Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
FDA is seeking public comment on proposed guidance for establishing that a tobacco product was commercially marketed in the U.S. as of February 15, 2007. This affects the PMTA process for vape and tobacco products.
Aforeworn detected this change in the Vape & Tobacco Retail Compliance space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Vape shops, tobacco retailers, e-liquid manufacturers, distributors/wholesalers should confirm how it applies to their specific situation before acting. There is a time constraint attached: Comments due by August 26, 2025 (60 days after publication on June 27, 2025).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Vape & Tobacco Retail Compliance continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA proposed a new guidance document outlining how to prove a product was marketed before February 15, 2007, which is critical for PMTA exemptions.
Who it affects
Vape shops, tobacco retailers, e-liquid manufacturers, distributors/wholesalers
What you must do
Submit comments to FDA on the proposed guidance by the deadline.
Deadline
Comments due by August 26, 2025 (60 days after publication on June 27, 2025).
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