FDA blocking a safer smoke


What if a product could save lives and millions in health-care costs? Imagine that product had undergone extensive tests and trials providing undisputed data showing it was safe. But what if a government agency with an anti-tobacco agenda from a previous administration made that product unavailable?

It’s happening now, as the Food and Drug Administration considers an application for a modified risk tobacco product submitted by the tobacco industry.

The Centers for Disease Control and Prevention says 480,000 people in the U.S. die each year from smoking. It’s the leading preventable cause of death and disease. Even with countless regulations, heavy taxation, anti-smoking campaigns, and numerous cessation programs, 37 million Americans continue to smoke. In North Carolina, 19 percent of the state’s adults smoke cigarettes. Medication, behavioral counseling, gum, patches, government programs, and support groups are available to people trying to quit.

Why do people smoke? Because they choose to.

The addictive nature of nicotine makes it hard for people to quit, even though they may want to. Choices for reduced risk and less harmful products based on extensive research and viable health outcomes should be options.

Economic freedom has provided us with unlimited choices. It has helped to unleash technology and innovation that has improved our lives, our health, and the opportunities before us.

Recognizing the health risks and cultural shift away from smoking, America’s tobacco industry has invested heavily in research, technology, and development of reduced-harm tobacco products, offering consumers a choice outside traditional combustible cigarettes. The market has produced alternative vaping products, nicotine-reduced cigarettes, nicotine replacement patches, and electronic cigarettes.

The newest products are based in part on technology developed by Duke Professor Jed Rose — co-inventor of the nicotine patch — and others. Commercially marketed as iQOS, one new technology uses a controlled heating mechanism with a specially designed tobacco stick inserted into what looks like a short cigarette holder. Because the tobacco is heated and not burned, the harmful toxics found in cigarette smoke are reduced by 90 percent or more. The user gets nicotine through an aerosol but without the harmful smoke and toxins.

The iQos smoking platform is available in 20 countries, including Japan and Italy, but not to U.S. consumers, because the Food and Drug Administration must approve it. The FDA mandates extensive health and safety testing, requiring years of work from hundreds of experts and mounds of paperwork, reports, data, and statistical analysis. Research and development on the iQOS platform began in 2003 and cost millions to bring the product this far.

Two application processes exist. Pre-market tobacco application would allow a company to sell a reduced-risk product — better than conventional cigarettes — but without health claims to the consumer. By statute, the FDA is supposed to review the applications within 180 days. It will probably exceed that for any new product application, but we could see IQOS on the market early next year if the feds follow those timelines.

Modified-risk tobacco product applications could take a year. This isn’t in statute, so it probably will take much longer. There are more hurdles — an FDA advisory committee and a comment period. FDA will also negotiate and discuss any “claims” with the producer before clearing it for the market.

According to the FDA, the agency “can issue an order authorizing the marketing of a product only if the evidence submitted in the application meets the requirements … including, among other things, showing that the product will or is expected to benefit the health of the population as a whole.”

While churning through the administrative bureaucracy, smokers who seek a less harmful alternative are left without one. It’s not just the health risks that are at stake, but it’s also the millions of dollars invested in the next generation of products. It’s the jobs that could be created. It’s the boost to North Carolina’s tobacco industry with the new supply that will be required for the production of the iQOS tobacco sticks. And it’s the message our federal government sends to every entrepreneur, every industry willing to invest in the new innovation, every engineer and systems technician, and researcher in groundbreaking disciplines. The FDA is a barrier to new innovations that save people’s lives, create jobs, and boost economies.

President Trump has called the FDA’s approval process “slow and burdensome.” His appointment to head the FDA, Dr. Scott Gottleib, a former FDA deputy commissioner, has pledged to “make certain the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes … .”

The John Locke Foundation was pleased to submit a public comment to the FDA in support of the approval of the application for a reduced-risk tobacco product. We believe in public safety supported by facts, personal responsibility, and individual liberty. Let’s hope the FDA does, too.

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Becki Gray is senior vice president for the John Locke Foundation.

Becki Gray is senior vice president for the John Locke Foundation.

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