FDA Extending Comment Period on E-cigarette Rules

From: Pharmaceutical Processing


RICHMOND, Va. (AP) — The public will have more time to weigh in on a federal proposal to regulate electronic cigarettes and other tobacco products.

The Food and Drug Administration said Friday that the public comment period slated to end July 9 is being extended an additional 30 days to Aug. 8 after getting lots of input on how to regulate e-cigarettes. Those are battery-powered devices that heat a liquid nicotine solution, creating vapor that users inhale. The FDA also proposed extending its authority to regulate cigars, hookahs, nicotine gels and pipe tobacco.

FDA Must Have ‘Open Mind’ on E-Cig Benefits

From: CSPnet.com

Regulators need to focus on nicotine delivery, acknowledge risk continuum: Zeller

By  Melissa Vonder Haar, Tobacco Editor

WASHINGTON — A comprehensive nicotine policy is one of Mitch Zeller’s top priorities, the director of the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) said during a Legacy Foundation Warner Series webinar. It was something that was brought up in the preamble to the CTP’s recently released proposed deeming regulations of electronic cigarettes and vaping products.

FDA Calculates “Lost Enjoyment” Costs of E-Cigarette Rules

From: NACS The Association for Convenience and Fuel Retailing

Cost-benefit analysis viewed as radical by some.

NEW YORK – As U.S. health regulators consider what rules to impose on electronic cigarettes, in their tally of costs and benefits they have placed a value on the lost pleasure consumers may suffer if they used the products less or not at all.

According to a report from Reuters, the U.S. Food and Drug Administration says in a little-noticed document released alongside its April proposal for e-cigarette regulation that the projected benefits of the new rules — which also apply to cigars, hookahs and other vapor products — should be cut by 70% to account for the deprivation consumers would suffer.

CASAA’s Comment to OIRA Highlights Deeming Regulation’s Paperwork Burden

Editor’s Note: CASAA’s comments highlight a crucial aspect of the FDA’s deeming proprosal, the regulation’s inordinate burden on small American companies.

From: Tobacco Today