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For FDA to revoke a standard, the agency must find that the standard is "no longer appropriate for the protection of public health." 93 When enacting the TCA, Congress recognized that flavors, specifically, can make tobacco products more appealing to youth and expose tobacco users to additional carcinogens or other toxic constituents

With M2 it has been possible to reduce the inhalation of tar and nicotine by smokers by more than 70%, and what is more important, a reduction in the carbon monoxide inhalation has been achieved by more than 40%

14 This approach is suitable for patients who smoke within one hour of waking (most reliable indicator of dependence) and those who smoke ten or more cigarettes per day

While the FDA Certificate of Free Sale is essential for international trade, some countries may demand an Apostille for additional authentication