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Tobacco Regulation Report

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

TPSAC: What Does the Committee Do?

 Jul. 17, 2018

Generally, the role of TPSAC is to review and evaluate scientific issues, including safety, dependence and health issues relating to tobacco products, and provide advice, information and recommendatio...

Tobacco Regulation Report

TPSAC: How Can the Public Comment?

 Jul. 17, 2018

Public comments have an important role in the MRTP review process, the agency said, and the FDA recognizes that TPSAC meetings provide the public with an opportunity to present information to TPSAC me...

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...

Tobacco Regulation Report

Health-Warning Statements: Additional Deadlines

Jun. 15, 2018

Compliance deadlines for the new nicotine warning statements are as follows:—Aug. 10, 2018: Advertisements for these tobacco products must bear the new addictiveness warning. This applies to man...

Tobacco Regulation Report

Deeming Applications: 2021-2022

Jun. 15, 2018

Under the original deadlines set in the FDA deeming rule for electronic cigarettes, cigars and other previously undeemed tobacco products, manufacturers would be facing important deadlines this year: ...

Tobacco Regulation Report

Vaping Manufacturer Documents: Due July 12, 2018

Jun. 15, 2018

The FDA sent letters requesting similar documentation from four additional e-cig and vaping companies on May 17, 2018. The agency said the companies/products were selected based on attributes that ove...

Tobacco Regulation Report

Nicotine ANPRM: Comments Due July 16, 2018

Jun. 15, 2018

The first of the three ANPRM deadlines looks at whether the FDA should limit nicotine levels in cigarettes. The agency is seeking input on several issues, including:—Appropriate maximum nicotine...

Tobacco Regulation Report

ANPRM: The Value in Commenting

Jun. 15, 2018

With the deadlines on these three ANPRMs fast approaching, Lakeville, Minn.-based NATO has encouraged interested parties to submit comments.“FDA staff members have indicated publicly that they r...

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