Advocates for e-cigarettes are perplexed as to why the Trump Food and Drug Administration is taking such an aggressive posture against the industry, especially after other agencies like the Environmental Protection Agency have adopted more industry-friendly policies.
E-cigarette advocates have said they are disappointed in the FDA’s threats of bans on e-cigarette sales in convenience stores and new regulations. The FDA has ratcheted up scrutiny of the burgeoning industry in response to what the agency calls an “epidemic” of e-cigarette use among minors.
“I expected the administration to have a de-regulatory policy as they have done at other agencies like the EPA,” said Jeff Stier, senior fellow at the consumer advocacy group Consumer Choice Center. “I expected that approach [at EPA] that we can protect the environment while still cutting regulations. Why can’t the FDA do the same?”
Several advocates who talked to the Washington Examiner said that the FDA’s sharp rhetoric, which is backed up by Health and Human Services Secretary Alex Azar, is lashing compared to other federal agencies’ deregulatory attitudes.
“The FDA seems to be the only agency within the Trump administration that doesn’t understand the directive of this president for a de-regulatory and light touch approach to businesses and consumers,” said Paul Blair, director of strategic initiatives for Americans for Tax Reform, a group led by Grover Norquist.
Other advocates are waiting to see what moves Gottlieb will make, saying that he hasn’t made any official ban yet.
“Some of his rhetoric has been disappointing but ultimately actions matter more than words,” said Gregory Conley, president of the American Vaping Association, which is a nonprofit vaping advocacy group.
While the FDA acknowledges that e-cigarettes are safer than traditional combustible cigarettes, it has argued there is no scientific consensus that e-cigarettes are an effective device to stop smoking.
The agency has also issued warnings to more than 1,300 retailers for sales to minors. It also raided the offices of popular e-cigarette maker JUUL Labs in a surprise inspection and seized documents on its marketing practices.
Gottlieb has previously said that he thinks e-cigarettes are safer to use than traditional combustible cigarettes, but he doesn’t want the trade-off to be getting an entire generation hooked on nicotine. He cited preliminary federal data that showed e-cigarette use among middle schoolers increased by about 50 percent in 2017.
The FDA’s likely next move is not to ban sales in convenience stores but instead to force companies to get FDA approval for products already on the market, several advocates said.
Gottlieb has threatened to speed up an approval deadline, which could wreak havoc on the e-cigarette industry and invite “a lot of litigation,” Stier said.
Gottlieb has said he’ll move the deadline up if the industry doesn’t crack down on sales to minors, an about-face given that he had previously extended the deadline to 2022 from this year.
“If products are being unlawfully marketed and outside the FDA’s compliance policy, we’ll act to remove them,” Gottlieb said in a statement last month. “This includes revisiting our compliance policy that has resulted in certain e-cigarettes, including flavored e-cigarettes, remaining on the market until 2022 while their manufacturers submit applications for premarket authorization.”
The FDA referred the Washington Examiner to past statements by Gottlieb when asked for comment.
Anti-smoking groups are pleased with the agency’s crackdown on e-cigarettes. The Campaign for Tobacco-Free Kids recently told the Washington Examiner that it is hoping the FDA will soon ban flavors for e-liquids, which are used in e-cigarettes. They believe that flavors are a key way that entices kids to use e-cigarettes.
But the agency should not focus on the manufacturers but the resellers of e-cigarettes that are ignoring federal law that prohibits sales to minors, said Peter Pitts, president and co-founder of the group Center for Medicine in the Public Interest.
Pitts worked with Gottlieb at the FDA during the George W. Bush administration. He said that he was a bit surprised in Gottlieb’s approach but added that his former colleague is “dealing with a lot of issues.”
He suggested that Gottlieb should focus on a more “subtle and collaborative approach.
“If you are trying to regulate somebody out of business, I don’t think you can expect anything other than pushback,” he said.
Post time: Oct-26-2018