New regulations cut down on flavored e-cigs.
In a new flavored tobacco crackdown, the FDA is putting the e-cigarette industry on notice.
Yesterday, the Food and Drug Administration announced the release of their draft compliance policy — a regulatory proposal for certain tobacco products, including e-cigarettes (which the FDA refers to as “electronic nicotine delivery systems,” or ENDS) and flavored cigars.
It’s the latest step in implementing the FDA’s original comprehensive tobacco plan announced in July 2017.
Flavored tobacco products and youth access to e-cigarettes are in its crosshairs.
“Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization. We’ll prioritize enforcement to prevent the access and appeal of these products to kids,” said FDA Commissioner Dr. Scott Gottlieb, in an accompanying press statement.
The new regulations
In November 2018, the agency proposed regulations to help curb youth access to e-cigarettes. The compliance policy gives a sense of how those regulations would be implemented and enforced.
Those policies include:
- Limiting the sale of flavored e-cigarettes in brick-and-mortar locations to age-restricted retailers, such as smoke shops, or within areas of stores that can only be accessed by individuals 18 or older.
- Increasing regulation of e-cigarette products sold online through “heightened age verification processes.”
- Prioritizing enforcement of the sale of flavored tobacco products and e-cigarettes aimed at minors. The agency has already warned companies with products or marketing that resembles “kid-friendly” foods and products.
“Evidence shows that youth are especially attracted to flavored e-cigarette products, and that minors are able to access these products from both brick-and-mortar retailers, as well as online, despite federal restrictions on sales to anyone under 18,” Gottlieb said.
However, there are some obvious omissions from the flavor crackdown. Mint, menthol, and tobacco-flavored products won’t be subject to the same strict regulations as other flavors. These products will remain available at retailers where other flavored tobacco products in the future likely will not.
According to Gottlieb, mint and menthol flavors are more frequently used by adults than minors. They also may still have a beneficial role to play for adult smokers in kicking the habit. Keeping these products available, while limiting the availability of other flavors, he said, represents a “careful balancing of public health considerations.”
The FDA has also moved up the deadline for manufacturers of flavored e-cigarettes to submit premarket applications by one year. The makers of these products now have until Aug. 8, 2021, to demonstrate that their products meet public health standards.
Under the current premarket approval process, e-cigarette products on the market before August 2016 have largely been able to remain on the market while manufacturers apply for FDA authorization.
Public health experts react
This week’s announcement is underwhelming, say public health advocates.
“FDA’s draft guidance is simply not enough to make a difference in the e-cigarette epidemic. We’re disappointed that FDA, instead of deciding that they were going to review each product now, which is what is required under the law, has still decided to keep things delayed until 2021. The bottom line is that unless FDA takes action and removes flavored products from the market, there will still be a youth e-cigarette epidemic,” said Erika Sward, assistant vice president of national advocacy for the American Lung Association (ALA).
The ALA has urged the FDA to take action on flavored tobacco products as early as possible.
“That date was supposed to be this year, so it still falls well short of what is needed to protect the public health,” Sward said.
Patricia Folan, RN, DNP, director of the Center for Tobacco Control at Northwell Health in Great Neck, New York, was also critical of the policy, though she does say it has a silver lining.
“The FDA’s announcement to restrict flavored e-cigarettes does increase awareness of the fast-growing epidemic of e-cigarette use among youth,” Folan said.
“However, more young people are initiating vaping at alarming rates. Consequently, enforcement of these proposed restrictions and regulations need to happen as soon as possible,” she added.
Both Folan and Sward also urge mint and menthol products to be included in the FDA’s proposed flavor restrictions and enforcement as well.
The recent announcement of Gottlieb’s resignation from the FDA is also ill-timed. Teen vaping has become a pillar issue of the FDA under Gottlieb’s leadership. With his departure, those policies could be thrown into doubt.
“The lung association is hopeful that whomever Dr. Gottlieb’s successor is will take meaningful action to protect the public from e-cigarettes and other tobacco products,” Sward said.
“There are a lot of things that would really have a meaningful impact on reducing the terrible toll of tobacco in the U.S. that we hope his successor will finish — and quickly,” she said.