FDA Issues Guidelines for E-Cig Makers Seeking Approval Of Vape Devices

The Food and Drug Administration released new guidelines Tuesday for manufacturers seeking approval to continue selling e-cigarettes, or vaping devices, and the liquids used in the devices to deliver nicotine. 

What Happened

Under FDA regulation of e-cigarettes that began in 2016, e-cigarettes, known by the agency as electronic nicotine delivery systems, or ENDS, that were already on the market had to apply for FDA approval to remain available after August 2021.

As part of the process, manufacturers must submit a “Premarket Tobacco Product Application” in which they have to show the product is "appropriate for the protection of public health."  

The guidelines released Tuesday give companies an idea of what they must do to stay on the market. So far, no e-cigarettes have reached the end of the process. 

What It Means

"The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product," Acting FDA Commissioner Ned Sharpless said in a statement. 

"There are no authorized e-cigarettes currently on the market."

Federal officials were caught off guard by research showing growing youth use of e-cigarettes last year and have made reducing the figure a major focus.

The E-Cig Market

Juul has about 75 percent of the U.S. e-cigarette market, according to Nielsen data cited by The Financial Times. U.S. cigarette maker Altria Group Inc. MO has a 35-percent stake in Juul. 

British American Tobacco PLC BTI makes the second-largest e-cigarette brand, Vuse. 

Philip Morris International Inc. PM received approval through the premarket application process April 30 to sell an electronic device that heats tobacco without burning it to produce a nicotine-infused aerosol. That device, iQOS, is already sold in several countries. 

Price Action

Altria shares were up 2.07 percent at the time of publication, while British American was trading higher by 1.33 percent and Philip Morris was up 1.61 percent. 

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