21 U.S.C. § 387a–1 — Final rule

(a) Cigarettes and smokeless tobacco (1) In general: The Secretary of Health and Human Services must publish a final rule about cigarettes and smokeless tobacco. It must come out on the first day the Federal Register is published that is at least 180 days after June 22, 2009. This rule counts as issued under the tobacco chapter of the Food, Drug, and Cosmetic Act, and counts as following all the normal rulemaking procedures under chapter 5 of title 5 and other rulemaking laws. (2) Contents of rule: The final rule must be almost identical to the FDA regulation published in the Federal Register on August 28, 1996 (part 897). But it must make these specific changes: (A) assign jurisdiction the way this law requires; (B) delete the "Labels" subpart and one related label section; (C) delete three old definitions and replace them with the definitions of "cigarette," "cigarette tobacco," and "smokeless tobacco" used in the Food, Drug, and Cosmetic Act; (D) add "or roll-your-own paper" to the section listing products that aren't cigarettes or smokeless tobacco; (E) adjust one advertising-related section if needed to follow First Amendment court rulings, including the Supreme Court's Lorillard Tobacco Co. v. Reilly decision; (F) take effect one year after June 22, 2009; and (G) rewrite the free-sample rule (section 897.16(d)) as follows. The rewritten free-sample rule: (1) No manufacturer, distributor, or retailer may hand out free samples of cigarettes, smokeless tobacco, or other tobacco products, unless (2) allows it. (2) Free samples of smokeless tobacco are allowed inside a "qualified adult-only facility," though states and local governments can still ban or limit that. A "qualified adult-only facility" must meet six tests: it checks a government photo ID for age at the door; it doesn't sell, serve, or give out alcohol; it isn't next to or across from an area used mainly for marketing to young people; it's a temporary structure built only to hand out smokeless tobacco samples; it's enclosed by an opaque barrier running from no more than 12 inches off the ground to at least 8 feet high (or the ceiling), that outsiders can't see through without real effort; and its outside can't display tobacco ads, a lone brand name, or wording that implies a sponsorship banned under section 897.34(c). Each adult may take home only one package, no more than 0.53 ounces (15 grams) of smokeless tobacco, split into no more than 8 individual portions if divided that way, and distributors must take reasonable steps to enforce this one-package-per-adult-per-day limit. (3) Even under these rules, no one may give free smokeless tobacco samples to a sports team or entertainment group, or at football, basketball, baseball, soccer, hockey, or other events the Secretary names. (4) The Secretary must set up a compliance program and report to Congress within 18 months of the Act's enactment. (5) Nothing here excuses giving a free tobacco sample to someone under the legal age to buy that product. (3) Amendments to rule: Before amending this rule later, the Secretary must first propose the change through the normal notice process under chapter 5 of title 5. (4) Rule of construction: Other than that limit, nothing here stops the Secretary from amending the regulation through normal rulemaking, including its free-sample provisions. (5) Enforcement of retail sale provisions: The Secretary must make sure this law, its amendments, and its rules — including those on retail tobacco sales — are enforced both within the states and on Indian tribal lands. (6) Qualified adult-only facility: If such a facility is also a retailer and violates the rules as a retailer, it does not get the retailer penalty limits in section 103(q); instead it faces the penalties made for qualified adult-only facilities. (7) Congressional review provisions: Congress's usual power to review and block new agency rules, under section 801 of title 5, does not apply to this final rule. (b) Limitation on advisory opinions: As of June 22, 2009, four older FDA documents no longer count as binding "advisory opinions" under FDA's own rules — except for how they apply to tobacco products — and the Secretary or FDA cannot cite them as binding precedent. The four documents are: (1) the preamble to the 1995 proposed rule on restricting cigarette and smokeless tobacco sales to protect children and teens; (2) the 1995 document declaring that nicotine in cigarettes and smokeless tobacco is a drug and that these products are nicotine delivery devices; (3) the preamble to the 1996 final rule on the same youth-protection restrictions; and (4) the 1996 document on FDA's jurisdiction, again treating nicotine as a drug and the products as delivery devices.