENDED ORDER.—An 

19 amended order under subparagraph (A)— 

20 ‘‘(i) shall not include recall of the die21 tary supplement or the product marketed 

22 or sold as a dietary supplement from indi23 viduals; and 

24 ‘‘(ii) shall provide for notice to indi25 viduals, at the expense of retailers and to 


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1 the satisfaction of the Secretary, subject to 

2 the risks associated with the use of such 

3 dietary supplement. 

4 ‘‘(C) NOTIFICATION.—In providing the no5 tice required by subparagraph (B)(ii), if a sig6 nificant number of such individuals cannot be 

7 identified, the Secretary shall notify such indi8 viduals pursuant to section 705(b).’’. 

Æ 


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