Category Archives for "FDA"

Feb 15

FDA Proposes Its First-Ever Tobacco Product Standard


On January 23, 2017, the U.S. Food and Drug Administration proposed its first-ever tobacco product standard, a rule for smokeless tobacco that would dramatically reduce the most carcinogenic compound in these products, significantly reducing the death and disease caused by smokeless tobacco.

N-nitrosonornicotine, or NNN, is a powerful carcinogen found in tobacco products. The FDA’s proposed product standard would require manufacturers to reduce NNN in smokeless tobacco products to no greater than 1 microgram per gram of tobacco, a move that the agency estimates would save 2,200 lives and prevent 12,700 cases of oral cancer in the first 20 years after the rule is implemented.

The FDA has had the authority to establish product standards for tobacco products since the Tobacco Control Act became law in 2009. This power allows the agency to identify harmful substances in tobacco products and to set standards that limit consumer exposure to those substances.

Comments from the public health community sharing evidence and observations about how the rule would impact health can shape changes to strengthen the rule, if needed, and help the agency build an administrative record that will support a final rule implementing this standard. Scientific information on NNN in smokeless tobacco and how restricting it could protect public health would be useful to include in a comment to inform the FDA’s decision making process. Unless the deadline is extended, comments are due by April 10, 2017.

For additional information about the rule, including topics to consider in your comments, view our Talking Points resource.

View the FDA’s proposed rule.

Submit your comment on the public docket.


Source: Public Health Law Center

Jan 17

FDA Issues Draft Guidance on Prohibiting Free Samples of Tobacco Products


The FDA recently issued a draft guidance, The Prohibition of Distributing Free Samples of Tobacco Products, for public comment. When finalized, this guidance will help tobacco product manufacturers, distributors, and retailers understand—and comply with—the prohibition of distributing free samples of tobacco products. The free sample ban prohibits tobacco product manufacturers, distributors, and retailers from distributing free samples of tobacco products, except for smokeless tobacco products distributed in “qualified adult-only facilities” in accordance with the regulations. In the draft guidance, the FDA interprets this to mean that manufacturers, distributors, and retailers may distribute tobacco products to consumers only through a tobacco product sales transaction and only in exchange for money.

When the FDA first issued the free sample ban in 2010, the prohibition applied to cigarettes (including roll-your-own tobacco), cigarette tobacco, and smokeless tobacco. As a result of the FDA’s final deeming rule, which went into effect on Aug. 8, 2016, the ban on distributing free samples applies to all tobacco products (and their components and parts) that are subject to the FDA’s tobacco product authority. This prohibition includes newly-regulated tobacco products such as e-cigarettes, cigars, and hookah tobacco.

This draft guidance explains, among other things, what and who are subject to the prohibition, as well as how the prohibition of distributing free samples applies to the distribution of tobacco products through:

  • Nonmonetary exchanges
    Membership and rewards programs
    Contests and games of chance
    Business-to-business exchanges

The prohibition on free samples of tobacco products is among the FDA’s most important provisions to help reduce youth access to tobacco products. When finalized, The Prohibition of Distributing Free Samples of Tobacco Products draft guidance will better assist manufacturers, distributors, and retailers in complying with these regulations.

For more information, please read the guidance.

Read Guidance CTA