FDA’s misguided approach to regulation of e-cigarettes will harm public health
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The innovation that led to vapor products such as e-cigarettes is without question one of the most exciting advancements in public health and tobacco harm reduction in the last 10 years. Despite an overabundance of distorted and misleading information propagated by some in the public health community, responsibly manufactured vapor products are not only a safer alternative to traditional combustible products, they also provide smokers with a viable path to reducing their tobacco consumption and quitting altogether.

As is so often the case, this technological revolution in smoking cessation is outpacing the ability of a lumbering government to appropriately regulate vapor products. Which results in a game of regulatory catch up that is creating more dangerous consequences for public health.

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Earlier this year, the U.S. Food and Drug Administration (FDA) announced that it was reflexively regulating the batteries, circuit boards, wires, and handful of constituents in e-liquids that comprise vapor technology products — as if they are the same as those leafy tobacco products infused with 5,000 chemicals and wrapped in cigarette paper.  “TAG!  You’re tobacco” the FDA said, as if that was all they needed to do to make the public safer.  

Of course, nothing is further from the truth.  Much has been written about how the FDA’s tobacco regulations are so burdensome and so onerous that they make it nearly impossible for all but the largest tobacco corporations to seek much less secure approval for their products.

On August 8, 2016, the date that the FDA’s regulations took effect, the leading industry analyst in the tobacco and vapor space Wells Fargo explained that, “As is, [the] deeming regs are a clear ‘win’ for big tobacco, not necessarily public health,” warning that “the sweep of the new regulation has been a real blow to the broader vapor industry, particularly smaller, less well-funded players.”

Putting aside the fact that the FDA has unwittingly placed the future of anti-smoking vapor product innovation in the hands of the largest cigarette companies, and putting aside the fact that “public health” groups have cheered them on, these regulations will directly endanger public health.

This will happen over the course of the next three years by yanking responsibly manufactured vapor products from the hands of adult smokers and replacing them with the cigarettes they had been trying to give up.

The FDA acknowledges that its antiquated regulations will eliminate 99 percent of vapor products from the market within two years. Under any mindset, eliminating options for smokers who are trying to quit is not sound public policy.

Furthermore, as of August 8, 2016, the FDA forbids every technology company in the vapor technology industry from offering any innovation or change to their products.  

As is the case with so many products, technology innovates much more rapidly that government can regulate.  Take the short time it took to move from the iPod to the groundbreaking iPhone. Only a few years go by, and sometimes only months, before new devices render old models obsolete. The same is true for vapor products.

But now, not a single change to any e-liquid or any battery or any component will be allowed without going through the FDA’s multi-year bureaucratic pre-approval application process.

To be clear, no matter how important an innovation is developed to enhance product safety, consumer safety or, for that matter, public safety, the FDA will place that safety innovation at the end of the incredibly long line of applications for keeping existing products on the market.

Not only has the FDA banned innovation, it has locked into the marketplace products. The FDA claims, without evidence, is potentially dangerous. In other words, the FDA is forcing consumers for the next three or more years to rely on products that it claims are dangerous while at the same time prohibiting any changes that could be made to make those products safer.   

Opponents of vapor products, who so loudly call for the FDA to act immediately, are ignoring the rapidly growing body of research supporting the hope of vapor products.

The latest evidence of this research is a report released last month by the Royal College of Physicians (RCP) — an organization representing 32,000 physicians worldwide whose primary mission is to improve the practice of medicine —  reaffirms what many in the public health community already know to be true.

Vapor products represent a significant advancement in harm reduction, and proposed U.S. regulatory policy will only serve to deprive adult smokers of this smoking alternative. Specifically, the report concludes that long-term health risks of e-cigarettes are unlikely to exceed five percent of the risks associated with cigarettes, and may even be substantially lower.

However, we, as an industry, cannot simply sit back, complain about government regulation and fail to offer any solutions.

Members of the Vapor Technology Association have been active across the globe in developing international product standards that protect children and ensure the safety and integrity of vaping products used by adult consumers.

Now, we are bringing this constructive approach to Capitol Hill. We can and should do the same here in the United States, and several members of both parties in Congress took the first step toward a commonsense solution earlier this year.

During a markup of the Agriculture, Rural Development, Food and Drug Administration bill, Representatives Tom Cole (R-OK) and Sanford Bishop (D-GA) offered a bipartisan approach that would accomplish the goal of protecting small businesses and preserving the industry. This would set the stage for common sense regulations that will protect youth and ensure the safety of consumers. It is a solution that allows the leaders and standard bearers in the industry to continue to innovate to make vapor products as safe as any electronic device.

This is exactly the type of legislative solution that we need. Unlike the FDA’s one-size-fits-all approach, the Cole-Bishop approach seeks to regulate vapor products as the new technology they are, not as the tobacco products that they are not.

Vapor technology is a growing industry comprised of the best that America has to offer. We are an industry of responsible manufacturers, wholesalers, suppliers, small business owners and entrepreneurs. We have a responsibility to work with legislators and regulators to develop a comprehensive and responsible regulatory scheme that works for everyone. The Cole-Bishop approach is that way forward.

Tony Abboud is the National Legislative Director of the Vapor Technology Association. 


The views expressed by contributors are their own and not the views of The Hill.