134
reason or basis for the recommendation. A copy of such
report and recommendation shall be made public by the
Secretary.
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES.
‘‘(a) NOTIFICATION.—If the Secretary determines
that—
‘‘(1) a tobacco product which is introduced or
delivered for introduction into interstate commerce
for commercial distribution presents an unreasonable
risk of substantial harm to the public health; and
‘‘(2) notification under this subsection is nec-
essary to eliminate the unreasonable risk of such
harm and no more practicable means is available
under the provisions of this chapter (other than this
section) to eliminate such risk,
the Secretary may issue such order as may be necessary
to assure that adequate notification is provided in an ap-
propriate form, by the persons and means best suited
under the circumstances involved, to all persons who
should properly receive such notification in order to elimi-
nate such risk. The Secretary may order notification by
any appropriate means, including public service announce-
ments. Before issuing an order under this subsection, the
Secretary shall consult with the persons who are to give
notice under the order.
135
‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—
Compliance with an order issued under this section shall
not relieve any person from liability under Federal or
State law. In awarding damages for economic loss in an
action brought for the enforcement of any such liability,
the value to the plaintiff in such action of any remedy
provided under such order shall be taken into account.
‘‘(c) RECALL AUTHORITY.—
‘‘(1) IN GENERAL.—If the Secretary finds that
there is a reasonable probability that a tobacco prod-
uct contains a manufacturing or other defect not or-
dinarily contained in tobacco products on the market
that would cause serious, adverse health con-
sequences or death, the Secretary shall issue an
order requiring the appropriate person (including
the manufacturers, importers, distributors, or retail-
ers of the tobacco product) to immediately cease dis-
tribution of such tobacco product. The order shall
provide the person subject to the order with an op-
portunity for an informal hearing, to be held not
later than 10 days after the date of the issuance of
the order, on the actions required by the order and
on whether the order should be amended to require
a recall of such tobacco product. If, after providing
an opportunity for such a hearing, the Secretary de-
136
termines that inadequate grounds exist to support
the actions required by the order, the Secretary shall
vacate the order.
‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE-
CALL.—
‘‘(A) If, after providing an opportunity for
an informal hearing under paragraph (1), the
Secretary determines that the order should be
amended to include a recall of the tobacco prod-
uct with respect to which the order was issued,
the Secretary shall, except as provided in sub-
paragraph (B), amend the order to require a
recall. The Secretary shall specify a timetable in
which the tobacco product recall will occur and
shall require periodic reports to the Secretary
describing the progress of the recall.
‘‘(B) An amended order under subpara-
graph (A)—
‘‘(i) shall not include recall of a to-
bacco product from individuals; and
‘‘(ii) shall provide for notice to per-
sons subject to the risks associated with
the use of such tobacco product.
In providing the notice required by clause (ii),
the Secretary may use the assistance of retail-
137
ers and other persons who distributed such to-
bacco product. If a significant number of such
persons cannot be identified, the Secretary shall
notify such persons under section 705(b).
‘‘(3) REMEDY
NOT
EXCLUSIVE.—The remedy
provided by this subsection shall be in addition to
remedies provided by subsection (a) of this section.
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD-
UCTS.
‘‘(a) IN GENERAL.—Every person who is a tobacco
product manufacturer or importer of a tobacco product
shall establish and maintain such records, make such re-
ports, and provide such information, as the Secretary may
by regulation reasonably require to assure that such to-
bacco product is not adulterated or misbranded and to
otherwise protect public health. Regulations prescribed
under the preceding sentence—
‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary when-
ever the manufacturer or importer receives or other-
wise becomes aware of information that reasonably
suggests that one of its marketed tobacco products
may have caused or contributed to a serious unex-
pected adverse experience associated with the use of
the product or any significant increase in the fre-
138
quency of a serious, expected adverse product experi-
ence;
‘‘(2) shall require reporting of other significant
adverse tobacco product experiences as determined
by the Secretary to be necessary to be reported;
‘‘(3) shall not impose requirements unduly bur-
densome to a tobacco product manufacturer or im-
porter, taking into account the cost of complying
with such requirements and the need for the protec-
tion of the public health and the implementation of
this chapter;
‘‘(4) when prescribing the procedure for making
requests for reports or information, shall require
that each request made under such regulations for
submission of a report or information to the Sec-
retary state the reason or purpose for such request
and identify to the fullest extent practicable such re-
port or information;
‘‘(5) when requiring submission of a report or
information to the Secretary, shall state the reason
or purpose for the submission of such report or in-
formation and identify to the fullest extent prac-
ticable such report or information; and
‘‘(6) may not require that the identity of any
patient or user be disclosed in records, reports, or
139
information required under this subsection unless re-
quired for the medical welfare of an individual, to
determine risks to public health of a tobacco prod-
uct, or to verify a record, report, or information sub-
mitted under this chapter.
In prescribing regulations under this subsection, the Sec-
retary shall have due regard for the professional ethics of
the medical profession and the interests of patients. The
prohibitions of paragraph (6) of this subsection continue
to apply to records, reports, and information concerning
any individual who has been a patient, irrespective of
whether or when he ceases to be a patient.
‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.—
‘‘(1) Except as provided in paragraph (3), the
Secretary shall by regulation require a tobacco prod-
uct manufacturer or importer of a tobacco product
to report promptly to the Secretary any corrective
action taken or removal from the market of a to-
bacco product undertaken by such manufacturer or
importer 
if 
the 
removal 
or 
correction 
was
undertaken—
‘‘(A) to reduce a risk to health posed by
the tobacco product; or
144
adequate information to justify any deviation
from such standard;
‘‘(E) such samples of such tobacco product
and of components thereof as the Secretary
may reasonably require;
‘‘(F) specimens of the labeling proposed to
be used for such tobacco product; and
‘‘(G) such other information relevant to
the subject matter of the application as the Sec-
retary may require.
‘‘(2) REFERENCE TO ADVISORY COMMITTEE.—
Upon receipt of an application meeting the require-
ments set forth in paragraph (1), the Secretary—
‘‘(A) may, on the Secretary’s own initia-
tive; or
‘‘(B) shall, upon the request of an appli-
cant,
refer such application to an advisory committee and
for submission (within such period as the Secretary
may establish) of a report and recommendation re-
specting approval of the application, together with
all underlying data and the reasons or basis for the
recommendation.
‘‘(c) ACTION ON APPLICATION.—
‘‘(1) DEADLINE.—
145
‘‘(A) As promptly as possible, but in no
event later than 180 days after the receipt of
an application under subsection (b) of this sec-
tion, the Secretary, after considering the report
and recommendation submitted under para-
graph (2) of such subsection, shall—
‘‘(i) issue an order approving the ap-
plication if the Secretary finds that none of
the grounds for denying approval specified
in paragraph (2) of this subsection applies;
or
‘‘(ii) deny approval of the application
if the Secretary finds (and sets forth the
basis for such finding as part of or accom-
panying such denial) that one or more
grounds for denial specified in paragraph
(2) of this subsection apply.
‘‘(B) An order approving an application for
a tobacco product may require as a condition to
such approval that the sale and distribution of
the tobacco product be restricted but only to
the extent that the sale and distribution of a to-
bacco product may be restricted under a regula-
tion under section 906(d).
146
‘‘(2) DENIAL
OF
APPROVAL.—The Secretary
shall deny approval of an application for a tobacco
product if, upon the basis of the information sub-
mitted to the Secretary as part of the application
and any other information before the Secretary with
respect to such tobacco product, the Secretary finds
that—
‘‘(A) there is a lack of a showing that per-
mitting such tobacco product to be marketed
would be appropriate for the protection of the
public health;
‘‘(B) the methods used in, or the facilities
or controls used for, the manufacture, proc-
essing, or packing of such tobacco product do
not conform to the requirements of section
906(e);
‘‘(C) based on a fair evaluation of all mate-
rial facts, the proposed labeling is false or mis-
leading in any particular; or
‘‘(D) such tobacco product is not shown to
conform in all respects to a performance stand-
ard in effect under section 907, compliance with
which is a condition to approval of the applica-
tion, and there is a lack of adequate informa-
tion to justify the deviation from such standard.
147
‘‘(3) DENIAL INFORMATION.—Any denial of an
application shall, insofar as the Secretary determines
to be practicable, be accompanied by a statement in-
forming the applicant of the measures required to
place such application in approvable form (which
measures may include further research by the appli-
cant in accordance with one or more protocols pre-
scribed by the Secretary).
‘‘(4) BASIS
FOR
FINDING.—For purposes of
this section, the finding as to whether approval of a
tobacco product is appropriate for the protection of
the public health shall be determined with respect to
the risks and benefits to the population as a whole,
including users and non-users of the tobacco prod-
uct, and taking into account—
‘‘(A) the increased or decreased likelihood
that existing users of tobacco products will stop
using such products; and
‘‘(B) the increased or decreased likelihood
that those who do not use tobacco products will
start using such products.
‘‘(5) BASIS FOR ACTION.—
‘‘(A) For purposes of paragraph (2)(A),
whether permitting a tobacco product to be
marketed would be appropriate for the protec-
148
tion of the public health shall, when appro-
priate, be determined on the basis of well-con-
trolled investigations, which may include one or
more clinical investigations by experts qualified
by training and experience to evaluate the to-
bacco product.
‘‘(B) If the Secretary determines that
there exists valid scientific evidence (other than
evidence derived from investigations described
in subparagraph (A)) which is sufficient to
evaluate the tobacco product the Secretary may
authorize that the determination for purposes
of paragraph (2)(A) be made on the basis of
such evidence.
‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.—
‘‘(1) IN GENERAL.—The Secretary shall, upon
obtaining, where appropriate, advice on scientific
matters from an advisory committee, and after due
notice and opportunity for informal hearing to the
holder of an approved application for a tobacco
product, issue an order withdrawing approval of the
application if the Secretary finds—
‘‘(A) that the continued marketing of such
tobacco product no longer is appropriate for the
protection of the public health;
149
‘‘(B) that the application contained or was
accompanied by an untrue statement of a mate-
rial fact;
‘‘(C) that the applicant—
‘‘(i) has failed to establish a system
for maintaining records, or has repeatedly
or deliberately failed to maintain records
or to make reports, required by an applica-
ble regulation under section 909;
‘‘(ii) has refused to permit access to,
or copying or verification of, such records
as required by section 704; or
‘‘(iii) has not complied with the re-
quirements of section 905;
‘‘(D) on the basis of new information be-
fore the Secretary with respect to such tobacco
product, evaluated together with the evidence
before the Secretary when the application was
approved, that the methods used in, or the fa-
cilities and controls used for, the manufacture,
processing, packing, or installation of such to-
bacco product do not conform with the require-
ments of section 906(e) and were not brought
into conformity with such requirements within a
150
reasonable time after receipt of written notice
from the Secretary of nonconformity;
‘‘(E) on the basis of new information be-
fore the Secretary, evaluated together with the
evidence before the Secretary when the applica-
tion was approved, that the labeling of such to-
bacco product, based on a fair evaluation of all
material facts, is false or misleading in any par-
ticular and was not corrected within a reason-
able time after receipt of written notice from
the Secretary of such fact; or
‘‘(F) on the basis of new information be-
fore the Secretary, evaluated together with the
evidence before the Secretary when the applica-
tion was approved, that such tobacco product is
not shown to conform in all respects to a per-
formance standard which is in effect under sec-
tion 907, compliance with which was a condi-
tion to approval of the application, and that
there is a lack of adequate information to jus-
tify the deviation from such standard.
‘‘(2) APPEAL.—The holder of an application
subject to an order issued under paragraph (1) with-
drawing approval of the application may, by petition
filed on or before the thirtieth day after the date
151
upon which he receives notice of such withdrawal,
obtain review thereof in accordance with subsection
(e) of this section.
‘‘(3) TEMPORARY SUSPENSION.—If, after pro-
viding an opportunity for an informal hearing, the
Secretary determines there is reasonable probability
that the continuation of distribution of a tobacco
product under an approved application would cause
serious, adverse health consequences or death, that
is greater than ordinarily caused by tobacco prod-
ucts on the market, the Secretary shall by order
temporarily suspend the approval of the application
approved under this section. If the Secretary issues
such an order, the Secretary shall proceed expedi-
tiously under paragraph (1) to withdraw such appli-
cation.
‘‘(e) SERVICE OF ORDER.—An order issued by the
Secretary under this section shall be served—
‘‘(1) in person by any officer or employee of the
department designated by the Secretary; or
‘‘(2) by mailing the order by registered mail or
certified mail addressed to the applicant at the ap-
plicant’s last known address in the records of the
Secretary.
152
‘‘SEC. 911. JUDICIAL REVIEW.
‘‘(a) IN GENERAL.—Not later than 30 days after—
‘‘(1) the promulgation of a regulation under
section 907 establishing, amending, or revoking a
performance standard for a tobacco product; or
‘‘(2) a denial of an application for approval
under section 910(c),
any person adversely affected by such regulation or order
may file a petition with the United States Court of Ap-
peals for the District of Columbia or for the circuit where-
in such person resides or has his principal place of busi-
ness for judicial review of such regulation or order. A copy
of the petition shall be transmitted by the clerk of the
court to the Secretary or other officer designated by the
Secretary for that purpose. The Secretary shall file in the
court the record of the proceedings on which the Secretary
based the Secretary’s regulation or order and each record
or order shall contain a statement of the reasons for its
issuance and the basis, on the record, for its issuance. For
purposes of this section, the term ‘record’ means all no-
tices and other matter published in the Federal Register
with respect to the regulation or order reviewed, all infor-
mation submitted to the Secretary with respect to such
regulation or order, proceedings of any panel or advisory
committee with respect to such regulation or order, any
hearing held with respect to such regulation or order, and
153
any other information identified by the Secretary, in the
administrative proceeding held with respect to such regu-
lation or order, as being relevant to such regulation or
order.
‘‘(b) COURT MAY ORDER SECRETARY TO MAKE AD-
DITIONAL FINDINGS.—If the petitioner applies to the
court for leave to adduce additional data, views, or argu-
ments respecting the regulation or order being reviewed
and shows to the satisfaction of the court that such addi-
tional data, views, or arguments are material and that
there were reasonable grounds for the petitioner’s failure
to adduce such data, views, or arguments in the pro-
ceedings before the Secretary, the court may order the
Secretary to provide additional opportunity for the oral
presentation of data, views, or arguments and for written
submissions. The Secretary may modify the Secretary’s
findings, or make new findings by reason of the additional
data, views, or arguments so taken and shall file with the
court such modified or new findings, and the Secretary’s
recommendation, if any, for the modification or setting
aside of the regulation or order being reviewed, with the
return of such additional data, views, or arguments.
‘‘(c) STANDARD OF REVIEW.—Upon the filing of the
petition under subsection (a) of this section for judicial
review of a regulation or order, the court shall have juris-
154
diction to review the regulation or order in accordance
with chapter 7 of title 5, United States Code, and to grant
appropriate relief, including interim relief, as provided in
such chapter. A regulation or order described in paragraph
(1) or (2) of subsection (a) of this section shall not be
affirmed if it is found to be unsupported by substantial
evidence on the record taken as a whole.
‘‘(d) FINALITY OF JUDGMENT.—The judgment of the
court affirming or setting aside, in whole or in part, any
regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28,
United States Code.
‘‘(e) OTHER REMEDIES.—The remedies provided for
in this section shall be in addition to and not in lieu of
any other remedies provided by law.
‘‘(f) REGULATIONS
AND ORDERS MUST RECITE
BASIS IN RECORD.—To facilitate judicial review under
this section or under any other provision of law of a regu-
lation or order issued under section 906, 907, 908, 909,
910, or 914, each such regulation or order shall contain
a statement of the reasons for its issuance and the basis,
in the record of the proceedings held in connection with
its issuance, for its issuance.
155
‘‘SEC. 912. POSTMARKET SURVEILLANCE
‘‘(a) DISCRETIONARY
SURVEILLANCE.—The Sec-
retary may require a tobacco product manufacturer to
conduct postmarket surveillance for a tobacco product of
the manufacturer if the Secretary determines that
postmarket surveillance of the tobacco product is nec-
essary to protect the public health or is necessary to pro-
vide information regarding the health risks and other safe-
ty issues involving the tobacco product.
‘‘(b) SURVEILLANCE
APPROVAL.—Each tobacco
product manufacturer required to conduct a surveillance
of a tobacco product under subsection (a) of this section
shall, within 30 days after receiving notice that the manu-
facturer is required to conduct such surveillance, submit,
for the approval of the Secretary, a protocol for the re-
quired surveillance. The Secretary, within 60 days of the
receipt of such protocol, shall determine if the principal
investigator proposed to be used in the surveillance has
sufficient qualifications and experience to conduct such
surveillance and if such protocol will result in collection
of useful data or other information necessary to protect
the public health. The Secretary may not approve such
a protocol until it has been reviewed by an appropriately
qualified scientific and technical review committee estab-
lished by the Secretary.
156
‘‘SEC. 913. REDUCED RISK TOBACCO PRODUCTS.
‘‘(a) REQUIREMENTS.—
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, the term ‘reduced risk tobacco product’ means
a tobacco product designated by the Secretary under
paragraph (2).
‘‘(2) DESIGNATION.—
‘‘(A) IN
GENERAL.—A product may be
designated by the Secretary as a reduced risk
tobacco product if the Secretary finds that the
product will significantly reduce harm to indi-
viduals caused by a tobacco product and is oth-
erwise appropriate to protect public health,
based on an application submitted by the manu-
facturer of the product (or other responsible
person) that—
‘‘(i) demonstrates through testing on
animals and short-term human testing that
use of such product results in ingestion or
inhalation of a substantially lower yield of
toxic substances than use of conventional
tobacco products in the same category as
the proposed reduced risk product; and
‘‘(ii) if required by the Secretary, in-
cludes studies of the long-term health ef-
fects of the product.
157
If such studies are required, the manufacturer
may consult with the Secretary regarding proto-
cols for conducting the studies.
‘‘(B) BASIS FOR FINDING.—In making the
finding under subparagraph (A), the Secretary
shall take into account—
‘‘(i) the risks and benefits to the pop-
ulation as a whole, including both users of
tobacco products and non-users of tobacco
products;
‘‘(ii) the increased or decreased likeli-
hood that existing users of tobacco prod-
ucts will stop using such products includ-
ing reduced risk tobacco products;
‘‘(iii) the increased or decreased likeli-
hood that those who do not use tobacco
products will start to use such products,
including reduced risk tobacco products;
and
‘‘(iv) the risks and benefits to con-
sumers from the use of a reduced risk to-
bacco product as compared to the use of
products approved under chapter V to re-
duce exposure to tobacco.
158
‘‘(3) MARKETING REQUIREMENTS.—A tobacco
product may be marketed and labeled as a reduced
risk tobacco product if it—
‘‘(A) has been designated as a reduced risk
tobacco product by the Secretary under para-
graph (2);
‘‘(B) bears a label prescribed by the Sec-
retary concerning the product’s contribution to
reducing harm to health; and
‘‘(C) complies with requirements prescribed
by the Secretary relating to marketing and ad-
vertising of the product, and other provisions of
this chapter as prescribed by the Secretary.
‘‘(b) REVOCATION OF DESIGNATION.—At any time
after the date on which a tobacco product is designated
as a reduced risk tobacco product under this section the
Secretary may, after providing an opportunity for an in-
formal hearing, revoke such designation if the Secretary
determines, based on information not available at the time
of the designation, that—
‘‘(1) the finding made under subsection (a)(2)
is no longer valid; or
‘‘(2) the product is being marketed in violation
of subsection (a)(3).
159
‘‘(c) LIMITATION.—A tobacco product that is des-
ignated as a reduced risk tobacco product that is in com-
pliance with subsection (a) shall not be regulated as a
drug or device.
‘‘(d) DEVELOPMENT OF REDUCED RISK TOBACCO
PRODUCT TECHNOLOGY.—A tobacco product manufac-
turer shall provide written notice to the Secretary upon
the development or acquisition by the manufacturer of any
technology that would reduce the risk of a tobacco product
to the health of the user for which the manufacturer is
not seeking designation as a ‘reduced risk tobacco product’
under subsection (a).
‘‘SEC. 914. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY.
‘‘(a) ADDITIONAL REQUIREMENTS.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), nothing in this Act shall be construed as
prohibiting a State or political subdivision thereof
from adopting or enforcing a requirement applicable
to a tobacco product that is in addition to, or more
stringent than, requirements established under this
chapter.
‘‘(2) PREEMPTION
OF
CERTAIN
STATE
AND
LOCAL REQUIREMENTS.—
160
‘‘(A) Except as provided in subparagraph
(B), no State or political subdivision of a State
may establish or continue in effect with respect
to a tobacco product any requirement which is
different from, or in addition to, any require-
ment applicable under the provisions of this
chapter relating to performance standards, pre-
market approval, adulteration, misbranding,
registration, reporting, good manufacturing
standards, or reduced risk products.
‘‘(B) Subparagraph (A) does not apply to
requirements relating to the sale, use, or dis-
tribution of a tobacco product including require-
ments related to the access to, and the adver-
tising and promotion of, a tobacco product.
‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT
LIABILITY.—No provision of this chapter relating to a to-
bacco product shall be construed to modify or otherwise
affect any action or the liability of any person under the
product liability law of any State.
‘‘(c) WAIVERS.—Upon the application of a State or
political subdivision thereof, the Secretary may, by regula-
tion promulgated after notice and an opportunity for an
oral hearing, exempt from subsection (a), under such con-
ditions as may be prescribed in such regulation, a require-
161
ment of such State or political subdivision applicable to
a tobacco product if—
‘‘(1) the requirement is more stringent than a
requirement applicable under the provisions de-
scribed in subsection (a)(3) which would be applica-
ble to the tobacco product if an exemption were not
in effect under this subsection; or
‘‘(2) the requirement—
‘‘(A) is required by compelling local condi-
tions; and
‘‘(B) compliance with the requirement
would not cause the tobacco product to be in
violation of any applicable requirement of this
chapter.
‘‘SEC. 915. EQUAL TREATMENT OF RETAIL OUTLETS.
‘‘The Secretary shall issue regulations to require that
retail establishments for which the predominant business
is the sale of tobacco products comply with any advertising
restrictions applicable to retail establishments accessible
to individuals under the age of 18.’’.
SEC. 402. CONFORMING AND OTHER AMENDMENTS TO GEN-
ERAL PROVISIONS.
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND
COSMETIC ACT.—Except as otherwise expressly provided,
whenever in this section an amendment is expressed in
162
terms of an amendment to, or repeal of, a section or other
provision, the reference is to a section or other provision
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is
amended—
(1) by inserting ‘‘tobacco product,’’ in sub-
section (a) after ‘‘device,’’;
(2) by inserting ‘‘tobacco product,’’ in sub-
section (b) after ‘‘device,’’;
(3) by inserting ‘‘tobacco product,’’ in sub-
section (c) after ‘‘device,’’;
(4) by striking ‘‘515(f), or 519’’ in subsection
(e) and inserting ‘‘515(f), 519, or 909’’;
(5) by inserting ‘‘tobacco product,’’ in sub-
section (g) after ‘‘device,’’;
(6) by inserting ‘‘tobacco product,’’ in sub-
section (h) after ‘‘device,’’;
(7) by striking ‘‘708, or 721’’ in subsection (j)
and inserting ‘‘708, 721, 904, 905, 906, 907, 908,
or 909’’;
(8) by inserting ‘‘tobacco product,’’ in sub-
section (k) after ‘‘device,’’;
(9) by striking subsection (p) and inserting the
following:
163
‘‘(p) The failure to register in accordance with section
510 or 905, the failure to provide any information re-
quired by section 510(j), 510(k), 905(i), or 905(j), or the
failure to provide a notice required by section 510(j)(2)
or 905(J)(2).’’;
(10) by striking subsection (q)(1) and inserting
the following:
‘‘(q)(1) The failure or refusal—
‘‘(A) to comply with any requirement prescribed
under section 518, 520(g), 906(f), or 908;
‘‘(B) to furnish any notification or other mate-
rial or information required by or under section 519,
520(g), 904, 906(f), or 909; or
‘‘(C) to comply with a requirement under sec-
tion 522 or 912.’’;
(11) by striking ‘‘device,’’ in subsection (q)(2)
and inserting ‘‘device or tobacco product,’’;
(12) by inserting ‘‘or tobacco product’’ in sub-
section (r) after ‘‘device’’ each time that it appears;
and
(13) by adding at the end thereof the following:
‘‘(aa) The sale of tobacco products in violation
of a no-tobacco-sale order issued under section
303(f).’’.
164
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f))
is amended—
(1) by amending the caption to read as follows:
‘‘(f) CIVIL
PENALTIES; NO-TOBACCO-SALE
OR-
DERS.—’’;
(2) by inserting ‘‘or tobacco products’’ after
‘‘devices’’ in paragraph (1)(A);
(3) by redesignating paragraphs (3), (4), and
(5) as paragraphs (4), (5), and (6), and inserting
after paragraph (2) the following:
‘‘(3) If the Secretary finds that a person has
committed repeated violations of restrictions promul-
gated under section 906(d) at a particular retail out-
let then the Secretary may impose a no-tobacco-sale
order on that person prohibiting the sale of tobacco
products in that outlet. A no-tobacco-sale order may
be imposed with a civil penalty under paragraph
(1).’’;
(4) by striking ‘‘assessed’’ the first time it ap-
pears in subparagraph (A) of paragraph (4), as re-
designated, and inserting ‘‘assessed, or a no-tobacco-
sale order may be imposed,’’;
(5) by striking ‘‘penalty’’ in such subparagraph
and inserting ‘‘penalty, or upon whom a no-tobacco-
order is to be imposed,’’;
165
(6) by inserting after ‘‘penalty,’’ in subpara-
graph (B) of paragraph (4), as redesignated, the fol-
lowing: ‘‘or the period to be covered by a no-tobacco-
sale order,’’;
(7) by adding at the end of such subparagraph
the following: ‘‘A no-tobacco-sale order permanently
prohibiting an individual retail outlet from selling to-
bacco products shall include provisions that allow
the outlet, after a specified period of time, to request
that the Secretary compromise, modify, or terminate
the order.’’;
(8) by adding at the end of paragraph (4), as
redesignated, the following:
‘‘(D) The Secretary may compromise, mod-
ify, or terminate, with or without conditions,
any no-tobacco-sale order.’’;
(9) by striking ‘‘(3)(A)’’ in paragraph (5), as
redesignated, and inserting ‘‘(4)(A)’’;
(10) by inserting ‘‘or the imposition of a no-to-
bacco-sale order’’ after ‘‘penalty’’ the first 2 places
it appears in such paragraph;
(11) by striking ‘‘issued.’’ in such paragraph
and inserting ‘‘issued, or on which the no-tobacco-
sale order was imposed, as the case may be.’’; and
166
(12) by striking ‘‘paragraph (4)’’ each place it
appears in paragraph (6), as redesignated, and in-
serting ‘‘paragraph (5)’’.
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is
amended—
(1) by striking ‘‘and’’ before ‘‘(D)’’ in sub-
section (a)(2);
(2) by striking ‘‘device.’’ in subsection (a)(2)
and inserting a comma and ‘‘(E) Any adulterated or
misbranded tobacco product.’’;
(3) by inserting ‘‘tobacco product,’’ in sub-
section (d)(1) after ‘‘device,’’;
(4) by inserting ‘‘or tobacco product’’ in sub-
section (g)(1) after ‘‘device’’ each place it appears;
and
(5) by inserting ‘‘or tobacco product’’ in sub-
section (g)(2)(A) after ‘‘device’’ each place it ap-
pears.
(e) SECTION
702.—Section 702(a) (21 U.S.C.
372(a)) is amended—
(1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and
(2) by adding at the end thereof the following:
‘‘(2) For a tobacco product, to the extent feasible,
the Secretary shall contract with the States in accordance
167
with paragraph (1) to carry out inspections of retailers
in connection with the enforcement of this Act.’’.
(f) SECTION 703.—Section 703 (21 U.S.C. 373) is
amended—
(1) by inserting ‘‘tobacco product,’’ after ‘‘de-
vice,’’ each place it appears; and
(2) by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’ each place it appears.
(g) SECTION 704.—Section 704 (21 U.S.C. 374) is
amended—
(1) by inserting ‘‘tobacco products,’’ in sub-
section (a)(1)(A) after ‘‘devices,’’ each place it ap-
pears;
(2) by inserting ‘‘or tobacco products’’ in sub-
section (a)(1)(B) after ‘‘restricted devices’’ each
place it appears; and
(3) by inserting ‘‘tobacco product,’’ in sub-
section (b) after ‘‘device,’’.
(h) SECTION
705.—Section 705(b) (21 U.S.C.
375(b)) is amended by inserting ‘‘tobacco products,’’ after
‘‘devices,’’.
(i) SECTION 709.—Section 709 (21 U.S.C. 379) is
amended by inserting ‘‘or tobacco product’’ after ‘‘device’’.
(j) SECTION 801.—Section 801 (21 U.S.C. 381) is
amended—
168
(1) by inserting ‘‘tobacco products,’’ after ‘‘de-
vices,’’ in subsection (a) the first time it appears;
(2) by inserting ‘‘or subsection (j) of section
905’’ in subsection (a) after ‘‘section 510’’;
(3) by striking ‘‘drugs or devices’’ each time it
appears in subsection (a) and inserting ‘‘drugs, de-
vices, or tobacco products’’;
(4) by inserting ‘‘tobacco product,’’ in sub-
section (e)(1) after ‘‘device,’’; and
(5) by redesignating paragraph (4) of sub-
section (e) as paragraph (5) and inserting after
paragraph (3), the following:
‘‘(4) Paragraph (1) does not apply to any to-
bacco product—
‘‘(A) which does not comply with an appli-
cable requirement of section 907 or 910; or
‘‘(B) which under section 906(f) is exempt
from either such section.
This paragraph does not apply if the Secretary has
determined that the exportation of the tobacco prod-
uct is not contrary to the public health and safety
and has the approval of the country to which it is
intended for export or the tobacco product is eligible
for export under section 802.’’.
169
(k) SECTION 802.—Section 802 (21 U.S.C. 382) is
amended—
(1) by striking ‘‘device—’’ in subsection (a) and
inserting ‘‘device or tobacco product—’’;
(2) by striking ‘‘and’’ after the semicolon in
subsection (a)(1)(C);
(3) by striking subparagraph (C) of subsection
(a)(2) and all that follows in that subsection and in-
serting the following:
‘‘(C) is a banned device under section 516;
or
‘‘(3) which, in the case of a tobacco product—
‘‘(A) does not comply with an applicable
requirement of section 907 or 910; or
‘‘(B) under section 906(f) is exempt from
either such section,
is adulterated, misbranded, and in violation of such
sections or Act unless the export of the drug, device,
or tobacco product is, except as provided in sub-
section (f), authorized under subsection (b), (c), (d),
or (e) of this section or section 801(e)(2) or
801(e)(4). If a drug, device, or tobacco product de-
scribed in paragraph (1), (2), or (3) may be ex-
ported under subsection (b) and if an application for
such drug or device under section 505, 515, or 910
170
of this Act or section 351 of the Public Health Serv-
ice Act (42 U.S.C. 262) was disapproved, the Sec-
retary shall notify the appropriate public health offi-
cial of the country to which such drug, device, or to-
bacco product will be exported of such disapproval.’’;
(4) by inserting ‘‘or tobacco product’’ in sub-
section (b)(1)(A) after ‘‘device’’ each time it ap-
pears;
(5) by inserting ‘‘or tobacco product’’ in sub-
section (c) after ‘‘device’’ and inserting ‘‘or section
906(f)’’ after ‘‘520(g).’’;
(6) by inserting ‘‘or tobacco product’’ in sub-
section (f) after ‘‘device’’ each time it appears; and
(7) by inserting ‘‘or tobacco product’’ in sub-
section (g) after ‘‘device’’ each time it appears.
(l) SECTION 1003.—Section 1003(d)(2)(C) (as redes-
ignated by section 101(a)) is amended—
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and
(2) inserting a comma and ‘‘and tobacco prod-
ucts’’ after ‘‘devices’’.
(m) EFFECTIVE
DATE
FOR
NO-TOBACCO-SALE
ORDER AMENDMENTS.—The amendments made by sub-
section (c), other than the amendment made by paragraph
(2) thereof, shall take effect only upon the promulgation
of final regulations by the Secretary—
171
(1) defining the term ‘‘repeated violation’’, as
used in section 303(f) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333(f)) as amended by
subsection (c), by identifying the number of viola-
tions of particular requirements over a specified pe-
riod of time that constitute a repeated violation;
(2) providing for notice to the retailer of each
violation at a particular retail outlet;
(3) providing that a person may not be charged
with a violation at a particular retail outlet unless
the Secretary has provided notice to the retailer of
all previous violations at that outlet;
(4) establishing a period of time during which,
if there are no violations by a particular retail out-
let, that outlet will not be considered to have been
the site of repeated violations when the next viola-
tion occurs; and
(5) providing that good faith reliance on false
identification does not constitute a violation of any
minimum age requirement for the sale of tobacco
products.
SEC. 403. FDA RULE IN EFFECT.
The final regulations promulgated by the Secretary
in the August 28, 1996, issue of the Federal Register (62
Fed. Reg. 44615–44618) and codified at part 897 of title
172
21, Code of Federal Regulations, are hereby deemed to
be lawful and to have been lawfully promulgated by the
Secretary under chapter IX and section 701 of the Federal
Food, Drug, and Cosmetic Act, as amended by this title,
and not under chapter V of the Federal Food, Drug, and
Cosmetic Act. Such regulations shall apply to all tobacco
products and shall take effect upon such date as the Sec-
retary determines by order, not later than 12 months after
enactment of this title. The Secretary shall amend the des-
ignation of authority in such regulations in accordance
with this subsection.
TITLE 
V—TOBACCO 
PRODUCT
WARNINGS AND SMOKE CON-
STITUENT DISCLOSURE
Subtitle A—Product Warnings,
Labeling, and Packaging
SEC. 501. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) IN GENERAL.—Section 4 of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1333) is amend-
ed to read as follows:
‘‘SEC. 4. LABELING.
‘‘(a) LABEL REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any
person to manufacture, package, or import for sale
or distribution within the United States any ciga-
174
25 percent of the front and rear panels of the
package. The word ‘‘WARNING’’ shall appear
in capital letters and all text shall be in con-
spicuous and legible 17-point type, unless the
text of the label statement would occupy more
than 70 percent of such area, in which case the
text may be in a smaller conspicuous and leg-
ible type size, provided that at least 60 percent
of such area is occupied by required text. The
text shall be black on a white background, or
white on a black background, in a manner that
contrasts, by typography, layout, or color, with
all other printed material on the package, in an
alternating fashion under the plan submitted
under subsection (b)(4).
‘‘(B) FLIP-TOP BOXES.—For any cigarette
brand package manufactured or distributed be-
fore January 1, 2000, which employs a flip-top
style (if such packaging was used for that
brand in commerce prior to June 21, 1997), the
label statement required by paragraph (1) shall
be located on the flip-top area of the package,
even if such area is less than 25 percent of the
area of the front panel. Except as provided in
175
this paragraph, the provisions of this subsection
shall apply to such packages.
‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU-
TION.—The provisions of this subsection do not
apply to a tobacco product manufacturer or dis-
tributor of cigarettes which does not manufacture,
package, or import cigarettes for sale or distribution
within the United States.
‘‘(b) ADVERTISING REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any
tobacco product manufacturer, importer, distributor,
or retailer of cigarettes to advertise or cause to be
advertised within the United States any cigarette
unless its advertising bears, in accordance with the
requirements of this section, one of the labels speci-
fied in subsection (a) of this section.
‘‘(2) TYPOGRAPHY, ETC.—Each label statement
required by subsection (a) of this section in cigarette
advertising shall comply with the standards set forth
in this paragraph. For press and poster advertise-
ments, each such statement and (where applicable)
any required statement relating to tar, nicotine, or
other constituent yield shall comprise at least 20
percent of the area of the advertisement and shall
appear in a conspicuous and prominent format and
176
location at the top of each advertisement within the
trim area. The Secretary may revise the required
type sizes in such area in such manner as the Sec-
retary determines appropriate. The word ‘‘WARN-
ING’’ shall appear in capital letters, and each label
statement shall appear in conspicuous and legible
type. The text of the label statement shall be black
if the background is white and white if the back-
ground is black, under the plan submitted under
paragraph (4) of this subsection. The label state-
ments shall be enclosed by a rectangular border that
is the same color as the letters of the statements
and that is the width of the first downstroke of the
capital ‘‘W’’ of the word ‘‘WARNING’’ in the label
statements. The text of such label statements shall
be in a typeface pro rata to the following require-
ments: 45-point type for a whole-page broadsheet
newspaper advertisement; 39-point type for a half-
page broadsheet newspaper advertisement; 39-point
type for a whole-page tabloid newspaper advertise-
ment; 27-point type for a half-page tabloid news-
paper advertisement; 31.5-point type for a double
page spread magazine or whole-page magazine ad-
vertisement; 22.5-point type for a 28 centimeter by
3 column advertisement; and 15-point type for a 20
177
centimeter by 2 column advertisement. The label
statements shall be in English, except that in the
case of—
‘‘(A) an advertisement that appears in a
newspaper, magazine, periodical, or other publi-
cation that is not in English, the statements
shall appear in the predominant language of the
publication; and
‘‘(B) in the case of any other advertise-
ment that is not in English, the statements
shall appear in the same language as that prin-
cipally used in the advertisement.
‘‘(3) ADJUSTMENT BY SECRETARY.—The Sec-
retary may, through a rulemaking under section 553
of title 5, United States Code, adjust the format and
type sizes for the label statements required by this
section or the text, format, and type sizes of any re-
quired tar, nicotine yield, or other constituent disclo-
sures, or to establish the text, format, and type sizes
for any other disclosures required under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et.
seq.). The text of any such label statements or dis-
closures shall be required to appear only within the
20 percent area of cigarette advertisements provided
by paragraph (2) of this subsection. The Secretary
178
shall promulgate regulations which provide for ad-
justments in the format and type sizes of any text
required to appear in such area to ensure that the
total text required to appear by law will fit within
such area.
‘‘(4) MARKETING REQUIREMENTS.—
‘‘(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in
each 12-month period, in as equal a number of
times as is possible on each brand of the prod-
uct and be randomly distributed in all areas of
the United States in which the product is mar-
keted in accordance with a plan submitted by
the tobacco product manufacturer, importer,
distributor, or retailer and approved by the Sec-
retary.
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in al-
ternating sequence in advertisements for each
brand of cigarettes in accordance with a plan
submitted by the tobacco product manufacturer,
importer, distributor, or retailer to, and ap-
proved by, the Secretary.
179
‘‘(C) The Secretary shall review each plan
submitted under subparagraph (B) and approve
it if the plan—
‘‘(i) will provide for the equal distribu-
tion and display on packaging and the ro-
tation required in advertising under this
subsection; and
‘‘(ii) assures that all of the labels re-
quired under this section will be displayed
by the tobacco product manufacturer, im-
porter, distributor, or retailer at the same
time.’’.
(b) REPEAL OF PROHIBITION ON STATE RESTRIC-
TION.—Section 5 of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1334) is amended—
(1) by striking ‘‘(a) ADDITIONAL
STATE-
MENTS.—’’ in subsection (a); and
(2) by striking subsection (b).
SEC. 502. AUTHORITY TO REVISE CIGARETTE WARNING
LABEL STATEMENTS.
Section 4 of the Federal Cigarette Labeling and Ad-
vertising Act ( 15 U.S.C. 1333), as amended by section
301 of this title, is further amended by adding at the end
the following:
180
‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec-
retary may, by a rulemaking conducted under section 553
of title 5, United States Code, adjust the format, type size,
and text of any of the warning label statements required
by subsection (a) of this section, or establish the format,
type size, and text of any other disclosures required under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.), if the Secretary finds that such a change would
promote greater public understanding of the risks associ-
ated with the use of smokeless tobacco products.’’.
SEC. 503. SMOKELESS TOBACCO LABELS AND ADVERTISING
WARNINGS.
Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402) is amend-
ed to read as follows:
‘‘SEC. 3. SMOKELESS TOBACCO WARNING.
‘‘(a) GENERAL RULE.—
‘‘(1) It shall be unlawful for any person to man-
ufacture, package, or import for sale or distribution
within the United States any smokeless tobacco
product unless the product package bears, in accord-
ance with the requirements of this Act, one of the
following labels:
‘‘WARNING: This product can cause mouth cancer’’
181
‘‘WARNING: This product can cause gum disease
and tooth loss’’
‘‘WARNING: This product is not a safe alternative
to cigarettes’’
‘‘WARNING: Smokeless tobacco is addictive’’
‘‘(2) Each label statement required by para-
graph (1) shall be—
‘‘(A) located on the 2 principal display
panels of the package, and each label statement
shall comprise at least 25 percent of each such
display panel; and
‘‘(B) in 17-point conspicuous and legible
type and in black text on a white background,
or white text on a black background, in a man-
ner that contrasts by typography, layout, or
color, with all other printed material on the
package, in an alternating fashion under the
plan submitted under subsection (b)(3), except
that if the text of a label statement would oc-
cupy more than 70 percent of the area specified
by subparagraph (A), such text may appear in
a smaller type size, so long as at least 60 per-
cent of such warning area is occupied by the
label statement.
182
‘‘(3) The label statements required by para-
graph (1) shall be introduced by each tobacco prod-
uct manufacturer, packager, importer, distributor, or
retailer of smokeless tobacco products concurrently
into the distribution chain of such products.
‘‘(4) The provisions of this subsection do not
apply to a tobacco product manufacturer or dis-
tributor of any smokeless tobacco product that does
not manufacture, package, or import smokeless to-
bacco products for sale or distribution within the
United States.
‘‘(b) REQUIRED LABELS.—
‘‘(1) It shall be unlawful for any tobacco prod-
uct manufacturer, packager, importer, distributor, or
retailer of smokeless tobacco products to advertise or
cause to be advertised within the United States any
smokeless tobacco product unless its advertising
bears, in accordance with the requirements of this
section, one of the labels specified in subsection (a).
‘‘(2) Each label statement required by sub-
section (a) in smokeless tobacco advertising shall
comply with the standards set forth in this para-
graph. For press and poster advertisements, each
such statement and (where applicable) any required
183
statement relating to tar, nicotine, or other con-
stituent yield shall—
‘‘(A) comprise at least 20 percent of the
area of the advertisement, and the warning area
shall be delineated by a dividing line of con-
trasting color from the advertisement; and
‘‘(B) the word ‘‘WARNING’’ shall appear
in capital letters and each label statement shall
appear in conspicuous and legible type. The text
of the label statement shall be black on a white
background, or white on a black background, in
an alternating fashion under the plan submitted
under paragraph (3).
‘‘(3)(A) The label statements specified in sub-
section (a)(1) shall be randomly displayed in each
12-month period, in as equal a number of times as
is possible on each brand of the product and be ran-
domly distributed in all areas of the United States
in which the product is marketed in accordance with
a plan submitted by the tobacco product manufac-
turer, importer, distributor, or retailer and approved
by the Secretary.
‘‘(B) The label statements specified in sub-
section (a)(1) shall be rotated quarterly in alter-
nating sequence in advertisements for each brand of
184
smokeless tobacco product in accordance with a plan
submitted by the tobacco product manufacturer, im-
porter, distributor, or retailer to, and approved by,
the Secretary.
‘‘(C) The Secretary shall review each plan sub-
mitted under subparagraph (B) and approve it if the
plan—
‘‘(i) will provide for the equal distribution
and display on packaging and the rotation re-
quired in advertising under this subsection; and
‘‘(ii) assures that all of the labels required
under this section will be displayed by the to-
bacco product manufacturer, importer, dis-
tributor, or retailer at the same time.
‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is
unlawful to advertise smokeless tobacco on any medium
of electronic communications subject to the jurisdiction of
the Federal Communications Commission.’’.
SEC. 504. AUTHORITY TO REVISE SMOKELESS TOBACCO
PRODUCT WARNING LABEL STATEMENTS.
Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402), as
amended by section 303 of this title, is further amended
by adding at the end the following:
185
‘‘(d) AUTHORITY
TO
REVISE
WARNING
LABEL
STATEMENTS.—The Secretary may, by a rulemaking con-
ducted under section 553 of title 5, United States Code,
adjust the format, type size, and text of any of the warn-
ing label statements required by subsection (a) of this sec-
tion, or establish the format, type size, and text of any
other disclosures required under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary
finds that such a change would promote greater public un-
derstanding of the risks associated with the use of smoke-
less tobacco products.’’.
SEC. 505. TAR, NICOTINE, AND OTHER SMOKE CON-
STITUENT DISCLOSURE TO THE PUBLIC.
Section 4(a) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333 (a)), as amended by sec-
tion 301 of this title, is further amended by adding at
the end the following:
‘‘(4)(A) The Secretary shall, by a rulemaking
conducted under section 553 of title 5, United
States Code, determine (in the Secretary’s sole dis-
cretion) whether cigarette and other tobacco product
manufacturers shall be required to include in the
area of each cigarette advertisement specified by
subsection (b) of this section, or on the package
label, or both, the tar and nicotine yields of the ad-
186
vertised or packaged brand. Any such disclosure
shall be in accordance with the methodology estab-
lished under such regulations, shall conform to the
type size requirements of subsection (b) of this sec-
tion, and shall appear within the area specified in
subsection (b) of this section.
‘‘(B) Any differences between the requirements
established by the Secretary under subparagraph (A)
and tar and nicotine yield reporting requirements es-
tablished by the Federal Trade Commission shall be
resolved by a memorandum of understanding be-
tween the Secretary and the Federal Trade Commis-
sion.
‘‘(C) In addition to the disclosures required by
subparagraph (A) of this paragraph, the Secretary
may, under a rulemaking conducted under section
553 of title 5, United States Code, prescribe disclo-
sure requirements regarding the level of any ciga-
rette or other tobacco product smoke constituent.
Any such disclosure may be required if the Secretary
determines that disclosure would be of benefit to the
public health, or otherwise would increase consumer
awareness of the health consequences of the use of
tobacco products, except that no such prescribed dis-
closure shall be required on the face of any cigarette
187
package or advertisement. Nothing in this section
shall prohibit the Secretary from requiring such pre-
scribed disclosure through a cigarette or other to-
bacco product package or advertisement insert, or by
any other means under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).’’.
Subtitle B—Testing and Reporting
of Tobacco Product Smoke Con-
stituents
SEC. 511. REGULATION REQUIREMENT.
(a) TESTING, REPORTING, AND DISCLOSURE.—Not
later than 24 months after the date of enactment of this
title, the Secretary, through the Commissioner of the Food
and Drug Administration, shall promulgate regulations
under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) that meet the requirements of sub-
section (b).
(b) CONTENTS OF RULES.—The rules promulgated
under subsection (a) of this section shall require the test-
ing, reporting, and disclosure of tobacco product smoke
constituents and ingredients that the Secretary determines
should be disclosed to the public in order to protect the
public health. Such constituents shall include tar, nicotine,
carbon monoxide, and such other smoke constituents or
ingredients as the Secretary may determine to be appro-
188
priate. The rule may require that tobacco product manu-
facturers, packagers, or importers make such disclosures
relating to tar and nicotine through labels or advertising,
and make such disclosures regarding other smoke con-
stituents or ingredients as the Secretary determines are
necessary to protect the public health.
(c) AUTHORITY.—The Food and Drug Administra-
tion shall have authority to conduct or to require the test-
ing, reporting, or disclosure of tobacco product smoke con-
stituents.
SEC. 512. FDA AMENDMENT.
Section 526(a)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bb(a)(2)) is amended by in-
serting ‘‘or targets and mechanisms of pathogenesis of dis-
eases’’ after ‘‘disease or condition’’.
Æ