A Modest Reform Could Mean Life or Death for the Vaping Industry

The e-cigarette industry is on the edge of a cliff, with Food and Drug Administration rules threatening to wipe out 10,000 small businesses and remove 99 percent of vapor products from the market in just 18 months' time.

The e-cigarette industry is on the edge of a cliff, with Food and Drug Administration rules threatening to wipe out 10,000 small businesses and remove 99 percent of vapor products from the market in just 18 months’ time.

The FDA’s infamous deeming rule requires all vapor products that came on the market after Feb. 15, 2007, to undergo a prohibitively expensive pre-approval process. These applications can run into the millions of dollars and thousands of hours of paperwork.

Since the e-cigarette market in the U.S. prior to 2007 was virtually nonexistent, all vapor products currently on the market will be subject to this pre-approval process, and the consequences of this rule for both retailers and consumers will be devastating.
The majority of the vapor industry consists of thousands of small and medium-sized companies who cannot come anywhere close to meeting the costs of these regulations. That is, with the exception of big tobacco companies, which can afford to jump these regulatory hurdles.

“As is, [the] deeming regs are a clear ‘win’ for big tobacco, not necessarily public health,” Wells Fargo’s top tobacco and vapor analyst, Bonnie Herzog, commented last year. “The sweep of the new regulation has been a real blow to the broader vapor industry, particularly smaller, less well-funded players.”

Regulations originally intended to limit the entry of extremely hazardous new tobacco products are now being applied in a way that would enrich tobacco companies and limit access to safer products.

This would be a major blow for tobacco harm reduction, given that e-cigarettes are unlikely to exceed 5 percent of the risks of associated with cigarettes, according to the Royal College of Physicians. Left unchanged, it is highly probable the deeming rule would result in large numbers of vapers reverting back to smoking or turning to the black market to access the products they desire.

Whether by design or by accident, millions of vapers are faced with the prospect of losing products that are helping them quit smoking where other methods, like going cold turkey and nicotine replacement therapy, have failed.

But not all may be lost for vapers. A bipartisan bill introduced Feb. 16 by Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) would give a much-needed reprieve to the e-cigarette industry preventing the de facto prohibition of most vapor products.

The Deeming Authority Clarification Act of 2017 would amend the Federal Food, Drug, and Cosmetics Act to change the predicate date from Feb. 15, 2007, to when the deeming regulations came into effect, on Aug. 8, 2016.

This would allow products currently on the market to remain available to consumers and prevent the destruction of the tremendous amount innovation that has taken place in the e-cigarette space.

The bill also introduces product standards and includes limits on e-cigarette advertising. While extremely modest in scope, the bill would have a huge impact. Tens of thousands of jobs would be saved and consumers would retain the option to switch to a reduced risk product that could save their lives.

The advent of e-cigarettes is one of the most promising innovations of the last decade. Few could have imagined a scenario where tens of thousands of jobs and businesses would be created by making it enjoyable to quit smoking. Thanks to innovation and entrepreneurship, switching from cigarettes to reduced-risk products and slashing the risk of deadly disease has never been more appealing.

The bill is a welcome step not only to save an industry from near complete destruction but could also serve as the trigger for a pause and rethink about the direction of federal tobacco policy.

The current policy is rooted in ideas dating back to the old tobacco wars and an “abstinence-only” ideology with regards to nicotine, which is especially strange given that it is the smoke produced by burning tobacco, not nicotine, that is responsible for smoking-related diseases.

Both innovation and our experience with the failure of abstinence-only messages in other public areas show the present approach is hopelessly out of date.

For the millions of Americans who find it difficult to quit smoking or are unwilling to forgo nicotine, the answer should not be “quit or die.” Instead, policymakers would improve both public health and job creation by embracing a message of harm reduction paired with a respect for consumer choice.

Reps. Cole and Bishop’s bill is a small step in the right direction, but in the long term, policy needs to move beyond preventing prohibition to embracing harm reduction.

This column first appeared in the Hill