Tobacco Product Regulations

Tobacco products including e-cigarettes and combustibles are now subject to regulatory approval before they can be marketed. Regulations are not harmonized and are in evolution . USA submissions are made to Centre for Tobacco products (CTP) a subdivision of FDA and can be either PMTA or MRTP (if making claims about a health benefit). In Europe there is the Tobacco Products Directive (TPD) and products to aid smoking cessation are licensed via MAA medical product route

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