FDA Considering Enhanced Regulation or Ban On Menthol Cigarettes
With the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, (“Tobacco Act”) Congress granted the FDA the authority to regulate all tobacco products marketed within the United States. As part of this expansion of FDA jurisdiction, Congress required the FDA to establish the Tobacco Products Scientific Advisory Committee (“Tobacco Committee”) to provide the FDA with “advice, information and recommendations” regarding the regulation of tobacco in conformance with the Act. Additionally, the Tobacco Committee was charged with studying and issuing a report on the impact of the use of menthol in cigarettes on the public health and recommendations for regulations to develop “a tobacco product standard is appropriate for the protection of the public health.”
In preparation for its full release, the Tobacco Committee has released its draft report, available here, giving insight into possible recommendations. Though the Tobacco Committees draft report reaches the conclusion that “evidence is insufficient to conclude that smokers of menthol cigarettes face a different risk of tobacco-caused diseases than smokers of non-menthol cigarettes,” the report also found that “menthol has cooling and anesthetic effects that reduce the harshness of cigarette smoke” and that “the evidence is sufficient to conclude that it is biological[ly] plausible that menthol makes cigarette smoking more addictive.” As a result of the report, possible recommendations include reduction in the amount of menthol in cigarettes or even a total ban on the use of menthol in cigarettes in order to help make cigarettes less addictive or palatable.
On March 23, 2011, the FDAs Tobacco Products Scientific Advisory Committee is due to submit its report and recommendations to the FDA regarding the health effects of menthol cigarettes. However, two menthol cigarette manufacturers, Lorillard and R.J. Reynolds filed suit to block the committees recommendations. The suit alleges that the committee cannot provide fair advice because three of its members have conflicts of interests, which are expressly prohibited under the Tobacco Act.
The potential ban on menthol cigarettes comes after a 13 year battle over whether the FDA had jurisdiction to regulate cigarettes culminating with Congresss passage of the Tobacco Act of 2009. The battle for jurisdiction to regulate cigarettes began in 1996 when the FDA attempted to regulate cigarettes as drug/device combination products under its authority in the Food, Drug, and Cosmetic Act (“FDCA”). Prior to this time, the FDA asserted that it could only regulate tobacco products under the FDCA if they were sold for “therapeutic uses,” i.e. use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” under 21 U.S.C. § 321(g)(1)(B) of the FDCA. In FDA v. Brown & Williamson, 529 U.S. 120 (2000), the Supreme Court rejected the FDAs argument that the FDCA gave it authority to regulate tobacco products that made no “therapeutic claims” under the FDCA.
As a result of regulatory gap left by Brown & Williamson, Congress passed the Tobacco Act in 2009 to grant FDA the authority to regulate tobacco products as traditionally marketed. However, even with the passage of the Tobacco Act, FDA has still attempted to regulate tobacco products under the FDCA. As we previously reported, on December 7, 2010, the D.C. Circuit Court issued an injunction against the FDA and ruled that the FDA did not have jurisdiction to regulate e-cigarettes under the FDCAs drug/device provisions.
On December 7, 2010, FDAs jurisdiction to regulate tobacco products was summarized by the D.C. Circuit in NJOY v. FDA: 1) Together Brown & Williamson and the Tobacco Act establish that the FDA cannot regulate customarily marketed tobacco products under the FDCAs drug/device provisions; however, 2) the FDA can regulate tobacco products marketed for therapeutic purposes under the FDCA, and 3) the FDA can regulate customarily marketed tobacco products under the Tobacco Act.
It is important to note that tobacco product regulation in the United States also involves the U.S. Customs and Border Protection (CBP) and the U.S. Department of the Treasury, Alcohol, Tobacco, Tax and Trade Bureau (TTB). Additionally, the Department of Justice, Office of Consumer Litigation (OCL) regulates Cigarette labeling and advertising, and the Bureau of Alcohol, Tobacco, and Firearms (ATF) investigates and enforces interstate trafficking of contraband cigarettes. State laws may also be implicated.
Experienced attorneys at FI can help establish calculation of duty including excise taxes and user fees, ensure compliance with invoice, permit, and recordkeeping requirements, ensure legal labeling and product packaging and defend action administrative actions and litigation. If you have questions pertaining to the FDCA or the Tobacco Act or how to ensure that your business maintains regulatory compliance at both the state and federal levels, contact Fuerst Ittleman PL at firstname.lastname@example.org.