Federal · Title 21 — Food and Drugs

21 U.S.C. § 387r: Drug products used to treat tobacco dependence

Read the full statutory text
at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 356 of this title ; consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention. total abstinence from tobacco use; reductions in consumption of tobacco; and reductions in the harm associated with continued tobacco use. The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and Drug Administration should coordinate and facilitate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of Health, the Centers for Disease Control and Prevention, and other relevant agencies.

Verify at the official source: Federal legislative text

Facing this? Know exactly what happens next.

MOFRD turns this code section into your situation: the deadlines that apply to you, the forms your county uses, and the resolution paths people in your position actually take. Free for 3 days — no card required.

This page is legal information, not legal advice. Code text is sourced from official publications and may lag amendments — always confirm at the official source linked above. Plain-English summaries and relationship data are AI-derived and reviewed on an ongoing basis; verify with a licensed attorney before acting.