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Senator seeks answers from FDA on e-cigarette regulations

Senator seeks answers from FDA on e-cigarette regulations

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A U.S. senator is not backing away from his concerns that planned Food and Drug Administration regulations on electronic cigarettes could harm small businesses and potentially public health.

Sen. Ron Johnson, R-Wis., sent Friday a third letter to FDA Commissioner Dr. Robert Califf that expressed his frustrations about the agency providing “inadequate responses” to the regulatory oversight questions he posed May 17.

Johnson is chairman of the Senate Committee on Homeland Security and Governmental Affairs. The committee’s mission includes examining the regulatory burdens that federal agencies place on small businesses.

The FDA’s responses to Johnson’s questions came in a June 16 letter and a July 8 presentation to the committee that Johnson said repeated previously disclosed information.

“The American public deserves complete answers from the FDA about its rulemaking,” Johnson wrote. He said he wants a complete response by 5 p.m. July 29.

FDA spokesman Michael Felberbaum said Friday that the agency is reviewing the letter and “will respond directly to the senator.”

Johnson’s letters could play a role in slowing, or even halting, the Aug. 8 implementation of most new FDA regulations that were disclosed May 5 for nicotine and tobacco product innovations.

Johnson said his questions address the potential reduced-risk role that e-cigs, vaporizers and hookahs could play in public health, and the new regulations’ effect on small e-cig and vapor companies.

E-cigs and vaporizers have become big business for tobacco manufacturers, chains, and mom-and-pop stores since they hit the mainstream marketplace in recent years.

E-cigs sales are expected to reach $1.6 billion in 2016, according to Wells Fargo Securities analyst Bonnie Herzog. They are mostly sold in convenience stores, with R.J. Reynolds Vapor Co.’s Vuse being the top-selling brand.

Vuse is made exclusively in Reynolds’ Tobaccoville plant.

Meanwhile, vaporizers and similar products are projected by Herzog to hit $2.5 billion in sales this year. They are sold mostly in vape shops and online.

Johnson said the committee is concerned that the cost of adhering to the retroactive review process — projected by analysts at several million dollars per application — could drive many, if not most, out of business. The FDA has said it estimates the average cost at $466,563 per application.

“It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes,” Johnson said.

In the June 16 letter, the FDA did not provide a conclusive answer to Johnson’s question on whether the agency was concerned that new regulations could drive tobacco users back to traditional cigarettes. The agency said it is up to manufacturers of e-cigs, vaporizers and similar products to meet the FDA regulations if they want to keep their products in the marketplace past Aug. 8, 2019.

No firm numbers

Johnson said the FDA has not provided a firm projection for how many businesses will be affected by the regulations.

In the June 16 response, the FDA estimates there are between 5,200 and 10,200 businesses in the United States that make and/or sell electronic nicotine-delivery systems.

It said that number could drop between 30 percent and 70 percent with the new regulations, or to a range of 1,500 to 7,000 still in the marketplace.

The FDA’s acknowledgement that it has, at best, incomplete information “raises questions about the adequacy of the FDA’s justification for the rule,” Johnson wrote.

“Without a concrete understanding of the rule’s effect on a growing industry, the FDA’s decision to implement this regulation could lead to the elimination of thousands of jobs and businesses.”

The agency will provide technical assistance to small tobacco-product manufacturers interested in submitting an application, Felberbaum said.

Johnson also described as inadequate the answers that Dayle Cristinzio, the FDA’s acting associate commissioner for legislation, provided when asked if the FDA would alter its regulations “if sufficient data demonstrates that e-cigarettes are a safer alternative to traditional cigarettes.”

There have been numerous studies, most notably by the Royal College of Physicians, that claim up to a 95 percent reduced-risk role for e-cigs and vaporizers compared with traditional cigarettes.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, acknowledged May 5 that there are “anecdotal studies” that show individuals weaning themselves from traditional cigarettes through e-cigs.

However, Zeller stressed that “there is no definitive support of e-cigs playing a cessation role.”

Johnson said the FDA “gave an ambiguous answer, reasoning that the FDA must regulate in order to obtain more information about e-cigarettes.”

“Rather than conduct research to better understand the effects of the product prior to regulating, the FDA chose to issue a rule without a proper understanding of the product itself,” Johnson wrote.

The FDA repeated its assertion that part of its regulatory mission is to ensure that e-cigs and similar products do not “re-normalize smoking, encourage youth to initiate smoking, or prompt users to continue or to escalate to cigarette use.”

There are numerous studies supporting both sides of the re-normalizing aspect of e-cigs, but no report has gained consensus approval.

“Because federal regulatory agencies seldom shrink their own jurisdiction, the FDA’s action could result in a far-reaching regulation that fails to consider the regulatory impact on small businesses selling e-cigarettes, product innovation and the public’s health,” Johnson said.

FDA being sued

The FDA is facing several federal lawsuits, each attempting to secure a preliminary injunction on the new regulations.

The new FDA regulations would require e-cigs, vaporizers and hookah products that debuted after Feb. 15, 2007, to undergo a heightened regulatory review process. The process is to determine whether the product has a negative impact on public health unless there is a substantially equivalent product available before that date.

The FDA allows for up to a three-year exception for products whose manufacturer enters the regulatory gantlet by Aug. 8.

The U.S. House Agriculture appropriations bill for 2016-17 contains language that would only permit funding for FDA “substantial equivalent” restrictions on e-cigs, vaporizers and hookahs with a predicate date of Aug. 8, 2016.

Gregory Conley, president of the American Vaping Association, has stressed for years that the predicate date of Feb. 15, 2007, “will destroy thousands of small businesses and hand over the vapor industry to Big Tobacco.”

“We are asking that the FDA not treat vapor products far worse than they do Big Tobacco’s deadly cigarettes.”

Matt Myers, president of the Campaign for Tobacco-Free Kids, said the U.S. House Appropriations committee is “protecting the tobacco industry at the expense of America’s kids and public health.”

Besides the language in the appropriations budget with the later predicate date, an appropriations subcommittee would cut from $210 million to $100 million the annual federal funding for the tobacco control programs of the Centers for Disease Control and Prevention.

“Why in the world would Congress want to cut back a program with such a strong track record of saving lives and money?” Myers asked.

rcraver@wsjournal.com (336) 727-7376 @rcraverWSJ

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