The U.S. Food and Drug Administration (FDA) has issued a proposed rule addressing the requirements for the content, format and FDA’s review of and communications procedures for premarket tobacco products applications (PMTAs). PMTAs are part of the process which manufactures of deemed tobacco products–including cigars, pipe tobacco, e-cigarettes and vaping products–can take to get authorization from the FDA to sell, distribute and market tobacco products in the U.S.
Through the PMTA process, manufacturers are responsible for demonstrating to the FDA that the marketing of the new tobacco products would be “appropriate for the protection of the public health.” The FDA takes into consideration the risks and benefits to the population as a whole, including users of these products and non-users. The FDA will look at each tobacco products’ ingredients, additives, constituents, toxicological profile and components and how they will impact the public health. The evaluation process also includes examining how the products are manufactured, packaged and labeled.
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