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Examples of deficiencies that lead to an RTA include: if the submission does not pertain to a tobacco product, if it is not in English or does not contain complete English translations, if it is in an electronic format FDA cannot process, read, review, and archive, or if the submission does not include an environmental assessment or valid claim of categorical exclusion

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Heated Tobacco In May, I noted: In heated tobacco, BATs new devices, namely glo HYPER X2, and heat sticks have received positive responses from consumers, but still trail the success of PMIs IQOS ILUMA, and now face additional competition of new HTP variants from JT and others, potentially weighing on the companys ability to take incremental share and exercise positive pricing