The Death of “Low Tar” Cigarettes… Or Maybe Not.

Is this the best the FDA can do?

Lots of cigarette news lately. To begin with, cigarette manufacturers will no longer be able to market specific brands as “low tar” or “light.” And while David Kessler, former head of the Food and Drug Administration (FDA), called for the regulation of nicotine levels in cigarettes, cancer researchers were backpedaling away from some questionable numbers about cancer risk from smokeless tobacco offered up by the National Cancer Institute (NCI). Meanwhile, the American Medical Association (AMA) called on the FDA to ban so-called e-cigarettes.

Covering nicotine news is inherently confusing, ambiguous, and tentative, since the product in question is a legal drug responsible for an immense amount of tax revenues. It is also addictive. The relatively inelastic nature of demand for nicotine products makes governments reluctant to, er, snuff out the tax bonanza in its entirety.

Nonetheless, Congress gave the FDA broad new regulatory power over cigarettes a year ago with the passage of the Tobacco Control Act of 2009.  Last week, various provisions of the bill became effective, including provisions that “prohibit the advertising or labeling of tobacco products with the descriptors ‘light,’ ‘mild,’ or ‘low’ or similar descriptors” without specific permission from the FDA.  (See earlier post). In addition, health warning labels will be strengthened on smokeless tobacco packaging.

“As FDA continues implementation of the Tobacco Control act, we are committed to assuring that the actions we are taking are grounded in science and are open and transparent with participation by various stakeholders,” according to a press release from the agency’s Center for Tobacco Products.

The problem, as a glance at the photograph above aptly demonstrates, is that the America tobacco industry is already a jump ahead of the FDA’s measured approach. The industry plans to “let the colors speak to smokers in the same way the soon-to-be banned words ‘mild,’ ‘light,’ and ‘ultralight’ did,” Stephen Smith wrote last year in the Boston Globe.

Thus Pall Mall Lights become Pall Mall Blues. Whereas Salem Lights will forever after be known as Salem Gold Box. And so on. “These tricks are now well-established,” tobacco control specialist Stanton Glantz of the University of California told the Boston Globe. “The real question for the FDA is, are they going to let them get away with these shenanigans?”

The FDA is changing colors on the packages, and roughing up the warning labels, and starting to zero in on menthol, but one of the things it won't be doing is lowering the nicotine levels in cigarettes. Former FDA chairman David Kessler, for one, insists that this is the only substantive change likely to make a difference in addiction rates. In an AP report by Michael Felberbaum, Kessler said: “The tobacco industry knew 40 years ago that there was a threshold below which people would quit. Reducing the level of nicotine in cigarettes will change smoking as we know it. It is the ultimate harm reduction strategy.”

Meanwhile, on another contested front, (see earlier post) the Partnership at Drugfree.org reported that the AMA called on the FDA to regulate electronic cigarettes, which to date the agency has declined to do.  “Very little data exists on the safety of e-cigarettes,” said AMA board member Edward Langston. “Because e-cigarettes have not been thoroughly tested, one cannot conclude that they are less harmful or less dangerous than conventional cigarettes.” E-cigarettes also come in different candy and fruit flavors, the AMA pointed out during the process of adopting the policy at its annual meeting in Chicago.

And finally, a Wall Street Journal report by Carl Bialik in April caused a good deal of embarrassment at the American Cancer Society, which conceded that it had stopped using its long-cited figure of a 50-fold increase in the risk of oral cancer among users of smokeless tobacco. The National Cancer Institute has also cited the 50-times risk figure in its literature. As it turned out, the original survey had been about dry snuff, a form of tobacco rarely used in America today. Other scientists have concluded that the increased risk of oral cancer from smokeless tobacco is on the order of a factor of 10, not 50.

Photo credit: http://www.google.com/

House Tobacco Bill Moves to Senate

Bill would give FDA control over nicotine products.

It is one of the most popular drugs in America, used and abused by millions. Yet it is not regulated by any government agency. There is no federal testing, no quality control, no standards of any kind. As representative Jared Polis (D-Colorado) memorably told the U.S. House of Representatives: “Tobacco use is the single largest cause of preventable death in our country. Yet it continues to receive less regulation than a head of lettuce.”

That deplorable situation may soon change, as the U.S. Senate takes up a bill recently passed by the House. The legislation would give the Food and Drug Administration (FDA) broad new powers to regulate the tobacco industry for the first time in history.

The house bill is similar to one passed last session, which died in the Senate after it was opposed by the Bush administration. According to reports by Duff Wilson in the New York Times, the legislation would enable the FDA to “approve or reject current and proposed tobacco products and ingredients, based on scientific and health findings.” The FDA would be able to restrict harmful chemicals and reject new tobacco products, but in a major concession to Philip Morris, the nation’s largest cigarette maker, the bill “would not allow a complete ban of tobacco products, or permit the agency to order the complete removal of nicotine.” The Times article also said the bill would lead to larger and more graphic warning labels on cigarette packs.

Senator Edward Kennedy (D-Massachusetts) said he plans to introduce the bill later this month. The legislation is supported by President Obama. An official statement released by the administration said that tobacco use “is a major factor driving the increasing costs of health care in the U.S. and accounts for over a hundred billion dollars annually in financial costs to the economy.” Attempts to mandate FDA regulation of tobacco have been made repeatedly over the past decade.

Tobacco industry supporters have vowed to fight the bill on the Senate floor. Senator Richard Burr (R-North Carolina) said he was considering a filibuster. House Republican Virginia Foxx, also of North Carolina, derided the legislation as “an unnecessary and expensive regulatory scheme at the expense of our rural farming communities.” North Carolina is the country’s leading tobacco growing state.

A spokesperson for the American Heart Association said the Senate was expected to act quickly on the bill: “This has certainly been a passion of Senator Kennedy’s and a legacy he can leave to the public health of America.”

Photo Credit: Winston-Salem Journal

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