FDA Pulls Back on Burdensome E-Cig Regulations

MacIver News Service | July 28, 2017

By Chris Rochester

[Madison, Wis…] After months of public pressure, the federal government is putting the brakes on a costly new set of regulations that vaping industry advocates say would decimate their budding industry and run countless businesses into the ground.

Scott Gottlieb, commissioner of the federal Food and Drug Administration, announced Friday the agency will extend by four years a key deadline in the battle between the FDA and the vaping industry. That gives operators of e-cig, or vaping, businesses breathing room in submitting costly new applications to the FDA to keep their products on the market. The new deadline will be Aug. 8, 2022.

The announcement came the day after the Village of Hartland sent a letter to the FDA demanding the agency begin proceedings to coordinate its regulations with local governments or face a lawsuit. “Coordination” by federal regulators is the process of – and requirement to – work with localities heavily impacted by new regulations.

“Today the FDA opened the door to coordination,” said Mark Block, founder and director of the Electronic Vaping Coalition of America, which has led efforts to block the burdensome regulations.

“Hartland has insisted on public input starting with its third day of hearings back in April. And pushing back the timeline for what would have been a very costly preapplication process shows the FDA clearly recognizes what Hartland has advised – it needs far more information from actual stakeholders before implementing such vague overreach,” Block said.

The regulations would pinch Hartland, a Wisconsin village of just over 9,000, especially hard. Johnson Creek Vapor Company, based in Hartland, is a major local employer. It’s America’s top producer of e-liquid, the nicotine-containing fluid that is converted to vapor in e-cigarettes and the second largest e-liquid manufacturer in the world, according to Johnson Creek Vapor CEO Christian Berkey.

Berkey estimates the Obama-era rule would cost his company alone a staggering $200 million. The local impact spurred Hartland to take action, including the July 27 letter to the FDA.

The onerous Obama-era rules, called “deeming” regulations, categorize vaping products as tobacco products and subjects them to a rigorous new application and approval process. The regulations also grandfather products on the market as of Feb. 15, 2007, exempting traditional cigarettes.

But Friday’s decision marks a major shift in how the FDA will regulate tobacco and nicotine products in the future, with a new focus on harm reduction. The new direction is intended “to make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes,” the FDA stated.

The FDA also wants to ensure its regulations are guided by “the proper scientific and regulatory foundation.” Studies have shown vaping to be a less-harmful alternative to traditional, combustible cigarettes. One study by Public Health England showed e-cigarette use to be 95 percent less harmful than smoking.

In an interview earlier this year with the MacIver Institute, Berkey said he was optimistic the then-incoming Trump administration would be more responsive than the outgoing Obama administration. “They are far more reasonable and amenable…today I’m far more hopeful that we’ll get a resolution, and fairly soon,” Berkey said.

While the FDA’s regulations would run most e-liquid producers like Johnson Creek out of business, it would also have a dramatic impact on numerous small “vape shops” that sell e-cigarette products in communities throughout Wisconsin and the country.

When EVCA surveyed vape shop owners throughout Wisconsin, the majority said they had already reduced or eliminated inventory and would be forced to lay off employees as a result of the new regulations.

“If you want to see how regulations can destroy an entire industry, this is it,” said Berkey. Fortunately for him and entrepreneurs across the country, the FDA has relented in its war on their businesses – at least for a few more years.