FDA Releases Long-Awaited E-Cig Rules

WASHINGTON, D.C. – Three years after saying it would regulate electronic cigarettes as tobacco products, the Food and Drug Administration (FDA) finally released its proposed regulations today.

The agency has the authority to regulate tobacco products under the Family Smoking and Tobacco Control Act of 2009, but the FDA must issue deeming regulations to extend its authority to cover additional tobacco products. Products included in today's proposal include electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and certain dissolvables not already under the FDA's authority.

The agency currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

The new proposed regulations call for minimum age and identification restrictions to prevent sales of the products to underage youth; requirements to include health warnings; and prohibition of vending machine sales unless in a facility that never allows minors, such as bars and nightclubs.

With the effects of electronic cigarettes on public health still largely unknown, the warning labels for e-cigarettes will only be addictive warnings, Mitch Zeller, director of the FDA's Center for Tobacco Products, said during a briefing today.

According to the FDA, under the proposed rules, manufacturers of newly deemed tobacco products would, among other requirements:

• Register with the FDA and report product and ingredient listings;
• Only market new tobacco products after FDA review;
• Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim, and that marketing the product will benefit public health as a whole; and
• Not distribute free samples.

"This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products," stated FDA Commissioner Margaret A. Hamburg. "Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth."

What's Next?

The public now has 75 days to comment on the proposed deeming regulations. While all comments, data, research and other information submitted to the docket will be considered, the FDA is specifically requesting comments in certain areas:

• The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
• The FDA seeks answers to the many public health questions posed by products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products. The FDA seeks comment in this proposed rule as to how such products should be regulated.

The agency is also proposing different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.

What's Missing?

Industry watchers were expecting the proposed regulations to closely mirror those of cigarettes, which the FDA began implementing in 2009.

While the proposal released today does include some components of cigarette regulations, it does not do not immediately call for a flavor ban, restrictions on marketing such as television advertising, a ban on online sales, or set product standards.

Any future regulations will require separate rulemaking and public comment once the proposed deeming rule is finalized. In order to impose restrictions on marketing and advertising, for example, the FDA must first have jurisdiction over the products, which is what deeming regulations accomplish, Zeller said.

"It is sort of walk before you run," he explained.

Zeller added that although online sales are not prohibited under the proposal, online sales will be subject to the age restriction once the rule is finalized

Bonnie Herzog, managing director of beverage, tobacco and convenience store research at Wells Fargo Securities LLC, pointed out that the FDA cannot enact a federal tax on e-vapor products or ban Internet sales because those actions fall under the realm of Congress. In addition, the agency cannot legally ban e-cigarette advertising because it is considered "commercial speech," which is protected by the First Amendment, she said.

"We believe the process could take as long as two years before final regulations are implemented given the rulemaking process, though some items will need to be complied with immediately," Herzog concluded.