As electronic cigarettes soar in popularity, the U.S. government Thursday is proposing historic rules to ban their sale to minors and require warning labels as well as federal approval.
Three years after saying it would regulate e-cigarettes, the Food and Drug Administration is moving to control not only these battery-powered devices but also cigars, pipe tobacco, hookahs (water pipes) and dissolvable tobacco products. Currently, the FDA regulates cigarettes, roll-your-own tobacco and smokeless products such as snuff.
The proposed rules won't ban advertising unless the products make health-related claims nor will they ban the use of flavors such as chocolate or bubble gum, which public health officials say might attract children.
"This is an important moment for consumer protection," said FDA Commissioner Margaret Hamburg, noting tobacco remains "the leading cause of death and disease in this country." The rules will require manufacturers to report their ingredients to the FDA and obtain its approval. They also ban free tobacco samples and most vending-machine sales.
"Some of these regulations will be very restrictive," said Ray Story, founder of industry group TVECA (Tobacco Vapor Electronic Cigarette Association), who added he obtained his own pre-release copy of the rules. He said they could be costly for smaller businesses and slow the growth of a product that advocates say has helped many smokers kick the habit.
Still, Story said, consumers might benefit, because "it provides them a product that will be consistent." E-cigarettes contain varying ingredients and levels of nicotine that are heated into a vapor that users inhale in a practice known as "vaping." Most look like conventional cigarettes but some resemble everyday items such as pens and USB memory sticks.
The rules come as e-cigarette sales, buoyed by TV ads with Hollywood celebrities , have soared in recent years and debate has risen about whether the devices are more apt to lure kids toward tobacco or help adults quit smoking.
An increasing number of states have cracked down by extending indoor smoking restrictions to e-cigarettes. Last month, U.S. poison centers reported a surge in illnesses linked to the liquid nicotine used in the devices.
While they don't contain many of the harmful chemicals of conventional cigarettes, the FDA found trace amounts of toxic and carcinogenic ingredients in several samples in late 2008 when the e-cigarette market was just beginning in the United States. It sought to regulate them as drug-delivery devices, but in 2010, a federal judge ruled it could only do so if they made therapeutic claims. So in April 2011, the agency said it would regulate them as tobacco products, because the nicotine is derived from tobacco leaves.
"It's taken more than three years to issue a proposed rule, which we think is inexcusable," said Vince Willmore of the Campaign for Tobacco-Free Kids, an anti-smoking group. "It's allowed a Wild West marketplace with irresponsible marketing and no control over the product." He says the FDA should quickly finalize the rules, which face a 75-day public comment period and further review.
The proposed rules walk a narrow path. They will require tobacco products that weren't on the market by Feb. 25, 2007 — a date set by a federal law — to apply for FDA review within 24 months after the rules are issued. The products can stay on the market pending FDA's review, says Mitch Zeller, director of FDA's Center for Tobacco Products, adding they can seek an exemption from additional reviews if minor changes are made.
Despite these requirements, the proposal doesn't contain the marketing restrictions sought by some critics that were almost sure to trigger litigation. Craig Weiss, CEO of NJoy, a top-selling e-cigarette, said he supports "reasonable regulation" but would "respond very forcefully to any attempt to limit my free speech right to promote my product."
Several dominant e-cigarette manufacturers, which now include the nation's three largest cigarette makers — Philip Morris, R.J. Reynolds and Lorillard — have embraced limited regulation such as a ban on sales to minors. Yet they've argued that their e-products shouldn't be regulated as tightly as conventional cigarettes — an approach the FDA appears to be taking.
The FDA said the rule aims to bolster product safety. It said since e-cigarettes have not been fully studied, consumers have no way to know how much nicotine or other chemicals they contain and whether they're safe or beneficial.
FDA's 20-year road to regulating tobacco:
August 1996: FDA issues rules to ban tobacco sales to minors and its advertising near schools or playgrounds
March 2000: U.S. Supreme Court, in 5-4 decision, rules that Congress did not give FDA such authority
December 2008: FDA, after detaining import shipments of e-cigarettes, declares they're unapproved drug delivery devices
April 2009: E-cigarette distributor Smoking Everywhere files suit against the FDA, joined a month later by Sottera (doing business as NJOY)
June 2009: Congress passes law granting FDA authority to regulate tobacco products
January 2010: U.S. District Court for the District of Columbia bans FDA from stopping e-cigarette imports
June 2010: FDA issues final rules to ban the sale of cigarettes and smokeless tobacco to minors and to restrict their marketing
December 2010: U.S. Court of Appeals for the D.C. Circuit, upholding lower court decision, rules e-cigarettes can be regulated as tobacco products but not as drugs/devices unless marketed for therapeutic purposes
April 2011: FDA says it intend to expand to its authority over tobacco products to include e-cigarettes
June 2011: FDA issues new graphic warning labels that will need to be placed on cigarette packs and ads by Sept. 2012
April 2014: FDA proposes rules to regulate e-cigarettes and cigars as tobacco products