ABA Health eSource
June 2010 Volume 6 Number 10

Food and Drug Administration Regulation of Tobacco: New Opportunities and Challenges

By Matthew R. Herington, Montana Department of Public Health & Human Services, Helena, MT

AuthorThe Family Smoking Prevention and Tobacco Control Act

On June 22, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). 1 By amending the Federal Food, Drug, and Cosmetic Act, the Tobacco Control Act, for the first time, expressly gives jurisdiction over tobacco products to the Food and Drug Administration (FDA). As part of this delegation of jurisdiction, the Tobacco Control Act requires that FDA reissue its 1996 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, with certain limited modifications. 2 The Tobacco Control Act notes that the regulations are “deemed to be in compliance with all applicable provisions” of the Administrative Procedure Act. 3

What is in the (New and Improved) Regulations?

The new, modified regulations become effective June 22, 2010. The regulations provide for fairly comprehensive restrictions on the advertising, sale, and distribution of cigarettes and smokeless tobacco to minors. Specifically, the sale of cigarettes and smokeless tobacco to anyone younger than 18 years of age is prohibited. If a person wishing to buy the products is 26 years old or younger, the retailer must obtain photographic identification from the prospective customer to verify that the person is indeed at least 18 years old. 4 Retailers are also prohibited from selling or distributing individual cigarettes or packages that contain less than 20 cigarettes. No quantity of cigarettes or smokeless tobacco that is smaller than the smallest package distributed by the manufacturer for individual use may be sold or distributed either. 5 Another key component of the new rule is that the distribution of free samples of cigarettes and smokeless tobacco, including through the mail, is now severely restricted. 6 The distribution of free samples of cigarettes is now prohibited altogether, while only a limited amount of smokeless tobacco may be distributed as free samples, and only in certain defined facilities. 7 Certain restrictions also significantly curtail advertising methods. In particular, audio advertisements are not permitted to contain any music or sound effects, while video advertisements are limited to static black text on a white background. Any audio soundtrack accompanying a video advertisement is limited to words only, with no music or sound effects. 8 The FDA is empowered by the Tobacco Control Act to conduct inspections of retailers to enforce the regulations, as well as to contract with states to conduct their own inspections. Penalties can be levied against retailers for noncompliance. 9

A part of the regulations that has seen recent controversy is located at 21 CFR 1140.32(a). This is the so-called “tombstone” provision that, with certain exceptions, requires any labeling or advertisements for cigarettes or smokeless tobacco to utilize only black text on a white background; no color is permitted. Several tobacco companies challenged this provision in US District Court, claiming that the provision was “more extensive than necessary to achieve Congress’s goal” of reducing tobacco use by minors. The Court agreed, and quoting from Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001), found that the ban “on all uses of color and images in tobacco labels and advertising has a ‘uniformly broad sweep…[that] demonstrates a lack of tailoring.’” 10 Consequently, the FDA has been enjoined from enforcing this part of the provision. The FDA is currently appealing the decision.

Overall Impact of the New Regulations

Overall, the effect of the regulations will be a net positive for the nation’s health. It is likely that, over time, there will be at a least a small drop in the number of youth who initiate tobacco use as a consequence of the provisions I outlined above. At the same time, however, there is continued cause for concern. The court order barring the FDA from enforcing the “tombstone” provision is worrisome. This is an important provision, as its effect would be to decrease the visibility of tobacco products. Only time will tell as to how this issue will be resolved in the courts. Another serious problem is that the current regulations do not apply to cigars, pipe tobacco, or hookah tobacco, even though these products are used by young people today. In addition, in part as a consequence of the Lorillard decision, the regulations do not restrict outdoor advertising. The FDA, however, is currently beginning a rulemaking process to address this issue. 11 Unfortunately, the Lorillard decision may limit the effectiveness of outdoor advertising regulation. In spite of these misgivings, there is little doubt that the regulations are an important step towards improving the public health of current and future generations of Americans.


1 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009).
2 After the regulations were issued for the first time in 1996, the US Supreme Court ruled in FDA v. Brown & Williamson Tobacco Co., 529 US 120 (2000) that the regulations were improper because Congress had not delegated jurisdiction over tobacco to the Food and Drug Administration.
3 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, § 102, 123 Stat. 1776, 1830 (2009).
4 21 C.F.R. § 1140.14 (2010).
5 Id.
6 21 C.F.R. § 1140.16 (2010).
7 Id.
8 21 C.F.R. § 1140.32 (2010).
9 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, § 103, 123 Stat. 1776, 1833-1841 (2009).
10 Commonwealth Brands, Inc v. United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 2010).
11 Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act, 75 Fed. Reg. 13241 (Mar. 19, 2010).

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