A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

From: CSPnet.com

E-cigarette advocates call omission a “modern-day prohibition”

By Melissa Vonder Haar, Tobacco Editor, CSP

WASHINGTON — A rider that would have helped electronic-cigarette manufacturers better survive the upcoming U.S. Food and Drug Administration (FDA) deeming regulations was not included in the final $1.1-billion spending bill legislators approved earlier this month. Approved by the House Appropriations Committee’s Agriculture, Rural Development, Food & Drug Administration & Related Agencies Subcommittee in June, the rider would have exempted products already on the market from the FDA’s cost-prohibitive Pre-Market Tobacco Application (PMTA) requirement, allowing companies to instead submit a less costly substantial equivalence (SE) application.

From: Daily Caller

Guy Bentley

A policy rider that could’ve saved 99 percent of the e-cigarette of from de facto prohibition failed to make it into the House’s omnibus spending bill released Tuesday night.

The rider would’ve changed the Food and Drug Administration‘s (FDA) rules requiring all e-cigarette products released after February 15, 2007, to undergo the costly Pre-Market Tobacco Applications (PMTA) process. This provision was vitally important to vaping businesses and advocates because the cost of the PMTA process for each individual product can run between $2-10 million.

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From: CSPnet.com

By Thomas A. Briant, NATO Executive Director

This year has been marked by both anticipation of the FDA’s deeming tobacco regulations and other actions by the agency as it moves forward with regulating tobacco products. Most of the attention has been focused on finalizing the extension of the agency’s authority to cigars, pipe tobacco, e-cigarettes, hookah tobacco, dissolvables and nicotine gels. However, the other actions pursued by the FDA in 2015 are just as important.

From: NACS Online

More than 30 meetings are planned with White House officials as the final review of new regulations takes place.   

WASHINGTON, D.C. – Ahead of some of the most sweeping changes to rules governing cigars and e-cigarettes, industry groups and health advocates have been bending the ear of the White House to press their suggestions, The Hill reports. The Office of Management and Budget (OMB) is conducting a final review of the new regulations, which move cigars and e-cigs under the U.S. Food and Drug Administration (FDA) for the first time.

From: AllGov.com

Robert Califf, MD, who is currently deputy commissioner of the Food and Drug Administration (FDA), was nominated by President Barack Obama on Sept. 15, 2015, to be the FDA’s commissioner.

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Among the early issues facing Califf if he’s confirmed is the regulation of e-cigarettes and the challenge of getting drugs to market sooner. At the time of his appointment as deputy commissioner, Califf said he was in favor of streamlining the drug approval process.

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