nity involvement in reducing tobacco product
use.
‘‘(3) EVENT TRANSITIONAL SPONSORSHIP PRO-
GRAM.—
‘‘(A) IN GENERAL.—Activities for the tran-
sitional sponsorship of certain activities, includ-
ing grants to—
‘‘(i)(I) pay the costs associated with
the transitional sponsorship of an event or
activity;
‘‘(II) provide for the transitional spon-
sorship of an individual or team;
‘‘(III) pay the required entry fees as-
sociated with the participation of an indi-
vidual or team in an event or activity;
‘‘(IV) provide financial or technical
support to an individual or team in connec-
tion with the participation of that individ-
ual or team in an activity described in sub-
paragraph (C)(iii); or
‘‘(IV) for any other purposes deter-
mined appropriate by the State; and
‘‘(ii) promote images or activities to
discourage individuals from using tobacco
products or encourage individuals who use
such products to quit.
‘‘(B) 
ELIGIBILITY.—A 
State 
program
funded under this paragraph shall ensure that
to be eligible to receive assistance under this
paragraph an entity or individual shall prepare
and submit to the State an application at such
time, in such manner, and containing such in-
formation as the State may require, including—
‘‘(i) a description of the event, activ-
ity, team, or entry for which the grant is
to be provided;
‘‘(ii) documentation that the event,
activity, team, or entry involved was spon-
sored or otherwise funded by a tobacco
manufacturer or distributor prior to the
date of the application; and
‘‘(iii) a certification that the applicant
is unable to secure funding for the event,
activity, team, or entry involved from
sources other than those described in
clause (ii).
‘‘(C) PERMISSIBLE
SPONSORSHIP
ACTIVI-
TIES.—Events, activities, teams, or entries for
which a grant may be provided under this para-
graph include—
‘‘(i) an athletic, musical, artistic, or
other social or cultural event or activity
that was sponsored in whole or in part by
a tobacco manufacturer or distributor prior
to the date of enactment of this title;
‘‘(ii) the participation of a team that
was sponsored in whole or in part by a to-
bacco manufacturer or distributor prior to
the date of enactment of this title, in an
athletic event or activity; and
‘‘(iii) the payment of a portion or all
of the entry fees of, or other financial or
technical support provided to, an individual
or team by a tobacco manufacturer or dis-
tributor prior to the date of enactment of
this title, for participation of the individual
in an athletic, musical, artistic, or other
social or cultural event.
‘‘(d) ALLOCATION OF FUNDS.—A State shall ensure
that amounts received under a block grant under sub-
section (a) are used to carry out each of the activities de-
scribed in subsection (c).
‘‘(e) FUNDING.—The Secretary shall use amounts
available under section 2812(b)(4) to carry out this sec-
tion.
‘‘Subtitle C—Reduction in
Underage Tobacco Use
‘‘SEC. 2831. PURPOSE.
‘‘It is the purpose of this subtitle to encourage the
achievement of reductions in the number of underage con-
sumers of tobacco products through the imposition of ad-
ditional financial deterrents relating to tobacco products
if certain underage tobacco-use reduction targets are not
met.
‘‘SEC. 2832. CHILD TOBACCO USE SURVEYS.
‘‘(a) ANNUAL PERFORMANCE SURVEY.—Not later
than 1 year after the date of the enactment of this Act
and annually thereafter the Secretary shall conduct a sur-
vey to determine the number of children who used each
manufacturer’s tobacco products within the past 30 days.
‘‘(b) EXCLUSION OF CERTAIN AGES.—The Secretary
may exclude from the survey conducted under subsection
(a), children under the age of 12 years (or such other less-
er age as the Secretary may establish) to strengthen the
validity of the survey.
‘‘(c) BASELINE LEVEL.—The baseline level of the
child tobacco product use of a manufacturer (referred to
in this subtitle as the ‘baseline level’) is the number of
children determined to have used the tobacco products of
such manufacturer in the first annual performance survey
for 1998.
‘‘(d) ADDITIONAL MEASURES.—In order to increase
the understanding of youth tobacco product use, the Sec-
retary may, for informational purposes only, add addi-
tional measures to the survey under subsection (a), con-
duct periodic or occasional surveys at other times, and
conduct surveys of other populations such as young adults.
The results of such surveys shall be made available to
manufacturers and the public to assist in efforts to reduce
youth tobacco use.
‘‘(e) DEFINITION.—As used in this subtitle, the term
‘tobacco product’ means cigarettes, smokeless tobacco
products, and roll-your-own tobacco products.
‘‘SEC. 2833. REDUCTION IN UNDERAGE TOBACCO PRODUCT
USAGE.
‘‘(a) STANDARDS
FOR
EXISTING
MANUFACTUR-
ERS.—Each manufacturer which manufactured a tobacco
product on or before the date of the enactment of this
title shall reduce the number of children who use its to-
bacco products so that the number of children determined
to have used its tobacco products on the basis of—
‘‘(1) the fourth annual performance survey is
equal to or less than—
‘‘(A) 60 percent of the manufacturer’s
baseline level; or
‘‘(B) the de minimis level;
whichever is greater;
‘‘(2) the fifth annual performance survey is
equal to or less than—
‘‘(A) 50 percent of the manufacturer’s
baseline level; or
‘‘(B) the de minimis level;
whichever is greater;
‘‘(3) the sixth annual performance survey is
equal to or less than—
‘‘(A) 40 percent of the manufacturer’s
baseline level; or
‘‘(B) the de minimis level;
whichever is greater;
‘‘(4) the seventh annual performance survey is
equal to or less than—
‘‘(A) 35 percent of the manufacturer’s
baseline level; or
‘‘(B) the de minimis level;
whichever is greater;
‘‘(5) the eighth annual performance survey is
equal to or less than—
‘‘(A) 30 percent of the manufacturer’s
baseline level; or
‘‘(B) the de minimis level;
whichever is greater;
‘‘(6) the ninth annual performance survey is
equal to or less than—
‘‘(A) 25 percent of the manufacturer’s
baseline level; or
‘‘(B) the de minimis level;
whichever is greater; and
‘‘(7) the 10th annual performance survey and
each annual performance survey conducted there-
after is equal to or less than—
‘‘(A) 20 percent of the manufacturer’s
baseline level; or
‘‘(B) the de minimis level;
whichever is greater.
‘‘(b) STANDARDS FOR NEW MANUFACTURERS.—Any
manufacturer of a tobacco product which begins to manu-
facture a tobacco product after the date of the enactment
of this title shall ensure that the number of children deter-
mined to have used the manufacturer’s tobacco products
in each annual performance survey conducted after the
manufacturer begins to manufacture tobacco products is
equal to or less than the de minimis level.
‘‘(c) DE MINIMIS LEVEL.—The de minimis level shall
be 0.5 percent of the total number of children determined
to have used tobacco products in the first annual perform-
ance survey.
‘‘SEC. 2834. NONCOMPLIANCE.
‘‘(a) VIOLATION OF STANDARD.—If, with respect to
a year, a manufacturer of a tobacco product fails to com-
ply with the required reduction under section 2833(a), the
manufacturer shall pay to the Secretary a noncompliance
fee for each unit of tobacco products manufactured by the
manufacturer which is distributed for consumer use in the
year following the year in which the noncompliance occurs,
in the amount specified in subsection (b).
‘‘(b) NONCOMPLIANCE FEE PER UNIT.—
‘‘(1) IN GENERAL.—With respect to a year, a
manufacturer of a tobacco product shall be required
to pay a noncompliance fee for each unit of tobacco
products manufactured by the manufacturer if the
noncompliance factor of the manufacturer (as deter-
mined under paragraph (3)) for the year is greater
than zero.
‘‘(2) AMOUNT
OF
FEE.—The amount of the
noncompliance fee that is required to be paid by a
manufacturer under this section for each unit of to-
bacco products manufactured by the manufacturer
for the year involved shall be equal to—
‘‘(A) 2 cents multiplied by so much of the
noncompliance factor as does not exceed 5;
‘‘(B) 3 cents multiplied by so much of the
noncompliance factor as exceeds 5 but does not
exceed 10;
‘‘(C) 4 cents multiplied by so much of the
noncompliance factor as exceeds 10 but does
not exceed 15;
‘‘(D) 5 cents multiplied by so much of the
noncompliance factor as exceeds 15 but does
not exceed 20; and
‘‘(E) 6 cents multiplied by so much of the
noncompliance factor as exceeds 20 but does
not exceed 25.
‘‘(3) 
NONCOMPLIANCE
FACTOR.—The 
non-
compliance factor of a manufacturer shall be equal
to 100 multiplied by the noncompliance percentage
of the manufacturer (as determined under para-
graph (4)).
‘‘(4) 
NONCOMPLIANCE
PERCENTAGE.—The
noncompliance percentage (if any) of a manufacturer
shall be equal to 1 less the ratio of—
‘‘(A) the actual reduction that is achieved
by the manufacturer in the number of children
who use the manufacturer’s tobacco products in
the year involved; and
‘‘(B) the reduction required under section
2833(a) in the number of children who use the
manufacturer’s tobacco products for the year.
‘‘(c) NONCOMPLIANCE FEES FOR CONSECUTIVE VIO-
LATIONS.—If a manufacturer of a tobacco product fails
to comply with the required reduction under section
2833(a) in 2 or more consecutive years, the noncompliance
fee that is required to be paid by the manufacturer under
this section for each unit of tobacco products manufac-
tured by such manufacturer which is distributed for
consumer use in the year following the year in which the
noncompliance occurs, shall be the amount determined
under subsection (b) for the year multiplied by the number
of consecutive years in which the manufacturer has failed
to comply with such required reductions.
‘‘(d) PROHIBITION
ON
SINGLE-PACK
SALES
IN
CASES OF REPEATED NONCOMPLIANCE.—Not later than
1 year after the date of enactment of this title, the Sec-
retary shall establish regulations to prohibit the sale of
single packs of a manufacturer’s tobacco products in cases
of repeated noncompliance with the reductions required
under section 2833(a). Such regulations shall require that,
if a manufacturer fails to comply with such reductions in
3 or more consecutive years, the manufacturer’s tobacco
products may be sold in the following year only in pack-
ages containing not less than 10 units of the product per
package (200 cigarettes per package in the case of ciga-
rettes, and a corresponding package size for other tobacco
products).
‘‘(e) REQUIRED GENERIC PACKAGING
IN SEVERE
CASES OF REPEATED NONCOMPLIANCE.—Not later than
1 year after the date of enactment of this title, the Sec-
retary shall establish regulations to require units and
packages of a manufacturer’s tobacco products to have ge-
neric packaging in severe cases of repeated noncompliance
with the reductions required under section 2833(a). Such
regulations shall require that, if a manufacturer fails to
comply with such reductions in 4 or more consecutive
years, the manufacturer’s tobacco products may be sold
in the following year only in units and packages whose
packaging contains no external images, logos, or text
(other than any required labels), except that the brand
name and the identifier ‘tobacco’ may appear on the pack-
aging in block lettering in black type on a white back-
ground.
‘‘(f) PAYMENT.—The noncompliance fee to be paid
by a manufacturer under this section shall be paid on a
quarterly basis, with payments due not later than 30 days
after the end of each calendar quarter.
‘‘SEC. 2835. USE OF AMOUNTS.
‘‘Of the amounts received under section 2834—
‘‘(1) 37.5 percent of such amounts shall be
made available to the National Biomedical and Basic
Scientific Research Board for research, training and
demonstration project grants under section 2822;
‘‘(2) 37.5 percent of such amounts shall be
made available to the Secretary for healthy child de-
velopment grants under section 2823; and
‘‘(3) 25 percent of such amounts shall be made
available to the Secretary for reduction and addic-
tion prevention research grants and for grants under
the national tobacco usage reduction and education
program under part 2 of subtitle C.
‘‘SEC. 2836. MISCELLANEOUS PROVISIONS.
‘‘(a) JUDICIAL REVIEW.—A manufacturer of tobacco
products may seek judicial review of any action under this
subtitle only after a noncompliance fee has been assessed
and paid by the manufacturer and only in the United
States District Court for the District of Columbia. In an
action by a manufacturer seeking judicial review of an an-
nual performance survey, the manufacturer may prevail—
‘‘(1) only if the manufacturer shows that the
results of the performance survey were arbitrary and
capricious; and
‘‘(2) only to the extent that the manufacturer
shows that it would have been required to pay a less-
er noncompliance fee if the results of the perform-
ance survey were not arbitrary and capricious.
‘‘(b) PASS-THROUGH.—Nothing in this subtitle shall
be construed as prohibiting a manufacturer from passing
the costs of the amount of any noncompliance fee assessed
under this subtitle on to consumers of tobacco products
as a further economic deterrent to the use of such prod-
ucts.
‘‘(c) PROHIBITION.—No stay or other injunctive re-
lief may be granted by the Secretary or any court that
has the effect of enjoining the imposition and collection
of noncompliance fees to be applied under this section.
‘‘(d) CHILD.—As used in this subtitle, the term
‘child’ means, except as provided in section 2832(b), an
individual who is under the age of 18.
‘‘Subtitle D—Miscellaneous
Provisions
‘‘SEC. 2841. WHISTLEBLOWER PROTECTIONS.
‘‘(a) PROHIBITION OF REPRISALS.—An employee of
any manufacturer, distributor, or retailer of a tobacco
product may not be discharged, demoted, or otherwise dis-
criminated against (with respect to compensation, terms,
conditions, or privileges of employment) as a reprisal for
disclosing to an employee of the Food and Drug Adminis-
tration, the Department of Health and Human Services,
the Department of Justice, or any State or local regu-
latory or enforcement authority, information relating to a
substantial violation of law related to this title or a State
or local law enacted to further the purposes of this title.
‘‘(b) ENFORCEMENT.—Any employee or former em-
ployee who believes that such employee has been dis-
charged, demoted, or otherwise discriminated against in
violation of subsection (a) may file a civil action in the
appropriate United States district court before the end of
the 2-year period beginning on the date of such discharge,
demotion, or discrimination.
‘‘(c) REMEDIES.—If the district court determines
that a violation has occurred, the court may order the
manufacturer, distributor, or retailer involved to—
‘‘(1) reinstate the employee to the employee’s
former position;
‘‘(2) pay compensatory damages; or
‘‘(3) take other appropriate actions to remedy
any past discrimination.
‘‘(d) LIMITATION.—The protections of this section
shall not apply to any employee who—
‘‘(1) deliberately causes or participates in the
alleged violation of law or regulation; or
‘‘(2) knowingly or recklessly provides substan-
tially false information to the Food and Drug Ad-
ministration, the Department of Health and Human
Services, the Department of Justice, or any State or
local regulatory or enforcement authority.
‘‘SEC. 2842. NATIONAL TOBACCO DOCUMENT DEPOSITORY.
‘‘(a) PURPOSE.—It is the purpose of this section to
provide for the disclosure of previously nonpublic or con-
fidential documents by manufacturers of tobacco products,
including the results of internal health research, and to
provide for a procedure to settle claims of attorney-client
privilege, work product, or trade secrets with respect to
such documents.
‘‘(b) ESTABLISHMENT.—
‘‘(1) IN GENERAL.—The Secretary shall provide
for the establishment, either within the Department
of Health and Human Services or through a private
nonprofit entity, of a National Tobacco Document
Depository (in this section referred to as the ‘Depos-
itory’). Such Depository shall be located in the
Washington, D.C. area and be open to the public.
‘‘(2) DOCUMENTS.—Manufacturers of tobacco
products, acting in conjunction with the Tobacco In-
stitute and the Council for Tobacco Research,
U.S.A., shall, not later than 30 days after the date
of enactment of this title, provide documents to the
Depository in accordance with this section.
‘‘(3) FUNDING.—The entities described in para-
graph (2) shall bear the sole responsibility for fund-
ing the Depository.
‘‘(c) USE OF DEPOSITORY.—The Depository shall be
maintained in a manner that permits the Depository to
be used as a resource for litigants, public health groups,
and any other individuals who have an interest in the cor-
porate records and research of the manufacturers concern-
ing smoking and health, addiction or nicotine dependency,
safer or less hazardous cigarettes, and underage tobacco
use and marketing.
‘‘(d) CONTENTS.—The Depository shall include (and
manufacturers and the Tobacco Institute and the Council
for Tobacco Research, U.S.A. shall provide)—
‘‘(1) within 90 days of the date of the establish-
ment of the Depository, all documents provided by
such entities to plaintiffs in—
‘‘(A) civil or criminal actions brought by
State attorneys general (including all docu-
ments selected by plaintiffs from the Guilford
Repository of the United Kingdom);
‘‘(B) Philip Morris Companies Inc.’s defa-
mation action against Capital Cities/American
Broadcasting Company News;
‘‘(C) the Federal Trade Commission’s in-
vestigation concerning Joe Camel and underage
marketing;
(D) Haines v. Liggett Group, Inc. (814 F.
Supp. 414 (D.N.J., Jan. 26, 1993)) and
Cippollone v. Liggett Group, Inc. (822 F. 2d
335, 56 USLW 2028, 7 Fed. R. Serv. 3d 1438
(3rd Cir. (N.J.), Jun. 8, 1987)); and
(E) Estate of Burl Butler v. Philip Morris,
Inc. (case No. 94–4–53);
‘‘(2) within 90 days after the date of the estab-
lishment of the Depository, any existing documents
discussing or referring to health research, addiction
or dependency, safer or less hazardous cigarettes,
studies of the smoking habits of minors, and the re-
lationship between advertising or promotion and
youth smoking, that the entities described in sub-
section (b) have not completed producing as required
in the actions described in paragraph (1);
‘‘(3) within 30 days of the date of the establish-
ment of the Depository, all documents relating to in-
dices (as defined by the court in State of Minnesota
and Blue Cross and Blue Shield of Minnesota v.
Philip Morris, Inc., et al) of documents relating to
smoking and health, including all indices identified
by the manufacturers in the the State of Texas v.
American Tobacco Company, et al.;
‘‘(4) upon the settlement of any action referred
to in this subsection, and after a good-faith, de novo,
document-by-document review of all documents pre-
viously withheld from production in any actions on
the grounds of attorney-client privilege, all docu-
ments determined to be outside of the scope of the
privilege;
‘‘(5) all existing or future documents relating to
original laboratory research concerning the health or
safety of tobacco products, including all laboratory
research results relating to methods used to make
tobacco products less hazardous to consumers;
‘‘(6) a comprehensive new attorney-client privi-
lege log of all documents, itemized in sufficient de-
tail so as to enable any interested individual to de-
termine whether the individual will challenge the
claim of privilege, that the entities described in sub-
section (b) (based on the de novo review of such doc-
uments by such entities) claim are protected from
disclosure under the attorney-client privilege;
‘‘(7) all existing or future documents relating to
studies of the smoking habits of minors or docu-
ments referring to any relationship between advertis-
ing and promotion and underage smoking; and
‘‘(8) all other documents determined appro-
priate under regulations promulgated by the Sec-
retary.
‘‘(e) DISPUTE RESOLUTION PANEL.—
‘‘(1) ESTABLISHMENT.—The Judicial Con-
ference of the United States shall establish a To-
bacco Documents Dispute Resolution Panel, to be
composed of 3 Federal judges to be appointed by the
Conference, to resolve all disputes involving claims
of attorney-client, work product, or trade secrets
privilege with respect to documents required to be
deposited into the Depository under subsection (d)
that may be brought by Federal, State, or local gov-
ernmental officials or the public or asserted in any
action by a manufacturer.
‘‘(2) BASIS FOR DETERMINATIONS.—The deter-
minations of the Panel established under paragraph
(1) shall be based on—
‘‘(A) the American Bar Association/Amer-
ican Law Institute Model Rules or the prin-
cipals of Federal law with respect to attorney-
client or work product privilege; and
‘‘(B) the Uniform Trade Secrets Act with
respect to trade secrecy.
‘‘(3) DECISION.—Any decision of the Panel es-
tablished under paragraph (1) shall be final and
binding upon all Federal and State courts.
‘‘(4) ASSESSING OF FEES.—As part of a deter-
mination under this subsection, the Panel estab-
lished under paragraph (1) shall determined whether
a claimant of the privilege acted in good faith and
had a factual and legal basis for asserting the claim.
If the Panel determines that the claimant did not
act in good faith, the Panel may assess costs against
the claimant, including a reasonable attorneys’ fee,
and may apply such other sanctions as the Panel de-
termines appropriate.
‘‘(5) ACCELERATED REVIEW.—The Panel estab-
lished under paragraph (1) shall establish proce-
dures for the accelerated review of challenges to a
claim of privilege. Such procedures shall include as-
surances that an individual filing a challenge to such
a claim need not make a prima facie showing of any
kind as a prerequisite to an in camera review of the
documents at issue.
‘‘(6) SPECIAL
MASTERS.—The Panel estab-
lished under paragraph (1) may appoint Special
Masters in accordance with Rule 53 of the Federal
Rules of Civil Procedure. The cost relating to any
Special Master shall be assessed to the manufactur-
ers as part of a fee process to be established under
regulations promulgated by the Secretary.
‘‘(f) OTHER PROVISIONS.—
‘‘(1) NO WAIVER OF PRIVILEGE.—Compliance
with this section by the entities described in sub-
section (b) shall not be deemed to be a waiver on be-
half of such entities of any applicable privilege or
protection.
‘‘(2) AVOIDANCE OF DESTRUCTION.—In estab-
lishing the Depository, procedures shall be imple-
mented to protect against the destruction of docu-
ments.
‘‘(3) DEEMED
PRODUCED.—Any documents
contained in the Depository shall be deemed to have
been produced for purposes of any tobacco-related
litigation in the United States.
‘‘(g) DOCUMENTS.—For purposes of this section, the
term ‘documents’ shall include any paper documents that
may be printed using data that is contained in computer
files.
‘‘(h) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to interfere in any way with the
discovery rights of courts or parties in civil or criminal
actions involving tobacco products, or the right of access
to such documents under any other provision of law.
‘‘SEC. 
2843. 
TOBACCO 
OVERSIGHT 
AND 
COMPLIANCE
BOARD.
‘‘(a) ESTABLISHMENT.—
‘‘(1) IN
GENERAL.—There is established an
independent board to be known as the Tobacco
Oversight and Compliance Board (referred to in this
section as the ‘Board’).
‘‘(2) MEMBERSHIP.—The Board shall consist of
5 members with expertise relating to tobacco and
public health. The members, including the chair-
person, shall be appointed by the Secretary. The ini-
tial members of the Board shall be appointed by the
Secretary within 30 days of the date of the enact-
ment of this title. A member of the Board may be
removed by the Secretary only for neglect of duty
or malfeasance in office.
‘‘(3) TERMS.—The term of office of a member
of the Board shall be 6 years, except that the mem-
bers first appointed shall have terms of 2, 3, 4, and
5 years, respectively, as determined by the Sec-
retary.
‘‘(b) GENERAL DUTY.—The Board shall oversee and
monitor the operations of the tobacco industry to deter-
mine whether tobacco product manufacturers are in com-
pliance with this Act.
‘‘(c) DISCLOSURE
OF TOBACCO INDUSTRY DOCU-
MENTS.—
‘‘(1) SUBMISSION
BY
MANUFACTURERS.—Not
later than 3 months after the date of the enactment
of this title, and as otherwise required by the Board,
each tobacco manufacturer shall submit to the
Board a copy of all documents in the manufacturer’s
possession—
‘‘(A) relating to—
‘‘(i) any health effects, including ad-
diction, caused by the use of tobacco prod-
ucts;
‘‘(ii) the manipulation or control of
nicotine in tobacco products; or
‘‘(iii) the sale or marketing of tobacco
products to children; or
‘‘(B) produced, or ordered to be produced,
by the tobacco manufacturer in the case enti-
tled State of Minnesota v. Philip Morris, Inc.,
Civ. Action No. C1–94–8565 (Ramsey County,
Minn.) including attorney-client and other docu-
ments produced or ordered to be produced for
in camera inspection.
‘‘(2) DISCLOSURE BY THE BOARD.—Not later
than 6 months after the date of the enactment of
this title, and otherwise as required by the Board,
the Board shall, subject to paragraph (3), make
available to the public the documents submitted
under paragraph (1).
‘‘(3) PROTECTION
OF
TRADE
SECRETS.—The
Board, members of the Board, and staff of the
Board shall not disclose information that is entitled
to protection as a trade secret unless the Board de-
termines that disclosure of such information is nec-
essary to protect the public health. This paragraph
shall not be construed to prevent the disclosure of
the adverse health effects or addiction caused by the
use of tobacco products.
‘‘(e) AUTHORITY.—The Board, any member of the
Board, or staff designated by the Board may hold hear-
ings, administer oaths, issue subpoena, require the testi-
mony or deposition of witnesses, the production of docu-
ments, or the answering of interrogatories, or, upon pres-
entation of the proper credentials, enter and inspect facili-
ties.
‘‘(f) ENFORCEMENT.—Notwithstanding any other
provision of law, tobacco manufacturers shall provide any
testimony, deposition, documents, or other information,
answer any interrogatories, and allow any entry or inspec-
tion required pursuant to this section, except to the extent
that a constitutional privilege protects the tobacco manu-
facturer from complying with such requirement.
‘‘(g) ADMINISTRATION.—
‘‘(1) STAFF.—The Chairperson of the Board
shall exercise the executive and administrative func-
tions of the Board and shall have the authority to
hire such staff as may be necessary for the operation
of the Board.
‘‘(2) SALARIES.—The members of the Board
shall receive such salary and benefits as the Sec-
retary deems necessary, except that the salary of the
Chairperson shall not be less than that provided for
under level III of the Executive Schedule in section
5314 of title 5, United States Code.
‘‘SEC. 2844. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY.
‘‘Except as otherwise provided for in this title or the
Healthy and Smoke Free Children Act (or an amendment
made by such Act), nothing in this title or such Act shall
be construed as prohibiting a State from imposing require-
ments, prohibitions, penalties or other measures to further
the purposes of this title or Act that are in addition to
the requirements, prohibitions, or penalties required under
this title or Act. To the extent not inconsistent with the
purposes of this title or Act, State and local governments
may impose additional tobacco product control measures
to further restrict or limit the use of such products by
minors.
‘‘SEC. 2845. REGULATIONS.
‘‘The Secretary may promulgate regulations to en-
force the provisions of this title, or to modify, alter, or
expand the requirements and protections provided for in
this title if the Secretary determines that such modifica-
tions, alternations, or expansion is necessary.’’.
TITLE II—FDA JURISDICTION
OVER TOBACCO PRODUCTS
Subtitle A—Amendments to the
Federal Food, Drug and Cos-
metic Act
SEC. 201. REFERENCE.
Whenever in this subtitle an amendment or repeal is
expressed in terms of an amendment to, or repeal of, a
section or other provision, the reference shall be consid-
ered to be made to a section or other provision of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).
SEC. 202. STATEMENT OF GENERAL AUTHORITY.
The Secretary of Health and Human Services, acting
through the Food and Drug Administration, shall have the
authority under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321 et seq.) (above and beyond the existing
authority of the Secretary to regulate tobacco products as
of the date of enactment of this Act) to regulate the manu-
facture, labeling, sale, distribution, and advertising of to-
bacco products.
SEC. 203. TREATMENT OF TOBACCO PRODUCTS AS DRUGS
AND DEVICES.
(a) DEFINITIONS.—
(1) DRUG.—Section 201(g)(1) (21 U.S.C.
321(g)(1)) is amended by striking ‘‘; and (D)’’ and
inserting ‘‘(including nicotine in tobacco products);
and (D)’’.
(2) DEVICES.—Section 201(h) (21 U.S.C.
321(h)) is amended—
(A) in paragraph (3), by inserting before
the comma the following: ‘‘(including tobacco
products containing nicotine); and
(B) by adding at the end the following:
‘‘For purposes of this Act a tobacco product
shall be classified as a class II device.’’.
(3) OTHER
DEFINITIONS.—Section 201 (21
U.S.C. 321) is amended by adding at the end there-
of the following new paragraphs:
‘‘(ii)(1) The term ‘tobacco product’ means cigarettes,
cigarillos, cigarette tobacco, little cigars, pipe tobacco, and
smokeless tobacco, and roll-your-own tobacco.
‘‘(2) The term ‘cigarette’ means any product which
contains nicotine, is intended to be burned under ordinary
conditions of use, and consists of—
‘‘(A) any roll of tobacco wrapped in paper or in
any substance not containing tobacco; and
‘‘(B) any roll of tobacco wrapped in any sub-
stance containing tobacco which, because of its ap-
pearance, the type of tobacco used in the filler, or
its packaging and labeling, is likely to be offered to,
or purchased by, consumers as a cigarette described
in subparagraph (A).
‘‘(3) The term ‘cigarette tobacco’ means any product
that consists of loose tobacco that contains or delivers nic-
otine and is intended for use by persons in a cigarette.
Unless otherwise stated, the requirements of this title per-
taining to cigarettes shall also apply to cigarette tobacco.
‘‘(4) The term ‘smokeless tobacco’ means any product
that consists of cut, ground, powdered, or leaf tobacco that
contains nicotine and that is intended to be placed in the
oral or nasal cavity.
‘‘(5) The term ‘roll-your-own tobacco’ has the mean-
ing given such term by section 5702(p) of the Internal
Revenue Code of 1986.
‘‘(6) The term ‘little cigars’ means any roll of tobacco
wrapped in leaf tobacco or any substance containing to-
bacco (other than any roll of tobacco which is a cigarette
within the meaning of this Act) an as to which 1,000 units
weigh not more than 3 pounds.
‘‘(7) The term ‘cigar’ means any roll of tobacco
wrapped in leaf tobacco or in any substance contain-
ing tobacco (other than any roll of tobacco which is
a cigarette or cigarillo within the meaning of para-
graph (3) or (4)).
‘‘(8) The term ‘cigarillos’ means any roll of to-
bacco wrapped in leaf tobacco or any substance con-
taining tobacco (other than any roll of tobacco which
is a cigarette within the meaning of paragraph (3))
and as to which 1,000 units weigh not more than 3
pounds.
‘‘(9) The term ‘pipe tobacco’ means any loose
tobacco that, because of its appearance, type, pack-
aging, or labeling, is likely to be offered to, or pur-
chased by, consumers as a tobacco product to be
smoked in a pipe.
‘‘(10) The term ‘nicotine’ means the chemical sub-
stance 
named 
3-(1-Methyl-2-pyrrolidinyl)pyridine 
or
C10H14N2, including any salt or complex of nicotine.’’.
‘‘(11) The term ‘tobacco additive’ means any sub-
stance the intended use of which results or may reasonably
be expected to result, directly or indirectly, in the sub-
stance becoming a component of, or otherwise affecting
the characteristics of, any tobacco product, including any
substance that may have been removed from the tobacco
product and then readded in the substance’s original or
modified form.
‘‘(12) The term ‘tar’ means mainstream total articu-
late matter minus nicotine and water.’’.
(b) MISBRANDING.—Section 502(q) (21 U.S.C.
352(q)) is amended—
(1) by striking ‘‘or (2)’’ and inserting ‘‘(2)’’;
and
(2) by inserting before the period the following:
‘‘or (3) in the case of a tobacco product, it is sold,
distributed, advertised, labeled, or used in violation
of this Act or the regulations prescribed under this
Act.’’.
(c) REGULATORY AUTHORITY.—Section 503(g)(1)
(21 U.S.C. 353(g)(1)) is amended by inserting ‘‘(including
any tobacco product)’’ after ‘‘products’’ the first place
such term appears.
(d) CLASS II DEVICES.—Section 513(a)(1)(B) (21
U.S.C. 360c(a)(1)(B)) is amended—
(1) by striking ‘‘A device’’ and inserting ‘‘(i) A
device’’; and
(2) by adding at the end the following: ‘‘To-
bacco products shall be categorized as Class II de-
vices.
‘‘(ii) The sale of tobacco products to adults
that comply with Performance Standards estab-
lished for these products pursuant to section
514, title XXVIII of the Public Health Service
Act, and this Act, and any regulations pre-
scribed under this Act, shall not be prohibited
by the Secretary, notwithstanding sections
502(j), 516, and 518.’’.
(e) PERFORMANCE STANDARDS.—Section 514(a) (21
U.S.C. 360d(a)) is amended—
(1) in paragraph (2), by striking ‘‘device—’’
and inserting ‘‘non-tobacco product device—’’;
(2) by redesignating paragraphs (3) and (4) as
paragraphs (4) and (5), respectively; and
(3) by adding at the end the following:
‘‘(3)(A) A performance standard established under
this section for a tobacco product device—
‘‘(i) shall include provisions to reduce the over-
all health risks to the public, including the reduction
in risk to consumers thereof and the reduction in
harm which will result from those who continue to
use the product, but less often and from those who
stop or do not start using the product, taking into
account all factors that the Secretary determines to
be relevant;
‘‘(ii) shall, where necessary to provide a reduc-
tion in the overall health risks to the public, in-
clude—
‘‘(I) provisions regarding the construction,
components, 
constituents, 
ingredients, 
and
properties of the tobacco product device, includ-
ing the reduction or elimination of nicotine and
the other components, ingredients, and con-
stituents of the tobacco product and its compo-
nents, based upon the best available technology;
‘‘(II) provisions for the testing of the to-
bacco product device (on a sample basis or, if
necessary, on an individual basis) or, if it deter-
mined that no other more practicable means are
available to the Secretary to assure the con-
formity of the tobacco product device to the
standard, provision for the testing (on a sample
basis or, if necessary, on an individual basis) by
the Secretary or by another person at the direc-
tion of the Secretary;
‘‘(III) provisions for the measurement of
the performance characteristics of the tobacco
product device;
‘‘(IV) provisions requiring that the results
of each or of certain of the tests of the tobacco
product device required to be made under sub-
clause (II) show that the tobacco product device
is in conformity with the portions of the stand-
ard for which the test or tests were required;
and
‘‘(V) a provision that the sale, advertising,
and distribution of the tobacco product device
be restricted but only to the extent the sale, ad-
vertising, and distribution of a tobacco product
device may be restricted under this Act or title
XXVIII of the Public Health Service Act; and
‘‘(iii) shall, where appropriate, require the use
and prescribe the form and content of labeling for
use of the tobacco product device.
‘‘(B) The Secretary shall provide for the periodic
evaluation of a performance standard established under
this paragraph to determine if such standards should be
changed to reflect new medical, scientific, or other techno-
logical data.
‘‘(C) In carrying out this paragraph, the Secretary
shall, to the maximum extent practicable—
‘‘(i) use personnel, facilities, and other technical
support available in other Federal agencies;
‘‘(ii) consult with the Scientific Advisory Com-
mittee established under section 905 and other Fed-
eral agencies concerned with standard-setting and
other nationally or internationally recognized stand-
ard-setting entities; and
‘‘(iii) invite appropriate participation, through
joint or other conferences, workshops, or other
means, by informed persons representative of sci-
entific, professional, industry, or consumer organiza-
tions who in the judgment of the Secretary can
make a significant contribution.’’.
(f) RESTRICTED
DEVICES.—Section 520(e) (21
U.S.C. 360j(e)) is amended by adding at the end the fol-
lowing:
‘‘(3) A tobacco product is a restricted device.’’.
(g) REGULATIONS.—Section 701(a) (21 U.S.C.
371(a)) is amended by inserting before the period the fol-
lowing: ‘‘, including the authority to regulate the manufac-
ture, sale, distribution, advertising and marketing of to-
bacco products’’.
SEC. 204. GENERAL HEALTH AND SAFETY REGULATION OF
TOBACCO PRODUCTS.
The Act (21 U.S.C. 301 et seq.) is amended—
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901, 902, 903,
904, and 905 as sections 1001, 1002, 1003, 1004,
and 1005, respectively; and
(3) by adding after chapter VIII the following
new chapter:
‘‘CHAPTER IX—TOBACCO PRODUCTS
‘‘SEC. 901. DEFINITIONS.
‘‘For purposes of this chapter and in addition to the
definitions contained in section 201, the definitions under
section 2801 of the Public Health Service Act shall apply.
‘‘SEC. 902. PURPOSE.
‘‘It is the purpose of this chapter to impose a regu-
latory scheme applicable to the development and manufac-
turing of tobacco products. Such scheme shall include—
‘‘(1) with respect to ingredients contained in
such products—
‘‘(A) the immediate and annual reporting,
in accordance with section 909(a), of all ingre-
dients contained in such products;
‘‘(B) the performance, in accordance with
section 909(b), of safety assessments with re-
spect to ingredients contained in such products;
and
‘‘(C) the approval, in accordance with sec-
tion 909(b), of ingredients contained in such
products; and
‘‘(2) the imposition of standards to reduce the
level of certain constituents contained in such prod-
ucts, including nicotine.
‘‘SEC. 903. PROMULGATION OF REGULATIONS.
‘‘The Commissioner shall promulgate regulations gov-
erning the misbranding, adulteration, and dispensing of
tobacco products that are consistent with this chapter and
with the manner in which other products that are ingested
into the body are regulated under this Act. Such regula-
tions shall be promulgated not later than 12 months after
the date of enactment of this chapter.
‘‘SEC. 904. MINIMUM REQUIREMENTS.
‘‘(a) MISBRANDING.—The regulations promulgated
under section 903 shall at a minimum require that a to-
bacco product be deemed to be misbranded if the labeling
of the package of such product is not in compliance with
the provisions of this chapter, of other applicable provi-
sions of this Act, or of section 910 (as applicable to the
type of product involved) of the Public Health Service Act.
‘‘(b) ADULTERATION.—The regulations promulgated
under section 903 shall at a minimum require that a to-
bacco product be deemed to be adulterated if the Commis-
sioner determines that any tobacco additive in such prod-
uct, regardless of the amount of such tobacco additive, ei-
ther by itself or in conjunction with any other tobacco ad-
ditive or ingredient is harmful under the intended condi-
tions of use when used in a specified amount.
‘‘SEC. 905. SCIENTIFIC ADVISORY COMMITTEE.
‘‘(a) ESTABLISHMENT.—Not later than 1 year after
the date of enactment of this chapter, the Secretary shall
establish an advisory committee, to be known as the ‘Sci-
entific Advisory Committee’, to assist the Secretary in es-
tablishing, amending, or revoking a performance standard
under section 512(a)(3).
‘‘(b) MEMBERSHIP.—The Secretary shall appoint as
members of the Scientific Advisory Committee any individ-
uals with expertise in the medical, scientific, or other tech-
nological data involving the manufacture and use of to-
bacco products, and of appropriately diversified profes-
sional backgrounds. The Secretary may not appoint to the
Committee any individual who is in the regular full-time
employ of the Federal Government. The Secretary shall
designate 1 of the members of each advisory committee
to serve as chairperson of the Committee.
‘‘(c) COMPENSATION AND EXPENSES.—
‘‘(1) COMPENSATION.—Members of the Sci-
entific Advisory Committee who are not officers or
employees of the United States, while attending con-
ferences or meetings of the Committee or otherwise
serving at the request of the Secretary, shall be enti-
tled to receive compensation at rates to be fixed by
the Secretary, which rates may not exceed the daily
equivalent of the rate of pay for level 4 of the Senior
Executive Schedule under section 5382 of title 5,
United States Code, for each day (including travel-
time) they are so engaged.
‘‘(2) EXPENSES.—While conducting the busi-
ness of the Scientific Advisory Committee away from
their homes or regular places of business, each mem-
ber may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section
5703 of title 5 of the United States Code for per-
sons in the Government service employed intermit-
tently.
‘‘(d) DUTIES.—The Scientific Advisory Committee
shall—
‘‘(1) assist the Secretary in establishing,
amending, or revoking performance standards under
section 514(a)(3);
‘‘(2) examine and determine the effects of the
alteration of the nicotine yield levels in tobacco prod-
ucts;
‘‘(3) examine and determine whether there is a
threshold level below which nicotine yields do not
produce dependence on the tobacco product involved,
and, if so, determine what that level is; and
‘‘(4) review other safety, dependence or health
issues relating to tobacco products as determined ap-
propriate by the Secretary.
‘‘SEC. 906. REQUIREMENTS RELATING TO NICOTINE AND
OTHER CONSTITUENTS.
‘‘(a) GENERAL RULE.—The Secretary may adopt a
performance standard under section 514(a)(3) that re-
quires the modification of a tobacco product in a manner
that involves—
‘‘(1) the reduction or elimination of nicotine
yields of the product; or
‘‘(2) the reduction or elimination of other con-
stituents or harmful components of the product.
‘‘(b) TOBACCO CONSTITUENTS.—The Secretary shall
promulgate regulations for the testing, reporting and dis-
closure of tobacco smoke constituents that the Secretary
determines the public should be informed of to protect
public health, including tar, nicotine, and carbon mon-
oxide. Such regulations may require label and advertising
disclosures relating to tar and nicotine.
‘‘(c) LIMITATION ON TAR.—Not later than 3 years
after the date of enactment of this chapter, the Secretary
shall promulgate regulations that limit the amount of tar
in a cigarette to no more than 12 milligrams. Nothing in
the preceding sentence shall be construed as limiting the
authority of the Secretary to promulgate regulations fur-
ther limiting the amount of tar that may be contained in
a cigarette.
‘‘SEC. 907. REDUCED RISK PRODUCTS.
‘‘(a) MISBRANDING.—Except as provided in sub-
section (b), the regulations promulgated in accordance
with section 904(a) shall require that a tobacco product
be deemed to be misbranded if the labeling of the package
of the product, or the claims of the manufacturer in con-
nection with the product, can reasonably be interpreted
by an objective consumer as stating or implying that the
product presents a reduced health risk as compared to
other similar products.
‘‘(b) EXCEPTION.—
‘‘(1) IN
GENERAL.—Subsection (a) shall not
apply to the labeling of a tobacco product, or the
claims of the manufacturer in connection with the
product, if—
‘‘(A) the manufacturer, based on the best
available scientific evidence, demonstrates to
the Commissioner that the product significantly
reduces the risk to the health of the user as
compared to other similar tobacco products;
and
‘‘(B) the Commissioner approves the spe-
cific claim that will be made a part of the label-
ing of the product, or the specific claims of the
manufacturer in connection with the product.
‘‘(2) REDUCTION IN HARM.—The Commissioner
shall promulgate regulations to permit the inclusion
of scientifically based specific health claims on the
labeling of a tobacco product package, or the making
of such claims by the manufacturer in connection
with the product, where the Commissioner deter-
mines that the inclusion or making of such claims
would reduce harm to the public and otherwise pro-
mote public health.
‘‘(c) DEVELOPMENT OF REDUCED RISK PRODUCT
TECHNOLOGY.—
‘‘(1) NOTIFICATION
OF
COMMISSIONER.—The
manufacturer of a tobacco product shall provide
written notice to the Commissioner upon the devel-
opment or acquisition by the manufacturer of any
technology that would reduce the risk of such prod-
ucts to the health of the user.
‘‘(2) CONFIDENTIALITY.—The Commissioner
shall promulgate regulations to provide a manufac-
turer with appropriate confidentiality protections
with respect to technology that is the subject of a
notification under paragraph (1) that contains evi-
dence that the technology involved is in the early de-
velopmental stages.
‘‘(3) LICENSING.—
‘‘(A) IN GENERAL.—With respect to any
technology developed or acquired under para-
graph (1), the manufacturer shall—
‘‘(i) use such technology in the manu-
facture of its tobacco products; or
‘‘(ii) permit the use of such tech-
nology (for a reasonable fee) by other man-
ufacturers of tobacco products to which
this chapter applies.
‘‘(B) FEES.—The Commissioner shall pro-
mulgate regulations to provide for the payment
of a commercially reasonable fee by each manu-
facturer that uses the technology described
under subparagraph (A) to the manufacturer
that submits the notice under paragraph (1) for
such technology. Such regulations shall contain
procedures for the resolution of fee disputes be-
tween manufacturers under this subparagraph.
‘‘(d) REQUIREMENT OF MANUFACTURE AND MAR-
KETING.—
‘‘(1) PURPOSE.—It is the purpose of this sub-
section to provide for a mechanism to ensure that
tobacco products that are designed to be less hazard-
ous to the health of users are developed, tested, and
made available to consumers.
‘‘(2) DETERMINATION.—Upon a determination
by the Commissioner that the manufacture of a to-
bacco product that is less hazardous to the health of
users is technologically feasible, the Commissioner
may, in accordance with this subsection, require that
certain manufacturers of such products manufacture
and market such less hazardous products.
‘‘(3) MANUFACTURER.—
‘‘(A) REQUIREMENT.—Except as provided
in subparagraph (B), the requirement under
paragraph (2) shall apply to any manufacturer
that provides a notification to the Commissioner
under subsection (c)(1) concerning the tech-
nology that is the subject of the determination
of the Commissioner.
‘‘(B) EXCEPTION.—The requirement under
subparagraph (A) shall not apply to a manufac-
turer if—
‘‘(i) the manufacturer elects not to
manufacture such products and provides
notice to the Commissioner of such elec-
tion; and
‘‘(ii) the manufacturer agrees to pro-
vide the technology involved, for a commer-
cially reasonable fee, to other manufactur-
ers that enter into agreements to use such
technology to manufacture and market to-
bacco products that are less hazardous to
the health of users.
‘‘SEC. 908. GOOD MANUFACTURING PRACTICE STANDARDS.
‘‘(a) AUTHORITY.—
‘‘(1) IN GENERAL.—The Secretary may, in ac-
cordance with paragraph (2), prescribe regulations
requiring that the methods used in, and the facilities
and controls used for, the manufacture, pre-produc-
tion design validation (including a process to assess
the performance of a tobacco product), packing, and
storage of a tobacco product conform to current
good manufacturing practice, as prescribed in such
regulations, to ensure that such products will be in
compliance with this chapter.
‘‘(2) 
REQUIREMENTS
PRIOR
TO
REGULA-
TIONS.—Prior to the Secretary promulgating any
regulation under paragraph (1) the Secretary
shall—
‘‘(A) afford the Scientific Advisory Com-
mittee established under section 905 an oppor-
tunity (with a reasonable time period) to submit
recommendations with respect to the regula-
tions proposed to be promulgated; and
‘‘(B) afford an opportunity for an oral
hearing.
‘‘(b) MINIMUM REQUIREMENTS.—The regulations
promulgated under subsection (a) shall at a minimum re-
quire—
‘‘(1) the implementation of a quality control
system by the manufacturer of a tobacco product;
‘‘(2) a process for the inspection, in accordance
with this Act, of tobacco product material prior to
the packaging of such product;
‘‘(3) procedures for the proper handling and
storage of the packaged tobacco product;
‘‘(4) after consultation with the Administrator
of the Environmental Protection Agency, the devel-
opment and adherence to applicable tolerances with
respect to pesticide chemical residues in or on com-
modities used by the manufacturer in the manufac-
ture of the finished tobacco product;
‘‘(5) the inspection of facilities by officials of
the Food and Drug Administration as otherwise pro-
vided for in this Act; and
‘‘(6) record keeping and the reporting of certain
information.
‘‘(c) 
PETITIONS
FOR
EXEMPTIONS
AND
VARIANCES.—
‘‘(1) IN GENERAL.—Any person subject to any
requirement prescribed by regulations under sub-
section (a) may petition the Secretary for an exemp-
tion or variance from such requirement. Such a peti-
tion shall be submitted to the Secretary in such form
and manner as the Secretary shall prescribe and
shall—
‘‘(A) in the case of a petition for an ex-
emption from a requirement, set forth the basis
for the petitioner’s determination that compli-
ance with the requirement is not required to en-
sure that the device is in compliance with this
chapter;
‘‘(B) in the case of a petition for a vari-
ance from a requirement, set forth the methods
proposed to be used in, and the facilities and
controls proposed to be used for, the manufac-
ture, packing, and storage of the product in lieu
of the methods, facilities, and controls pre-
scribed by the requirement; and
‘‘(C) contain such other information as the
Secretary shall prescribe.
‘‘(2) SCIENTIFIC ADVISORY COMMITTEE.—The
Secretary may refer to the Scientific Advisory Com-
mittee established under section 905 any petition
submitted under paragraph (1). The Scientific Advi-
sory Committee shall report its recommendations to
the Secretary with respect to a petition referred to
it within 60 days of the date of the petition’s refer-
ral. Within 60 days after—
‘‘(A) the date the petition was submitted
to the Secretary under paragraph (1); or
‘‘(B) if the petition was referred to the Sci-
entific Advisory Committee, the expiration of
the 60-day period beginning on the date the pe-
tition was referred to such Committee;
whichever occurs later, the Secretary shall by order
either deny the petition or approve it.
‘‘(3) APPROVAL OF PETITION.—
‘‘(A) IN
GENERAL.—The Secretary may
approve—
‘‘(i) a petition for an exemption for a
tobacco product from a requirement if the
Secretary determines that compliance with
such requirement is not required to assure
that the product will comply with this
chapter; and
‘‘(ii) a petition for a variance for a to-
bacco product from a requirement if the
Secretary determines that the methods to
be used in, and the facilities and controls
to be used for, the manufacture, packing,
and storage of the product in lieu of the
methods, controls, and facilities prescribed
by the requirement are sufficient to ensure
that the product will comply with this
chapter.
‘‘(B) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall
prescribe such conditions respecting the meth-
ods used in, and the facilities and controls used
for, the manufacture, packing, and storage of
the tobacco product to be granted the variance
under the petition as may be necessary to en-
sure that the product will comply with this
chapter.
‘‘(4) INFORMAL HEARING.—After the issuance
of an order under paragraph (2) respecting a peti-
tion, the petitioner shall have an opportunity for an
informal hearing on such order.
‘‘(d) AGRICULTURAL PRODUCERS.—The Secretary
may not promulgate any regulation under this section that
has the effect of placing regulatory burdens on tobacco
producers (as such term is used for purposes of the Agri-
cultural Adjustment Act of 1938 (7 U.S.C. 1281 et seq.)
and the Agricultural Act of 1949 (7 U.S.C. 1441 et seq.))
in excess of the regulatory burdens generally placed on
other agricultural commodity producers.
‘‘SEC. 909. DISCLOSURE AND REPORTING OF NONTOBACCO
INGREDIENTS AND CONSTITUENTS.
‘‘(a) DISCLOSURE OF ALL INGREDIENTS.—
‘‘(1) IMMEDIATE AND ANNUAL DISCLOSURE.—
Not later than 30 days after the date of enactment
of this chapter, and annually thereafter, each manu-
facturer of a tobacco product shall submit to the
Secretary an ingredient list for all brands of tobacco
products that contains the information described in
paragraph (2).
‘‘(2) REQUIREMENTS.—The list described in
paragraph (1) shall, with respect to each brand of
tobacco product of a manufacturer, include
‘‘(A) a list of all ingredients, constituents,
substances, and compounds that are added to
the tobacco (and the paper or filter of the prod-
uct if applicable) in the manufacture of the to-
bacco product, for each brand of tobacco prod-
uct so manufactured;
‘‘(B) a description of the quantity of the
ingredients, constituents, substances, and com-
pounds that are listed under subparagraph (A)
with respect to each brand of tobacco product;
‘‘(C) a description of the nicotine content
of the product, measured in milligrams of nico-
tine;
‘‘(D) with respect to cigarettes a descrip-
tion of—
‘‘(i) the filter ventilation percentage
(the level of air dilution in the cigarette as
provided by the ventilation holes in the fil-
ter, described as a percentage);
‘‘(ii) the pH level of the smoke of the
cigarette; and
‘‘(iii) the nicotine delivery level under
average smoking conditions reported in
milligrams of nicotine per cigarette;
‘‘(E) with respect to smokeless tobacco
products a description of—
‘‘(i) the pH level of the tobacco;
‘‘(ii) the moisture content of the to-
bacco expressed as a percentage of the
weight of the tobacco; and
‘‘(iii) the nicotine content—
‘‘(I) for each gram of the prod-
uct, measured in milligrams of nico-
tine;
‘‘(II) expressed as a percentage
of the dry weight of the tobacco; and
‘‘(III) with respect to unionized
(free) nicotine, expressed as a percent-
age per gram of the tobacco and ex-
pressed in milligrams per gram of the
tobacco; and
‘‘(F) any other information determined ap-
propriate by the Secretary.
‘‘(b) SAFETY ASSESSMENTS.—
‘‘(1) APPLICATION TO NEW INGREDIENTS.—
‘‘(A) IN GENERAL.—Not later than 1 year
after the date of enactment of this chapter, and
annually thereafter, each manufacturer shall
submit to the Secretary a safety assessment for
each new ingredient, constituent, substance, or
compound that such manufacturer desires to
make a part of a tobacco product. Such new in-
gredient, constituent, substance, or compound
shall not be included in a tobacco product prior
to approval of such a safety assessment.
‘‘(B) DEFINITION OF NEW INGREDIENT.—
For purposes of subparagraph (A), the term
‘new ingredient, constituent, substance, or
compound’ means an ingredient, constituent,
substance, or compound listed under subsection
(a)(1) that was not used in the brand of to-
bacco product involved prior to the date of en-
actment of this chapter.
‘‘(2) APPLICATION TO OTHER INGREDIENTS.—
With respect to the application of this section to in-
gredients, constituents, substances, or compounds
listed under subsection (a) to which paragraph (1)
does not apply, all such ingredients, constituents,
substances, or compounds shall be approved through
the safety assessment process within the 5-year pe-
riod beginning on the date of enactment of this
chapter. The Secretary shall develop a procedure
that staggers the percentage of such ingredients,
constituents, substances, or compounds for which
safety assessments must be submitted for approval
by manufacturers in each year.