101 
reduce risk or exposure and relating to human 
health; 
‘‘(6) data and information on how consumers 
actually use the tobacco product; and 
‘‘(7) such other information as the Secretary 
may require. 
‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall 
make the application described in subsection (d) publicly 
available (except matters in the application which are 
trade secrets or otherwise confidential, commercial infor-
mation) and shall request comments by interested persons 
on the information contained in the application and on the 
label, labeling, and advertising accompanying such appli-
cation. 
‘‘(f) ADVISORY COMMITTEE.— 
‘‘(1) IN GENERAL.—The Secretary shall refer to 
the Tobacco Products Scientific Advisory Committee 
any application submitted under this section. 
‘‘(2) RECOMMENDATIONS.—Not later than 60 
days after the date an application is referred to the 
Tobacco Products Scientific Advisory Committee 
under paragraph (1), the Advisory Committee shall 
report its recommendations on the application to the 
Secretary. 
‘‘(g) MARKETING.—
102 
‘‘(1) MODIFIED
RISK
PRODUCTS.—Except as 
provided in paragraph (2), the Secretary shall, with 
respect to an application submitted under this sec-
tion, issue an order that a modified risk product 
may be commercially marketed only if the Secretary 
determines that the applicant has demonstrated that 
such product, as it is actually used by consumers, 
will— 
‘‘(A) significantly reduce harm and the 
risk of tobacco-related disease to individual to-
bacco users; and 
‘‘(B) benefit the health of the population 
as a whole taking into account both users of to-
bacco products and persons who do not cur-
rently use tobacco products. 
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 
‘‘(A) IN
GENERAL.—The Secretary may 
issue an order that a tobacco product may be 
introduced or delivered for introduction into 
interstate commerce, pursuant to an application 
under this section, with respect to a tobacco 
product that may not be commercially marketed 
under paragraph (1) if the Secretary makes the 
findings required under this paragraph and de-
103 
termines that the applicant has demonstrated 
that— 
‘‘(i) such order would be appropriate 
to promote the public health; 
‘‘(ii) any aspect of the label, labeling, 
and advertising for such product that 
would cause the tobacco product to be a 
modified risk tobacco product under sub-
section (b) is limited to an explicit or im-
plicit representation that such tobacco 
product or its smoke does not contain or is 
free of a substance or contains a reduced 
level of a substance, or presents a reduced 
exposure to a substance in tobacco smoke; 
‘‘(iii) scientific evidence is not avail-
able and, using the best available scientific 
methods, cannot be made available without 
conducting long-term epidemiological stud-
ies for an application to meet the stand-
ards set forth in paragraph (1); and 
‘‘(iv) the scientific evidence that is 
available without conducting long-term epi-
demiological studies demonstrates that a 
measurable and substantial reduction in 
morbidity or mortality among individual
104 
tobacco users is reasonably likely in subse-
quent studies. 
‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 
To issue an order under subparagraph (A) the 
Secretary must also find that the applicant has 
demonstrated that— 
‘‘(i) the magnitude of the overall re-
ductions in exposure to the substance or 
substances which are the subject of the ap-
plication is substantial, such substance or 
substances are harmful, and the product as 
actually used exposes consumers to the 
specified reduced level of the substance or 
substances; 
‘‘(ii) the product as actually used by 
consumers will not expose them to higher 
levels of other harmful substances com-
pared to the similar types of tobacco prod-
ucts then on the market unless such in-
creases are minimal and the reasonably 
likely overall impact of use of the product 
remains a substantial and measurable re-
duction in overall morbidity and mortality 
among individual tobacco users;