SALT LAKE CITY — The Food and Drug Administration has proposed a new, long-awaited rule that would regulate e-cigarettes by extending the agency's tobacco authority to other tobacco products, including e-cigarettes.
Regulation of e-cigarettes would mean production oversight, quality standards and reduced youth access.
The proposal comes in the wake of soaring numbers of poison control center calls and climbing rates of youths using e-cigarettes — which for Utah youths increased by 300 percent during the past year, according to Dr. Kevin Nelson, a pediatrician at Primary Children’s Hospital.
County and state health department officials in Utah said thursday they appreciate the step forward but said the FDA isn't going far enough as it tries to catch up with the e-cigarette industry.
"It’s a step in the right direction, but we still have a lot of work to do on a state and local level to get this thing right. We’re glad to see some movement, but it’s not near far enough," said Brian Bennion, executive director of the Weber-Morgan Health Department.
The proposed rule would require registration with the FDA for ingredient review and would ban health-related claims without scientific evidence. It would also forbid free sample distribution, require heath warnings, prohibit vending machine sales and restrict sales to underage youth.
After 75 days of public comment on the proposal, the FDA will finalize regulations. If the rule passes, the regulations will go into effect in two years.
Trouble for youths
"Anecdotally, in the past year, the brush fire of e-cigarettes has just blown so hard and so fast far too many kids are getting these things illegally, and they're saddling themselves with potential for a life-long addiction," said Adam Bramwell of the Utah Department of Health.
Utah already has some regulation in place. Individuals under 19 cannot purchase or possess any devices or accessories, and e-cigarettes are already part of the Utah Indoor Clean Air Act, so e-cigarettes are prohibited wherever conventional cigarettes are prohibited.
"In Utah, just like with cigarettes, you have to be 19 to purchase an e-cigarette, but, in other states, that's not the case, so this will protect youth nationwide," Bramwell said.
What the regulation lacks is licensing requirements to sell e-cigarettes. County and state health department officials agree the state needs to look at licensing to curb sales to minors.
"Because there's no regulation on who can and can't sell the products even if we do know an individual or a shop that's selling e-cigarettes to youth wantonly, there's only so much we can do. We can't revoke a license to get the product, as we can with cigarettes," Bramwell said.
However, health officials were glad to see the manufacturing regulations in the proposal — a main concern of the state health department.
"What that means to a local e-cigarette shop is they can no longer mix their product in their store without submitting a list of ingredients and product findings to the FDA, and then allow the FDA to come in and inspect their facility," Bramwell said. "So these days of the bathtub e-juice creation will be over at that point in time. I say that tongue in cheek, but unfortunately that happens."
Impact of rules
Bramwell said the rule will likely be cost-prohibitive for a lot of businesses. Utah has about 10 manufacturers, and e-cigarettes are sold in 40 speciality shops, smoke shops, convenience stories, gas stations and grocery stores.
The compliance cost for nicotine liquid manufacturers could be detrimental to their business.
"That process is notoriously very expensive. We’re talking tens of hundreds of thousands of dollars," said Aaron Frazier, director of Utah Vapers, an electronic cigarette trade organization.
Frazier said costs could be through the roof if each flavor, nicotine strength and size requires a separate application to the FDA.
"We're absolutely happy that there are regulations," he said. "As far as the regulations themselves, there's some good and there's some bad and there's some ugly. Hopefully, we as an industry can work with the FDA."
The Weber-Morgan Health Department wants authority to perform compliance checks for selling to minors. Bennion said compliance checks for conventional cigarettes contributed to the decrease in stores selling to minors, from about 30 percent to 10 percent.
Bennion said he'd also like to see bans or restrictions on online sales, television advertising and flavors.
Anna Guymon of the Weber-Morgan Health Department noted that Weber County has the highest rate of youth use in the state, with almost 1 in 5 youths regularly using an e-cigarette in 2013 — compared to 13.6 percent of adults in the same area.
The national rate for high school use, according to the Centers for Disease Control and Prevention, rose from 4.7 percent to 10 percent from 2011 to 2012. For middle schoolers, the rate went from 1.4 percent to 2.7 percent.
Nationally, the number of calls to poison centers involving nicotine liquids for e-cigarettes shot up from one per month in September 2010 to 215 per month in February 2014, according to a CDC study published earlier this month. Just over half of the calls involved children under 5. The study noted e-cigarettes aren't required to be childproof, and their candy flavors are attractive to children.
One Utah legislator was tired of the waiting on the FDA and proposed legislation earlier this year that would create production oversight and restrict youth access. HB112 ultimately didn't make it through the process before time expired on the last day of the session.
"What I hope they do, what they need to do, is just treat it the same as you would a tobacco product because that’s what it is. Nicotine is a tobacco derivative," said HB112 sponsor Rep. Paul Ray, R-Clearfield, who said he had the FDA proposal on his desk.
His plan now is to study up on the regulations and fill in any gaps he finds with legislation next session.
Ray said the FDA's proposal is a result of a directive from Congress, which is "fed up" with the problem of nicotine poisoning. He said it looks like the FDA will require labeling and child-proof caps.
"We’ve done a fantastic job in this state of decreasing youth smoking, and then these came a long and just blew that out of the water," Ray said. "In Weber County, you have more youth using e-cigarettes than you do adults, so that tells you there’s a huge problem."
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