Omnibus Bill Could Shape E-Cigarette Regulation

Electronic cigarette manufacturers are pushing hard for a policy rider in the year-end catchall spending bill that would shield them from a costly, time-consuming Food and Drug Administration approval process.

The FDA last year proposed the first-ever regulations for e-cigarettes, a growing market estimated by Wells Fargo Securities to be worth around $3.5 billion in 2015. Under the proposal, e-cigarettes that were on the market as of Feb. 15, 2007, are exempt or “grandfathered” from the agency’s review process. FDA officials stated they don’t have the authority to change that date, which was in the 2009 Tobacco Control Act.

But House appropriators included language in the fiscal 2016 spending bill that covers the FDA that would exempt any e-cigarettes on the market before the FDA regulations are finalized from the approval process required for new products. Final FDA regulations are currently undergoing review by the White House Office of Management and Budget, the last step before they are released.

Public health groups argue the move would significantly weaken the FDA’s ability to act against flavored products that appeal to young people who could get hooked on nicotine.

“The rider would greatly reduce the information manufacturers must provide and allow these products to remain on the market indefinitely without a thorough FDA review as currently and wisely required by the law,” public health groups including the American Lung Association wrote in a recent letter to appropriators.

E-cigarette supporters warn the approach the FDA proposed last year would be too costly for most manufacturers, leaving the market dominated by large tobacco companies with the resources to win agency approval.

Vape Shops’ Plea

In addition to big tobacco companies, which produce both traditional cigarettes and e-cigarette products, the market is filled with smaller shops that develop flavored nicotine liquids. Those liquids also will face the costly FDA approval process.

“The irony is that, unless something changes, the FDA will hand over the vapor space to big tobacco,” said Cynthia Cabrera, executive director of the Smoke Free Alternatives Trade Association, predicting many small manufacturers would shut down.

A policy rider in the omnibus could salvage smaller retailers.

“FDA has had many meetings with advocates and vapor companies and realize that only big companies would be able to comply,” said Gregory Conley, the president of the American Vaping Association. He was “cautiously optimistic” the rider would be in the final spending package.

Even though big tobacco companies might more easily comply with new regulations, the manufacturers also want to change the February 2007 date, when very few e-cigarettes were sold. Under the FDA proposal, the makers of most e-cigarettes will likely have to go through the more difficult process.

“If maintained, it risks creating a de facto ban on the very category of products that many researchers have concluded to present much lower risks than most of the tobacco products that are currently regulated,” David Howard, spokesman for the Reynolds American Service Company, wrote in an email.

Not only would the rider exempt any products that are on the market before the FDA rules are finalized, but it also would provide manufacturers with a shorter approval process for future products.

Most new tobacco products go through a review known as “substantial equivalence,” in which manufacturers must demonstrate that a new product is like another product on the market and doesn’t pose any new or significant health risks.

That process is considered less burdensome than the other option, the premarket tobacco product application. Only one company, Swedish Match, completed that approval pathway for any of its products. It took many years and thousands of hours to put nearly 120,000 pages of material together.

Future Products

Future e-cigarette products would only have to show they were similar to the products that were exempted by the congressional rider.

Most companies would not voluntarily undergo the longer process.

“I think it would be extremely challenging for any company,” said Gerry Roarty, the general council for Swedish Match North America.

Michael B. Siegel, a professor at Boston University School of Public Health, said applications would have to be submitted for every flavor and nicotine strength, as well as for different components, such as mouthpieces and coils. He noted that manufacturers would have to provide data in each application to show the product benefits public health. The costs per application could range between $1 million and $3 million, he estimated.

Siegel would prefer the agency to set safety standards for all products to follow, such as maximum temperature and requiring childproof containers. He supports changing the grandfather date as a “first step that needs to be done to salvage what would be a disaster” and hopes the move would force FDA to change its approach.

‘Extraordinarily Concerned’

Erika Sward, the American Lung Association’s assistant vice president of national advocacy, said lawmakers who included the 2007 grandfather date recognized the tobacco industry’s history of changing existing products to make them more addictive or appealing to children. Her group is “extraordinarily concerned” the rider could get into a year-end spending package. Advocates already think FDA would give manufacturers too much leeway in the proposed rule by allowing products to remain on the market while their applications are under review.

“The bottom line when it comes to tobacco products is they’re guilty until they’re proven innocent,” Sward said.

Cabrera of the Smoke Free Alternatives Trade Association said the group’s members are lobbying Capitol Hill and the White House but expressed concern the rider could get crowded out by more hot-button issues such as abortion and the environment.

“The problem is that while this is a big important issue to us, there are much bigger issues that are consuming legislators’ time,” she said. “This is something that could easily be used as a trading chip to get something.”

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