FDA Affirms Its Intent to Regulate E-Cigarettes As Combination Drug/Device Products

By Nisha P Shah –

In a letter to the Electronic Cigarette Association, FDA stated its intention to regulate electronic cigarettes (also referred to as e-cigarettes or e-cigs) as drug products.  Specifically, FDA maintained that e-cigarettes “meet the definitions of both a drug and device under the [Federal Food, Drug, and Cosmetic] Act and the definition of a combination product … with a drug primary mode of action.”  Therefore, to market these products, FDA states that companies will have to comply with the drug approval process, which includes submission of an investigational new drug ("IND") application and completion of the new drug approval process.

FDA also issued Warning Letters to five distributors of electronic cigarettes for certain violations of Federal Food, Drug, and Cosmetic Act, including making unsubstantiated drug claims and poor manufacturing practices.  In the letters, FDA claims that e-cigarettes are devices intended to deliver a drug, nicotine, and points to the fact that the corresponding marketing materials and websites are unlawfully promoting e-cigarettes as smoking-cessation aids.  Because the products are being marketed as smoking cessation aids, FDA warns that the products must receive premarket approval.

Earlier this year, the District Court for the District of Columbia ruled that FDA cannot regulate e-cigarettes as combination drug/device products absent a showing that the products are intended to assist in treating nicotine addiction or to “affect the structure or function of the body in a way distinguishable from ‘customarily marketed’ tobacco products” (see our prior post here).  That case is under appeal.