Are E-Cigarettes Regulated by the FDA?

E-cigarettes are battery-powered devices that provide inhaled doses of nicotine through a vaporized solution contained in cartridges inserted into the device. No smoke or combustion is involved; the device emits only vapor when used.

E-cigarettes may be legally sold in the United States under federal law. In 200, the U.S. Food and Drug Administration (FDA) sought to establish authority over e-cigarettes as drugs or drug delivery devices, but in 2010 a federal appeals court ruled the FDA does not have that authority.[1] The ruling does not necessarily apply to all e-cigarettes on the market. If an e-cigarette company markets its products as a smoking cessation aid, the FDA may still have the authority to regulate it as a drug or drug delivery device.

History of the FDA’s Attempt to Regulate E-Cigarettes

In 2008, the FDA moved to establish authority over e-cigarettes as drugs or drug delivery devices by blocking the import of new e-cigarette shipments into the United States. The FDA has authority to regulate “drugs,” “devices,” or drug/device combinations through the Food, Drug and Cosmetic Act.[2]

In 2009, the e-cigarette manufacturer Sottera, which makes NJOY e-cigarettes, sued the FDA. Sottera said the agency didn’t have the authority over e-cigarettes as drugs or drug delivery devices and therefore could not stop shipments from entering the country. The manufacturer asked the federal district court in Washington, D.C., for an injunction (a court order) to prohibit the FDA from continuing to ban incoming e-cigarette shipments.

In January 2010, the district court agreed with the e-cigarette manufacturer and held that the FDA may not regulate e-cigarettes as a drug or drug delivery device. Instead, because the nicotine contained in the e-cigarette cartridges is derived from tobacco, the court held that the FDA may regulate them as a tobacco product.

The FDA appealed the lower court’s ruling to the federal Court of Appeals in Washington, DC. A three-judge panel at the Court of Appeals ruled on December 7, 2010 that the lower court was correct. It held that because the NJOY e-cigarettes are not marketed as tobacco cessation aids (such as nicotine gum or patches), the FDA does not have authority over e-cigarettes as a drug or drug delivery device.

The court’s decision limits the FDA’s ability to test NJOY e-cigarettes for safety and prohibits it from banning e-cigarettes entirely. However, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) expressly allows state and local governments to regulate the sale or use of tobacco products, which would include e-cigarettes.[3]

What’s Next for the FDA and E-Cigarettes?

The FDA decided not to appeal the ruling to the U.S. Supreme Court, announcing instead that it plans to issue regulations on e-cigarettes as a tobacco product under the 2009 FDA Law. The FDA's process of establishing authority over e-cigarettes and issuing regulations for them will take some period of time--likely a year or more.

The FDA may still have the authority to regulate e-cigarettes that are marketed as a smoking cessation aid under its power to regulate drugs or drug delivery devices. If so, the FDA could conduct safety tests on these e-cigarettes, ban e-cigarettes that it finds unsafe, or require a doctor’s prescription to obtain e-cigarettes marketed as a smoking cessation aid.[4]

The FDA’s website on e-cigarettes is a good resource for following the agency’s next moves regarding e-cigarette regulation.

Although the FDA's ability to regulate e-cigarettes is somewhat limited, local and state governments may create much stronger restrictions on e-cigarettes, up to and including a complete ban on their sale or use. If you have any questions about the e-cigarette court decision or creating new restrictions on e-cigarettes, please submit your question to us.

For more information about legal limits on e-cigarettes, please see our associated FAQ “Are There Restrictions on the Use or Sale of E-Cigarettes?” and our fact sheet “Electronic Cigarettes: How They Are – and Could Be – Regulated."

[1] Sottera, Inc.  v. FDA, No. 10-5032 (D.C. Cir. 2010).
[2] 21 U.S.C. § 321(g) and (h).
[3] 21 U.S.C. 387p.
[4] 21 U.S.C.A. § 301 et seq.