The administration for food and medicines (FDA), the American regulatory authority in the field of food and medicines, authorized, on January 16, 2025, the marketing of 20 types of Nicotine Nicotine.
The decision is based on an exhaustive analysis of the available scientific evidence and is the result of a long process, initiated by Swedish Match USA, a company part of the Philip Morris International (PMI) group, in March 2020.
The FDA has established that the specific products that have received a marketing authorization fulfill the public health standard imposed by the law to prevent smoking in the family and the 2009 tobacco control. This standard takes into account the risks and benefits of the population products as a whole. The assessment of the agency has shown that authorized nicotine envelopes contain substantially smaller amounts of harmful constituents than cigarettes and most smoke -free tobacco products, such as SNUFF and Snus products, therefore have a lower risk of serious diseases. Also, the evaluation report of the FDA refers to evidence received as part of the authorization process, which shows that a considerable number of adult smokers and users of other tobacco products have completely passed to newly authorized nicotine envelopes.
Zyn thus becomes the first and only product of nicotine envelope for authorized oral use in the US.
Zyn nicotine envelopes, developed by the Swedish Swedish Match company, are part of the PMI portfolio and are intended exclusively for adult users.
“In order to authorize the commercialization of these products, the FDA must have sufficient evidence that they offer greater benefits for the health of the population than risks.”he said Matthew Farrelly, Ph.D., director of the Science Department of the FDA tobacco products center. “In this case, the data show that nicotine envelopes meet the imposed standards, because they offer such benefits to smokers or smoke -free users who make the complete transition to these products.”
As part of his evaluation, the FDA has analyzed data on the risk of use by young people and found that young use of nicotine envelopes remains low, despite the growing sales of recent years.
The FDA will closely monitor the marketing and use of these products. To reduce the potential for exposing young people, the FDA authorizations require strict restrictions on the advertising of these products, including measures to ensure that advertisements are carefully directed to major people in the US, over 21 years old.
“It is essential for the manufacturer to market these products responsibly to prevent their use by young people.”he said Brian King, Ph.D., MPH, director of the FDA center for tobacco products. “While current data shows that the use of young people remains a low one, FDA closely monitors the American market and undertakes to take measures, as the case may be, to protect public health.”
“The recent decision of the FDA to authorize the US marketing in Nicotine Zyn envelopes is an important confirmation of the solid scientific evidence under this product. The FDA decision emphasizes that Zyn nicotine envelopes contain significantly smaller amounts of harmful substances compared to cigarettes. Thus, this decision represents a crucial step in the direction of protecting public health by diversifying better alternatives to cigarettes and other tobacco products for adult smokers ”, said Dr. Mihai Bundoi, Head of Scientific & Medical Affairs, Philip Morris Romania.
Philip Morris International: For a smoke -free future
Philip Morris International (PMI) is an international top-in tobacco industry that aims to build a smoke-free future and expand, in the long term, the portfolio of products outside the product sector containing tobacco or nicotine. The current product portfolio of the company consists mainly in cigarettes and smoke -free products. Since 2008, the PMI has invested over $ 12.5 billion to develop, scientifically substantiate and market innovative smoke -free products for adults who would continue to smoke, in order to completely stop the sale of cigarettes. For this, world scientific evaluation capacities have been built, especially in preclinical fields, such as systems toxicology, in clinical and behavioral research, as well as in market introduction. In 2022, PMI purchased Swedish Match – leader in the manufacture and marketing of nicotine products for oral use – and is thus at the forefront of companies that promote a smoke -free future through its brands IQOS and Zyn. The US Food and Drug Administration (FDA) has authorized the marketing of versions of the IQOS device developed by the PMI and the related consumables, as well as the SNUS product of Swedish Match as modified risk tobacco products (MRTP). Currently, the approval of renewal applications for these products is expected. On June 30, 2024, smoke -free products developed by the PMI were available for sale in 90 markets, and PMI estimates that about 36.5 million adults are using PMI -free products. Smoke-free products represented about 38% of the total net income of the PMI in the first nine months of 2024. With a solid base and significant expertise in life sciences, in February 2021, the PMI announced its ambition to expand in the fields wellness and health care and aims to improve the quality of life by providing integrated health experiences.
For more information you can visit www.pmi.com and www.pmiscience.com
Material made with the support of Philip Morris Romania
