New FDA regulations affect vape pens, e-cigarettes and other smoking products
April 29, 2014
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Comments to the FDA can be sumbmitted through the Federal eRulemaking Portal at http://www.regulations.gov. All submissions must include the Agency name, Docket No. FDA-2014-N-0189 and RIN 0910-AG38.
For more information, contact Gerie Voss, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, at (877) 287-1373 or CTPRegulations@fda.hhs.gov.
People who make, sell or buy electronic cigarettes, vaporizers and other tobacco or marijuana products could soon be affected by new federal regulations.
The Food and Drug Administration released a proposal Thursday to expand its definition of tobacco products to include electronic cigarettes, pipe tobacco, hookah tobacco, dissolvables, gels and potentially some cigars. Premium cigars might be exempt.
Local smoke shop owners and employees said Saturday that they were unfamiliar with the new regulations.
At Slope Side Cigars in Breckenridge, co-owner Trent Iorio said he thought e-cigarettes and vaping are in "kind of a gray area."
Iorio and his business partner have talked about doubling the amount of e-cigarette and vaporizer products the store offers due to their growing popularity.
The new rules also will cover parts of tobacco products, like air/smoke filters, tubes, papers, pouches, flavorings (such as flavored hookah charcoals and hookah flavor enhancers) and e-cigarettes cartridges. And the regulations will include future products that deliver nicotine, like current medicinal nicotine patches, if they're not marketed for therapeutic purposes.
What does this mean? The rules that now apply to cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco will apply to the new products. They will be banned for sale to minors, and the agency will require registration, premarket ingredient reviews, inspections and health warning labels for anything containing nicotine.
The heath effects of e-cigarettes are unclear. Some experts say they are safer because they don't have the carcinogens in traditional cigarettes and secondhand smoke. According to the FDA, e-cigarettes attract young people who wouldn't otherwise use tobacco products, and the number of cigarette smokers who quit tobacco by switching to e-cigarettes is low.
For example, the Centers for Disease Control and Prevention reported a 32.8 percent decrease in cigarette consumption between 2000 and 2011.
But the consumption of non-cigarette combustible products over the same period increased from 15.2 billion to 33.8 billion "cigarette equivalents" (per-cigarette equivalents for pipe tobacco, roll-your-own tobacco and small and large cigars), a 123.1 percent increase.
Pipe tobacco consumption also increased 482.1 percent, and consumption of large cigars increased 233.1 percent.
With all the unregulated makers of e-cigarettes on the market, said Abby Clark, an employee at High Altitude in Frisco, consumers don't know if the products they're buying are safe.
"Who knows what kind of chemicals they're going to release," she said.
High Altitude has been selling more vaporizers and e-cigarettes since recreational marijuana was legalized in January, she said, and vape pens appeal to customers because most can be used, at least in Colorado, for both tobacco and marijuana in dry and liquid forms.
"Unless they really crack down on regulations," she said, "it's probably just going to keep getting bigger and bigger."
The agency recognized that if e-cigarettes lead to fewer children and teens starting to smoke and more smokers quitting, the impact could be positive. If the opposite is true, however, and more people use traditional and new tobacco products, the public health impact could be negative.
"Nobody knew smoking wasn't healthy until 20 years later and people started dying," Iorio said, adding that "only time will tell" the health effects of vaping and whether the FDA will allow the practice to continue.
He said the new regulations sound like a government attempt to collect more tax money.
The new rules stem from the 2009 Tobacco Control Act, which banned candy and fruit flavors in traditional cigarettes. Though the proposed regulations did not ban kid-friendly flavors, they are a step in that direction.
Stevie Day, owner of Smok N' Bra in Frisco, said some young adults buy fruit-flavored fillers for vaporizers that contain no nicotine, which would not be regulated under the new rules.
"They just want that vapor feel," she said.
She said the nicotine-related products she sells already come with warning labels and she makes sure to educate customers about their effects and the proper way to use the devices.
Some say the regulations could lead to industry consolidation, as smaller companies won't be able to afford agency approval.
The proposal is open to public comment for 75 days before the agency makes final changes. The rules will go into effect two years from the date the regulations are finalized, giving companies time to apply for FDA approval of their products, which will stay on shelves in the meantime.