FDA Extends Comment Period on Implementation of Tobacco Control Act
The Food and Drug Administration is extending the comment period on the implementation of the Family Smoking Prevention and Tobacco Control Act, for which it has established a public docket for all interested parties to provide information and share views.
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FDA states that these comments will inform strategies to protect the public health as it implements its new authority over tobacco, particularly comments on the approaches and actions it should initially consider to increase the likelihood of reducing tobacco product use and protecting the public health. FDA will also consider these comments in establishing the new Center for Tobacco Products.
Comments on are now due by December 28, 2009 (from September 29, 2009).
90-Day Extension of Comment Period Not to Significantly Delay Rulemaking
Pursuant to a request, FDA is extending the comment period for the notice for 90 days, until December 28, 2009, as it believes that the extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.
Act Grants FDA New Tobacco Authority, Requires Finalization of 1996 Regulation
In June 2009, the President signed the Family Smoking Prevention and Tobacco Control Act into law (H.R. 1256, Public Law 111-31), granting FDA new authority over tobacco in order to:
regulate the manufacture, marketing, and distribution of tobacco products;
require disclosure of tobacco product ingredients and additives;
regulate "modified risk" tobacco products;
create standards, including for the reduction or elimination of certain constituents;
restrict sales, distribution, advertising, and promotion of tobacco products; and
require stronger health warnings on packaging.
Public Law 111-31 also requires FDA to make final its 1996 regulation restricting the sale and distribution of nicotine-containing cigarettes and smokeless tobacco products, with provisions designed to limit young people's access to tobacco products, as well as restrictions on marketing to curb the appeal of these products to minors.
(See ITT's Online Archives or 07/07/09 news, (Ref:09070725), for BP summary of FDA's original request for comments.
See ITT's Online Archives or 06/24/09 news, 09062415, for BP summary of Public Law 111-31, granting FDA new regulatory powers over tobacco products.)
FDA contact - Erik Mettler 301-796-4830
FDA notice (FDA-2009-N-0294, FR Pub 10/01/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-23607.pdf
The Family Smoking Prevention and Tobacco Control Act, available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1256enr.txt.pdf