According to a statement issued by the official website of the American Electronic Cigarette Association, Gregory Conley, chairman of the association, said in an announcement after the FDA approved that the heat-not-burn product IQOS of Philip Morris International (PMI) could be launched in the United States. This is a huge victory for public health and adult smokers seeking to meet low-risk alternatives.
But Gregory Conley still criticized the FDA’s regulatory system in the statement. He said that PMI spent billions of dollars to establish the necessary scientific basis to submit this application to FDA. However, the FDA ignored the statutory requirements and it took more than two years to decide on part of the PMI application.
Gregory Conley believes that unless the FDA’s regulatory system is reformed, no one other than the largest tobacco company will receive E-cigarette products through the FDA’s pre-market approval process.
Gregory Conley also said that since the FDA approved the sales and marketing of IQOS, the agency should take immediate action to respond to PMI applications, truthfully inform adult smokers, and fully turn to IQOS to reduce disease risk and chemical exposure. Concealing the truth about adult smokers, many of whom are confused about the potential benefits of smoke-free alternatives.
On April 30th, US local time, after more than two years of waiting for PMI, the FDA announced that it has approved its heat-not-burn IQOS, Marlboro heater, Marlboro mint and other products to launch in the United States, which is the sales of Altria in the United States. Cleared the obstacles.
Although the application was submitted by the manufacturer Philip Morris SA (a division of Philip Morris International – PMI), IQOS will be sold in the United States by Altria Group, the largest cigarette manufacturer in the United States. Its Marlboro brand is the most popular cigarette brand in the United States.
The FDA has not yet issued a decision on PMI’s improved product risk tobacco product application. Through these applications, PMI is seeking to inform adult consumers that a complete shift to IQOS can reduce the user’s risk of disease and/or exposure to harmful chemicals.
In fact, in addition to waiting too long for the FDA to take action on the application, the high cost of submitting PMTA will prevent all applicants except a very small number of e-cigarette steam manufacturers (probably just JUUL and major tobacco companies) from submitting a valid application. No one can provide extensive research and analysis for their IQOS applications.
Tobacco companies reportedly spent billions of dollars on their PMTA and MRTP submissions.
The FDA passed the PMTA, which is the PreMarket Tobacco product Application, a pre-marketing tobacco product application review, rather than MRTP, Modified Risk Tobacco Product, an adjusted tobacco product risk review, but still recognizes carbon monoxide in IQOS aerosols. Exposure is comparable to environmental exposure, with levels of acrolein and formaldehyde being 89% to 95% and 66% to 91% lower, respectively than combustible cigarettes.
The PMTA review is a must for tobacco manufacturers to demonstrate to the presiding agency that the sale of new tobacco products will be suitable for the protection of public health, with strict standards for tobacco product recognition, additives, health risks, product manufacturing, packaging, and labeling. The review of IQOS products primarily considers the increased or decreased likelihood that existing tobacco product users will stop using tobacco products and the likelihood that people who do not use tobacco products will start using tobacco products.
It was found that the aerosol produced by the IQOS tobacco heating system contained less toxic chemicals than cigarette smoke, and many of the toxins identified were currently lower than cigarette smoke.
In addition, IQOS provides nicotine levels close to combustible cigarettes, suggesting that IQOS users may be completely transitioning from combustible cigarettes and using only IQOS.
In terms of regulation, the United States also gave the view that unburned cigarettes (cartridges) are “non-burning” or “heated” tobacco products, but they are consistent with the definition of cigarettes. These products must comply with FDA-defined cigarette restrictions and other federal laws that prohibit advertising, including inductive advertising through websites and social media platforms during marketing, packaging labels and advertisements with “nicotine addiction” warnings and other Warning, to prevent consumers from thinking that the use of IQOS is not addictive.
Next, the FDA continues to conduct a substantive scientific review of the PMI’s MRTP application. PMI requires an MRTP license from the FDA to sell tobacco products, which will require additional proof that products that reduce exposure to certain chemicals or use the product are less harmful than other tobacco products or will reduce the risk of disease. If the company sells tobacco products as MRTP without authorization, it will violate the law and may face FDA investigations.
IQOS is not a traditional e-cigarette product. Traditional e-cigarette steam products heat liquid solutions to produce steam, while IQOS and other tobacco products use real tobacco. However, due to the absence of smoke, the level of harmful components in cigarette smoke is eliminated or reduced by more than 90%.
In Japan and South Korea, with the launch of IQOS and other tobacco products, cigarette sales have fallen sharply. For example, in Japan, traditional e-cigarette steam products are banned, and unless they are approved as medicines, the Japanese cigarette market has shrunk by a third in just three years. Currently, heated tobacco products account for 23% of the Japanese tobacco market.