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

 Aug. 28, 2012 (Munich, Germany) — Electronic cigarettes do not appear to be bad for your heart, according to the first study to look at the effects of smoking e-cigarettes on heart function.

The devices — battery-powered metal cartridges that simulate the effect of smoking by heating nicotine-containing liquid into vapor — can be helpful to smokers trying to kick the habit, says researcher Konstantinos Farsalinos, MD, of the Onassis Cardiac Surgery Center in Athens, Greece.

CNN

Washington (CNN) — A government mandate requiring tobacco companies to place graphic images on their products warning of the dangers of smoking was tossed out Friday by a divided federal appeals court, with the majority saying the requirements were a violation of free speech protections.

The Food and Drug Administration was ordered to immediately revise its rules.

MedicalxPress

NACS ONLINE

The FDA is looking into regulations for premium cigars, which has some members of Congress looking for ways to exclude the tobacco products from agency rules.

FDA Daily Digest

FDA Center for Tobacco Products Participates in 2012 National Conference on Tobacco or Health

 The National Conference on Tobacco or Health (NCTOH) is one of the largest gatherings of the United States tobacco control movement. This year’s theme, “A New Era of Tobacco Control: Policy, Regulation, and Prevention”, will attract a diverse tobacco control audience including more than 2,500 national, state and local tobacco control scientists, program managers, communicators, and advocates, and over 30 public health exhibitors.

The purpose of the conference is to help improve and sustain the effectiveness and reach of tobacco control programs and activities in the United States.

 The law firm of Miller and Zois reports:

 “In early 2011, the FDA received over 500 reports of Pradaxa bleeding injuries—this within months of the drug’s release.  Users of Pradaxa may suffer from internal bleeding, hemorrhaging, or other problems.  By December of 2011, the FDA announced a Pradaxa safety review, the first step toward determining whether a Pradaxa recall is necessary. 

The National Institutes of Health reports 932 serious events between January 2011 and March 2011:

• 120 deaths
• 25 permanent disabilities because of the drug
• 543 hospitalizations
• 505 incidents of hemorrhage or internal bleeding

Editor’s Note:  RIP Harm Reduction.  The public policy question is not whether e-cigarettes are “safe” but whether they impart less harm than coventional cigarettes.  If we applied the type of thinking set forth in the article below there would  be very few prescription drugs on the market.

Tonawanda  News

The jury is still out on safety of e-cigarettes

By Danielle Haynes, danielle.haynes@tonawanda-news.

Examiner

In a recent Op-Ed for Reuters, FDA Commissioner Margaret Hamburg boasted about the success of the 2009 Family Smoking Prevention and Tobacco Control Act. The news would be quite welcome — if only it were true.

Unfortunately, the effectiveness of the new law’s various measures is nil. Its ban on candy cigarettes and requirement that cigarette makers divulge their ingredients will save exactly zero smokers. And the FDA’s recent attempt to impose large graphic health warning labels on cigarette packages and ads is another empty gesture: Most studies show that such graphic labels have no impact. Dr. Hamburg’s praise for the enforcement actions in the law would be appropriate, except that those rules were enacted first by the Tobacco Master Settlement Agreement in 1999.

The Arkansas Project

 just got back from an ALEC conference — a meeting for state legislators and others who are interested in state-level policy ideas that promote free markets, limited government, and federalism. As you may know, ALEC has recently become an object of controversy, largely because some people find the notion of state legislators getting together to discuss conservative ideas frightening and dangerous. Indeed, the attacks on ALEC are typically devoid of analysis; in fact, those attacks are usually composed of (as Lionel Trillingonce wrote in a very different context) “irritable mental gestures which seek to resemble ideas.”

Editor’s Note:  The sale of legal cigarettes to minors continues to decline but the sale of  contraband  cigarettes to minors continues to increase.  Federal regulatory agencies  continue to devote the entirety  of their effort to regulating the sale of  legal cigarettes and have walked away from their responsibility to address the contraband issue.

Washington  Post

RICHMOND, Va. — Sales of tobacco to minors in the U.S. reached an all-time low in 2011 under a federal and state inspection program intended to curb underage tobacco use, according to a report released Thursday.

Editor’s Note:  FDA should take note that, not withstanding the deference generally accorded to federal agencies, courts are willing to enforce agency adherence to legal requirements that regulatory proceedings be balanced.  Consequentially, FDA should view the decision to deny the agency’s motion to dismiss the lawsuit as having ramifications that are considerably broader than the TPSAC; the District Court’s precedent effectively upholds and applies to the balance requirements for all agency peer reviewed documents.

 By Associated Press

RICHMOND, Va. — A challenge by two of the nation’s largest cigarette makers alleging conflicts of interest in the Food and Drug Administration advisory panel’s review of tobacco products can move forward, a federal judge has ruled.