HR 1108 RFS 
‘‘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. 
‘‘(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 
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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-
termines that inadequate grounds exist to support 
the actions required by the order, the Secretary shall 
vacate the order. 
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‘‘(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 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 re-
call. 
‘‘(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 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-
ers and other persons who distributed such to-
bacco product. If a significant number of such 
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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). 
‘‘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-
quency of a serious, expected adverse product experi-
ence; 
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‘‘(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 
information required under this subsection unless re-
quired for the medical welfare of an individual, to 
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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) 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) 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 correc-
tion was undertaken— 
‘‘(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. 
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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 
action or removal of a tobacco product may be re-
quired under paragraph (1) if a report of the correc-
tive action or removal is required and has been sub-
mitted under subsection (a). 
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO-
BACCO PRODUCTS. 
‘‘(a) IN GENERAL.— 
‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For 
purposes of this section the term ‘new tobacco prod-
uct’ means— 
‘‘(A) any tobacco product (including those 
products in test markets) that was not commer-
cially marketed in the United States as of Feb-
ruary 15, 2007; or 
‘‘(B) any modification (including a change 
in design, any component, any part, or any con-
stituent, including a smoke constituent, or in 
the content, delivery or form of nicotine, or any 
other additive or ingredient) of a tobacco prod-
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uct where the modified product was commer-
cially marketed in the United States after Feb-
ruary 15, 2007. 
‘‘(2) PREMARKET REVIEW REQUIRED.— 
‘‘(A) NEW
PRODUCTS.—An order under 
subsection (c)(1)(A)(i) for a new tobacco prod-
uct is required unless— 
‘‘(i) the manufacturer has submitted a 
report under section 905(j); and the Sec-
retary has issued an order that the tobacco 
product— 
‘‘(I) is substantially equivalent to 
a tobacco product commercially mar-
keted (other than for test marketing) 
in the United States as of February 
15, 2007; and 
‘‘(II) is in compliance with the 
requirements of this Act; or 
‘‘(ii) the tobacco product is exempt 
from the requirements of section 905(j) 
pursuant to a regulation issued under sec-
tion 905(j)(3). 
‘‘(B) APPLICATION TO CERTAIN POST-FEB-
RUARY 15, 2007, PRODUCTS.—Subparagraph (A) 
shall not apply to a tobacco product— 
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‘‘(i) that was first introduced or deliv-
ered for introduction into interstate com-
merce for commercial distribution in the 
United States after February 15, 2007, 
and prior to the date that is 21 months 
after the date of enactment of the Family 
Smoking Prevention and Tobacco Control 
Act; and 
‘‘(ii) for which a report was submitted 
under section 905(j) within such 21-month 
period, 
except that subparagraph (A) shall apply to the 
tobacco product if the Secretary issues an order 
that the tobacco product is not substantially 
equivalent. 
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 
‘‘(A) IN
GENERAL.—In this section and 
section 905(j), the term ‘substantially equiva-
lent’ or ‘substantial equivalence’ means, with 
respect to the tobacco product being compared 
to the predicate tobacco product, that the Sec-
retary by order has found that the tobacco 
product— 
‘‘(i) has the same characteristics as 
the predicate tobacco product; or 
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‘‘(ii) has different characteristics and 
the information submitted contains infor-
mation, including clinical data if deemed 
necessary by the Secretary, that dem-
onstrates that it is not appropriate to reg-
ulate the product under this section be-
cause the product does not raise different 
questions of public health. 
‘‘(B) 
CHARACTERISTICS.—In 
subpara-
graph (A), the term ‘characteristics’ means the 
materials, 
ingredients, 
design, 
composition, 
heating source, or other features of a tobacco 
product. 
‘‘(C) LIMITATION.—A tobacco product may 
not be found to be substantially equivalent to a 
predicate tobacco product that has been re-
moved from the market at the initiative of the 
Secretary or that has been determined by a ju-
dicial order to be misbranded or adulterated. 
‘‘(4) HEALTH INFORMATION.— 
‘‘(A) SUMMARY.—As part of a submission 
under section 905(j) respecting a tobacco prod-
uct, the person required to file a premarket no-
tification under such section shall provide an 
adequate summary of any health information 
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