123STA T . 1 789PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 09 ‘ ‘ (5)iftheS e cr et a r y ha s iss u e d re g u l ati on sre q uiring that its la b eling bear adequate directions for use , or adequate w arnings against use by children, that are necessary for the p rotection of users unless its labeling confor m s in all respects to such regulations
‘‘( 6 ) if it was manufactured, prepared, propagated, com - pounded, or processed in an establishment not duly registered under section 90 5(b), 905(c), 905(d), or 905(h), if it was not included in a list required by section 905(i), if a notice or other information respecting it was not pro v ided as required by such section or section 905( j ), or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 905(e) as the Secretary by regulation requires; ‘‘( 7 ) if, in the case of any tobacco product distributed or offered for sale in any State — ‘‘( A ) its advertising is false or misleading in any par- ticular; or ‘‘( B ) it is sold or distributed in violation of regulations prescribed under section 906(d); ‘‘( 8 ) unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, pac k er, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product— ‘‘(A) a true statement of the tobacco product ’ s estab- lished name as described in paragraph ( 4 ), printed promi- nently; and ‘‘(B) a brief statement of— ‘‘(i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindica- tions; and ‘‘(ii) in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appro- priate to protect the public health, a full description of the components of such tobacco product or the for- mula showing quantitatively each ingredient of such tobacco product to the e x tent 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 tobacco product standard established under section 907, unless it bears such labeling as may be prescribed in such tobacco product standard; or ‘‘( 1 0) if there was a failure or refusal— ‘‘(A) to comply with any requirement prescribed under section 904 or 908; or ‘‘(B) to furnish any material or information required under section 909 . ‘‘(b) PRIO RA P PRO VAL O FL A BE LS T ATE M E N T S .— T he Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product to ensure that such statements do not violate the misbranding provisions of subsection (a) and that such statements comply with other provisions of the F amily Regulations.H ea r ings.
