Wednesday, July 8, 2009

FDA: Futzing and Diddling Around with Nicotine

Last month Congress passed, and President Obama signed legislation giving the FDA regulatory authority over tobacco products. There is doubt about whether the FDA is the appropriate agency to oversee tobacco use among 45 million Americans. But one thing is certain: The agency has already botched the regulation of nicotine, the highly addictive but otherwise virtually harmless drug found in all tobacco products.

Nicotine replacement medications for smokers have been around for over 20 years. Almost 15 years ago, the agency moved some forms from prescription to over-the-counter status, which typically makes medicines more affordable and more available to consumers. Not this time.

Nicotine medications remain very expensive, they provide only a fraction of the nicotine available in cigarettes, and the FDA limits their use to only 10-12 weeks. In effect, the FDA is telling smokers: “Achieve abstinence (from tobacco and nicotine), or take your chances with cancer, heart attacks and emphysema.”

Doesn’t the FDA know that it’s the smoke that kills? Nicotine is not the cause of any smoking-related disease. It’s about as safe as caffeine, another addictive substance enjoyed by millions of consumers of coffee, tea and cola drinks.

The FDA has assured that nicotine medications are expensive and unsatisfying. First, they are exorbitantly expensive. Smokers struggle to afford $5 to $10 for a pack of cigarettes, so how can they fork out $30 to $50 for a box of nicotine gum or patches? Second, nicotine medications are extremely low-dose, so they don’t provide the nicotine spike that smokers get when they light up. Finally, smokers can only use nicotine medications for 10 to 12 weeks – a period that many find too short to enable them to quit smoking. 

 With a regulatory framework like this, no wonder nicotine medications are successful for only about 7% who try them. For what other medications does the FDA accept a 93% failure rate? It is outrageous that the agency and, for the most part, the public health community are complacent with this dismal statistic.

There are simple fixes for this mess, but the FDA has shown little interest. In 1995, I published an open letter in the Pittsburgh Tribune-Review to FDA commissioner David Kessler, urging him to make pharmaceutical nicotine products more available to smokers. The FDA did nothing over the next 12 years to make these medications more effective and more affordable.

In February 2008, New York State Health Commissioner Richard Daines filed a petition requesting minor revisions in package labeling and sale of nicotine that would greatly expand consumer awareness and availability. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA responded by… Well, they didn’t respond at all. It is hard to imagine how the agency could do worse than to not approve these simple changes. And now Congress has given the FDA regulatory authority over all tobacco products.

The FDA signaled in April that it was about to make another mistake -- banning e-cigarettes, which are battery-powered devices delivering pure nicotine vaporized with propylene glycol (both of which are already approved for human consumption by the agency). The FDA rationale for the ban: “We don't want the public to perceive them as a safer alternative to cigarettes,” said FDA spokeswoman Rita Chappelle.

Apparently, the FDA does not want the public to know that e-cigarettes are safer, which is depressing, coming from the federal agency dedicated to “protecting and promoting your health.” Tobacco users who are looking to the FDA for science-based regulation cannot be impressed. Compared with combustible products, e-cigarettes are definitely minimal risk. For more information, visit End Smoking New Zealand, which has conducted laboratory tests on e-cigarettes.

The vast majority of e-cigarette users are former smokers. The FDA intends to ban a virtually risk-free nicotine delivery system, forcing users to resume cigarette smoking. This move is more bad news for those trying to quit, and it betrays President Obama’s inaugural pledge to “restore science to its rightful place.”
Cigarette smoking will continue to be a leading cause of death in this country until the public health community and government agencies drop their anti-nicotine agenda and start helping, rather than punishing, smokers who are desperate to quit their deadly habit without quitting nicotine altogether.

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