FDA Talks Tips for Premarket Review Applications

SILVER SPRING, Md. — The Food and Drug Administration (FDA) continues to offer help to the tobacco industry as it works to understand and comply with the final deeming rule.

In May, the agency's Center for Tobacco Control said it would offer a series of webinars to help the industry understand the recently finalized rule extending the FDA's authority to all tobacco products. Some of the webinars are designed for specific audiences — tobacco retailers, vape shops, or manufacturers and importers, for example — to help them understand and comply with the new rule.

The latest webinar, "Timing and Tips — Newly Deemed Tobacco Product Applications," outlines when manufacturers should submit applications for the premarket review of their products and the compliance periods for each premarket pathway. 

It also provides a list of helpful reminders for submitting product review applications, according to the FDA.

To view the webinar, click here.

The deeming rule goes into effect Aug. 8. It extends the FDA's authority to all tobacco products, allowing it to now regulate electronic cigarettes, cigars, hookah tobacco, pipe tobacco and more, in addition to cigarettes and smokeless tobacco, which have fallen under its authority since Congress passed the Family Smoking Prevention and Tobacco Control Act of 2009.


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