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Small vaping manufacturers hoping to remain on the market beyond Sept. 9, 2021 are scrambling to begin the serious work of testing their products, so they’ll be able to show the FDA they’re making a good-faith effort toward completing the PMTA requirements. The FDA has discretion to grant case-by-case extensions to manufacturers for good cause. Many believe that showing evidence of progress toward completing the testing requirements will earn a temporary reprieve from FDA enforcement. Applicants that are serious about remaining on the market face major challenges completing the complex and expensive evaluations required of their products—including stability testing, toxicology reports, behavioral studies and HPHC testing.
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