HHS decision shows science, politics joined at the hip

By: Jeffrey P. Bishop and Mark J. Cherry | 12/29/11 8:05 PM
OpEd Contributors
For the first time ever, a Secretary of the Department of Health & Human Services has overturned a Food and Drug Administration drug approval.Secretary Kathleen Sebelius overturned the FDA’s recent approval for over-the-counter use of Plan B One-Step for girls 16-years-of-age and younger.

In “dueling press releases” by Sebelius and FDA Commissioner Margaret Hamburg, the latter cited studies showing Plan B safety below the age of 16, while Sebelius claimed insufficient testing in 11-year-old girls, of whom 10 percent are capable of becoming pregnant.

Dick Durbin: Ban Flavored Cigars—for the Children

| Reason Magazine

A couple of weeks ago, I noted that if the FDA chooses to regulate cigars it could decide to follow New York City’s asinine example by banning flavored varieties because they supposedly encourage kids to smoke. Last week five senators—Dick Durbin (D-Ill.), Frank Lautenberg (D-N.J.), Sherrod Brown (D-Ohio), Jeff Merkley (D-Ore.), and Richard Blumenthal (D-Conn.)—urged the FDA to do just that:

As teenagers turn to cigars instead of cigarettes, these products pose a serious threat to public health and threaten to undermine the important public health protections of the Family Smoking Prevention and Tobacco Control Act. 

FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies in Electronic Cigarette News



A note of clarification here: While the FDA has announced their intent to regulate not only e-cigarettes but all tobacco products under the Tobacco Act, this has not yet occurred. The Family Smoking Prevention and Tobacco Control Act (which became Chapter IX of the Food, Drug, and Cosmetics Act) named specific products. NOT named were such products as cigars, hookahs, e-cigarettes. In order to bring these additional products in, the FDA will need to propose the regulations (which they have already announced that they plan to do, but have not done so yet). Then, there will be a period of public comment (Regulations.gov). Finally, the FDA will announce that it has published (or decided to drop) the proposed regulation.

E-Cigarette Bans? Legitimate, Or The Work Of Cultural Mullahs?

At some point we need to either ban cigarettes or call off the fundamentalist ranting about smokers.  Yes, smoking is bad for you, everyone knows that by now, but having the state of California increase taxes on cigarette smokers – making the state government even more reliant on them – while they use some of that money for anti-smoking campaigns, which means the government now wants to kill the revenue source it is making itself more reliant on, is the kind of thing only…well… progressive government would do.

If you have a risk factor for lung cancer, smoking is going to make it worse.  Sure, if you have a rick factor you may get lung cancer whether you smoke or not and 90% of smokers will never get lung cancer, but the multi-billion dollar marketing campaign against smoking doesn’t like to engage in science or fact – yet an “e-cigarette” would seem to be a happy medium for everyone, right? They mimic mimic the look, feel and taste of traditional cigarettes, and deliver the dose of nicotine a smoker craves without most of the 10,000 chemicals in cigarettes. That has to be better, for people who just will not quit. 

Med Page claims that “Industry Studies Obscure Harm from Tobacco Additives”

Editor’s Note: Industry documents have been on public record for months if not years. At no time during the extensive public comment period provided by  the FDA did the aformentioned “researchers” surface these argments.–unlike CRE who not only  made all their arguments public but allowed the public to comment on them on this Interactive Public Docket.  Notwithstanding the constant flow of ‘hail mary” passes against menthol, CRE will read  the study and if warrants a review CRE will  conduct a detailed review  and report the findings herein. Interesting the “researchers” refuse to look at the toxic effects of contraband.

Senators Call for FDA Ban on Flavored Cigars

Fox  News

Swisher Sweets could be the next target of federal tobacco regulation. 

A group of U.S. senators is urging the Food and Drug Administration to ban flavored cigars, claiming the “candy-like flavorings” increasingly are luring teens into the smoking habit — even as they turn away from cigarettes. 

“Cigars contain the same toxic and cancer-causing chemicals contained in cigarettes, and public health experts have warned that cigars are not safe alternatives to cigarettes,” the senators wrote in a letter to FDA Commissioner Margaret Hamburg

2011 in Review: Local Tobacco IssuesNATO executive director looks at issues that have affected retailers at the local level this year

Tobacco E-News

In 2011, there has been an increase in local governments considering ordinances to further regulate tobacco products, restrict tobacco advertising and impose new local excise taxes on tobacco products. Aside from budget deficits prompting proposals to raise excise taxes, there are two main reasons why local governments have been pursuing more restrictive laws and higher taxes on tobacco products.

The Critical Role of Civil Servants

Historically, federal civil servants played a critical role in developing and implementing federal policy. The attached article in the Administrative Law Review, published by the American Bar Association in conjunction  with the Washington College of Law of the American University, sets forth in Section D on page 54  the critical role career federal employees had in the establishment of centralized regulatory review in the White House Office of Management and Budget.

Going Down in Flames


Dan Holler  


It is easy to see why one-in-five small businesses list regulations as their biggest obstacle; just look at Tampa-based J.C. Newman Cigar Company.

At 116 years old, it is America’s oldest family-owned premium cigar maker. In 1895, J.C. Newman borrowed $50 and started a cigar company. At the time, he was an unemployed cigar maker eager to achieve the American Dream. He did just that, building a small business that withstood 19 recessions, three panics, two depressions, two world wars and the Cuban embargo. Newman Cigar Co. innovated and adapted to a changing world, and today employs 125 people.

FDA Appeals Cigarette Warning Ruling

Fox  News

The Obama administration on Tuesday appealed a U.S. judge’s ruling and injunction that blocked tobacco companies from having to display graphic images on cigarette packs and advertising, such as a man exhaling smoke through a hole in his throat.

The appeal had been widely expected after U.S. District Judge Richard Leon earlier this month sided with tobacco companies and granted a temporary injunction blocking the requirement.

He said the companies would likely succeed in their lawsuit challenging the new graphic warnings as unconstitutional because it compels speech in violation of the First Amendment.

Test Markets Reveal Women Choose Dissolvable Tobacco


WINSTOM-SALEM, N.C. — Since starting a second round of testing, R.J. Reynolds Tobacco Co.’s dissolvable tobacco products are proving popular among women.

The product line — Camel Sticks, Camel Strips and Camel Orbs –do not require spitting, which could be a deciding factor among female tobacco users. According to a report in the Winston-Salem Journal, females represented 45 percent of all adult smokers who bought Camel Sticks, Camel Strips and Camel Orbs during September and October. Of all adult tobacco users, 31 percent were women.

By comparison, the news outlet reported that adult males make up 85 percent of moist snuff and Camel Snus users.