be restricted under a regulation under sec-
tion 906(d); 
‘‘(C) shall, where appropriate, require the 
use and prescribe the form and content of label-
ing for the proper use of the tobacco product; and 
‘‘(D) shall require tobacco products con-
taining foreign-grown tobacco to meet the same 
standards applicable to tobacco products con-
taining domestically grown tobacco. 
‘‘(5) PERIODIC
REEVALUATION
OF
TOBACCO 
PRODUCT STANDARDS.—The Secretary shall provide 
for periodic evaluation of tobacco product standards 
established under this section to determine whether 
such standards should be changed to reflect new med-
ical, scientific, or other technological data. The Sec-
retary may provide for testing under paragraph 
(4)(B) by any person. 
‘‘(6) INVOLVEMENT
OF
OTHER
AGENCIES; IN-
FORMED PERSONS.—In carrying out duties under this 
section, the Secretary shall endeavor to— 
‘‘(A) use personnel, facilities, and other 
technical support available in other Federal 
agencies; 
‘‘(B) consult with other Federal agencies 
concerned with standard setting and other na-
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tionally or internationally recognized standard- 
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, or 
other means, by informed persons representative 
of scientific, professional, industry, agricultural, 
or consumer organizations who in the Secretary’s 
judgment can make a significant contribution. 
‘‘(b) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL ACHIEVABILITY.—The Secretary 
shall consider information submitted in connection 
with a proposed standard regarding the technical 
achievability of compliance with such standard. 
‘‘(2) OTHER
CONSIDERATIONS.—The Secretary 
shall consider all other information submitted in con-
nection with a proposed standard, including informa-
tion concerning the countervailing effects of the to-
bacco product standard on the health of adolescent to-
bacco users, adult tobacco users, or nontobacco users, 
such as the creation of a significant demand for con-
traband or other tobacco products that do not meet 
the requirements of this chapter and the significance 
of such demand. 
‘‘(c) PROPOSED STANDARDS.— 
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‘‘(1) IN GENERAL.—The Secretary shall publish 
in the Federal Register a notice of proposed rule-
making for the establishment, amendment, or revoca-
tion of any tobacco product standard. 
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of 
proposed rulemaking for the establishment or amend-
ment of a tobacco product standard for a tobacco 
product shall— 
‘‘(A) set forth a finding with supporting 
justification that the tobacco product standard is 
appropriate for the protection of the public 
health; 
‘‘(B) invite interested persons to submit a 
draft or proposed tobacco product standard for 
consideration by the Secretary; 
‘‘(C) invite interested persons to submit 
comments on structuring the standard so that it 
does not advantage foreign-grown tobacco over 
domestically grown tobacco; and 
‘‘(D) invite the Secretary of Agriculture to 
provide any information or analysis which the 
Secretary of Agriculture believes is relevant to 
the proposed tobacco product standard. 
‘‘(3) FINDING.—A notice of proposed rulemaking 
for the revocation of a tobacco product standard shall 
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set forth a finding with supporting justification that 
the tobacco product standard is no longer appropriate 
for the protection of the public health. 
‘‘(4) COMMENT.—The Secretary shall provide for 
a comment period of not less than 60 days. 
‘‘(d) PROMULGATION.— 
‘‘(1) IN GENERAL.—After the expiration of the 
period for comment on a notice of proposed rule-
making published under subsection (c) respecting a 
tobacco product standard and after consideration of 
comments submitted under subsections (b) and (c) 
and any report from the Tobacco Products Scientific 
Advisory Committee, if the Secretary determines that 
the standard would be appropriate for the protection 
of the public health, the Secretary shall— 
‘‘(A) promulgate a regulation establishing a 
tobacco product standard and publish in the 
Federal Register findings on the matters referred 
to in subsection (c); or 
‘‘(B) publish a notice terminating the pro-
ceeding for the development of the standard to-
gether with the reasons for such termination. 
‘‘(2) EFFECTIVE
DATE.—A regulation estab-
lishing a tobacco product standard shall set forth the 
date or dates upon which the standard shall take ef-
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fect, but no such regulation may take effect before 1 
year after the date of its publication unless the Sec-
retary determines that an earlier effective date is nec-
essary for the protection of the public health. Such 
date or dates shall be established so as to minimize, 
consistent with the public health, economic loss to, 
and disruption or dislocation of, domestic and inter-
national trade. In establishing such effective date or 
dates, the Secretary shall consider information sub-
mitted in connection with a proposed product stand-
ard by interested parties, including manufacturers 
and 
tobacco 
growers, 
regarding 
the 
technical 
achievability of compliance with the standard, and 
including information concerning the existence of pat-
ents that make it impossible to comply in the time-
frame envisioned in the proposed standard. If the Sec-
retary determines, based on the Secretary’s evaluation 
of submitted comments, that a product standard can 
be met only by manufacturers requiring substantial 
changes to the methods of farming the domestically 
grown tobacco used by the manufacturer, the effective 
date of that product standard shall be not less than 
2 years after the date of publication of the final regu-
lation establishing the standard. 
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‘‘(3) LIMITATION ON POWER GRANTED TO THE 
FOOD AND DRUG ADMINISTRATION.—Because of the 
importance of a decision of the Secretary to issue a 
regulation— 
‘‘(A) banning all cigarettes, all smokeless to-
bacco products, all little cigars, all cigars other 
than little cigars, all pipe tobacco, or all roll- 
your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine 
yields of a tobacco product to zero, 
the Secretary is prohibited from taking such actions 
under this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon the 
Secretary’s own initiative or upon petition of an 
interested person, may by a regulation, promul-
gated in accordance with the requirements of 
subsection (c) and paragraph (2), amend or re-
voke a tobacco product standard. 
‘‘(B) EFFECTIVE
DATE.—The Secretary 
may declare a proposed amendment of a tobacco 
product standard to be effective on and after its 
publication in the Federal Register and until the 
effective date of any final action taken on such 
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amendment if the Secretary determines that 
making it so effective is in the public interest. 
‘‘(5) REFERRAL TO ADVISORY COMMITTEE.— 
‘‘(A) IN
GENERAL.—The Secretary may 
refer a proposed regulation for the establishment, 
amendment, or revocation of a tobacco product 
standard to the Tobacco Products Scientific Ad-
visory Committee for a report and recommenda-
tion with respect to any matter involved in the 
proposed regulation which requires the exercise of 
scientific judgment. 
‘‘(B) INITIATION OF REFERRAL.—The Sec-
retary may make a referral under this para-
graph— 
‘‘(i) on the Secretary’s own initiative; 
or 
‘‘(ii) upon the request of an interested 
person that— 
‘‘(I) demonstrates good cause for 
the referral; and 
‘‘(II) is made before the expira-
tion of the period for submission of 
comments on the proposed regulation. 
‘‘(C) PROVISION OF DATA.—If a proposed 
regulation is referred under this paragraph to 
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the Tobacco Products Scientific Advisory Com-
mittee, the Secretary shall provide the Advisory 
Committee with the data and information on 
which such proposed regulation is based. 
‘‘(D) REPORT AND RECOMMENDATION.—The 
Tobacco Products Scientific Advisory Committee 
shall, within 60 days after the referral of a pro-
posed regulation under this paragraph and after 
independent study of the data and information 
furnished to it by the Secretary and other data 
and information before it, submit to the Sec-
retary a report and recommendation respecting 
such regulation, together with all underlying 
data and information and a statement of the 
reason or basis for the recommendation. 
‘‘(E) PUBLIC AVAILABILITY.—The Secretary 
shall make a copy of each report and rec-
ommendation under subparagraph (D) publicly 
available. 
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 
‘‘(a) NOTIFICATION.—If the Secretary determines 
that— 
‘‘(1) a tobacco product which is introduced or de-
livered for introduction into interstate commerce for 
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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 prop-
erly receive such notification in order to eliminate such 
risk. The Secretary may order notification by any appro-
priate means, including public service announcements. Be-
fore issuing an order under this subsection, the Secretary 
shall consult with the persons who are to give notice under 
the order. 
‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—Com-
pliance 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.— 
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‘‘(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 ordi-
narily contained in tobacco products on the market 
that would cause serious, adverse health consequences 
or death, the Secretary shall issue an order requiring 
the appropriate person (including the manufacturers, 
importers, distributors, or retailers of the tobacco 
product) to immediately cease distribution of such to-
bacco product. The order shall provide the person sub-
ject to the order with an opportunity for an informal 
hearing, to be held not later than 10 days after the 
date of the issuance of the order, on the actions re-
quired by the order and on whether the order should 
be amended to require a recall of such tobacco prod-
uct. If, after providing an opportunity for such a 
hearing, the Secretary determines 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) IN GENERAL.—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 
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the tobacco product with respect to which the 
order was issued, the Secretary shall, except as 
provided in subparagraph (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) NOTICE.—An amended order under 
subparagraph (A)— 
‘‘(i) shall not include recall of a to-
bacco product from individuals; and 
‘‘(ii) shall provide for notice to persons 
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 retailers 
and other persons who distributed such tobacco 
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 pro-
vided by this subsection shall be in addition to rem-
edies provided by subsection (a). 
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‘‘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 tobacco 
product is not adulterated or misbranded and to otherwise 
protect public health. Regulations prescribed under the pre-
ceding sentence— 
‘‘(1) may require a tobacco product manufac-
turer or importer to report to the Secretary whenever 
the manufacturer or importer receives or otherwise be-
comes aware of information that reasonably suggests 
that one of its marketed tobacco products may have 
caused or contributed to a serious unexpected adverse 
experience associated with the use of the product or 
any significant increase in the frequency of a serious, 
expected adverse product experience; 
‘‘(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 protection of 
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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 submis-
sion of a report or information to the Secretary state 
the reason or purpose for such request and identify to 
the fullest extent practicable such report or informa-
tion; 
‘‘(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 informa-
tion and identify to the fullest extent practicable such 
report or information; and 
‘‘(6) may not require that the identity of any 
patient or user be disclosed in records, reports, or in-
formation required under this subsection unless re-
quired for the medical welfare of an individual, to de-
termine risks to public health of a tobacco product, or 
to verify a record, report, or information submitted 
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) continue to apply to records, 
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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) IN GENERAL.—Except as provided in para-
graph (2), the Secretary shall by regulation require a 
tobacco product manufacturer or importer of a to-
bacco product to report promptly to the Secretary any 
corrective action taken or removal from the market of 
a tobacco product undertaken by such manufacturer 
or importer if the removal or correction was under-
taken— 
‘‘(A) to reduce a risk to health posed by the 
tobacco product; or 
‘‘(B) to remedy a violation of this chapter 
caused by the tobacco product which may present 
a risk to health. 
A tobacco product manufacturer or importer of a to-
bacco product who undertakes a corrective action or 
removal from the market of a tobacco product which 
is not required to be reported under this subsection 
shall keep a record of such correction or removal. 
‘‘(2) EXCEPTION.—No report of the corrective ac-
tion or removal of a tobacco product may be required 
under paragraph (1) if a report of the corrective ac-
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