FDA OKs Restricted Sales of 'Heat-Not-Burn' Tobacco Devices
TUESDAY, April 30, 2019 -- The U.S. Food and Drug Administration on Tuesday announced it will allow the sale of controversial "heat-not-burn" tobacco devices, but only under tight restrictions aimed at keeping the devices out of the hands of youths.
Called IQOS and marketed by Philip Morris, the devices warm tobacco to 500 degrees Fahrenheit, so it can be inhaled as an aerosol and not as smoke.
"The agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes," the FDA explained in a news release.
"While the authorization of new tobacco products doesn't mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole," said Mitch Zeller, director of the FDA's Center for Tobacco Products.
"This includes how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes," he added.
"We'll be keeping a close watch on the marketplace, including how the company is marketing these products, and will take action as necessary to ensure the continued sale of these products in the U.S. remains appropriate and make certain that the company complies with the agency's marketing restrictions to prevent youth access and exposure," Zeller said.
In addition to no television or radio advertising, "to further limit youth access to the products and exposure to their advertising and promotion, the FDA is placing stringent restrictions on how the products are marketed -- particularly via websites and through social media platforms," the agency said.
Philip Morris must also show the FDA how it plans to restrict youth access and limit youth exposure to the products' labeling, advertising, marketing and promotion.
"The FDA also is requiring all package labels and advertisements for these products to include a warning about the addictiveness of nicotine, in addition to other warnings required for cigarettes, to prevent consumer misperceptions about the relative addiction risk of using IQOS compared to combusted cigarettes," the agency said.
IQOS is already sold in many other countries, though research on the potential health impact of such devices is ongoing. In the United States, the products approved include the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.
Visit the U.S. Food and Drug Administration for more on tobacco products.
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Posted: April 2019