FDA determination to regulate E-Cigarettes and other smokeless tobacco products -
The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco.
The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.” The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act.
Under the FD&C Act, the definition of “drug” includes articles intended: (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body. Similarly, “device” is defined to include articles intended: (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body.
Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.
The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.
Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.
Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions. Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to premarket review. Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”
FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health.
Lawrence R. Deyton, M.S.P.H., M.D.
Center for Tobacco Products
Janet Woodcock, M.D.
Center for Drug Evaluation and Research