Dietary Supplement Safety Act 2010

111TH CONGRESS
2D SESSION S._____
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
_______________________
_______________introduced the following bill; which was read twice
and referred to the Committee on_________________
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 Representa
2 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’’.
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 oper
8 ation engaged in manufacturing, packaging, holding, dis
9 tributing, labeling, or licensing a dietary supplement for
10 consumption in the United States.’’.
11 (b) REGISTRATION OF DIETARY SUPPLEMENT FA
12 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 fol
16 lowing:
17 ‘‘(j) If it is a dietary supplement that is manufac
18 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.—Sec
22 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
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 fol
7 lowing:
8 ‘‘(B) DIETARY SUPPLEMENT FACILI
9 TIES.—
10 ‘‘(i) IN GENERAL.—A dietary supple
11ment 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 die
18 tary supplement registrant conducts busi
19 ness. At the time of registration, the die
20 tary supplement registrant shall also file
21 with the Secretary a list of all dietary sup
22 plements manufactured, packaged, held,
23 distributed, labeled, or licensed by the fa
24 cility. Such list shall be prepared in such
25 form and manner as the Secretary may
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 die
5 tary supplement.
6 ‘‘(ii) UPDATES.—Each dietary supple
7ment registrant shall update the reg
8 istrant’s registration annually on or before
9 the anniversary date of the registrant’s ini
10 tial registration. Each dietary supplement
11 registrant shall also update the registrant’s
12 registration to include information regard
13 ing any new dietary supplement, or refor
14 mulation of an existing dietary supplement,
15 on or before the date such dietary supple
16 ment is marketed for consumption in the
17 United States.’’; and
18 (ii) in paragraph (3), by inserting ‘‘or
19 dietary supplement registrant’’ after ‘‘no
20 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:
1 ‘‘(a) IN GENERAL.—A dietary supplement which con
2 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 ingre
5 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 pub
12 lished articles, which is the basis on which the manufac
13 turer or distributor has concluded that a dietary supple
14 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 informa
21 tion.’’;
22 (2) in subsection (c), by striking ‘‘was not mar
23 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
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 sub
7 section (a) shall create and maintain a scientifically rea
8 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 pre
11 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 supple
15 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-COMPLI
25 ANCE.—Section 303 of the Federal Food, Drug, and Cos-
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-COMPLI
4 ANCE.—Notwithstanding the provisions of subsection (a),
5 any person who manufacturers, packages, holds, distrib
6 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 pro
10 ceeds derived from the manufacture, packaging, holding,
11 distribution, labeling, or license of such dietary supple
12 ment.’’.
13 (e) ADVERSE EVENT REPORTING FOR DIETARY SUP
14 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 ‘‘SERI
17 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 ‘ad
21verse event report’ means a report of non-serious ad
22 verse events that is required to be submitted to the
23 Secretary under subsection (b).’’;
24 (3) in subsection (b)(1)—
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 ad
21verse events received during the preceding year.’’;
22 (5) in subsection (e)(1), by adding at the end:
23 ‘‘The responsible person shall maintain records re
24 lated to each annually submitted adverse event re
25 port for a period of 3 years.’’; and
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 annu
4 ally’’.
5 (f) RECALL AUTHORITY FOR DIETARY SUPPLE
6 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 SUPPLE
11MENTS.
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;
1 ‘‘(ii) notify distributors, importers, re
2 tailers, and consumers of the order; and
3 ‘‘(iii) instruct those distributors, im
4 porters, retailers, and consumers to cease
5 distributing, importing, selling, and using
6 the dietary supplement.
7 ‘‘(B) INFORMAL HEARING.—An order de
8 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 supple
16 ment. The person subject to the order shall
17 have 5 days to notify the Secretary of the per
18 son’s intent to challenge the order. If, after pro
19 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
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 mar
4 keted or sold as a dietary supplement with re
5 spect to which the order was issued, the Sec
6 retary shall, except as provided in subpara
7 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 ini
13 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 cha
16 lenge the initial order as permitted under para
17 graph (1).
18 ‘‘(B) CONTENT OF AMENDED ORDER.—An
19 amended order under subparagraph (A)—
20 ‘‘(i) shall not include recall of the die
21 tary supplement or the product marketed
22 or sold as a dietary supplement from indi
23 viduals; and
24 ‘‘(ii) shall provide for notice to indi
25 viduals, at the expense of retailers and to
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 no
5 tice required by subparagraph (B)(ii), if a sig
6 nificant number of such individuals cannot be
7 identified, the Secretary shall notify such indi
8 viduals pursuant to section 705(b).’’.

US Dietary Supplement Access Threatened Again.

The Maverick of the Senate, former Republican Presidential candidate, John McCain worried about his Senate re-election campaign, conducted a press conference just days before the Super Bowl and weeks before the Winter Olympics to introduce legislation promoted by the anti-dietary supplement coalition lead by the US Anti-Doping Agency (USADA) under the newly formed umbrella organization Safe Supplements Now (SSN).  Some view this as pandering to a large donor base just days before former Congressman J.D. Hayworth, conservative Republican announces entrance into the Republican primary race for the Arizona Senate seat that McCain currently holds.

The bill, S. 3002 – the “Dietary Supplement Safety Act of 2010” is a dangerous assault on the dietary supplement industry, health freedom and anyone living in the United States who consumes dietary supplements as a part of their overall approach to health promotion and wellness.  Republican Senator McCain of Arizona is joined by retiring Senator Byron Dorgan, a democrat from North Dakota.

We all need to work together to stop this bill from gaining any support in the Senate and keep any portion of it from becoming law. Click Here to take action by calling your senators.


Striking at the Heart of DSHEA, S. 3002 Seeks to Change in the Law:

1. Defines a Dietary Supplement Facility as: “any business or operation engaged in manufacturing, packaging, holding, distributing, labeling, or licensing a dietary supplement for consumption in the United States.’’

Why is this problematic? This expanded list of facilities who are subject to the registering and reporting requirements to the US Food and Drug Administration (FDA) will include not just manufacturers and large retail outlets that sell supplements, but every company in the distribution chain (warehouse, bottling facilities, and even truck stops, Seven-11s, and individuals and families who sell supplements through their membership in multi-level marketing organizations.)

2. Requires Federal Registration and Annual Reporting: S. 3002 seeks to expand the federal registration requirements previously only required of manufacturers to include every organization involved in the supply chain. This means that every manufacturer, retail outlet, truck stop, quick mart, warehouse, trucking company, and distributor for multi-level marketing companies will be required to register with the FDA, provide a complete list of products sold, their ingredients, and validation that the ingredients can be legally sold in the US. Furthermore, it requires annual updates including information on reformulations and changes to products. This type of activity will cost thousands of person hours of labor and lost revenues for every small business involved in the industry. Many businesses, in particular small retail outlets and multi-level marketing distributors will not have the knowledge or capacity to meet these requirements and be forced to reduce their family’s income potential as a result. In essence this Bill is bad for the economy.

3. Extensive Burdensome Documentation Requirements: All dietary supplement facilities (including manufacturer, retail outlet, and individuals who are multi-level marketing distributors will be required to create and maintain extensive files. The first is substantiation files which will contain “a scientifically reasonable substantiation file related to the claim that the dietary ingredient or dietary supplement will reasonably be expected to be safe.” (on each product and ingredient sold.) Each dietary supplement facility (now expended to include every step of the supply chain) shall prior to conducting their business (i.e. manufacturing, labeling, distributing, etc.) will be required to validate and obtain written certification that the entity in the supply chain just prior to them properly registered the product and met all requirements of the law. They further must retain the written evidence of compliance for review and inspection by the Government ‘upon request’. This regulatory burden which truthfully is impossible to meet, will drive the cost of doing business up dramatically and which will accomplish two things – loss of jobs in small businesses, passing the cost of this regulatory burden on to the consumer, thus driving costs up. The additional burden of activity on FDA staff will mean they will require additional resources, which means higher taxes.

4. Expanded Inspections and Grants FDA the Ability to Levy Monetary Penalties for Non-Compliance: The FDA would have the authority to inspect any of the registered facilities and in addition to other penalties already available to the agency, they will have the ability to levy monetary fines equal to twice the gross profits of a product FDA deems to be out of compliance. While FDA inspections in general are not a bad idea they are done to insure compliance with good manufacturing practices; this expansion is regulatory overkill. Furthermore, the ability for the FDA to levy monetary penalties that are capped at ‘twice the gross profits’ of the product determined to have been in violation will harm the small businesses and families who will be included in these reporting requirements.

5. Expands the Definition of Adulterated Food: to include any product for which any organization within the supply chain has not properly registered with the government. This creates an insurmountable challenge to the industry because a manufacturer risks their products being banned by the FDA if a whole sale warehouse, or retail facility, or even a distributor in their down line (for multi-level marketing) failed to complete the registration and annual reporting.

6. Changes the Language of DSHEA on New Dietary Ingredient Procedures: In DSHEA, products and ingredients that had been marketed prior to October 15, 1994 were declared legally marketable. Under S. 3002 this grandfathering in provision is removed and in its place an “Accepted Dietary Ingredients” list is to be created and maintained by the government. This is a backdoor attempt to codify the European Union’s “Positive List’ style policy which has resulted in the banning of many previously available supplements across Europe. This is the first step in forcing dietary supplements into a drug approval model – dietary supplements are foods not drugs and should not be treated like drugs. (Information about the European Union’s Positive List will be posted shortly on the Pop Campaign website.)

7. Modifies Recent Law that Requires Manufacturers to Report Serious Adverse Events: A modification to food laws that was supported by industry was a requirement for serious adverse events that were reported to the manufacturer had to be reported to the FDA within a certain time frame. It was extensively discussed at the time that only serious events should be reported because other non-serious events, things like slight digestive upset are not life threatening and only serve to drive the cost of managing such an activity exponentially higher. It creates a significant burden on both government and industry while not improving the knowledge base on product safety. S. 3002 seeks to expand the reporting organizations to include not just the manufacturer, but also the packer, holder, distributor, labeler, or licensee of a dietary supplement, whose name appears on the label of a dietary supplement marketed in the United States. They would each be required to maintain information on non-serious adverse events and submit the report annually to the FDA. In addition to the significant and unreasonable regulatory burden of this action, there is a large gray zone that will need to be addressed as to whether or not a known and expected side effect of a product (such as the Niacin flush) would be considered a non-serious adverse event.

8. Grants the FDA Unfettered Recall Authority: S. 3002 grants the government the authority to bar distribution of a product based solely on their determination that there is a ‘reasonable probability that a dietary supplement or product marketed or sold as a dietary supplement would cause serious adverse health consequence or death, or is adulterated or misbranded.’ They can also order the named entity to notify everyone in the distribution chain to stop manufacture, distribution and sale of the product and inform consumers to stop taking the product.

Why This is Problematic: No federal agency should be given the authority to bar the sale, distribution or consumption of a product based on a ‘reasonable probability’. Evidence of actual harm or contamination has been required in the past and should continue to be. Given the expanded definition of adulterated product, which will include a product or ingredient that is not registered properly, the FDA could bar the manufacture, sale and consumption of any product if a single retailer fails to register the products appropriately. Given the long history of disdain for dietary supplements in general, as well as the regulatory over reach, it is not a matter of if this power would be misused, but a matter of when and how often. Keep in mind the named party on the recall or cease order will bear the entire financial burden of notifying consumers and other parties as well as the legal costs of defending their business.

Every member of the Senate needs to be flooded with calls from constituents to request they oppose this bill. They need to hear that a majority of the people who keep them in their jobs support DSHEA and want it protected. They further need to receive letters by fax requesting they oppose the bill.

Call your Senator today and ask they oppose S. 3002, Senators McCain and Dorgan Anti-Dietary Supplement Bill. A list of Senators and their contact information is listed here : http://popcampaign.org/take-action/senate-numbers

____________________________________________________

Read the Bill S. 3002

IN THE SENATE OF THE UNITED STATES

__________________

_______________introduced the following bill; which was read twice
and referred to the Committee on_________________

_________________________________________________

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 Representa
2 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’’.

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 oper

8 ation engaged in manufacturing, packaging, holding, dis

9 tributing, labeling, or licensing a dietary supplement for

10 consumption in the United States.’’.

11 (b) REGISTRATION OF DIETARY SUPPLEMENT FA

12 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 fol

16 lowing:

17 ‘‘(j) If it is a dietary supplement that is manufac

18 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.—Sec

22 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

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 fol

7 lowing:

8 ‘‘(B) DIETARY SUPPLEMENT FACILI

9 TIES.—

10 ‘‘(i) IN GENERAL.—A dietary supple

11ment 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 die

18 tary supplement registrant conducts busi

19 ness. At the time of registration, the die

20 tary supplement registrant shall also file

21 with the Secretary a list of all dietary sup

22 plements manufactured, packaged, held,

23 distributed, labeled, or licensed by the fa

24 cility. Such list shall be prepared in such

25 form and manner as the Secretary may

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 die

5 tary supplement.

6 ‘‘(ii) UPDATES.—Each dietary supple

7ment registrant shall update the reg
8 istrant’s registration annually on or before

9 the anniversary date of the registrant’s ini

10 tial registration. Each dietary supplement

11 registrant shall also update the registrant’s

12 registration to include information regard

13 ing any new dietary supplement, or refor

14 mulation of an existing dietary supplement,

15 on or before the date such dietary supple

16 ment is marketed for consumption in the

17 United States.’’; and

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

19 dietary supplement registrant’’ after ‘‘no

20 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:

1 ‘‘(a) IN GENERAL.—A dietary supplement which con

2 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 ingre

5 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 pub

12 lished articles, which is the basis on which the manufac

13 turer or distributor has concluded that a dietary supple

14 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 informa

21 tion.’’;

22 (2) in subsection (c), by striking ‘‘was not mar

23 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

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 sub

7 section (a) shall create and maintain a scientifically rea

8 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 pre

11 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 supple

15 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-COMPLI

25 ANCE.—Section 303 of the Federal Food, Drug, and Cos-

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-COMPLI

4 ANCE.—Notwithstanding the provisions of subsection (a),

5 any person who manufacturers, packages, holds, distrib

6 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 pro

10 ceeds derived from the manufacture, packaging, holding,

11 distribution, labeling, or license of such dietary supple

12 ment.’’.

13 (e) ADVERSE EVENT REPORTING FOR DIETARY SUP

14 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 ‘‘SERI

17 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 ‘ad

21verse event report’ means a report of non-serious ad

22 verse events that is required to be submitted to the

23 Secretary under subsection (b).’’;

24 (3) in subsection (b)(1)—

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 ad

21verse events received during the preceding year.’’;

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

23 ‘‘The responsible person shall maintain records re

24 lated to each annually submitted adverse event re

25 port for a period of 3 years.’’; and

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 annu

4 ally’’.

5 (f) RECALL AUTHORITY FOR DIETARY SUPPLE

6 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 SUPPLE

11MENTS.

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;

1 ‘‘(ii) notify distributors, importers, re

2 tailers, and consumers of the order; and

3 ‘‘(iii) instruct those distributors, im

4 porters, retailers, and consumers to cease

5 distributing, importing, selling, and using

6 the dietary supplement.

7 ‘‘(B) INFORMAL HEARING.—An order de

8 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 supple

16 ment. The person subject to the order shall

17 have 5 days to notify the Secretary of the per

18 son’s intent to challenge the order. If, after pro

19 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

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 mar

4 keted or sold as a dietary supplement with re

5 spect to which the order was issued, the Sec

6 retary shall, except as provided in subpara

7 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 ini

13 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 cha

16 lenge the initial order as permitted under para

17 graph (1).

18 ‘‘(B) CONTENT OF AMENDED ORDER.—An

19 amended order under subparagraph (A)—

20 ‘‘(i) shall not include recall of the die

21 tary supplement or the product marketed

22 or sold as a dietary supplement from indi

23 viduals; and

24 ‘‘(ii) shall provide for notice to indi

25 viduals, at the expense of retailers and to

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 no

5 tice required by subparagraph (B)(ii), if a sig

6 nificant number of such individuals cannot be

7 identified, the Secretary shall notify such indi

8 viduals pursuant to section 705(b).’’.