FDA Proposes Its First-Ever Tobacco Product Standard


Feb 15

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