oes FDA now have the authority to regulate tobacco products?
Yes. On June 22, 2009, President Barack Obama signed into law the FSPTCA.
What specifically has FDA been charged with under this new legislation?
This historic legislation grants authority the U.S. Food and Drug Administration to regulate tobacco products. Among other things, the FSPTCA provides FDA with regulatory authority to regulate marketing and promotion of tobacco products and to set performance standards for tobacco products to protect the public health.
When will new FDA authorities to regulate tobacco products become effective?
The legislation went into effect when the President signed the bill into law. FDA is simultaneously establishing the internal administrative processes and scientific foundations needed to meet the requirements outlined in the FSPTCA.
What is the main goal in regulating tobacco products?
The main goal is to use the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.
What products are considered to be tobacco products as defined by the FSPTCA?
The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
What products are not considered to be tobacco products as defined by the FSPTCA?
The term “tobacco product” does not apply to raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product. Nor does it mean something that is defined as a drug, device, or combination product under the Federal Food, Drug, and Cosmetic Act.
What are some of the key regulatory timelines associated with the FSPTCA?
There are many requirements with deadlines outlined in the FSPTCA. Some highlights include:
* By October 2009, cigarettes will be prohibited from having candy, fruit, and spice flavors as their characterizing flavors.
* By January 2010, tobacco manufacturers and importers will submit information to FDA about ingredients and additives in tobacco products.
* By April 2010, FDA will reissue the 1996 regulation aimed at reducing young people’s access to tobacco products and curbing the appeal of tobacco to the young.
* By July 2010, tobacco manufacturers may no longer use the terms “light,” “low,” and “mild” on tobacco products without an FDA order in effect.
* By July 2010, warning labels for smokeless tobacco products will be revised and strengthened.
* By October 2012, warning labels for cigarettes will be revised and strengthened.
Is the FSPTCA related to FDA’s attempt to regulate tobacco as a drug in the mid-90s?
The FSPTCA, passed on June 22, 2009, is a piece of legislation that is separate from the regulation that FDA issued in the mid-1990s. However, as directed by the FSPTCA, one of the first regulations FDA will issue is the reissuance of the 1996 regulation aimed at reducing tobacco access to youth.
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