Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No. FDA-2010-N-0646—Paper Work Reduction Act Comments on Tobacco Products, Exemptions from Substantial Equivalence Requirements.

RIN: 0910-AG39

Dear Sir or Madam:

Conclusion: A menthol ban would harm public health. Menthol smokers would consume an increased quantity of illicitly-manufactured cigarettes, many of which contain much higher levels of
heavy metals and other contaminants than legally made products.

Conclusions: In China, counterfeit cigarettes can be produced from tobacco of various levels of quality, second-hand tobacco or even waste. Some of the chemicals that are used to process the low-quality tobacco, such as sulphur and carbamide, are poisonous and may cause health problems to cigarette consumers.

According to recent estimates, up to 400 billion counterfeit cigarettes are produced in China per year (Chen 2009; Joossens et al. 2009).

Conclusion: These findings suggest that variations in cigarette access may contribute to school differences in pupil smoking rates, and that the relationship between access and adolescent smoking is circular, with greater availability increasing rates, and higher rates enhancing access.

Conclusion: Schools and parental interventions should educate about the illegal
nature and health hazards of fake and foreign cigarettes obtained through social sources.