Implementation of the Family Smoking Prevention and Tobacco Control Act: FDA Wants to Hear From You

By David B. Clissold & Ricardo Carvajal –

In an unusually open-ended request, FDA is asking “all interested parties to provide information and share views” on FDA’s implementation of the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"), which was signed into law on June 22, 2009.  FDA seeks “comments that will inform strategies to protect the public health” as it implements the new legislation, and is “particularly interested in comments on the approaches and actions the agency should consider initially to increase the likelihood of reducing the incidence and prevalence of tobacco product use and protecting the public health.”  Notably, in taking certain actions under the Tobacco Act, FDA is required to consider the effects of its action on the incidence of tobacco product use and whether its action is appropriate for the protection of public health.  The notice asks that comments be organized into the following categories:

• Federal, State, and local government collaboration;
• New product submission and approval;
• Product ingredient disclosure;
• Prevention;
• Tobacco use by specific groups including minors, women, and racial and ethnic minority populations;
• Tobacco addiction;
• Smoking cessation;
• Data collection;
• Products with reduced harm/risk claims;
• Enforcement;
• Research and testing;
• Advertising and marketing of tobacco products;
• Label statements and warnings (including graphic warnings);
• Tobacco product standards (including flavors, ingredients, etc.);
• Sale and distribution of tobacco products;
• Manufacturing restrictions and facilities controls; and
• Other.

Information that FDA receives in response to its request could well help the agency implement the Tobacco Act within the aggressive timeframes that the Act imposes.  However, given the open-ended nature of the request, and the fact that FDA’s attempted regulation of tobacco in the mid-90’s netted over a half-million comments, FDA had better be ready for a deluge.