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Utah not enforcing own rule allowing only FDA approved e-cigs

As Mitt Romney, others urge FDA action, state lawmaker says Utah should act on 2015 regulations and ban items

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FILE - Sen. Mitt Romney, R-Utah, speaks at the Sutherland Institute in Salt Lake City on Monday, Aug. 19, 2019.

Scott G Winterton, Deseret News

SALT LAKE CITY — Utah adopted a rule four years ago that requires retailers to sell only e-cigarettes and vaping liquid approved by the Food and Drug Administration starting last month.

And because the FDA has not approved those products, a state lawmaker contends everything but the sale of closed cartridges, primarily used for smoking cessation, is illegal in Utah.

“Everybody forgot about that,” said Rep. Paul Ray, R-Clearfield, who sponsored the legislation that led to the rule.

The rule states: “As of Aug. 8, 2019, the retailer shall sell an electronic-cigarette substance that has been approved by the United States Food and Drug Administration through a Pre-Market Tobacco application or Substantial Equivalent application.”

Utah should enforce the law and vape shops should close, Ray said, adding that maybe legislation is needed to clean up the rule or reach a resolution with the vaping industry.

“But I’m really not in a negotiating situation right now. I’ve got people dying, and we have to address the problem,” he said.

The Utah Department of Health is well aware of the rule. It initially decided not to enforce it because the intent was to follow the FDA timeline for a decision on e-cigarettes, which was pushed back to no sooner than May 2021, said Ryan Bartlett, of the state Tobacco Prevention Control Program.

The department, he said, is now waiting for direction from the governor’s office. The question is whether to enforce the rule because people are getting sick and dying, Bartlett said.

“At this point we’re not sure whether or not we’re going to conform with FDA’s timeline or go ahead and enforce the rule as written because the industry did agree to that rule,” Bartlett said.

Gov. Gary Herbert’s office did not respond directly to Ray’s call for a ban, but urged Utahns to stop using e-cigarettes until the FDA and Centers for Disease Control and Prevention finish their investigations.

“While we don’t fully understand the link between electronic cigarettes and recent cases of severe pulmonary illnesses across the United States, we agree that some electronic cigarettes pose a significant danger to users,” Herbert spokeswoman Anna Lehnardt said.

The governor’s office believes the issue is critical to public health and looks forward to working with the Legislature to address it, she said.

Mike Berry, owner of Blackhouse Vapor Co. in Sugar House, said the FDA failed to do its job, and the state should continue to follow the agency’s schedule for approving or disapproving vaping products.

Ray, he said, sees the state rule as an opportunity to “pounce” on something he doesn’t like.

Berry said the controversy over e-cigarettes comes down to cartridges tainted with THC sold over the black market. He said regulators should investigate the source and not attack an entire industry.

“This is a black market issue. This has nothing to do with the legal vaping market,” he said, adding no business is going to put opioids in a product they sell knowing they’re regulated by the state and federal government.

Ray had an independent lab buy and test 12 vaping gels from Salt Lake area vape shops earlier this year. He said 10 of the 12 samples tested positive for at least trace amounts of PCP, THC, opioids and barbiturates.

While Ray did not identify the shops, Berry said Blackhouse Vapor, which opened four years ago, doesn’t not sell gels tainted with opioids or any other substance.

Students Against Electronic Vaping also weighed in on the issue, calling for Utah to enforce the rule.

“We are working closely with state legislators to ensure that open-ended e-cigarette systems are removed from Utah markets,” according to Cade Hyde, the group’s president. The statewide, student-run organization also favors an excise tax as high as 86% on closed-ended e-cigarettes.

After suggesting the government recall e-cigarettes, Sen. Mitt Romney asked the Department of Health and Human Services in a letter Wednesday to act quickly on what he sees as a pervasive public health crisis.

“On the recall front there’s no reason not to move precipitously,” he said.

Romney’s letter comes following reports of a sixth death tied to e-cigarette use.

“I think anybody who is using vaping products would be wise to put them down and not use them until we can understand what the health impacts are,” the Utah Republican said in an interview. “But I think the FDA has to take action to remove those products from public sale until we understand why people are dying and getting extremely sick from them.”

The Trump administration appears poised to take some immediate action. President Donald Trump met with Health and Human Services Secretary Alex Azar and acting FDA Commissioner Norman Sharpless on Wednesday morning about vaping.

“We’re going to have some very strong rules, regulations, and more important we’re going to have some very important information come out very shortly,” Trump told reporters.

Azar told reporters the agency is finalizing plans to remove all flavored e-cigarette products, except tobacco flavoring, from the market in an effort to discourage youth vaping. He said it would take several weeks to announce the proposal.

Romney later tweeted that eliminating flavors is a good first step.

Romney also sent a separate letter to Herbert asking for recommendations on how to address the issue in the Senate. Romney wrote that he’s “extremely troubled” at the escalating outbreak of severe illnesses linked to vaping, including 35 under investigation in Utah.

The senator noted in his letter to Azar that the doctor leading the CDC’s investigation of those incidents warned last week that consumers should consider not using e-cigarette while investigations are ongoing.

“In light of this guidance, and as investigations continue into reported illnesses and deaths, I urge the agencies to strongly consider whether these devices meet the recall classification standards of dangerous products that predictably cause serious or temporary health problems,” he wrote.

In a tweet Tuesday, Romney said the Food and Drug Administration should consider recalling e-cigarettes while it investigates the recent deaths and illnesses related to vaping. He said he’s concerned young people have been deceived into thinking e-cigarettes are safe.

Romney noted that a 20-year-old Provo man who nearly died from a vaping-related illness told the Washington Post that he was unaware of the potential dangers.

Vaping products haven’t gone through rigorous testing before they’re being sold, in many cases to kids, he said.

“I think the addition of flavors, which are clearly aimed at children, is an indictment of the producers of these products,” Romney said, adding some of the flavors should be prohibited. “They shouldn’t be marketed to kids.”

Michigan last week was the first state to ban flavored e-cigarettes.

Banning flavors nationwide would be a “public health travesty,” according to the Vapor Technology Association.

The trade group based in Washington, D.C., said in a statement that nicotine-vapor products are safer than cigarettes and federal flavor ban would force more than 10 million adults to choose to between smoking again or finding what they want on the black market.

The association urged the Trump administration to “change course before millions of Americans are forced to switch back to deadly cigarettes, small businesses around the country are forced to close their doors, and tens of thousands of people are laid off.”

In his letter, Romney wrote that electronic devices pose unique challenges, including refill pods, pop culture ubiquity and virtual inability to be detected in schools. As the FDA continues to warn the public about vaping risks, he asked the agency to report early progress or roadblocks to Congress so it could swiftly provide clearer legislative pathways, as needed.

The senator also urged the FDA and CDC to report to Congress and the public any new findings related to severe pulmonary disease, or other diseases, stemming from e-cigarette use.

Romney also encouraged the FDA to consider whether vaping devices should have refill pods or whether they should be limited to single-use. He said he has heard from constituents and seen across the country e-cigarette users modifying pods to include other illicit and harmful drugs.

In June, Romney and Sen. Mark Udall, D-N.M., introduced the Smoke-Free Schools Act of 2019 to ban e-cigarette use in educational and child care facilities. In April, he helped introduce the bipartisan Tobacco to 21 Act, legislation that would prohibit the sale of tobacco products, including e-cigarettes, to anyone under age 21.