The FDA's jurisdiction over tobacco has undergone serious changes over the years. In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (the FDC Act.) In 1996, the FDA asserted its jurisdiction under the FDC Act to regulate tobacco and smokeless tobacco products. This assertion went largely unchallenged until the Supreme Court heard FDA v. Brown & Williamson Tobacco Corp. and, in 2000, issued its decision finding that the FDA lacked jurisdiction over tobacco products since they are not drugs commonly prescribed for a therapeutic benefit.
Following this decision, Congress passed the Family Smoking Prevention and Tobacco Control Act, which amended the FDC Act to restore jurisdiction to the FDA by specifically designating the agency's authority to regulate tobacco and smokeless tobacco products. As such, the following references to the FDC Act should be understood to refer to the authority under the act as amended by the Family Smoking Prevention and Tobacco Control Act.
General Questions
Q: Why does the regulation of cigarettes and smokeless tobacco by the Food and Drug Administration (FDA or the Agency) result in preemption of some state and local requirements pertaining to these products?
A: The FDA is regulating cigarettes and smokeless tobacco as nicotine-delivery devices, pursuant to the Agency's statutory authority under the FDC Act. State and local requirements pertaining to cigarettes and smokeless tobacco may be preempted under Section 521(a) of the FDC Act (21 U.S.C. 360k(a)) which states that:
No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--
- which is different from, or in addition to, any requirement applicable under [the FDC Act] to the device, and
- which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the FDC Act].
For State or local requirements that are preempted, State or local governments may seek exemptions from preemption pursuant to section 521(b) of the FDC Act.
Q: What types of requirements are preempted? What types of requirements are not preempted?
A: With regard to cigarettes and smokeless tobacco, section 521(a) of the FDC Act preempts only those State and local requirements that, in fact, clearly impose specific requirements with respect to these products that are manifestly different from, or in addition to, analogous FDA requirements under the FDC Act.
For example, a State or local requirement that establishes a minimum age higher than 18 years for persons purchasing cigarettes or smokeless tobacco would be preempted because such a requirement is "different from" 21 CFR part 897 (FDA's final rule), which establishes 18 as the minimum age for purchasers. Similarly, a State or local requirement prohibiting all billboard advertising of cigarettes or smokeless tobacco would also be preempted because it is different from FDA's final rule, which allows some billboard advertising.
In contrast, a State or local requirement establishing age limits for persons selling cigarettes or smokeless tobacco would not be preempted because FDA's final rule does not establish analogous requirements. Similarly, a State or local licensing requirement for retailers or a State or local tax on cigarettes or smokeless tobacco would not be preempted because the final rule does not establish analogous requirements. In addition, a State or local requirement that is identical to a requirement under FDA's final rule or the FDC Act would not be preempted because it would not be "different from, or in addition to," any requirement.
Additional information on this issue can be found in 21 CFR 808.1, in the Federal Register of August 28, 1996 (61 FR 44396, at 44548-550), and in the Notice published in the Federal Register of November 7, 1996 (61 FR 57685).
Q: What happens if a State or local requirement is the same as a requirement under FDA's final rule, but the penalties for a violation of the State or local requirement differ from the penalties for a violation of the requirement under the final rule?
A: The penalties for a violation of a State or local requirement may differ from the penalties for a violation of an analogous requirement under FDA's final rule as long as the underlying State or local requirement is not itself different from, or in addition to, the Federal requirement.
Exemptions from Preemption
Q: What type of requirements will be granted exemptions from preemption?
A: Section 521(b) of the FDC Act authorizes the FDA to exempt a State or local requirement from preemption if:
- The State or local requirement is "more stringent" than a requirement under the FDC Act that would be applicable to the device if an exemption were not in effect; or
- The State or local requirement is "required by compelling local conditions" and "compliance with the regulatory requirement would not cause the device to be in violation of any applicable requirement" under the FDC Act.
Q: What would qualify as a "more stringent" requirement?
A: FDA regulations interpret the phrase "more stringent" as referring to "a requirement of greater restrictiveness or one that is expected to afford to those who may be exposed to a risk of injury from a device a higher degree of protection than is afforded by a requirement applicable to the device under [the FDC Act]." See 21 CFR 808.3(c).
So, for example, a State or local requirement that prohibits all sales from vending machines would be "more stringent" because it would be more restrictive than the requirements in part 897 (which permit vending machines in "adult-only" facilities). A State or local requirement that prohibits all outdoor advertising would be more stringent because FDA's regulation only restricts outdoor advertising within 1,000 feet of a school or public playground.
Q: What constitutes "compelling local conditions?"
A: FDA regulations interpret the phrase "compelling local conditions" as including "any factors, considerations, or circumstances prevailing in, or characteristic of, the geographical area or population of the State or political subdivision that justify exemption from preemption." See 21 CFR 808.3(b).
Procedures for Requests for Exemption from Preemption
Q: How does a State or local government request an exemption from preemption?
A: State and local governments that want to seek an exemption from preemption should submit an application for exemption to FDA. The application consists of a letter to the Commissioner of Food and Drugs, which is accompanied by supporting information and materials. Details regarding the requirements for the application can be found in 21 CFR 808.25 and in the Notice published in the Federal Register of November 7, 1996 (61 FR 57685) and revised April 1, 2015.
In order to facilitate and expedite review of applications involving State and local requirements pertaining to cigarettes and smokeless tobacco, the FDA will consider the applications in two separate groups. The groups, which are based on the effective dates for different requirements under FDA's final rule, are as follows:
- GROUP 1: State and local requirements governing the sale or distribution of cigarettes or smokeless tobacco that are different from, or in addition to, FDA requirements under Section 897.14(a) and Section 897.14(b) of the final rule. Section 897.14(a) prohibits retailers from selling cigarettes or smokeless tobacco to anyone younger than 18 years of age. Section 897.14(b) requires retailers (except in certain situations) to verify, by means of photographic identification containing the bearer's date of birth, that the person purchasing the product is not younger than 18 years of age. No such verification is required for any person over the age of 26.
- GROUP 2: State and local requirements governing the sale or distribution of cigarettes or smokeless tobacco that are different from, or in addition to, all other FDA requirements under the final rule.
State and local governments that want to file an application for exemption from preemption for such requirements should submit a separate application for each group.
Q: What procedure will the FDA use in considering applications for exemption from preemption?
A: Because the FDA anticipates that the issues raised within each group by the applications for exemption will be similar or related, the agency intends to consolidate all of the applications within each group and to use a separate proceeding for each of the two groups. The FDA notes that the Agency has consolidated proceedings on such matters in the past (e.g., hearing aids). The process for each consolidated proceeding will be as follows:
- Upon receipt of an application, the FDA will evaluate the application on its own merits and the circumstances applicable to the jurisdiction submitting the application in order to determine whether to grant or deny an exemption.
- The FDA will issue a single Federal Register document (proposed rule) for each group that will, for each applying State or local government, propose to grant or deny exemptions from preemption for existing State and local government requirements that fall within that group. At the same time, the FDA will issue a notice in the Federal Register providing an opportunity to request an oral hearing. If a hearing is requested and granted, it will cover all applications for exemption from preemption for those requirements that fall within the applicable group, and it will be conducted under FDA regulations in 21 CFR parts 15 and 808.
- For each group, the FDA will review all written comments submitted on the proposed rule and the administrative record of the oral hearing, if an oral hearing is granted, and will publish in the Federal Register a final rule identifying each requirement for which an exemption from preemption is granted, conditionally granted, or denied.
Specific details regarding the procedures under which applications will be processed can be found in 21 CFR 808.25.
Q: When can applications for exemption from preemption be submitted?
A: Applications for exemption from preemption for existing requirements that are preempted may be submitted now or at any time in the future. The application process will permit the FDA and State and local governments to act on requests for exemption from preemption before the provisions in the FDA's final rule become effective. Once the final rule becomes effective, State or local requirements that are preempted may not be enforced unless and until exemptions are granted.
Applications should only be submitted for those requirements that have the force and effect of law, i.e., have been enacted, promulgated, or issued in final form. However, an application may be submitted after the establishment of the statute or regulation by the State or local government, but before the effective date of the requirement. To the extent that requirements are enacted, promulgated, or issued in final form in the future, and such requirements are preempted under section 521(a) of the FDC Act, State or local governments may submit applications for exemption from preemption for such requirements at that time.
Q: Who can submit an application for exemption from preemption?
A: The application is submitted by a State or local government and is signed by an individual who is authorized to request an exemption from preemption on behalf of the State or local government. The grant of authorization to request an exemption is at the discretion of the State or local government submitting the application. In the past, most applications for exemption from preemption have been signed by a State's Attorney General. In some States or localities, other officials may also be authorized under State or local law to submit requests.
Q: Can State and local governments submit joint applications?
A: Nothing in the FDC Act or the FDA's regulations prohibits submission of joint applications. However, any joint application submitted must comply with the requirements established under 21 CFR 808.20. Thus, for example, the joint application would need to be signed by individuals who are authorized to request the exemption on behalf of each State or local government participating in the joint application. See 21 CFR 808.20(b).
Moreover, the joint application would need to include the required information for each requirement for which an exemption was being sought. See 21 CFR 808.20(c).
Advisory Opinions
Q: What is an advisory opinion? Why would a State or local government request an advisory opinion?
A: An advisory opinion represents the FDA's formal position on a matter of general applicability. See 21 CFR 10.85. If the preemptive status of a State or local requirement is unclear, any State, political subdivision, or other interested person may request an advisory opinion from the FDA.
It should be noted that the timeframes before requirements under the FDA's final rule become effective and have preemptive effect are fairly short. Thus, for time considerations, a State or local government may want to submit an application for exemption from preemption for a specific requirement rather than seeking an advisory opinion.
Q: Can an advisory opinion be converted to an application for exemption from preemption?
A: Yes. The FDA, in its discretion and after consulting the State or political subdivision, may treat a request by a State or political subdivision as an application for exemption from preemption. See 21 CFR 808.5(a)(2).
Other Questions
Q: What if a State requirement that had a preemptive effect on a local requirement is itself preempted by the FDA's final rule? Would the formerly-preempted local requirement remain preempted, or would it become effective?
A: Questions, such as this, regarding the interrelationship between Federal, State, and local laws are extremely complex and fact-based and can only be answered on a case-by-case basis, after a careful examination of the specific requirements involved. However, there may be instances where a local requirement would no longer be preempted by the State requirement once the State requirement was itself preempted by the FDA's final rule. It should be noted, however, that in such instances, the local requirement may then be preempted under section 521(a) if the local requirement is different from, or in addition to, an analogous Federal requirement under the FDA's final rule or the FDC Act.
Q: Does the issuance of the FDA's final rule preclude enactment of new tobacco control measures by State or local governments?
A: The issuance of the FDA's final rule does not in any way preclude State and local governments from enacting new tobacco control measures. The FDA recognizes the pioneering and continuing role in the area of regulation of youth access to tobacco products that States have played, particularly certain active tobacco-control States. Federal cooperation with, and continued reliance upon, innovative and aggressive State and local enforcement efforts is essential.
The FDA notes that State and local governments will need to submit applications for exemption from preemption for future-enacted State or local requirements that are different from, or in addition to, analogous Federal requirements under the FDA's final rule or the FDC Act.