FDA’s Actions Show Pathway for… | Campaign for Tobacco-Free Kids
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FDA’s Actions Show Pathway for Introducing New Tobacco Products is Feasible

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
November 11, 2015

WASHINGTON, DC – For the first time since being granted authority over tobacco products by a 2009 law, the U.S. Food and Drug Administration on Tuesday authorized the marketing of several new tobacco products after determining they met scientific standards set by the law to protect public health. The FDA allowed the marketing of eight snus smokeless tobacco products made by Swedish Match North America Inc.

It is important to note that this FDA action is separate from the agency’s consideration of Swedish Match’s application to market some of its snus products as “modified risk tobacco products” that are less harmful than other tobacco products. In April, the FDA’s Tobacco Products Scientific Advisory Committee recommended rejection of the application because Swedish Match failed to provide adequate data supporting its claims. Swedish Match’s application is still pending before the FDA, and the FDA’s order does not authorize Swedish Match to make any health-related claims.

While we have concern that several of the products covered by the FDA’s action are flavored, the FDA’s action shows that the pathway established by the 2009 law for the introduction of new tobacco products is feasible and manufacturers can satisfy the public health standard set by the law. Some tobacco manufacturers, including e-cigarette manufacturers, have complained that this standard is too rigorous, but the FDA’s action shows that it is possible to meet this important standard established to protect public health.

The 2009 law prohibits the introduction of a new tobacco product unless the manufacturer demonstrates to the FDA that allowing the product is “appropriate for the protection of the public health.” The FDA must consider the impact of allowing the product on the population as a whole, including its impact on the number of current tobacco users who quit and the number of new users, including kids, who start.

This standard is necessary and appropriate because of the tobacco industry’s long history of introducing new products that are more appealing to kids, more addictive or more harmful. These tactics have been spectacularly successful in attracting new tobacco users, most of whom are children, and in discouraging current users from quitting. The new product review process established by the 2009 law is critical to stopping these harmful practices.