FDA Seeks to Regulate e-Cigs, All Other Tobacco Products

Pam Harrison

April 25, 2014

In a bid to better protect public health, the US Food and Drug Administration (FDA) is proposing a long-awaited new rule that would extend its authority to regulate all tobacco products, including e-cigarettes.

"Science-based product regulation is one of the most powerful forms of consumer protection that can help reduce the public health burden of tobacco use in the American public, including youth," Margaret Hamburg, MD, FDA, commissioner, said at a press briefing.

"And a final deeming rule will help the FDA protect public health by requiring a review of all new products and health-related claims for regulated tobacco products [as well as] future regulation of additional tobacco products so as to have a positive impact on the health of our population."

The FDA initially announced its intention to assert jurisdiction over unregulated tobacco products back in 2010. In April 2011, the FDA announced its plans to include e-cigarettes among these products.

The new proposal would extend the FDA's basic authority to all other tobacco products beyond what it already regulates on the basis of the 2009 Family Smoking Prevention and Tobacco Control Act.

Currently, unregulated tobacco products include not only e-cigarettes but large and small cigars, as well as hookah and pipe tobacco, smokeless tobacco, and other tobacco products.

As stated by the FDA in a press release, the proposed regulation would require manufacturers to register with the FDA; disclose their products' ingredients to the agency; and prohibit tobacco companies from making health claims without FDA review.

The same proposal would also establish 18 years of age as the nation-wide minimum age for the legal purchase of tobacco products, even over the Internet.

"When finalized, the deeming rule will result in significant public health benefits, including reducing sales to youth; helping correct consumer misperception; preventing misleading health claims; and preventing new products from entering the market without prior scientific review by the FDA," Mitch Zeller, JD, director, Center for Tobacco Products, FDA, said during the same press conference.

"It will also allow us to propose further regulatory action on these and yet-to-be-conceived tobacco products under standards that are appropriate for the protection of public health. So the rule will represent a significant step in the agency's ability to effectively regulate all tobacco products and protect public health."

e-Cigarettes and Youth

Much of the discussion during the press conference centered on the need to control the sales and consumption of e-cigarettes to and by youth.

In September 2013, the Centers for Disease Control and Prevention (CDC) released new data showing that e-cigarette use among students in grades 6 to 12 had doubled to 6.8% in 2012 from 3.3% in 2011.

Similarly, the CDC has also documented a rapid rise in the use of cigars, including large cigars, particularly among male high school students, from 7.1% in 2009 to 16.7% in 2012.

"If someone is a pack-a-day smoker and they have no interest or ability to quit, then I think we could concede that that person is likely to be substantially reducing their risk if they substituted all of their combustible cigarettes with e-cigarettes," Zeller said.

On the other hand, e-cigarettes could be used as a "bridge" between those times when a person cannot simply "light up" and the next time when they can.

Thus, a putatively less harmful product could actually increase harm over time, because all it does is serve as a way for a smoker who might otherwise have used medically approved therapies to quit smoking to get from their last cigarette to their next, he added.

Regardless of whether a cigarette contains no burning tobacco, the effects of nicotine on the developing brain have been proven harmful, and youth should not be exposed to nicotine in any form, Zeller noted.

Furthermore, as Dr. Hamburg noted, if a young person starts with e-cigarettes, "nicotine being addictive, it creates a heightened vulnerability that they will go on to use other tobacco products," she said.

A burgeoning array of tobacco products are now highly attractive to youth because of the flavorings they offer. "So one can easily imagine a cycle that will bring serious dangers for health," she added.

Commenting on the proposal, Harold Wimmer, national president and CEO of the American Lung Association, noted that the American Lung Association welcomes the "long-awaited release" to extend the FDA's oversight of all tobacco products.

"The years of delay have allowed e-cigarette use among youth to double," he stated in a press release.

"We call upon the Obama administration and the FDA to finalize this proposal by the end of this year and ensure that it applies to all tobacco products."

The proposed rule will be available for public comment for 75 days.


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