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Tobacco Regulation Report

The latest national tobacco rules and news—and what may be on the horizon
Tobacco Regulation Report

Action Plan: Public Hearing

 Aug. 16, 2018

The FDA will hold a public meeting on the premarket application and review process Oct. 22-23. The goal of the meeting is to solicit comments on its processes and provide a dedicated venue for specifi...

Tobacco Regulation Report

Under Review: New Rules

 Aug. 16, 2018

The FDA hopes to achieve a common understanding around the basic processes regarding its premarket applications. Officials want to propose new rules to help the industry on topics such as substantial ...

Tobacco Regulation Report

Action Plan: Moving on Flavors

Aug. 16, 2018

On the issue of flavors, including flavored e-cigarettes and e-liquids, the FDA said it is concerned about youth and their exposure to nicotine but also understands the role flavored tobacco products ...

Tobacco Regulation Report

Action Plan: Next Steps

Aug. 16, 2018

While the FDA has taken several high-profile actions regarding e-cigarettes and its own application-review process in recent months, the path to developing standards and regulations has several steps ...

Tobacco Regulation Report

Under Review: Finding Efficiencies

Aug. 16, 2018

The FDA wants to explore opportunities for premarket review efficiencies in the hopes it can “modernize and improve the review process.” The FDA hopes to inject an increased flexibility an...

Tobacco Regulation Report

Action Plan: Develop an E-Cigarette Product Standard

Aug. 16, 2018

The FDA has begun exploring a product standard for e-cigarettes. As part of that standard-development process, the agency will consider, among other things, levels of toxicants and impurities in propy...

Tobacco Regulation Report

Chapter 10: Second-Guessing the New-Product Review Process

Aug. 16, 2018

About a year after announcing a tobacco strategy involving nicotine levels in cigarettes and other related measures to reduce tobacco use among Americans, the U.S. Food and Drug Administration (FDA) s...

Tobacco Regulation Report

Chapter 9: Scientific Review

Jul. 17, 2018

The U.S. Food and Drug Administration (FDA) continues its review of tobacco products to determine if manufacturers can claim them to be modified-risk or reduced-risk as compared to traditional combust...

Tobacco Regulation Report

TPSAC: Its Role in MRTP Applications

Jul. 17, 2018

By law, the FDA must refer MRTP applications to TPSAC, and TPSAC must report its recommendations on the applications. The FDA reviews and makes the determination as to whether to authorize an MRTP, an...

Tobacco Regulation Report

Past Decisions: iQOS

Jul. 17, 2018

In a public hearing conducted Jan. 24-25, TPSAC voted on several scientific recommendations for the FDA to consider in the agency’s ongoing review of New York-based Philip Morris International&r...

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