The Food and Drug Administration has authorized Philip Morris International to sell its heatless tobacco product, iQOS.
Philip Morris had submitted two separate applications to the regulatory agency, one simply to sell the device, which heats the tobacco rather than the burn, and another to market it as less harmful than the cigarette. The agency has not yet made a decision regarding this latest request.
"Even though the authorization of new tobacco products does not mean that they are safe, the review process ensures that the marketing of the products is appropriate for the protection of public health, taking into account the risks and consequences. Benefits for the general population "The director of the FDA's Tobacco Center, Mitch Zeller, said in a statement.
Even without the reduced risk claim, the FDA's decision marks a victory for Philip Morris and Altria, who will sell iQOS in the United States. The iQOS is a key element of the futures of both companies that are trying to run the cigarette beyond. Smoking rates in the United States continue to reach new lows, which has led the tobacco giants to diversify in search of growth.
PMI shares rose 1.8%, while Altria shares rose 2%.
The iQOS tobacco heating system consists of three parts: a support, a tobacco stick and a charger. The pen-shaped device contains a ceramic and gold plate that heats Philip Morris tobacco sticks to temperatures of up to 350 degrees Celsius. Tobacco in cigarettes burns at temperatures equal to or greater than 600 degrees Celsius.
When considering PMI's application, the FDA found that iQOS aerosol products "contain fewer toxic chemicals than cigarette smoke and that many of the identified toxins are present at levels below those of cigarette smoke ". The agency also found that iQOS provided nicotine levels similar to those of conventional cigarettes, "suggesting a likelihood that IQOS users will be able to move away completely from fuel cigarettes" and use only iQOS.
The data also suggests that nonsmokers and children will not be attracted to iQOS, the FDA said. Nevertheless, the agency imposes "strict restrictions" on the way iQOS is marketed, especially online and on social media. The company must inform the FDA of its labeling, advertising and marketing plans and how it plans to restrict youth access, advertising and promotions.
"We fully support this goal," said Andre Calantzopoulos, CEO of PMI, in a statement. "The FDA has set high standards and we look forward to working with them to implement the order so that the iQOS 's address to the public good, current adult smokers. "
Altria will soon start selling iQOS in Atlanta, although the company did not specify when. Altria plans to open an iQOS store and many mobile stores. Heatsticks, Marlboro brand tobacco sticks used with the iQOS device, will be available in approximately 500 stores, including Circle K, USA Murphy, QuikTrip, RaceTrac, Speedway and other retailers, said Altria.
"PM USA will act based on market knowledge and hopes to adapt IQOS quickly and efficiently," said Howard Willard, CEO of Altria, in a statement.
Last year, the reduced risk products generated a turnover of $ 4.1 billion, or about 14% of the total business turnover of $ 29.63 billion PMI . The company wants to bring this statistic between 38 and 42% by 2025.
Since the first launch of iQOS in Nagoya, Japan and Milan, in 2014, Philip Morris has introduced it to more than 40 markets around the world. In some places, growth has increased. In the United States, iQOS will enter a market where the growth of the e-cigarette is growing, largely thanks to Juul. In December, Altria invested $ 12.8 billion in a 35% stake in Juul.
The Centers for Disease Control and Prevention estimates that 34.3 million American adults currently smoke cigarettes. Philip Morris says that iQOS will attract adult smokers as it is an experience closer to traditional and less harmful cigarettes.
Anti-smoking groups disagree. They say that products that do not burn are just the latest Big Tobacco ploy to hook people to its products.
Former FDA Commissioner Scott Gottlieb had adopted the idea that nicotine substitutes could be an option for people who wanted to continue smoking. Under his leadership, the FDA has embraced the belief that nicotine products exist on a continuum of risk, where conventional cigarettes are the most lethal and the less harmful.
Read the full FDA statement below:
The US Food and Drug Administration today announced that it is allowing the commercialization of new tobacco products manufactured by Philip Morris Products SA for the IQOS Tobacco Heating System, an electronic device that can be used to heat water. sticks filled with tobacco wrapped in paper to generate an environment containing nicotine. aerosol. The FDA has imposed strict marketing restrictions on products to prevent youth access and exposure.
Following a rigorous scientific review of the pre-market tobacco product enforcement procedure, the Agency determined that the authorization of these products for the US market was appropriate for the protection of human health. because, among several key factors, products produce less or less lower levels of certain toxins than combustible cigarettes.
Licensed products include IQOS, Marlboro heating sticks, Marlboro Smooth Menthol heating sticks and Marlboro Fresh Menthol heating sticks.
The measures taken today allow the sale of tobacco products in the United States, but that does not mean that these products are safe or "FDA approved".
All tobacco products are potentially harmful and addictive, and those who do not use them should continue not to use them. In addition, today's action does not constitute a decision on the separate applications for modified risk tobacco products (MRTPs) that the company also submitted for these products in order to market them with claims of reduction of exposure or risk.
"Ensuring that new tobacco products are pre-marketed by the FDA is an essential part of our mission: to protect the public, especially young people, and to reduce the number of tobacco-related illnesses and deaths.The licensing of new tobacco products does not mean that they are safe, the review process ensures that the marketing of the products is appropriate for the protection of public health, taking into account the risks and benefits to the general population, including how products may affect nicotine use by youth and tobacco, and the potential of products to completely divert smokers adults use combustible cigarettes, "said Mitch Zeller, JD, director of the FDA's Center for Tobacco Products.
"It is important to note that the FDA is putting in place post-market requirements to, among other things, monitor market dynamics, such as the potential participation of young people.
We will closely monitor the market, including the manner in which the Company will market these products, and take the necessary steps to ensure that the continued sale of these products in the United States remains appropriate and that the Company complies with the requirements of the United States. agency. trade restrictions to prevent youth access and exposure. As other manufacturers seek to commercialize new tobacco products, the FDA remains committed to meeting the vital public health standards of the law and using all the tools at our disposal to ensure effective and appropriate tobacco products. "
In the context of the PMTA, manufacturers must demonstrate to the agency, inter alia, that the marketing of the new tobacco product would be appropriate for the protection of public health. According to this standard, the FDA must consider the risks and benefits to the entire population, including users and non-users of tobacco products. Importantly, this includes young people. The assessment of the agency includes the examination of the components, ingredients, additives and health risks of a tobacco product, as well as how the product is manufactured, packaged and labeled. The review for IQOS products has taken into account the increased or decreased likelihood that current users of tobacco products will stop using tobacco products and the likelihood will be increased or decreased than those who do not use products. tobacco are starting to use them.
In particular, thanks to the scientific evaluation of the company's applications by the FDA, to published literature and other sources, the agency found that the aerosol produced by the system IQOS tobacco heating contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are: present at levels lower than those of cigarette smoke. For example, the exposure to carbon monoxide from an IQOS aerosol is comparable to environmental exposure and the levels of acrolein and formaldehyde are respectively 89% to 95% lower and from 66% to 91% to those of combustible cigarettes.
In addition, IQOS releases nicotine at levels close to combustible cigarettes, suggesting that users of IQOS may be able to move away completely from fuel cigarettes and use IQOS exclusively. The available data, although limited, also indicate that few non-smoker users would likely choose to start using IQOS, including young people.
Although these unburned cigarettes can be described as "heated without burning" or "heated" tobacco products, they meet the definition of cigarettes in the Federal Food, Drugs and Cosmetics Act. Therefore, these products must comply with existing restrictions for cigarettes imposed by FDA regulations, as well as other federal laws prohibiting such advertising on television and radio. In addition, to further limit young people's access to products and their exposure to their advertising and promotions, the FDA imposes strict restrictions on the way products are marketed – including through websites and platforms. Social Media Forms – including providing advertising for adults. . The company must also inform the FDA, among other things, of its labeling, advertising, marketing plans, including information on specific target audiences for adults, and how it plans to restrict marketing. access of young people and limit their exposure to labeling, advertising. , marketing and promotion. The agency has issued a document explaining the post-sale requirements, outlining the important elements to consider for the review of the company's applications as well as any future PMTA for other products. .
The FDA also requires that all labels and advertisements for these products include a warning about the addictive nature of nicotine, in addition to the warnings required for cigarettes, to prevent consumers' misperceptions about the relative risk of nicotine. addiction to the use of IQOS compared to burned cigarettes.
With the authorization of these products, the FDA will evaluate new product data available through postmarketing records and reports required in the marketing order. The company is required to report regularly to the FDA with information about products on the market, including, but not limited to, ongoing and completed consumer studies, advertising, marketing sales data, information on current and new users, manufacturing changes. and adverse experiences. The FDA may withdraw a marketing order if, among other reasons, it determines that the continued marketing of a product is no longer appropriate for the protection of public health, such as produced by young people.
The FDA continues its in-depth scientific review of the company's MRTP applications. Before being able to market a tobacco product, the company should receive an order from the MRTP customer before it can market a tobacco product with implicit or explicit claims that, among other things, a product reduces exposure to certain products. chemicals or that the use of the product is less harmful than other tobaccos. produce or reduce the risk of disease. If a company markets a tobacco product as a MRTP without authorization, it would violate the law and could face advisory or enforcement actions from the FDA.