 |
FDA Announcements
State and local public health organizations petition the FDA to regulate all tobacco products
In September, a coalition of state and local public health organizations filed a formal Citizen Petition urging the U.S. Food and Drug Administration (FDA) to expand tobacco regulation to include all products that meet the Tobacco Control Act’s broad definition of tobacco products. The citizen petition was filed by the Tobacco Control Legal Consortium and comes four years after Congress granted the FDA the power to regulate all tobacco products through The Family Smoking Prevention and Tobacco Control Act of 2009. The petition provides compelling data on four classes of products unregulated by the FDA including cigars, dissolvable tobacco products, e-cigarettes, and hookah. Signatories argue that action on the petition will send a strong message that all tobacco products are harmful and will halt the tobacco industry’s exploitation of regulatory loopholes. Click here to learn more or click here to view the full Citizen Petition.
FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced that they have awarded up to $53 million, or a potential total of more than $273 million over the next five years, to create fourteen Tobacco Centers of Regulatory Science (TCORS). TCORS are funded by tobacco industry user fees established by the 2009 law granting the FDA authority over tobacco products and will be used to support research to inform the regulation of tobacco products. The National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung, and Blood Institute will administer TCORS. The funds will back research in seven core areas of tobacco control identified by the FDA and NIH including diversity of tobacco products, reducing addiction, reducing toxicity and carcinogenicity, adverse health consequences, communications, marketing of tobacco products, and economics and policies. Click here to read a statement from The Campaign for Tobacco-Free Kids or click here to view the NIH press release.
FDA extends deadline for public input on menthol in cigarettes
The U.S. Food and Drug Administration (FDA) has announced a 60-day extension of the comment period for the Advance Notice of Proposed Rulemaking (ANPRM) seeking additional information to help the agency make informed decisions about menthol in cigarettes. Specifically, the FDA is requesting information to inform its thinking about potential regulatory options, such as establishing tobacco product standards, sale and distribution restrictions, and other regulatory actions and considerations. Online or written comments may be submitted in response to the ANPRM under Docket #FDA-2013-N-0521 until November 22, 2013; click here to submit a comment. Click here to read FDA's press release, or click here for the FDA’s report, "Preliminary scientific evaluation of the possible public health effects of menthol versus nonmenthol cigarettes."
Compliance with regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents
The U.S. Food and Drug Administration (FDA) released a final guidance document titled “Compliance with regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.” The final guidance is intended to assist manufacturers, distributors, retailers, and others in understanding the final rule. The document explains who is subject to regulations, and outlines the restrictions on access, labeling and advertising restrictions, and prohibition on the sale and distribution of tobacco to individuals younger than 18 years of age. The regulations currently apply to cigarettes, cigarette tobacco, and smokeless tobacco products. Click here to view the final guidance.
top
Back to Table of Contents
|
 |