336 



93 



3. Low T«r wd Low Nicotine Clgtrette Label Inq fails to provide 

 directions for use and adequate labeling. Including warnings that 

 cigarettes are addictive . 



As noted earlier, a drug is deemed to be mlsbranded under Section 502(f) 

 of the Food, Drug, and Cosmetic Act: 



"(f) Unless Its labeling bears (1) adequate directions for use; and 

 (2) such adequate warnings against use in those pathological 

 conditions or by children where Its use My be dangerous to health, or 

 against unsafe dosage or methods or duration of administration or 

 application, in such manner and form, as are necessary for the 

 protection of users." 



Current advertising and labeling practices for low tar and nicotine 

 cigarettes do not provide any of the information (except the federally 

 mandated warning labeling) required by this section. This Is particularly 

 of concern with respect to children, a segment of the population 

 specifically addressed by the FOCA. NIOA estimates for example that 90% 

 of the new saoksrs In the United States are 19 years of age or under. 

 Once sacking patterns are begun, it is very difficult for smokers to quit. 

 It would be Incumbent upon the FOA then to at the very least to require 

 warnings about the use of these products by children, as well as adult 

 consumers, that the product is addictive. 



