The FDA’s words and actions do not match

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In a new paper in the New England Journal of Medicine, newly minted Food and Drug Administration Commissioner Scott Gottlieb and Mitch Zeller, longtime director of the FDA Center for Tobacco Products, commit themselves to a science-based regulatory framework that takes into account “the continuum of risk for nicotine-containing products” to reduce tobacco-related addiction, illness and death. To do this, the paper promises an FDA commitment to reduce nicotine levels in cigarettes to “non-addictive levels” and to “foster innovation in less harmful nicotine delivery.”

The proposal to reduce the nicotine content of cigarettes is based on two recent papers by Eric C. Donny and colleagues – one that also appeared in the NEJM and another that appeared in the journal Preventive Medicine. The Preventive Medicine paper outlines the issues that need to be addressed for such regulations to be developed. The NEJM paper details a six-week trial in which smokers were given free low-nicotine e-cigarettes to use, in addition to their usual cigarettes. The trial showed that smokers of low-nicotine cigarettes did not smoke more cigarettes on the last day of the trial than they had on the first day. Neither paper provides a sound basis to replace traditional cigarettes as we know them with a product that does not deliver significant amounts of nicotine.

For the past six years that Zeller has directed the Center for Tobacco Products, he has spoken of a “continuum of risk” and said he favored “fostering innovation.” Unfortunately, what has been reflected in FDA policy is direct opposite of those notions. The FDA has imposed no regulatory burden on cigarettes that wasn’t already imposed before adoption of the Tobacco Control Act of 2009. Meanwhile, the FDA continues to impose nearly impossible-to-meet requirements to approve any new product to the marketplace, including those that claim lower risk than cigarettes.

Despite overwhelming evidence that e-cigarettes are far lower in risk than cigarettes, and that they do not recruit teens to nicotine who otherwise would not have smoked, the FDA has done nothing to confirm or deny these research findings. Indeed, it has just announced a new anti-e-cigarette campaign.

The smokeless tobacco products currently on the American market have long been known to be far lower in risk than cigarettes. The FDA has done nothing to share this information with the public, and has even proposed a new set of smokeless tobacco regulations that threaten to remove almost all current smokeless products from the market.

FDA regulations continue to mandate that even the smallest change to any tobacco-related product now on the market would require immediate removal of that product, pending a new costly application for FDA approval of the modified product. So much for encouraging innovation.

The bottom line is this: neither science nor the fine words in this latest NEJM piece have anything to do with FDA policies that continue to protect cigarette sales and profits from competition from lower-risk nicotine-delivery products.


Image by Gustavo Frazao

 

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