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Archive for the ‘Tobacco’ category

The U.S. Food and Drug Administration (FDA) recently issued guidance for industry to assist with the submission of warning plans for cigars. On May 10, 2016, FDA published a final rule that granted the agency authority to regulate all tobacco products, including cigars, e-cigarettes, hookah tobacco, and pipe tobacco. What is a warning plan? A […]

The U.S. Food and Drug Administration (FDA) recently issued a guidance that extends the compliance dates for tobacco ingredient submissions for newly deemed tobacco products introduced into interstate commerce on or before August 8, 2016. FDA plans to enforce the ingredient list submission requirement on August 8, 2017 for businesses that are not small-scale manufacturers, and […]

On December 29, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 95863) describing the circumstances under which the agency will refuse to accept a tobacco product submission.  Covered submissions include: Premarket tobacco product applications (PMTAs) Modified risk tobacco product applications (MRTPAs) Substantial equivalence (SE) applications Exemption requests According to […]

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