FDA announces major tactical shift in nation’s war on smoking

cig-300x225The nation’s long war on one of its leading preventable killers has taken a surprising tactical turn, as the head of the federal Food and Drug Administration has declared that tobacco companies will face new regulations aimed at slashing nicotine in cigarettes.

FDA Commissioner Scott Gottlieb argues that cutting the noxious and addictive nicotine will help Americans unhook themselves from tobacco use, prompting less cigarette smoking, and, potentially increasing the use of possibly less harmful health vices, like nonburning “e-cigarettes” for vaping.

Gottlieb, at the same time, put further off a planned FDA crackdown on e-cigarette makers, delaying for several years requirements that they disclose ingredients in their colorful, flavored vaping liquids and demonstrate that they and other e-cigarette products do not cause health harms.

Big Tobacco stocks fell after the FDA proposals were released. Reaction from anti-smoking groups and health experts was guarded, with many noting that Gottlieb had given them little notice of his planned changes. The head of the FDA’s Center for Tobacco Products vowed that the agency would seek wide, evidence-based comment on its plans before translating them into regulations.

The Associated Press carried some of the few early assessments from independent experts on the FDA plan. A nicotine expert said the FDA strategy might work but only if the agency can force Big Tobacco to slash the addictive substance in its products. Studies show that smokers simply smoke more cigarettes with lower nicotine to get their accustomed buzz, unless the nicotine levels have been reduced by 90 or 95 percent, the expert said. Another scientist pointed out that the FDA emphasis on nicotine elimination fails to curb harms of other toxins like tar that smokers take in from burning tobacco.

As for the notion that curbing nicotine and shifting cigarette smokers to vaping might benefit Americans’ health, that’s a running, unresolved controversy, with experts expressing deep concern that nonburning nicotine-delivery devices act as a gateway for the young, launching them into tobacco abuse (cigarette smoking). Vaping also poses its own risks, especially because makers now do not disclose how their devices are made or what’s in the liquids they sell for vaporization.

Gottlieb noted that the FDA needs to research further vaping’s harms. He argued that it did not make sense to force makers to comply with proposed rigorous product rules until such study is complete. The agency, however, will not relax some of its existing vaping rules, barring sales and marketing of products to the underaged. He said the FDA will reexamine vaping flavors targeted at younger users.

The commissioner previously has disclosed that he was a board member and held stock in Kure, an e-cigarette maker. Once confirmed by the U.S. Senate, he pledged to divest himself of his extensive holdings in health care and other companies, including his post and shares in Kure.

In my practice, I see the major harms that patients can suffer while seeking medical services and the long, terrible toll that smoking causes. The FDA, in its nicotine policy announcement, noted that tobacco-related harms—including cancer, heart disease and more—are responsible for 480,000 American deaths annually and direct health care costs and lost productivity costs amounting to more than $300 billion a year. With smoking in decline for many Americans and current efforts to combat this nasty health peril showing some favorable results, count me a skeptic of the FDA tactical shift. But we all need to be all in when it comes to extinguishing Big Tobacco’s detriments to our health and well-being.

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