Altria urges FDA to loosen planned e-cig regulations for public health benefit

Source from:  Winston-Salem Journal 07/20/2016

The nation's top tobacco manufacturer, Altria Group Inc., is urging the U.S. Food and Drug Administration to loosen its planned tightened restrictions on electronic cigarettes and vaporizers even though its MarkTen brand could be a major beneficiary of the squeeze.

The FDA regulations are set to go into effect Aug. 8, though the agency faces several federal lawsuits requesting a preliminary injunction on the implementation.

MarkTen, made by Altria subsidiary Nu Mark LLC, is the No. 3 e-cig in the United States with a 16.3 percent market share, according to Nielsen data as of June 18. Vuse, made by R.J. Reynolds Vapor Co., is first at 35.7 percent.

However, the recent growth in sales of electronic nicotine-delivery systems, or ENDS, - the catch-all term for e-cigs and vaporizers - has tilted toward vaporizers whose nicotine liquid solutions typically are developed by small chains and individual shops.

Altria said in its 22-page comments to the FDA, sent July 11, that ENDS represent the type of reduced-risk products that Congress intended for the agency to support "when it empowered FDA to regulate tobacco products" to improve public health.

"If adopted in its current form, the draft guidance may result in many existing ENDS being forced off the market and make it difficult for some manufacturers to develop new ENDS products," Altria said. "Should this occur, adult tobacco consumers will be deprived of important product choices."

E-cigs sales are expected to reach $1.6 billion in 2016, according to Wells Fargo Securities analyst Bonnie Herzog. Vaporizers and similar products are projected to hit $2.5 billion in sales.

Perhaps the biggest regulatory challenge is that products introduced into the retail marketplace after Feb. 15, 2007 - including almost every e-cig and vaporizer - would have to retroactively go through stiffer regulatory requirements to prove they don't cause public harm or entice nonsmokers to consume those products. That includes providing more details about liquid-nicotine ingredients and their manufacturing process.

The FDA regulations would allow manufacturers to keep their products in the marketplace for up to three years if they enter the review pipeline.

Altria said the planned regulations "do not include an accelerated or modified pre-market tobacco product application pathway for ENDS to provided flexibility and recognize ENDS' position on the tobacco risk continuum."

Altria recommends that the FDA allow products to remain in the market "for as long as it takes the agency to issue an order permitting or prohibiting the marketing of a product."

Cost of regulations?

Anti-smoking advocates, as well as U.S. Sen. Ron Johnson, R-Wis., claim the cost of adhering to a retroactive FDA review process - projected by analysts at several million dollars per application - could drive many, if not most, e-cig and vapor manufacturers out of business.

The FDA has estimated to Johnson that there are between 5,200 and 10,200 businesses in the United States that make and/or sell electronic nicotine-delivery systems. The agency 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 post regulations.

The FDA has said its review requirements are not financially onerous, estimating 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 a letter sent Friday to FDA Commissioner Dr. Robert Califf.

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

Nielsen data, as well as recent quarterly earnings reports from Altria and Reynolds American Inc., have demonstrated a solid uptick in traditional cigarettes sales.

Some analysts credit that increase in part to anti-tobacco advocates and public health officials convincing smokers that e-cigs and vaporizers are not a safer alternative to traditional cigarettes.

There have been numerous studies, most prominently by the Royal College of Physicians, that determined e-cig and vaporizers have up to a 95 percent reduced risk to smokers compared with traditional cigarettes.

Mitch Zeller, the 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."

Baseline performance standards

Dr. Michael Siegel, an anti-smoking advocate and a professor at the Boston University School of Public Health, said the FDA should establish baseline performance standards for ENDS products "that, when met, would serve as the basis for an abbreviated or alternative marketing authorization pathway to satisfy the statutory (pre-market) requirements."

"Many of my colleagues continue to argue that Altria and Reynolds are insincere in wanting to promote vaping, that they are merely trying to promote smoking by encouraging vaping as a mechanism to avoid smoking cessation, and that their main purpose is to try to recruit new smoking customers by getting youth addicted to e-cigarettes, and then encouraging them to proceed on to tobacco cigarette smoking," Siegel said.

"What Altria and Reynolds are doing with vaping products is nothing like what they used to do with the marketing of tobacco cigarettes. They are not offering youth-friendly flavors, like bubble gum, cotton candy and gummy bear, and their marketing is not targeted at youth, either in its advertising placement or content," he said.

"Altria is actually trying to save at least some vitality in the e-cigarette and vaping market." Enditem