Manufacturers, Health Advocates Divided on FDA’s E-Cigarette Proposal
The Food and Drug Administration's plan to regulate electronic cigarettes drew a variety of reactions—with health groups saying the regulatory body took too long to act, but trade groups saying the plan is a good start, even if they have big questions on the details.
The Food and Drug Administration’s plan to regulate electronic cigarettes drew a variety of reactions—with health groups saying the regulatory body took too long to act but trade groups saying the plan is a good start, even if they have big questions on the details.
The electronic cigarette—a $2 billion industry complete with its own trade groups—has gone largely unregulated in recent years, despite the reputation of its analog cousin.
But this week, the Food and Drug Administration released a proposal that aims to change that. The regulatory plan, in the works for the past four years, takes some steps to regulate the devices (including limiting access to minors, something one retail trade group already anticipated), but leaves some other matters up in the air.
The proposal led to an array of reactions from public health and manufacturer groups, including:
Health advocates criticize long gestation: In a series of comments to NBC News, public health groups such as the American Cancer Society and the American Heart Association supported regulation of the products but raised concerns about the amount of advertising the proposed rules allowed as well as the timetable to mandate the regulations. “It should not take several more years for the FDA to be able to specify how it intends to regulate the unfettered marketing of many dangerous tobacco products,” John Seffrin, CEO of the American Cancer Society’s Cancer Action Network, told the news outlet. The Campaign for Tobacco-Free Kids added that it is “inexcusable that it has taken the FDA and the Administration so long to act.”
E-cigarette groups offer praise: Two major trade groups in the space, the Tobacco Vapor Electronic Cigarette Association (TVECA) and the Smoke Free Alternatives Trade Association (SFATA) both released statements largely in favor of the regulatory proposal—particularly its ban on the purchase of such devices by minors. TVECA was more bullish on the proposal, noting its success in working with regulatory bodies in Europe. “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 association stated. “This will not just benefit the ecig 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.” SFATA, meanwhile, spoke favorably about specific parts of the proposal, including the FDA’s decision not to regulate flavored vapors or limit the availability of the liquids used in the devices.
Paperwork challenges: Not every e-cigarette group was so bullish on the regulations. American Vaping Association President Greg Conley offered a statement expressing concerns that the standards would favor larger firms in the field by adding additional “regulatory barriers that will be insurmountable for many small and medium sized electronic cigarette companies” and would inhibit a growing industry. SFATA, which approved of some of the FDA’s regulations but opposed others, took a similar stance on this issue, noting the association has concerns “about any inordinately lengthy product registration or approval process.” The group added that “vaporizing products deserve a new and distinct set of regulations” separate from other tobacco products.
For health advocacy groups, the somewhat warm response to the proposal from e-cigarette manufacturers was a red flag.
“You should always be suspicious when the tobacco industry applauds something,” the American Cancer Society’s Tom Glynn, the group’s senior director of cancer science, told NBC News.