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Tobacco stocks soar on FDA guidance

May 12, 2026 1:42 PM

Investing.com -- British American Tobacco (NYSE: BTI) shares jumped 4.87% Monday, while Philip Morris International (NYSE: PM) rose 4.26% and Altria Group (NYSE: MO) gained 2.57%, following new FDA guidance on enforcement priorities for tobacco products.

The U.S. Food and Drug Administration published updated enforcement priorities for certain new tobacco products marketed without premarket authorization. The guidance covers eVapour products and oral nicotine pouches that lack premarket authorization but have pending applications under scientific review.

The FDA stated it does not intend to prioritize enforcement against nicotine pouch and e-vapor products that have a pending premarket tobacco application or a supplemental application that has been accepted and pending for more than 180 days. The agency said this approach allows it to better allocate resources, though unauthorized products remain illegal.

The FDA will create and maintain a publicly available list of products that it does not intend to prioritize enforcement against. The agency noted that whether a product falls within the new enforcement priorities has no bearing on whether it will ultimately receive authorization under the premarket tobacco application process.

Morgan Stanley analysts commented: "We view the FDA's new guidance on nicotine pouch/e-vapor as positive for PM (and to a lesser extent MO) by providing a pathway for accelerated new product launches."

Jefferies analysts said: "This could enable new eVapour and Pouch products from Big Tobacco and responsible independents to be commercialised on the US market. We see this as a +ve for BAT, PM and Japan Tobacco and a gentle +ve for MO."

The FDA guidance indicates the agency would consider whether a product has high nicotine content but does not define that threshold level.

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