The US Food and Drug Administration proposed measures today that would ban the sale of e-cigarettes to consumers younger than 18, but would not restrict flavoured products, online sales or TV advertising, likely disappointing some public health advocates.
Electronic cigarette advocates lobbied against restrictions on flavours and advertising, saying they would stifle innovation. Critics argue flavours such as strawberry and butterscotch appeal to youngsters, while unrestricted advertising threatens to make the products glamorous and could act as a gateway to traditional cigarettes.
If finalised, the long-awaited proposal would subject the $2 billion e-cigarette industry to federal regulation for the first time. A law passed in 2009 gave the FDA authority to regulate cigarettes, smokeless tobacco and roll-your-own tobacco and stipulated the agency could extend its jurisdiction to other nicotine products after issuing a rule to that effect.
FDA Commissioner Margaret Hamburg said at a briefing that the proposal represented the first "foundational" step towards a broader set of potential regulations that would establish quality standards and include restrictions on flavoring and marketing.
The current proposal "lays the foundation for many more actions and activities," she said.
In the short term, the rules would prohibit companies from distributing free e-cigarette samples, forbid vending machine sales except in adult-only venues and prohibit sales to minors.
Companies would be required to warn that nicotine is addictive, but no other health warnings would be required. The addiction warning would have to be added no later than two years after the rule is finalised. They would not be able to make health claims in any advertising.
The proposal is subject to a public comment period of 75 days.
If finalised, companies would be required to submit new and existing products to the FDA for approval. They would have two years to submit their applications from the time the rule goes into effect. Companies may continue selling their products and introducing new products, pending the FDA's review.
In the meantime, they would be required to register with the FDA and list the ingredients in their products. They would not be required to adhere immediately to specific product or quality control standards. That could come later, Hamburg said.
EVOLVING "VAPING" INDUSTRY
E-cigarettes and other "vaping" devices generate roughly $2 billion a year in the United States, and some industry analysts see e-vapor sales outpacing the $85-billion traditional cigarette industry within a decade.
Advocates of e-cigarettes, battery-powered cartridges that produce a nicotine-laced inhalable vapor, claim they are a safer alternative to smoking traditional cigarettes since they do not produce lung-destroying tar. But there is little data about the long-term safety of the products.
The FDA's proposal leaves many questions unanswered about how new products would be regulated over the long run. One key question relates to the mechanism by which products are approved.
Under the current law, new tobacco products can be approved if they can demonstrate they are "substantially equivalent" to a product that was on the market before February 15, 2007. It is unclear, however, whether any e-cigarettes were on the market before that date to be used as a benchmark.
Mitch Zeller, head of the FDA's tobacco division, said at a briefing that the agency would be seeking additional information during the public comment period on whether the "substantial equivalence" pathway is even valid for e-cigarettes.
If it turns out not to be, e-cigarette companies would have to apply through a different process that would require them to prove their products are appropriate for public health, a higher hurdle to clear.
Also unclear is the fate of some cigars. The current proposal would include e-vaping products and other tobacco products, but premium cigars may be excluded.
The FDA said it would seek public comment on whether all cigars should be regulated equally. One option proposed by the agency is to regulate them all. The other is to define a category of premium cigars that would not be subject to the FDA's authority.
Under the proposed rule, premium cigars are considered those wrapped in whole tobacco leaf, made manually by combining the wrapper, filler and binder, have no characterising flavour, have no filter, tip, or non-tobacco mouthpiece and are relatively expensive.
Tobacco company Lorillard Inc, owner of the blu e-cigarette brand, is the dominant player in the field, followed by privately held NJOY and LOGIC Technology. The three account for an estimated 80 percent of the market.