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FDA e-cigarette plan brings complaints from both sides

Steve Halligan, a pack-a-day smoker, tries out some sample flavors at Vape Daddy’s in Newton. At first skeptical, he left the store after buying two blends.Suzanne Kreiter/Globe Staff

“Keep Calm and Vape On,” a sign behind the counter in David Bershad’s Newton electronic cigarette store proclaims. But proposed federal regulations for e-cigarettes have him fired up.

“I hope there’s going to be some uproar,” said the co-owner of Vape Daddy’s, who plans to encourage customers to contact the Food and Drug Administration. “I’m sure going to stir it up.”

The FDA proposal unveiled Thursday would bring e-cigarettes and their ingredients under the agency’s review for the first time and ban sales to minors. Bershad, who already imposes age restrictions, supports the FDA on both counts.

But he worries about some obstacles e-cigarette makers would face under the new rules, including being barred from contending, without scientific evidence, that their products are safer than cigarettes. And he bristles at a ban on free samples, which draw customers to stores such as his with the incentive of free testing of e-cigarettes and sampling flavors.

In the five years since Congress empowered the FDA to draft the rules, e-cigarettes have surged from a niche product to a nearly $2 billion annual industry. Unlike conventional cigarettes, they are tobacco-free and smokeless; most deliver nicotine and flavoring by heating liquid into a nearly odorless vapor that only looks like smoke.


Organizations such as the Campaign for Tobacco-Free Kids criticized the FDA for foot-dragging and for not doing enough to keep e-cigarettes from children.

Thousands of smokers have embraced e-cigarettes as an alternative to tobacco-cessation aids or as a cigarette replacement where smoking is banned or frowned upon.

But critics say e-cigarettes can keep people from quitting altogether. They also contend the wide range of e-cigarette flavors, such as bubble gum and cotton candy, are intended to hook young people on nicotine.

The FDA stopped short of restricting advertising and online sales or banning sweet flavors. Bershad and other supporters say the variety of flavors is key to the appeal of e-cigarettes among adults, much like flavored vodka.


After Bershad replaced his cigar-a-day habit with “vaping” last year, he found his sense of taste and smell returned, and he now has an easier time catching his breath. But the 54-year-old advertising industry veteran did not know where to begin when he first considered the options for “e-juice” online — concoctions like apple-blueberry, cappuccino, and peppermint, as well as esoteric flavors like Grand Master and Shamrock.

Now he curates flavors at his store, which opened in December and caters to customers who would rather sample first than blindly shop online.

The FDA has not said when the regulations would take effect. Thursday’s release started a 75-day comment period, after which the FDA will review feedback and issue the final rules as quickly as possible, said spokeswoman Stephanie Yao. She said the proposed ban on free samples covers in-store sampling, freebies from manufacturers to retailers, and giveaways to customers.

Beyond Vape Daddy’s and a handful of similar shops, thousands of gas stations and convenience stores statewide carry e-cigarettes, usually stocking disposable or cartridge-based versions that resemble traditional cigarettes, as opposed to the more expensive rechargeable e-cigarettes that look like futuristic pens and contain refillable liquid chambers.

In Boston alone, 501 stores now sell e-cigarettes, up from 333 last year, according to figures from the Boston Public Health Commission.

Dr. Michael B. Siegel, a tobacco control specialist at the Boston University School of Public Health, said the FDA proposal appears to be a victory for Big Tobacco.


Smaller players in the industry could be driven out of business because of the cost of earning FDA approval for new or existing products, which would have two years to win the FDA stamp or be removed from shelves. That could check the growth of e-cigarettes, fueled in part by variety, and drive sales toward the three tobacco industry giants, which have invested in developing their own e-cigarettes or acquiring existing lines, and which would be better able to afford the application process, Siegel said.

Jamey Petruzzelli, who owns Malden’s Vapes R Us, says he is worried about losing some boutique flavors and brands or being saddled with a potentially unapproved product.

“If I’m loaded up on inventory and the small guy gets knocked out, that means all the juice is trash,” he said. “I’m hoping these companies will follow the FDA guidelines and get approved or attempt to get approved.”

Though some bullish analysts had predicted e-cigarettes could grow from 2 percent of the smoking market to as much as 50 percent, Siegel thinks the regulations might cause growth to plateau around 10 percent. He said the FDA rules also make it harder for e-cigarette makers to promote what should seem like obvious health advantages over combustible cigarettes, the country’s leading cause of preventable death.

“That doesn’t make sense,” Siegel said. “There simply is no product on the market that’s more dangerous than tobacco cigarettes, and nobody in their right mind would argue that cigarette smoking is less hazardous or even equally hazardous to vaping.”


Banning sales to minors would catch the nation up with 111 Massachusetts cities and towns that have already enacted an age requirement. Fifty-one of those communities, including Boston, also ban e-cigarettes wherever customary cigarettes are also banned under the state’s Smoke-free Workplace Law.

Many retailers in communities without bans, such as Cambridge, already restrict sales to minors. “We would rather be safe and keep it like regulated tobacco,” said Tom Chamberlain, an employee at Harvard Square’s Leavitt & Peirce, who said e-cigarettes “have been flying off the shelves for us over the past few months.”

But given that it could still be a year or more before the federal rules take effect, state Representative Jeffrey Sánchez said Beacon Hill should move swiftly to ban sales to minors statewide. Sánchez, who has filed legislation to add e-cigarettes to the state’s workplace-smoking ban, said he is particularly worried about their appeal to children.

“We want to make sure we regulate these things so we don’t create another generation of smokers,” the Jamaica Plain Democrat said.

With the rule pending, Bershad was still free Friday to offer samples to customers like Steve Halligan, a pack-a-day cigarette smoker since age 14 who has been unsuccessful at quitting cold-turkey or with nicotine-replacement products.

“The only thing I haven’t tried is really trying,” said Halligan, 37, an audiovisual specialist by day and a stand-up comedian by night.


Halligan hopes the electronic version can take the place of smoking, if not curb his nicotine addiction, keep him from continuing to duck out into the cold, and help him take the stairs again without getting winded. And he liked being able to test products in the store, trying flavors and sampling different models to find one that was discreet-looking enough but still provided the right “throat feel” when inhaling.

Skeptical at first, he took home a strawberry blend as well as a flavor that mimics tobacco. “I was sort of on the fence about whether I’d enjoy a flavor,” he said. “I found it to be surprisingly pleasant.”

Globe correspondent Derek J. Anderson contributed to this report. Eric Moskowitz can be reached at