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

From: WOWKTV.com

By Lisa Robbins, Reporter

CHARLESTON, WV –   There’s a new push for the federal government to take control of all tobacco products, including flavored cigars and e-cigarettes.According to the Centers for Disease Control, more than 2 out of 5 middle and high school students who smoke use flavored little cigars or flavored cigarettes.

Some lawmakers want the Food and Drug Administration to step in and regulate all tobacco products, specifically flavored ones, which some people think targets teenagers.

The  State of Massachusetts has established a commissioin to study the impacts of the sale of illicit tobacco products.

Illegal Tobacco Commission

SECTION 182.   There shall be a special commission to study the economic impact of the illegal tobacco market in the commonwealth which shall consist of: the commissioner of revenue or a designee, who shall serve as the chair; the state treasurer or a designee; 1 member of the house of representatives; 1 member of the senate; the secretary of administration and finance or a designee; the attorney general or a designee; the executive director of the Northeast Association of Wholesale Distributors or a designee; the executive director of the New England Convenience Store Association or a designee; and 1 person to be appointed by the governor.

Editor’s Note: Listen to the story here.

From: National Public Radio

By Melissa Block

Electronic cigarettes are popping up in more and more stores around the country and consumers are “vaping” in bars and restaurants with gusto. Sales of the devices are expected to reach nearly $2 billion this year. Until now, the top tobacco companies have been out of the game, but both Altria, which owns Phillip Morris, and R.J. Reynolds are now launching their own brands. Back in 2009, the FDA warned that e-cigarettes could pose health risks. This month, the agency is expected to release a set of proposed regulations on the devices.

Editor’s Note:  The GAO report “NEW TOBACCO PRODUCTS: FDA Needs to Set Time Frames for Its Review Process” is attached here.  In the report, GAO recommended “that FDA establish performance measures that include time frames for making decisions on new tobacco product submissions and that the agency monitor performance relative to those time frames.”  In HHS’ response to the report, ther Department committed to a series of measures to implement GAO’s recommendations.  CRE, a regulatory watchdog, will track and report on FDA/CTP’s response to GAO.

Below is an excerpt from the Department of Health and Human Services comments on the report.

Editor’s Note:  The FDA/Center for Tobacco Products response to the Tobacco Control Legal Consortium and affiliated organizations seeking a ban on menthol-flavored cigarettes is attached here.  Below is an excerpt from the FDA’s reponse.

“FDA has been unable to reach a decision on  your petition because it raises signficant, complex issues requiring extensive review and analysis be Agency officials.”

From: Forbes/Op-Ed

Jacob Sullum, Contributor

Judging from the comments on my recent post about a fear-mongering WNBC story warning that e-cigarettes encourage drug use by teenagers,  I should have more clearly stated what I thought was obvious: I do not agree that “e-cigarettes lead to heroin” (as I sarcastically summarized the story’s message), and WNBC presents no evidence to back up that claim. Instead the station quotes two sources, Nassau County Police Lt. Kevin Smith and Assemblywoman Linda Rosenthal (D-Manhattan), who offer variations on what is known as the “gateway” or “stepping stone” theory of drug use. “For young people, marijuana is a gateway,” says Smith, decrying the use of e-cigarettes to consume marijuana extracts. “The next thing you know they’re doing acid, molly, even heroin.” Rosenthal says it starts with nicotine rather than marijuana: “Once you try electronic cigarettes, you can become hooked to them, move on to cigarettes and then move on to other drugs.”

FDA:  The issuance of three substantial equivalence orders for Republic Tobacco Company products is an activity that is funded under FDA’s user fee program in the Center for Tobacco Products (CTP). Some FDA activities that do not rely on annual appropriations are continuing during the government shutdown.

Today, the U.S. Food and Drug Administration (FDA) announced that the Agency is authorizing the sale and marketing of three additional tobacco products through the substantial equivalence pathway. As directed by the Family Smoking Prevention and Tobacco Control Act, FDA has a responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.

From: New York Times

By ANDREW HIGGINS

STRASBOURG, France — In a decision likely to resonate in the United States and other countries struggling to get a grip on a galloping market for e-cigarettes, the European Parliament on Tuesday scrapped health officials’ proposals that the nicotine-delivery devices be tightly regulated as medical devices.

Instead, lawmakers endorsed a more permissive approach to their sale and use, although the products could not be sold to anyone younger than 18.

CRE’s comments to the FDA on their “Menthol in Cigarettes” Advance Notice of Proposed Rulemaking (ANPRM) document in detail many of the public health harms to children and other vulnerable populations from tobacco trafficking.  The comments also estimate the countervailing increase in the black market for menthol cigarettes that would ocurr if the FDA were to ban their sale.

CRE’s comments to the FDA, titled Weaponizing Poverty, are attached here.