Thursday, July 28, 2016

FDA Claims It Is Protecting Public Health by Keeping Slightly Altered Cigarettes Off the Market

Earlier this month, the FDA's Center for Tobacco Products (CTP) denied a substantially equivalent order for Maverick Menthol Silver Box 100s cigarettes. This means that this cigarette brand can no longer be marketed and sold in the U.S. By definition, a "not substantially equivalent" order means that the FDA has deemed that the product raises different questions of public health than cigarette brands already on the market in 2007.

Last year, CTP denied substantially equivalent orders for four Reynolds American brands: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes.

The director of FDA's CTP - Mitch Zeller - boasted that these orders will help protect the public's health by making sure that cigarette products meet "the public health bar set forth under law." These orders will "protect the public from the harms caused by tobacco use," he said:

"These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use. The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law."

The Rest of the Story

You can't be serious. This has to be some kind of nasty joke. How could the FDA possibly claim that by keeping these slightly altered brands off the market the agency is helping to protect the public from the harms caused by tobacco use? Is the FDA under the impression that the current cigarettes on the market are substantially healthier than these five slightly altered cigarettes, such that the new products don't reach "the public health bar," but the existing cigarettes do? How can the agency even suggest that one brand of combustible cigarette raises substantially different questions of public health than another? What the agency is saying is that some cigarettes on the market are safer than others.

What makes these rulings and statements even more ridiculous is that while the FDA apparently believes that slight variations in a cigarette may make that cigarette substantially healthier or more dangerous, the agency does not believe that completely eliminating the tobacco and completely eliminating the combustion process (i.e., an e-cigarette) makes a "cigarette" any safer. In fact, the agency has stated that it has not made a determination that e-cigarettes are any safer than combustible tobacco cigarettes which are killing more than 400,000 Americans each year.

This is an embarrassment. Our nation's leading medical and health regulatory agency believes that slight variations in a cigarette can make such a product substantially healthier, but the complete removal of the tobacco and elimination of the combustion may not have any effect on the safety of the product.

The FDA's official, stated position on the relative safety of tobacco vs. tobacco-free cigarettes is as follows: "There may be a perception that electronic cigarettes...are safer alternatives to conventional tobacco products. ... However, FDA is not aware of any scientific data to support those perceptions."

But apparently the agency does believe that minor differences in combustible tobacco cigarettes make some substantially safer than others, so that they raise different questions of public health. 

If I didn't know this was true, I would absolutely think that I was reading an Onion article.

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