Heat Not Burn: FDA Should Fight Lung Cancer, Not Smokers

New Food and Drug Administration (FDA) Director Dr. Scott Gottlieb has been a breath of fresh air at the agency. Both Gottlieb and Center for Tobacco Products (CTP) Director Mitch Zeller have demonstrated in their words, that they understand that it’s not nicotine or even tobacco that causes nearly half a million Americans to die prematurely every year, but the byproducts of burning tobacco from a lit cigarette.

Gottlieb and Zeller have acknowledged in the New England Journal of Medicine that while addiction to nicotine delivered from tobacco cigarettes is causing lung cancer and heart disease that kill smokers, it’s also nicotine delivered in non-combustible ways that likely hold the promise toward dramatically reducing the death toll from cigarettes.

Going forward, let’s also hope that these officials highlight the fact that most people, most smokers, many in the media, and even many doctors and nurses fail to understand the distinction between combustible cigarettes and nicotine delivered without burning anything. Sadly, it’s often U.S. government officials, local health departments and the tobacco control groups that have been responsible for spreading confusing or misleading information that keeps smokers smoking and dying when better alternatives are available.

Congress granted FDA the authority to regulate tobacco when President Obama signed the Family Smoking Prevention and Tobacco Control Act into law in 2009. FDA regulations allow two pathways for new products to be legally sold in the U.S. The substantial equivalence (SE) process is designed for FDA evaluate (and sometimes approve) new products that represent minor changes, or improvements to existing predicate products. The pre-market tobacco authorization (PMTA) process is designed to consider new products with no existing predicate product. The PMTA pathway is confusing, expensive and highly uncertain.

Pursuant to the Tobacco Control Act, FDA has also established a modified risk tobacco product (MRTP) process not to approve new products to be sold but to evaluate claims about product attributes that manufacturers might communicate to consumers. The right to sell safer products to long-term smokers yields reduced health benefits if the products are mistakenly believed to be as dangerous or even more dangerous than tobacco cigarettes. If we continue down the same worn tobacco control path we’ve followed for the last fifty years, the CDC says we should expect to continue to see hundreds of thousands of preventable deaths every year.

Frankly, that’s just not good enough. Since the Tobacco Act was signed into law in 2009, the FDA has yet to approve any claims pursuant to the MRTP application process. That’s a problem because while traditional tobacco cigarettes continue to be sold, safer products are kept from the market. If they are already on the market or are allowed by FDA, there is no way to educate smokers that switching to these alternatives might help smokers dramatically reduce their exposure to deadly toxicants.

U.S. smokers already have access to products that are much safer than smoking. Traditional American smokeless tobacco and Swedish-style snus products are demonstrably safer than smoking cigarettes. Yet most smokers, the public and even health professionals fail to realize it. New products, like electronic cigarettes or vapor products that contain nicotine but don’t contain tobacco and don’t produce smoke also allow smokers to dramatically reduce or eliminate exposure to chemical compounds that cause half of them to die. Perhaps the oldest and most esteemed medical society in the world – the Royal College of Physicians – concludes that vapor products are as much as 95 percent safer than smoking. That’s the same Royal College that preceded the U.S. Surgeon General in warning about the dangers of smoking by two years.

A new category of products that heat tobacco, but don’t burn it also seems to be showing enormous promise around the world. IQOS is a heat-not-burn product manufactured by cigarette giant Philip Morris. The product is putting a big dent in the cigarette market in countries around the world, particularly Japan. The product appeals to smokers because using it approximates the experience of smoking a real cigarette. Heat-not-burn products raise the temperature of a tobacco mix sufficiently to create an aerosol, but avoid deadly combustion.

Scientists and researchers have understood for decades that it’s not nicotine that causes 480,000 American smokers to die prematurely every year. Rather it’s burning tobacco and breathing in toxic smoke that kills smokers. If you can deliver nicotine that smokers crave, without the smoke and get smokers to switch, you could prevent most if not all incidents of smoking-related lung cancer and other diseases that kill too many smokers.

It’s not as easy as it seems. Nicotine replacement products like FDA-approved gums and patches have been available to smokers for years. They help some, but overall they just aren’t very effective and fail over 90 percent of the time. Vapor products are increasingly proving appealing to long-term smokers at least in part because vaping closely replicates the act of smoking and seems to deliver nicotine in a more satisfying fashion than other methods.

But vapor products aren’t a silver bullet that helps every smoker. The IQOS product takes things in a slightly different direction. Because the product uses actual tobacco, the taste and sensory experience in some ways more closely mimics smoking a cigarette. In some ways, that makes it less intimidating a switch for some. When activated, the experience lasts about six minutes – about as long as it takes someone to smoke a cigarette. With education and experience, smokers who switch to this type of heat-not-burn product can dramatically reduce their exposure to some of the most dangerous toxicants identified in cigarette smoke.

The IQOS is not yet legally approved for sale in the U.S. But it’s helping smokers in Japan, Great Britain and Italy kick cigarettes to the curb. Philip Morris has begun the MRTP process in the U.S. and is seeking FDA approval to specifically communicate with smokers about how the products differ from combustible cigarettes. On behalf of Reason Foundation, I co-authored a public comment on the MRTP application. Research indicates that some of the more dangerous toxicants in tobacco smoke can be reduced by 90 percent or more by this technology.

Knowledge is power and it’s time we empowered adult smokers with accurate, scientifically valid information to make more informed personal health choices. One way FDA can change things is to approve the MRTP application for IQOS and allow smokers to have critical information that might save their lives.

Brian Fojtik is a Senior Fellow with Reason Foundation.

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