E-Cigs, Other Tobacco Products Will Be FDA-Regulated

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By Martina Barash

May 5 — Electronic cigarettes and other products derived from or containing tobacco will soon be subject to some of the same prohibitions and requirements as conventional cigarettes.

Age restrictions for purchasing the products will go into effect in about three months under the Food and Drug Administration's new final rule. The rule deems the products subject to the Food, Drug and Cosmetics Act and the Tobacco Control Act and brings them under the agency's authority.

Health warnings will be required in two years.

The agency faced a balancing act in addressing e-cigarettes in particular—which could lead to more nicotine addiction through their popularity among young people, but are thought to have fewer negative health consequences than conventional cigarettes.

“We cannot let the enormous progress we have made toward a tobacco-free generation be undermined by products that impact our health and economy” by failing to regulate them, Secretary of Health and Human Services Sylvia Mathews Burwell told reporters May 5 after the rule was released.

The FDCA includes premarket approval requirements that will have to be met if e-cig makers want to keep their products on the market.

Under the requisites, manufacturers will either have to show their e-cigarettes are appropriate for the protection of the public health, or their products are similar to those that were on the market before a certain date.

But to avoid an interim ban on e-cigarettes and other novel products, the FDA created staggered deadlines—up to two years—for companies to submit applications for approval, and will allow an additional year for FDA review before bringing enforcement actions.

This enforcement policy is somewhat more restrictive than the one in the April 2014 proposed rule (42 PSLR 436, 4/28/14).

The multi-year review and approval process means that some difficult questions not addressed in the rule, such as what to do about flavored e-cigarettes that some health advocates say are deliberately marketed to minors, may not be taken up by the agency for some time.

Mixed Reactions

The American Medical Association—and two members of Congress who pushed for FDA regulation, Reps. Frank Pallone Jr. (D-N.J.) and Diana DeGette (D-Colo.)—applauded the agency's step.

“Since tobacco remains one of the leading causes of preventable disease in the U.S, no tobacco product should be exempt from regulation, and today’s rule moves us one step closer to making that a reality,” Pallone said in a statement.

But some health advocates were lukewarm.

“The rule is a welcomed starting point, but it is only a framework upon which to build meaningful regulation to end the tobacco epidemic in the United States once and for all,” Dr. Benard P. Dreyer, president of the American Association of Pediatrics, said in a statement.

“FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy, gummy bear and grape or to prevent marketing tactics that target children,” Dreyer said.

“Today’s announcement has good and bad aspects,” Prof. David D. Levy of the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center said in a statement.

A premarket review requirement could favor big tobacco companies that make e-cigarettes as well as conventional cigarettes and “have the financial resources and experience to overcome the regulatory obstacles that are likely to accompany the review process,” Levy said.

Aaron LoCascio, the CEO of VapeWorld, the largest distributor of electronic cigarettes and vaporizers in North America, told Bloomberg BNA in an e-mail, “We are, and have always been, in favor of regulations that keep products that are intended for responsible use by adults out of the hands of minors.”

“The key to successfully implementing these new regulations will be to not interfere with a consenting adult’s freedom to enjoy innovative vaporization products that are potentially less harmful than conventional delivery methods,” he said.

David Howard, a spokesman for Reynolds American Services Co., a traditional maker of regular cigarettes and other tobacco products that also has a line of e-cigarettes on the market, didn't oppose or support the rule.

“We look forward to discussing with FDA how best to establish a reasonable structure for review and approval of new products so that public health benefits can be expeditiously achieved,” he said in a statement.

Steve Callahan, a spokesman for Altria Client Services, expressed concern about the premarket review provisions.

“We are concerned that FDA did not update the predicate date,” Callahan said. “FDA acknowledges that e-vapor products are ‘likely less harmful' for individuals compared to continued use of cigarettes.”

Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, told Bloomberg BNA that she hadn't seen anything favorable for her members, which are mainly small and mid-sized businesses, in the regulation.

Premarket Review in Statute

A recent legislative effort would “grandfather” e-cigarettes currently on the market to skip the need for premarket authorization. The FDA and legislative provisions are intended to avoid a ban on e-cigarettes and other “electronic nicotine delivery systems” because the products are thought to have fewer adverse health effects than conventional cigarettes.

Notably, the FDA said it has identified an electronic product that may have been on the market by the early 2007 grandfathering date in the statute, which might allow makers of some newer products to show “substantial equivalence” to that device.

But “the reality for e-cigarettes” is that they will probably have to use a premarket tobacco application, Mitch Zeller, director of the FDA's Center for Tobacco Products, said in comments to reporters. That is the most burdensome pathway for getting the agency's approval.

White House Press Secretary Josh Earnest said at the daily press briefing that he hadn't seen the bills, but that “the president takes a very dim view of attaching ideological riders to appropriations bills.”

Applications: Cost, Importance

Zeller, in a later phone call with reporters May 5, said the FDA revised downward the estimated cost of $1 million per product for an e-cigarette or other new product maker to prepare a premarket tobacco application.

The new estimate for such an application is an average of “several hundred thousand dollars,” and Zeller said that efficiencies would be created over time, including the “bundling” of applications. “You might not have to submit five different applications” for five separate flavor and potency combinations, he said.

“One of the ways” the FDA plans to address flavors that appeal to young people is through the premarket authorization process, Zeller said.

The agency will also look at marketing plans when assessing applications, he said. The FDA “will evaluate the likelihood that products, including marketing, result in a net improvement or detriment to public health,” he said.

British Market Distinguished

A British group, the Royal College of Physicians, recently made policy recommendations in favor of e-cigarettes (44 PSLR 454, 5/2/16).

One fundamental difference in the U.S., Zeller said, is the product's “skyrocketing use among kids.” Further, the law in the U.S. requires the agency to look at “net impacts” across the population. The new products are “finally within our jurisdiction, and over time we'll get information” that will round out the picture, he said.

“Many critics of this rule have suggested that this rule took too long to implement,” Earnest said. “I actually think it underscores the care and caution and concern that our scientists took in implementing this rule effectively and fairly. So, you know, obviously this is something that our scientists believe would have a tangible impact on the basic public health and safety of the American people, particularly America's children.”

Cigars, Pipes Too

The new deeming rule applies to e-cigarettes and other electronic systems. But it also applies to cigars, pipe tobacco, waterpipe tobacco, gels and “dissolvable” nicotine products.

It includes premium cigars and components of tobacco products as well as future tobacco products that aren't currently marketed.

But it doesn't apply to accessories of tobacco products, such as hookah tongs and cigar foil cutters.

The rule is scheduled for publication in the Federal Register May 10.

With assistance from Jeannie Baumann and Cheryl Bolen.

To contact the reporter on this story: Martina S. Barash in Washington at mbarash@bna.com

To contact the editor responsible for this story: Steven Patrick at spatrick@bna.com

For More Information

The advance version of the final rule is available at http://src.bna.com/eIx.

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