E-cigarettes, tobacco vapor devices to come under FDA oversight

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The U.S. Food and Drug Administration will for the first time oversee electronic cigarettes, an attempt to bring control to a multibillion dollar industry that has grown rapidly in recent years.

Bloomberg reports the FDA says today in a statement that the long-awaited regulations cover products including cigar and pipe tobacco, along with vape pens and refillable vaporizers.

The rules prohibit sales to minors, ban free samples, require package warning labels, and call for makers of products released after 2007 to seek FDA permission to remain on store shelves.

The rules will impact big companies that also make combustible cigarettes, such as Reynolds American Inc. and Altria Group Inc., as well as smaller players in the e-cigarette and vapor industry, which was worth about $5.2 billion in 2015.

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Robert Martin, an assistant manager at Baton Rouge’s Don Juan’s Cigar Co. in Towne Center, says premium cigars are being unfairly included in the federal regulation.

The proposed regulations could have devastating effects on the cigar business as manufacturers spend more money to add more labels, other regulations and ultimately pass cost onto customers, he said.

“Anything that affects the cigars, it’s going to affect the cigar business,” Martin says.   

Congress gave the FDA authority to oversee tobacco products in 2009, but until now the agency had not finalized rules to regulate e-cigarettes and cigars.

Health officials say regulations were badly needed as growth of e-cigarettes and vapor products use among youth contrasts with declining rates of smoking traditional cigarettes.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” Health and Human Services Secretary Sylvia Burwell says in a statement. “All of this is creating a new generation of Americans who are at risk of addiction.”

Martin says he believes the FDA is overstepping its authority by including cigars under the federal regulations. “I don’t think the congressional intent was for the FDA to take this over in such as a way,” he says.

Martin adds that cigars do not contain all of the same chemicals found in cigarettes and are not marketed to minors. “Cigars are picked off the plant, it’s dried and it’s rolled, that’s all,” he says. The advocacy group Cigar Rights of America has been fighting against the regulations.

The American Cancer Society Cancer Action Network says that while the regulations are a move in the right direction, additional action is needed from the FDA to reduce the lure of tobacco products to young people.

“The FDA should immediately take action to address flavorings attractive to youth in all products and the egregious industry marketing practices,” Chris Hansen, president of the group, said in a statement. “The tobacco industry has taken full advantage to exploit the lack of regulations on these issues.”

Companies will have 24 months to file premarket applications for their products, according to the rule. The FDA then has a year to review the submission, during which the products can remain on shelves.

Manufacturers “were looking for that compromise,” said Kenneth Shea, a Bloomberg Intelligence analyst. “The critical question that no one really knows right now is, will the FDA conclude that these new products are unsafe or not?”

Altria and Reynolds representatives didn’t immediately respond to telephone and e-mailed requests for comment.

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