of the components of such tobacco product 
or the formula showing quantitatively each 
ingredient of such tobacco product to the 
extent required in regulations which shall 
be issued by the Secretary after an oppor-
tunity for a hearing; 
‘‘(9) if it is a tobacco product subject to a to-
bacco product standard established under section 
907, unless it bears such labeling as may be pre-
scribed in such tobacco product standard; or 
‘‘(10) if there was a failure or refusal— 
‘‘(A) to comply with any requirement pre-
scribed under section 904 or 908; or 
‘‘(B) to furnish any material or informa-
tion required under section 909. 
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.— 
The Secretary may, by regulation, require prior approval 
of statements made on the label of a tobacco product. No 
regulation issued under this subsection may require prior 
approval by the Secretary of the content of any advertise-
ment, except for modified risk tobacco products as pro-
vided in section 911. No advertisement of a tobacco prod-
uct published after the date of enactment of the Family 
Smoking Prevention and Tobacco Control Act shall, with 
respect to the language of label statements as prescribed
discontinuance, and the identity of its estab-
lished name. 
‘‘(C) If since the date the registrant re-
ported under subparagraph (B) a notice of dis-
continuance that person has resumed the manu-
facture, preparation, compounding, or proc-
essing for commercial distribution of the to-
bacco product with respect to which such notice 
of discontinuance was reported, notice of such 
resumption, the date of such resumption, the 
identity of such tobacco product by established 
name, and other information required by para-
graph (1), unless the registrant has previously 
reported such resumption to the Secretary 
under this subparagraph. 
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph 
or paragraph (1). 
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
SUBSTANTIALLY
EQUIVALENT
PRODUCTS
INTO 
INTERSTATE COMMERCE.— 
‘‘(1) IN
GENERAL.—Each person who is re-
quired to register under this section and who pro-
poses to begin the introduction or delivery for intro-
duction into interstate commerce for commercial dis-
tribution of a tobacco product intended for human 
use that was not commercially marketed (other than 
for test marketing) in the United States as of Feb-
ruary 15, 2007, shall, at least 90 days prior to mak-
ing such introduction or delivery, report to the Sec-
retary (in such form and manner as the Secretary 
shall prescribe)— 
‘‘(A) the basis for such person’s determina-
tion that— 
‘‘(i) the tobacco product is substan-
tially equivalent, within the meaning of 
section 910, to a tobacco product commer-
cially marketed (other than for test mar-
keting) in the United States as of Feb-
ruary 15, 2007, or to a tobacco product 
that the Secretary has previously deter-
mined, pursuant to subsection (a)(3) of 
section 910, is substantially equivalent and 
that is in compliance with the require-
ments of this Act; or 
‘‘(ii) the tobacco product is modified 
within the meaning of paragraph (3), the 
modifications are to a product that is com-
mercially marketed and in compliance with 
the requirements of this Act, and all of the