After Three Years, FDA Authorizes ‘Reduced Exposure’ Claims for PMI’s IQOS

WASHINGTON, D.C. — This morning, after an unnecessarily prolonged three year process, the Food & Drug Administration authorized Philip Morris International to market IQOS and its related tobacco and menthol Heatsticks with truthful reduced exposure claims, while simultaneously rejecting PMI’s request to make claims that the product reduces risk in adult smokers who completely switch to IQOS.

By granting the application for reduced exposure claims, IQOS is permitted to be marketed with the following statements:

AVAILABLE EVIDENCE TO DATE:

• •  The IQOS system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

IQOS is not a traditional nicotine vaping product. Nicotine vaping products heat a liquid solution in order to produce a vapor, while IQOS and other heated products use real tobacco. However, because IQOS does not emit no smoke, levels of harmful constituents found in cigarette smoke are eliminated or reduced by 90%-plus. Greater reductions in chemical and toxicant exposure are found with nicotine vaping products, but the American Vaping Association believes that adult consumers should have accurate information about all alternative products.

In Japan and South Korea, remarkable declines in cigarette sales have followed the introduction of IQOS and other tobacco vaping products to the market. For example, in Japan — where traditional vaping products are banned unless approved as drugs — the cigarette market has shrunk by a third in just three years.  A study by researchers with the American Cancer Society, published earlier this year in Tobacco Control, linked the introduction of IQOS to the Japanese market to a swift fall in combustible cigarette sales. Heated tobacco products were estimated to make up 23% of the Japanese tobacco market in 2019.

AVA President Gregory Conley commented on the FDA’s decision:

“We know that many adult smokers are grossly misinformed about the risks and benefits of smoke-free alternatives like heated tobacco products and nicotine vaping products. Allowing accurate labeling and advertising is one step toward fixing these misconceptions and fostering a regulatory system that encourages smokers to make smarter choices about their health. We believe that the science would have supported the FDA granting both the reduced exposure and modified risk claims, but ultimately we are just pleased that the FDA has finally acted on the applications.

“It should not take three years to get permission from the government to tell the truth. As the FDA prepares to review potentially hundreds of applications for nicotine vaping products this fall, this saga underscores the need for the FDA to do a better job of acting in a timely manner on tobacco product applications. In the time it took the FDA to review the scientific evidence and permit these obviously truthful claims to be made, over a million adults died from conditions linked to smoking cigarettes.

“For now, IQOS by PMI — the largest cigarette manufacturer in the world — is the only inhaled tobacco or nicotine product that is allowed to make reduced exposure claims. This is a reflection of America’s broken tobacco and nicotine regulatory system, where compliance costs are sky high and application guidelines are murky and ever-changing. America must reform its regulatory system and become an example to others around the world.”