WASHINGTON -- Speaking on a media conference call Thursday, Secretary Kathleen Sebelius of the U.S. Department of Health & Human Services (HHS) announced that the U.S. Food & Drug Administration (FDA) has issued an initial "deeming rule" that once finalized, will give the federal government jurisdiction over regulating electronic cigarettes and other tobacco products it does not currently control.
The rule aims to reduce tobacco use among Americans, especially youth.
Citing a study that showed how the use of e-cigarettes doubled among middle- and high-school students in the United States from 2011 to 2012, officials said the deeming rule is designed to bring e-cigarettes and other products derived from tobacco under the FDA umbrella of regulated commerce. These products can include e-cigarettes, cigars, pipe tobacco, dissolveables, nicotine gels and water-pipe tobacco, among other things.
Conceding that FDA did not know the “ramifications on health or have a full understanding if [these products] are a gateway to the use of regular [cigarettes],” Sebelius said the issuance of the proposed rule and eventual finalization of the FDA’s jurisdiction would allow for greater control over these new products in terms of ingredients, how they are made and accountability for what they claim to do, especially with regards to alleged health benefits.
While the proposed rule claims jurisdiction, FDA officials deferred on a number of matters, including just how certain products ought to be regulated, and even placed some issues outside the scope of today’s action, in particular, regulation over flavors of products and television and radio advertising.
She then turned much of the conference call to colleagues Margaret Hamburg, commissioner of food and drugs for the FDA, and Mitch Zeller, director of the Center for Tobacco Products within the FDA.
As of today, the proposed rule will undergo a public comment period for 75 days, which Hamburg said wouldn’t necessarily be the timeframe by which the rule would be finalized. That said, she did feel there was a “sense of urgency” to put the rules into play. Zeller said that once enacted, several things would move to quick enforcement, including anything having to do with the sale of products to underage customers, health-warning labels, vending machine sales, sampling bans and requirements to register, identify ingredients and not to misbrand or imply claims of health.
Zeller also suggested that the FDA was most interested in nuances, saying it had options to regulate all items that meet the definition of being a tobacco product in the same way, or having different rules for specific products such as premium cigars.
Additional Testing
Hamburg and Zeller both referred to additional testing that is currently under way to determine just how the public is using these products, the results of which would affect regulations that would subsequently emerge.
As an example, Zeller said a person with a pack-a-day cigarette habit who switched totally to e-cigarettes may lessen his or her health risk. But a smoker who uses e-cigarettes as a way to avoid kicking the habit, may not be achieving a higher level of health.
The other aspect of the rule that the two officials discussed in more detail was its initial limitations. Calling it a “foundation” and a “walk before you run” step, they said the rule was meant to initially establish jurisdiction over these products.
Currently, there is no regulation over these products—even to the extent of age restriction. Also, news accounts have said some of the devices have exploded while charging, according to Zeller, who called the category “the wild, wild West.”
Establishing jurisdiction would compel manufacturers to register new products, provide ingredient information and insight on how they made their products. It would broaden the research process already begun by the FDA and then move to involve manufacturers. Thus, additional issues like regulation over flavors or TV and online advertising, could then be taken on as separate matters, involving their own discovery timeframes and individual rulings.
The current proposal, once finalized, would require manufacturers to submit an application for FDA approval within a two-year timeframe. By doing so, it would allow for manufacturers to continue to produce, advertise and sell product while awaiting the FDA’s decision. Beyond that timeframe, all new products would have to await approval before going to market.
Zeller expressed confidence in the FDA’s ability to move on new applications, saying it has cleared any existing backlog in this category and is ready to move on new cases.
Sebelius thanked her team and said the move was one of many—including drug-store chain CVS deciding to stop selling tobacco, the state of Georgia banning smoking on college campuses and the FDA’s own media campaign to convince teens to stop smoking—as major efforts “to make the next generation of Americans tobacco free.”
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