FDA clears Philip Morris & # 39; iQOS, Altria prepares to sell the heated tobacco unit in the United States
The Centers for Disease Control and Prevention estimate that 34.3 million adults in the United States currently smoke cigarettes. Philip Morris says iQOS will appeal to adult smokers because it is a closer experience for traditional cigarettes even one that is less harmful.
Anti-tobacco groups disagree. They say that heat-non-burning products are just the latest trick from Big Tobacco to connect people to their products.
Former FDA Commissioner Scott Gottlieb had embraced the idea that nicotine alternatives could serve as an alternative for people who want to continue smoking. Under him, the FDA has adopted the belief that nicotine products exist on a continuum of risk where conventional cigarettes are the most lethal and others may not be so harmful.
Read the FDA's complete statement below:
The US Food and Drug Administration today announced that it has approved the marketing of new tobacco products manufactured by Philip Morris Products SA for the IQOS Tobacco Heating System ̵[ads1]1; an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol. The FDA has imposed strict marketing restrictions on the products in an effort to prevent youth access and exposure.
Following a thorough science-based review through the PMA Path (PMA), the Agency decided that these products were approved for the US market for public health protection because the products produce fewer or lower levels of some toxins than flammable cigarettes.
The products authorized for sale include the IQOS unit, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.
While today's action allows tobacco products to be sold in the United States, it 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 tobacco products should continue to fail. In addition, today's measures are not a decision on the separately modified risk tobacco product (MRTP) applications that the company has also submitted for these products to market them with reduced exposure or reduced risk requirements.
"To ensure that new tobacco products undergo a robust FDA pre-evaluation, an important part of our mission is to protect the public, especially youth, and to reduce tobacco-related illness and death. While the approval of new tobacco products does not mean they are safe , the review process considers that marketing the products is appropriate for public health protection, considering the risks and benefits to the population as a whole, including how the products can affect the use of nicotine and tobacco by young people and the potential for the products to move adults away from use. Flammable Cigarettes, says Mitch Zeller, JD, director of the FDA's Tobacco Products Center.
"It is important that the FDA put in place mail market needs, including market dynamics as a potential uptake of youth.
We're keeping an eye on the market, including how the company markets these products, and will take steps to ensure that the continued sale of these products in the US remains appropriate and ensure that the company complies with the agency's marketing restrictions to prevent youth access and exposure. As other manufacturers seek to market new tobacco products, the FDA is still committed to maintaining the vital public health standards under the law and using all the tools we have at our disposal to ensure effective and appropriate supervision of tobacco products. "
Under the PMTA course, manufacturers must refer to the agency, among other things, that marketing the new tobacco product would be appropriate for public health protection. This standard requires the FDA to assess the risks and benefits to the population as a whole, including users and non- It is important that this includes adolescents.The Agency's assessment includes review of the tobacco product's components, ingredients, additives and health hazards, as well as how the product is manufactured, packaged, and labeled.The review of IQOS products took into account increased or decreased likelihood that Existing tobacco users will stop using tobacco products, and it increased or decreased the likelihood that those who do not use tobacco products will start using them.
Through the FDA's scientific evaluation of company applications, peer-reviewed published literature and other sources, the agency discovered that the aerosol produced by IQOS Tobacco Hea Things System contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke. For example, the exposure of carbon monoxide from IQOS aerosol is comparable to environmental exposure, and the level of acrolein and formaldehyde is 89% to 95% and 66% to 91% lower than that of flammable cigarettes.
In addition, IQOS delivers nicotine at levels near flammable cigarettes which suggests a likelihood that IQOS users may be able to completely overcome flammable cigarettes and use IQOS exclusively. Available data, while limited, also indicates that few non-tobacco users are likely to choose to use IQOS, including adolescents.
Although these unburned cigarettes may be referred to as "non-burning" or "heated" tobacco products, they meet the definition of a cigarette in the Federal Food, Drug and Cosmetic Act. Therefore, these products must comply with existing restrictions on cigarettes under FDA regulations, as well as other federal laws which, among other things, prohibit television and radio advertising. In addition, to limit youth access to products and exposure to advertising and marketing, the FDA places stricter restrictions on how the products are marketed – particularly through websites and via social media platforms – by including advertising targeting adults. The company must also notify the FDA of, among other things, labeling, advertising, marketing plans, including information about specific adult audiences, and how it plans to restrict access to young people and limit youth exposure to product labeling, advertising, marketing, and marketing. The Agency has issued a document justifying these requirements in the postal market, highlighting important considerations for assessing company applications and any future PMTA for other products.
The FDA also requires all package labels and ads for these products to include a drug addiction warning, as well as other warnings required for cigarettes, to prevent consumer misconceptions about the relative dependency risk of using IQOS compared to burnt cigarettes.
With the approval of these products, the FDA will evaluate new available data about the products through postmarketing records and reports required in the marketing order. The company must regularly report to the FDA with information about the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, current and new user information, production changes, and negative experiences. The FDA can withdraw a marketing order if, among other things, it determines that the continued marketing of a product is no longer suitable for the protection of public health, for example if a product of youth is formed.
The FDA continues its substantive scientific review of the company's MRTP applications. The company will need to receive an MRTP order from the FDA before they can market a tobacco product with implicit or explicit claims that a product, among other things, reduces the exposure to certain chemicals or that the use of the product is less harmful than another tobacco product or will reduce the risk for disease. If a company markets a tobacco product as an MRTP without authorization, the company would violate the law and could face FDA advisory or enforcement actions.
