The FDA soon will regulate e-cigarette makers and distributors. The rules present new hurdles for manufacturers of existing e-cigarette products as well as future products. The new “deeming regulations” restrict youth access to e-cigarettes and extend certain regulations that apply to traditional tobacco products to e-cigarettes.

On May 5, 2016, the U.S. Food and Drug Administration announced its regulatory authority over e-cigarettes. Rules aimed at restricting youth access are effective as soon as August 2016. While the announcement did not come as a surprise—the FDA proposed regulations over two years ago—many in the industry argue that the FDA has overstepped its authority.

The FDA’s authority to regulate e-cigarettes is grounded in the Family Smoking Prevention and Tobacco Control Act of 2009. The Act gives the FDA the power to regulate production, distribution, and marketing of tobacco products. But before May 5, no federal law prohibited retailers from selling e-cigarettes, hookah tobacco, or cigars to people under age 18. In the absence of federal rules, many states took action. All but three states (Maine, Michigan, and Pennsylvania) restrict youth access to e-cigarettes in some way.

But some state laws may no longer be effective. The new FDA rules explicitly identify certain areas where local and state action could be preempted—namely laws relating to tobacco product manufacturing standards and labeling (detailed below).

The new FDA regulations are aimed at restricting youth access to e-cigarettes, including:

  • Prohibiting the sale of e-cigarettes to people under 18 (both in person and online);
  • Requiring age verification by photo ID;
  • Prohibiting the sale of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Prohibiting the distribution of free samples.

 

The new rules have a second component: to receive FDA marketing authorization, they require manufacturers, importers, and retailers of e-cigarette products introduced after February 15, 2007, to show that the products meet applicable public health standards. The so-called “deeming rule” extends those provisions that regulate traditional tobacco products to e-cigarettes. Notable provisions include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients and harmful and potentially harmful constituents to the FDA;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Prohibiting the sale of modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

 

The rules allow manufacturers to continue selling their products for up to two years while they navigate the FDA’s new approval process. Sales can continue for an additional year while the FDA reviews manufacturer submissions.

For manufacturers, the main concern is cost. While Mitch Zeller, director of the FDA, estimated that the new approval process will cost “several hundred thousand dollars,” industry advocates anticipate costs in the millions.

Nicopure Labs LLC, a company that manufactures the liquid solution for e-cigarettes, has already sued to challenge the new regulations. Nicopure contends that the FDA’s rulemaking process violated the Administrative Procedure Act, and that the rules violate the First Amendment by “prohibiting manufacturers from making truthful and nonmisleading statements regarding vaping devices, e-liquids, and related products.” The company further argues that the FDA ignored evidence that e-cigarettes are safer than traditional tobacco products.

E-cigarette manufacturers are not the only ones challenging the FDA’s deeming rule. A House committee recently approved legislation that would prevent the FDA from retroactively requiring pre-market review of products introduced after February 15, 2007. The new legislation would limit the rule to new products. The Senate has yet to weigh in on the FDA’s e-cigarette regulations, but the chairman of the Senate Homeland Security and Governmental Affairs Committee recently sent a letter to the FDA commissioner raising concerns about the new regulations.