On E-Cigarette Regulation, the Government Asked ACSH For Advice ... and Listened

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In late 2015, the American Council on Science and Health was asked to testify at the White House on the impact of the Food and Drug Administration's "deeming regulations," granted to it by the 2009 Tobacco Control Act, to cover all tobacco products.

This was after numerous other times that state, local and federal officials had asked for guidance on this complex subject. We made those recommendations, and it looks more and more like our advice will win the day, at least based on a committee vote today.

E-cigarettes are a hot-button topic. They have grown in popularity and so have grown in controversy. The Council, long America's foremost anti-smoking science-based organization, embraced them as smoking cessation tools, but also for harm reduction. It may seem stupid in 2016 that anyone would smoke at all, but they will, and many will want to quit, which is a difficult process. E-cigarettes can be a bridge to quitting because they have nicotine, like patches and gums, and like with patches and gums most people will fail at first, and some will do both, but overall the known benefits of fewer smokers outweigh the unknowns in e-cigarette use and so we have embraced them for harm reduction while we strive for a world where no one smokes at all.

While advocates (and outright zealots) on the e-cigarette side have long argued that there should be no regulation of any kind, that doesn't hold up to logical or legal scrutiny. Just because Red Bull is not regulated doesn't mean children should be fair game for every product. Some chemicals are bad and some products are bad so it can't be a free-for-all when it comes to public health. Meanwhile, advocates (and outright zealots) against e-cigarettes, including the Centers for Disease Control, have embraced any survey or paper that claims a correlation to harm. Suggesting that all tobacco is the same in harm is as ridiculous as IARC claiming sausage is as hazardous to health as plutonium (which they did). Some groups are in a war on tobacco companies instead of a war on smoking, and they don't like that tobacco companies are getting into e-cigarettes, all while claiming tobacco companies should get out of smoking.

It can be confusing for the public.

Enter The Council. We are tasked with being trusted guides for the public and policy makers on these complex issues, so arguing that e-cigarettes are "not tobacco" is a non-starter. Tobacco is how you get optically pure nicotine at a reasonable cost, and that is what people want. Until a synthetic version is available at a realistic cost nicotine is a tobacco product, so we did not argue that point with the White House or at other testimonies. That the industry would self-regulate was also unworkable. With a low barrier to entry, and already 10,000 shops operating, there are too many bad actors who can prey upon the public. A few high-profile poisonings or device explosions and then truly onerous regulations would come into force. So we knew it was better to guide the process than attempt to block it when it was clear that these regulations were going to happen.

In our testimony, we focused on protecting legitimate small businesses so that they were not wiped out by legislative fiat, and can live or die in a free-market environment, all the while making sure the public has expectations it will have access to a safe product.

We determined that this can all be brought about by a simple solution: changing the 'substantial equivalence' date from a rather onerous Feb. 15, 2007 to something more recent. With such a distant substantial equivalence date, the only companies that could survive long enough to undergo the agency's "premarket tobacco application" (PMTA) process would be, ironically, the Big Tobacco companies everyone seems to want to penalize.

Up to 100,000 e-cigarette and vapor products would have needed to undergo this expensive review process if that date went into force. So our recommendation to the White House and Congress was to make it 2014 or 2015. Today, the House Appropriations Committee voted 31-19 in favor of at least easing the process by changing the date. The actual date is to be negotiated, and a vote by the full House of Representatives has not been scheduled, but the fact that this committee vote happened at all, and this issue finally had both sides of the political aisle on the side of small business and harm reduction, is terrific news. We'll be ready to provide more guidance when the next round of negotiations are announced.

Most heartwarming is that constructive things can happen in controversial policy talks in an election year. Evidence and reason can make a difference, even in politics.