Groups take FDA vaping rules fight to Trump, Congress

By   /   March 10, 2017  /   News  /   No Comments

Groups looking to undo controversial new e-cigarette regulations say the federal government is running out of legitimate reasons to defend them.

And with lives in the balance, they want to strike while the science is hot.

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ONE-TWO PUNCH: Two groups are taking their fight against FDA overreach to the president and Congress to save thousands of businesses and millions of lives.

The Food and Drug Administration’s so-called “deeming” rule roped liquid nicotine products into the federal Tobacco Control Act last August, even though they contain no tobacco. The FDA and public health advocates insist the vapor-based products are gateways to harmful tobacco cigarette smoking, especially among the nation’s youth.

Opponents say the FDA and other federal agencies are ignoring solid data that show e-cigarettes are 95 percent less harmful than their tobacco counterparts, and smoking cessation products such as nicotine patches and gum fail 90 percent of the time.

In doing so, unelected bureaucrats intentionally suppress the one product that could accomplish their goals — to wipe out the massive health and economic burden caused by cigarette smoking and save lives.

The rule also subjects thousands of small and medium-sized businesses to a costly and exhaustive premarket approval process critics say will shutter 99 percent of the industry in the United States, removing from the table perhaps the most viable smoking cessation tool currently on the market.

Even the Centers for Disease Control and Prevention, which stands accused of spreading misleading information to keep e-cigarettes out of the tobacco harm reduction conversation, has acknowledged e-cig adoption could have saved $48 billion in Medicaid dollars in 2012, according to a 2015 Heartland Institute study.

RELATED: Science challenges FDA vaping regulation, and Trump may be next

Now, two new reports aim to bring President Trump and Congress into the fight.

One is a paper written by Counterfactual’s Clive Bates along with R Street Institute President Eli Lehrer and University of Ottawa law professor David Sweanor. “Reshaping American Tobacco Policy” calls out the perverse tobacco policy for failing the American public and destroying thousands of businesses that are part of the solution.

The report lays out eight strategies to fight smoking and “ignite a public health revolution.” The strategies include cancelling the FDA deeming rule before it destroys the U.S. vaping market, using new labels to inform consumers about relative risk, restoring honesty and candor to public health campaigns and refocusing tobacco science on public interest and not bureaucratic expansion.

And the intent is clear. As Bates wrote on his website, “This is our pitch to the Trump administration and (as yet undecided) incoming FDA Commissioner. We have been necessarily concise and see this as an opening gambit.”

The other side of the one-two punch is a report for the Heritage Foundation, “Rethinking Tobacco Policy: The Federal Government Should Stop Blocking Alternatives to Smoking.”

Report co-author Jeff Stier, a risk analyst with the National Center for Public Policy, says ignoring science is one thing, but federal agencies across the board continue to spread suspect information about a product that could save the lives of 4 to 8 million smokers.

“We call for a reversal of this approach through the entire apparatus of the federal government from the CDC, which is putting out misleading reports about the prevalence and the risk of vaping, to the FDA, to the legislation that dictates what the FDA does, to HUD and even the Dept of the Interior which is trying to ban vaping on gov’t lands,” Stier wrote. “And the Surgeon General, who, when he did his report on e-cigarettes, only focused on the youth and didn’t focus on benefits for adults smokers. It was intentionally one-sided.”

RELATED: Surgeon General’s e-cigarette panned as ‘truly terrible’

“There needs to do an about-face,” he added. “If the federal gov’t is to be involved at all in dictating how people make choices, then we need to go in the opposite direction.”

An all-out reversal is a tall order, however, given an institutionalized risk aversion that goes back decades.

Mercatus Center Senior Scholar Richard Williams is a former director of the FDA’s Center for Food Safety and Applied Nutrition and has seen this risk aversion first hand and written about it often. He tells there is no activity or compound on earth that is without risk.

“This means that anytime you stop or curtail an activity, another one with risk takes its place,” he said. “If you ban smoking, it will either be e-cigarettes or, evidence shows, in some cases it is pot. The question is, which is less risk, not which is no risk. Clearly, e-cigarettes are less risky and moving to them might save a significant portion of the 400,000 or so deaths each year.”

“The public health community hates the whole idea of risk-risk trade-offs. They don’t know what to do about them.”

Stier, who will be on hand at a panel discussion at the Heritage Foundation on March 16 to discuss the subject, is undaunted by the challenge.

“We’re hoping that will change from the top,” he said, referring to the still-vacant FDA commissioner position. “But even if it changes from the top there are still going to be bureaucrats, civil servants who still may get in the way. But that’s why a change in the leadership at the FDA is so critical.”

Kathy Hoekstra is a national regulatory reporter for Contact her at [email protected] and @khoekstra.