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Regulation Takes Up a New Residence


It was 2011 when the Food and Drug Administration (FDA) revealed it would take steps to regulate electronic cigarettes under the Tobacco Control Act of 2009 — after its bid to regulate the products as medical devices failed a legal challenge.

Three years later, on April 24, 2014, the federal agency released its long-awaited proposed “deeming rule,” which seeks to extend its authority to cover additional tobacco products including e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and certain dissolvables not already under the agency’s authority.

Another two years have now passed and that deeming rule is still in the proposal phase. As of press time, the proposed regulations sat with the White House Office of Management and Budget (OMB) awaiting final clearance, according to Ann Simoneau, director of the Office of Compliance and Enforcement at the FDA’s Center for Tobacco Products.

Speaking in mid-February to attendees of the Convenience Distribution Association’s Convenience Distribution Marketplace event, Simoneau said there is no exact date when OMB will give its approval. In fact, she thought it would have happened already.

If and when OMB takes action, though, it likely will not mean finality. As noted by Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO), it’s possible the OMB could send the deeming rule back to the FDA with recommended changes, which would continue the back-and-forth between the two government offices.

“The OMB has final regulatory approval; it cannot go into effect unless it signs off on it,” explained Briant, who was also a presenter at the Convenience Distribution Marketplace event, discussing the issue of tobacco regulation at all levels.

Expanding its authoritative reach to other tobacco products is not the FDA’s only focus these days either. The agency also counts tobacco research as a main priority — investing roughly $500 million on research to date, according to Briant. This research will shape future regulation, based on scientific studies. The FDA’s timeline, the NATO chief said, is three to five years. Any future litigation, however, could slow the regulatory process.

The agency may also use the research to craft new product standards. Any product that does not comply with any new FDA-issued standards would be pulled from the market, effectively banning products without the need of regulation or legislation, he cautioned.


While the industry still anxiously awaits the final deeming rule — the FDA’s first step in regulating tobacco products not specifically spelled out already in the Tobacco Control Act — local municipalities across the country are taking action of their own.

In fact, “the fight will be won or lost at the local level,” Briant boldly said.

His reasoning is that tobacco regulation has shifted from how products are sold — like banning cigarette vending machines — to what products are sold. For instance, at the local level, flavor bans on other tobacco products are gaining traction.

In Minnesota, Minneapolis’ ban on the sale of flavored tobacco products in convenience stores went into effect Jan. 1 of this year. One week later, St. Paul lawmakers followed suit and approved a similar ban, which was slated to go into effect April 1.

Providence, R.I., was the first municipality to enact a flavor ban. Larger cities like New York and Chicago also have restrictions in place, although NATO is fighting the ban in Chicago.

Along with flavors, local legislators are taking aim at other targets including pricing standards for tobacco products and package size restrictions (mainly for cigars).

Raising the minimum legal buying age for tobacco products is also becoming a trend. The federal minimum age stands at 18, but several state and local lawmakers have put forth proposals to up the age to 19 in some places, and as high as 21 in other locales.

On the state level, Hawaii became the first to raise its purchasing age to 21 statewide — the regulation went into effect Jan. 1. Similar statewide legislation failed to pass in 12 other states in 2015. But such measures are once again making an appearance this year.

Case in point: As of early March, California lawmakers had approved a statewide increase in the purchasing age to 21. At press time, the bill was awaiting Gov. Jerry Brown’s signature.

On the local level, there are individual cities with higher purchasing ages, as well. Currently, there are six local ordinances setting the age at 21 in California, five in Ohio, three in Missouri, 15 in New Jersey, and a staggering 73 in Massachusetts, Briant cited.

On the other hand, 19 states have pre-emptive laws so that local municipalities cannot adopt a minimum legal buying age higher than the state’s minimum.

While the industry still anxiously awaits the final deeming rule — the FDA’s first step in regulating tobacco products not specifically spelled out already in the Tobacco Control Act — local municipalities across the country are taking action of their own.

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