translated from Spanish: FDA authorizes sale of device that seeks to replace cigarette

The United States Food and Drug Administration Two (FDA) confirmed that IQOS, the electrically heated tobacco system of Philip Morris International (PMI), is appropriate for the protection of public health and has authorized it for sale in the United States. The FDA’s decision is the result of the comprehensive evaluation of the pre-marketing application for tobacco products (PMTA), submitted to the agency in the year 2017.
Unlike cigarettes, the IQOS system heats but does not burn tobacco. This is the first electrically heated tobacco product to qualify for sale in the United States under the 2009 law that empowers the FDA to regulate tobacco products, including the surveillance of innovative products.
“In particular, through the FDA’s scientific evaluation of the Company’s requests, published literature peer-reviewed and other sources, the agency found that the aerosol produced by the IQOS tobacco heating system contains less Toxic chemicals that cigarette smoke, and many of the identified toxins present lower levels than in cigarette smoke. For example, exposure to carbon monoxide from IQOS aerosol is comparable to environmental exposure, and acrolein and formaldehyde levels are 89% to 95% and 66% to 91% lower than those of combustion cigarettes, “the FDA statement says.
“In addition, IQOS supplies nicotine at levels close to combustion cigarettes, suggesting a possibility that IQOS users can completely switch from combustion cigarettes and use IQOS exclusively. The data available, while limited, also indicate that few non-tobacco users may decide to start using IQOS, including young people, “he adds.
Smoke free
About the FDA announcement, André Calantzopoulos, PMI CEO said that “the FDA’s decision to authorize IQOS in the United States is an important step forward for the approximately 40 million of American men and women who smoke. Some will leave it. Most will not, and for them IQOS offers an alternative to keep smoking, smoke-free. In just two years, 7.3 million people around the world have abandoned cigarettes and have completely changed to IQOS. All of us at PMI are committed to replacing cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation. The FDA announcement is a historic milestone. ”
The company is leading a transformation in the tobacco industry to create a smoke-free future and eventually replace cigarettes with smoke-free products for the benefit of adults who would otherwise continue to smoke, society, the company and their Shareholders. PMI is building a future with a new category of smoke-free products that, although not risk-free, are a much better choice than to continue smoking. PMI’s Smoke-free IQOS product portfolio includes steam products that heat but do not burn tobacco and contain nicotine. As of March 31, 2019, PMI estimates that approximately 7.3 million adult smokers around the world have already stopped smoking and switched to the product that heats but does not burn PMI tobacco, which is currently available for sale in 47 markets in key cities or Nationwide under the IQOS brand.

Original source in Spanish