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Tobacco Products

On June 22, 2009 President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act granting the FDA important new authority over tobacco products.  The FDA now oversees the manufacture, marketing, and distribution of tobacco products, an important departure from previous regulations.  In part, the new law amends the Federal Food, Drug, and Cosmetic Act (FDCA):

  • Establishes requirements for tobacco product establishment registration and product listings

  • Prohibits marketing of tobacco in combination with other articles/products regulated under the FDCA

  • Establishes requirements for tobacco product ingredient submissions by a manufacturer or importer

  • Requires submission of tobacco health documentation relating to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their  constituents (including smoke constituents), ingredients, components, and additives

  • Bans all cigarettes from containing an artificial or natural flavor that is a characterizing flavor.

  • Gains regulatory oversight over modified risk tobacco products


The FDA Center for Tobacco Products (CTP) is overseeing the implementation and enforcement of the Family Smoking Prevention and Tobacco Control Act.  The Center is setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.  Regulations involving much of this law are still in the rulemaking process and legal uncertainty may haunt your business.  Contact FI, an experienced firm to ensure compliance with the new law and gain important insight to the regulatory framework involving tobacco products.

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 TTB investigates and enforces interstate trafficking of contraband cigarettes.  State laws may also be implicated in your matter.  Experienced attorneys at C. Humphrey & Associates, P.A. 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.

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