For the first time, the Food and Drug Administration has extended its tobacco-oversight authority to e-cigarettes, cigars, and pipe tobacco, but antismoking advocates say the regulations don’t go far enough.
The FDA proposed Thursday a ban on the sale of e-cigarettes and other newly regulated products to persons under 18. It also required the products to carry warning labels about the addictive nature of nicotine. E-cigarettes, cigars, and pipe tobacco would be treated like traditional combustible cigarettes under the new rules. E-cigarettes vaporize nicotine, different from traditional combustible cigarettes which burn tobacco, a process known to release carcinogens.
Sen. Dick Durbin, an Illinois Democrat who has been among those in Congress pushing the FDA to regulate the e-cigarette market, called the FDA’s announcement “a political compromise” with the tobacco industry.
“Prohibiting sales to kids but doing nothing to protect children from candy-flavored marketing in children’s venues is an awful outcome,” Durbin said in an email. “Parents across America lost their best ally in protecting their kids from this insidious product.”
Although the agency has had the power to set guidelines for the e-cigarette market since 2009, when Congress passed the Tobacco Control Act, years of meetings with industry lobbyists and antismoking advocates led to Thursday’s regulations, seen by many as a “first step” in determining just how the FDA should assert its power over the growing e-cigarette industry.
“There’s so much potential for e-cigarettes to be safer,” said David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the Legacy Foundation, an antismoking nonprofit devoted to tobacco control. “If people switch to good-quality, regulated e-cigarettes, we could see a drop in the death and disease rates caused by traditional combustible cigarettes.”
The new regulations set the stage for the FDA to begin testing products on the market to determine their impact on public health. They also allow the FDA to monitor for quality control the market that was once described by Commissioner Margaret Hamburg as the “Wild, Wild West.”
Makers would have to register their products with the FDA and disclose ingredients. New tobacco products could only be marketed after FDA approval. Claims of products having a reduced risk of death and disease could only be marketed with scientific evidence.
“Tobacco-related disease and death is one of the most critical public-health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a press release. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”
The proposed rule sets in motion a 75-day comment period. Final regulations could take up to a year, antismoking advocates say.
One industry lobby group, the Tobacco Vapor Electronic Cigarette Association, said the FDA’s move will add necessary oversight to the e-cigarette market.
“This will help the industry thrive as it will demand that those irresponsible players adhere to rules and regulations that the responsible industry already abides by,” the group wrote in a letter posted online. “This will not just benefit the e-cig industry but ultimately the end user, as they will now get a reliable and consistent product that has been manufactured with the highest degree of oversight and control.”
But antismoking advocates, while pleased that the FDA had asserted its authority after a long wait, said what was missing from the proposal was worrisome.
The FDA did not propose restrictions on radio and television advertising, or limitations on candy-flavored products, which representatives from the American Cancer Society’s Cancer Action Network said were used by tobacco companies to hook youth.
“We think it’s critical that the FDA move as quickly as possible to address the advertising strategies and the design of the products that are clearly designed to be attractive to kids,” said Gregg Haifley, ACSCAN’s associate director of federal relations.
The FDA also proposed exempting premium cigars from oversight.
“There are health consequences associated with tobacco products, and we don’t think any should be exempt from regulation by the FDA,” Haifley said.