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FDA threatens to remove illegally marketed e-cigarettes from shelves

The U.S. Food and Drug Administration on Oct. 12 announced that it would pull e-cigarettes from shelves if it finds the devices are being marketed outside of existing law, continuing the agency's ongoing crackdown on the devices in an effort to curb use by minors.

The agency sent letters to 21 e-cigarette companies — including subsidiaries of tobacco giants British American Tobacco PLC, Japan Tobacco Inc. and Imperial Brands PLC — asking for more information and warning them that the agency received complaints that products were being marketed outside of the FDA's rules. E-cigarettes generally heat a flavored nicotine-infused vapor and are generally marketed as an alternative to combustible cigarettes.

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FDA Commissioner Scott Gottlieb

"Companies are on notice the FDA will not allow the proliferation of e-cigarettes or other tobacco products potentially being marketed illegally and outside of the agency's compliance policy, and we will take swift action when companies are skirting the law. ... If products are being unlawfully marketed and outside the FDA's compliance policy, we'll act to remove them," FDA Commissioner Scott Gottlieb said in a statement.

The FDA allows e-cigarette makers to sell products on the market as of Aug. 8, 2016, and manufacturers have until 2022 to submit those products for review. Products introduced after the deadline or modified with new features, formulations or flavors do not meet legal requirements, the FDA said.

Some of the products that appear to be illegally marketed, however, may still be in compliance with FDA policy, the agency said. That includes e-cigarettes that were on the market as of the deadline but were not publicly announced or advertised before then or a product sold under a different name that has since been rebranded.

A spokesman for Imperial Brands said all of its products on the market comply with FDA rules and the company will supply more information to the agency in the coming days.

British American Tobacco and Japan Tobacco did not immediately respond to request for comment from S&P Global Market Intelligence.

Juul Labs Inc., which leads the e-cigarette market and has also been targeted in the FDA's crackdown, was not included in the most recent round of letters as regulators recently held an on-site inspection at the company's San Francisco headquarters and collected more than 1,000 pages of documents to learn more about sales and marketing practices.

The announcement continues a crackdown that began over the summer and included 1,300 warning letters and fines to retailers that the FDA said illegally sold e-cigarettes to minors.

The agency in September sent letters to Juul, British American Tobacco, Japan Tobacco, Imperial Brands and Altria Group Inc., asking the companies to submit plans on how they intend to keep e-cigarettes away from minors.

Stocks in the major tobacco players were down in trading Oct. 12. Imperial Brands was hardest hit, closing more than 6% from the previous day's closing price to 2,516.50 pence on the London Stock Exchange.

On the New York Stock Exchange, British American Tobacco was down 2.9% in morning trading to $43.08, while Altria dropped 1.9% to $59.97. Japan Tobacco closed trading down by about 0.7% to ¥2,870 on the Tokyo Stock Exchange.

As of Oct. 11, US$1 was equivalent to ¥112.21.