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The company submitted applications to the FDA for two different regulatory approvals: one to market the product as a new tobacco product (called a Pre-Market approval) in March 2017, and the other to market the product as less harmful than other tobacco products (called a Modified Risk Tobacco Product approval) in December 2016

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Separate studies have demonstrated that PMIs oral nicotine pouches generally contain fewer and lower levels of almost all the toxicants measured, with many falling below their limits of quantification

Risk of oral cancer associated with gutka and other tobacco products: A hospital-based case-control study