An unexpected clash has emerged between the Trump administration’s Food and Drug Administration and conservative free-market advocates over the planned tightening of tobacco product regulations.
A coalition of 18 right-leaning groups released today an appeal to President Donald Trump and two federal agencies to “immediately halt” what it called an “aggressive FDA regulatory assault on businesses who sell and consumers who rely on less harmful alternatives to cigarettes in the United States.”
The coalition is led by conservative heavyweights Grover Norquist, president of Americans for Tax Reform, and Lisa Nelson, chief executive of ALEC Action.
The coalition said it is not certain that Trump is fully aware of the FDA’s agenda and how it is inconsistent with the administration’s overall regulatory approach.
“We are asking President Trump or Office of Management and Budget or Office of Information and Regulatory Affairs to intervene by, among other things, immediately conducting a cost-benefit analysis of the impact of (FDA Commissioner) Scott Gottlieb’s threats, actions, proposed rules, lack of guidance and inaction on pending product approvals,” according to the coalition.
The coalition told Trump the FDA’s stated regulatory plan “is inconsistent with your clearly articulated deregulatory objectives … and will destroy jobs, limit consumer freedoms and harm public health.”
On Tuesday, a coalition of public-health and anti-tobacco groups issued a statement calling out the coalition for its ties to the tobacco industry and for "launching an outrageous attack on the FDA because of its efforts to address the youth e-cigarette epidemic and reduce the death and disease caused by tobacco use in the United States."
The anti-tobacco group said 11 of the 16 groups have received tobacco industry funding.
"This letter comes just days after U.S. Sen. Richard Burr, R-N.C., in a speech on the Senate floor, attacked the FDA’s proposal to prohibit the sale of menthol cigarettes," the anti-tobacco groups said.
"Research shows menthol makes it easier to start and harder to quit smoking cigarettes. Reynolds American, maker of Newport, the best-selling menthol cigarette brand, is based in North Carolina."
"The FDA and the Trump Administration must reject these self-serving tobacco industry attacks and move forward with strong proposals they have made to protect kids from nicotine addiction, accelerate progress in reducing smoking and save countless lives."
Juul in the crosshairs
Gottlieb had been adamant about tightening tobacco regulations, particularly on top-selling electronic cigarette Juul, which has a 76 percent market share in the U.S.
Juul is sold in the form of a pen or a USB device. That design makes it easy to hide, which Gottlieb says has contributed to “an epidemic” of teenage use, albeit based on a small sample size nationally.
On Nov. 15, the FDA announced its plans to limit e-cig flavors to tobacco, menthol and mint and remove menthol traditional cigarettes. It is likely to take years for the FDA to accomplish its goals through the legal and regulatory systems.
The FDA’s agenda has gotten the attention of North Carolina’s two Republican U.S. senators, Richard Burr and Thom Tillis. They wrote Nov. 20 questioning Gottlieb’s strategy, especially considering that a Democratic-controlled Congress created a legal exemption for menthol cigarettes in 2009.
“It is troubling ... that an administration that pledges to put America first is targeting legal, American-made products instead of focusing its attention on states that flout federal drug laws,” the senators wrote.
Surgeon General Jerome Adams has issued an advisory to parents, teachers, health care and government officials encouraging them to stop children and teens from using e-cigs.
“I am emphasizing the importance of protecting our children from a lifetime of nicotine addiction and associated health risks by immediately addressing the epidemic of youth e-cigarette use,” Adams said.
The coalition claims the FDA “is currently pursuing several policies that are more extreme than those contemplated by the Obama administration.”
They question why Gottlieb and the FDA appear to be dismissing scientific studies that show e-cigs can be up to 95 percent less harmful to consume than a traditional cigarette.
One of the latest studies on the subject was released last week in the New England Journal of Medicine.
Researchers with the U.K. National Health Service determined e-cigs are nearly twice as effective — although on a low overall level — as nicotine replacement therapy products in helping smokers quit traditional cigarettes for at least one year.
Eighteen percent of the 886 study participants who used e-cigs quit for at least a year, while just 9.9 percent did through using nicotine replacement therapy products.
Researchers said both products were accompanied by behavioral support.
“Unfortunately, a spike in the use of these products by teens has resulted in regulatory panic and significant government overreach,” the coalition said.
Mitch Kokai, policy analyst with Libertarian think tank John Locke Foundation, said the coalition’s effort is to raise awareness that “the federal government is a vast behemoth, with just a small fraction of those working for it identifiable as members of the Trump administration.”
“Like other regulators, those at the FDA exist to regulate. It’s likely that highly motivated career staffers convinced their temporary appointed bosses that increased regulations made sense — regardless of the regulatory stance put forward by the White House.
“That’s why this letter is aimed directly at the president,” Kokai said. “If the topic interests him, he could shut the door on this increased regulation.”
Gottlieb has expressed concern about two main tobacco industry developments.
One is the growing popularity among teens of Juul.
The second is that Altria Group Inc., owner of the top-selling traditional cigarette Marlboro, has spent $12.8 billion to acquire a 35 percent stake in Juul Labs Inc. The companies said Juul Labs will continue to operate independently.
Altria said the Juul Labs investment “better positions Altria with adult smokers interested in alternatives while continuing to compete vigorously in all other tobacco product markets.”
Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health, called the investment “potentially a major game changer in the e-cigarette and cigarette marketplace.”
“If in fact Altria is serious about moving its harm reduction efforts forward and looking to a smokefree/cigarette free world, then we can expect that that is something that should be generally embraced.
“However, we should expect pushback from numerous other stakeholders,” Ballin said.
Pressure on marketing
The coalition said Gottlieb “has already pressured major manufacturers of e-cigarettes to remove many products from convenience store shelves, suggested that more than 100,000 retailers limit adult access to these products, and threatened to use agency power to remove thousands of legal products from the market.”
The coalition said it is not asking Trump and his administration “to ignore the concerns about the use of e-cigarettes by teens.”
“We do, however, urge your administration to subject the FDA’s response and actions to much closer scrutiny and examine it within the context of your broader deregulatory and pro-jobs agenda.”
The coalition cited the FDA’s regulatory agenda “as a one glaring exception.”
“It is likely that the impact of the FDA’s proposed, pending and possible new guidance and rules for retailers, manufacturers and consumers will amount to billions of dollars in lost economic activity and costs,” the coalition said.
An example of the coalition’s free-market concern came Jan. 8 when a leading tobacco industry analyst cautioned that British American Tobacco Plc, owner of Reynolds American Inc., could be in line for a pivotal revenue hit from a potential FDA ban of menthol cigarettes.
Vivien Azer, with Cowen & Co., downgraded BAT, Altria Group Inc. and Imperial Brands Plc from “outperform” to “market perform.”
“While we continue to like BAT’s positioning in the international cigarette market, as well as the stock’s attractive dividend yield,” Azer said that the FDA is “moving more aggressively than we would have envisioned under the Trump administration.”
The coalition said that “private sector initiative and sound public policy should not be held hostage by prohibitionist impulses. The FDA’s current efforts and attitude toward the e-cigarette industry make America a less appealing place to invest and do business.
“Without your intervention, Commissioner Gottlieb may not only destroy tens of thousands of jobs at small stores and manufacturers, but he will prevent some of the more than 35 million American adults who still smoke tobacco cigarettes from ever successfully quitting.”