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FDA OKs Restricted Sales of 'Heat-Not-Burn' Tobacco Devices

By HealthDay staff

TUESDAY, April 30, 2019 (HealthDay News) -- 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.

More information

Visit the U.S. Food and Drug Administration for more on tobacco products.

SOURCE: U.S. Food and Drug Administration, news release, April 30, 2019

Copyright © 2019 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=745718

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The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


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