FDA’s New E-Cigarette Rules, Now Taking Effect, Prove Divisive

The Food and Drug Administration on Monday began implementing regulations on a number of tobacco products—with the e-cigarette being the largest target. Health groups are applauding the changes, but vaping associations warn that the regulations could be an industry-killer.

Significant change arrived on Monday for electronic cigarettes. Whether the change is a positive or negative development depends on where you stand.

New Food and Drug Administration regulations went into effect Monday, creating stricter standards for how e-cigarettes and related products are sold and establishing a new product approval process. Under the new rules, e-cigarettes can no longer legally be sold to minors, though many retailers had voluntarily stopped selling them prior to the change. Alternative tobacco products had not previously been regulated by the FDA.

Health organizations, including the American Lung Association and the American Medical Association, cheered the FDA action, which will require all e-cigarette products currently on the market to be approved for sale by August 8, 2018, and will heavily regulate other non-cigarette tobacco products, such as hookah and cigars.

“Youth use e-cigarettes more than any other tobacco product on the market today, serving as an entry point to more traditional tobacco products and placing kids at risk to the harms and addiction of nicotine and other tobacco products,” ALA President and CEO Harold Wimmer said in a May statement. “Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products.”

Vaping Groups Pledge Fight

The American Vaping Association (AVA) and the Smoke-Free Alternatives Trade Association (SFATA), meanwhile, expressed alarm about the future of the industry under the new regulatory framework.

In comments posted on the group’s website Friday, AVA President Greg Conley warned that the industry would likely shrink substantially as a result of the rules, which he argued will limit innovation by e-cigarette makers because of an “extremely burdensome and expensive” new-product approval process.

After the rules were approved in May, SFATA suggested that the “enormously cost-prohibitive regulatory process for manufacturers” could lead many vapers to go back to smoking.

“Since a growing body of scientific evidence confirm that vapor products are more than 95 percent less harmful than combustible cigarettes, it is essential that congressional action be taken so vapor products can remain on the market as highly effective replacement tools for smokers,” SFATA said in its statement.

The groups pledged to fight the new rules in Congress and the courts.


Ernie Smith

By Ernie Smith

Ernie Smith is a former senior editor for Associations Now. MORE

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