E-cigarettes have not been fully studied, so consumers currently don’t know: the potential risks of e-cigarettes when used as intended, how much nicotine or other potentially harmful chemicals are being inhaled during use, or whether there are any benefits associated with using these products. Additionally, it is not known whether e-cigarettes will lead young people to try other tobacco products, including conventional cigarettes, whose health consequences are well documented.
The FDA has issued a proposed rule that would extend the agency’s tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e-cigarettes. 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 free aids or as a cigarette replacement where smoking is banned or frowned upon.
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. Dr. Michael B.Siegel 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.
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.”