WASHINGTON, D.C. — We are disappointed that the government today announced that it will not appeal a federal appeals court ruling that the Food and Drug Administration cannot regulate electronic cigarettes as drugs and devices. That ruling opened a loophole that would allow manufacturers to add nicotine to a wide range of products without the stringent regulation traditionally applied to smoking cessation medications and other non-tobacco products to which nicotine has been added.
However, the FDA today has taken appropriate action to protect public health by announcing that it intends to assert authority over other tobacco products that meet the statutory definition of “tobacco products” under the landmark 2009 tobacco regulation law. This includes regulating e-cigarettes as tobacco products, as the appeals court suggested.
The 2009 law specifically directed the FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. It also authorized the agency to extend its authority to other categories of tobacco products and to determine which regulations that Congress applied to cigarettes and smokeless tobacco products should apply to other tobacco products.
The FDA’s decision to assert jurisdiction over other tobacco products in light of the electronic cigarette decision is important because it will help prevent tobacco companies from creating loopholes and circumventing the law. Already, some companies have sought to evade a ban on flavored cigarettes by marketing flavored little cigars, and the FDA recently concluded that its current authority does not include certain non-traditional smokeless tobacco products. The FDA’s assertion of authority over other tobacco products will make it clear what products are subject to regulation and help prevent future evasions of the law.
It is important to note that the FDA today has taken only the first step by announcing its intention to extend its authority to other categories of tobacco products. Once it has asserted jurisdiction, the agency will then establish a regulatory scheme appropriate to each category of products.
With regard to e-cigarettes, the FDA should quickly assert jurisdiction and issue specific regulations protecting public health, including restrictions on marketing, sales to anyone under 18, health claims and product quality. The FDA should also make it clear that it will regulate any e-cigarettes that make smoking cessation claims, which many do, as drugs and devices and subject them to the same rigorous scientific review as other smoking cessation products.
The FDA’s rigorous regulation of tobacco products is critical to reduce the toll of death and disease from tobacco, which kills more than 400,000 Americans annually and is the number one cause of preventable death in the United States and around the world.