FDA Tobacco Oversight Signed into Law by President Obama
On June 21, 2009, President Obama signed into law legislation that gives the Food and Drug Administration regulatory control over tobacco products. The legislation gives the FDA broad power to regulate cigarettes, smokeless tobacco and other tobacco products, including provisions restricting tobacco advertising, requiring new and more explicit health warnings, requiring tobacco companies to disclose contents of tobacco products, requiring manufacturers to operate consistent with "good manufacturing practice" and giving the FDA authority to require changes in tobacco products, including the removal or reduction of harmful ingredients.
Set forth below is the timeline of the applicability of the legislation's key provisions:
Date of Act passage | Effective date of user fees applicable to all manufacturers |
Three months after Act passage | Prohibition on flavored cigarettes |
Six months after Act passage | Regulations reinstating 1996 FDA regulations regarding advertising and marketing |
Six months after Act passage | Manufacturers must submit ingredients lists |
Six months after Act passage | Manufacturers must submit documents relating to products’ health effects |
One year after Act passage | New cigarette label and advertising warnings |
One year after Act passage | Effective date of provisions for “modified risk” products |
18 months after Act passage | Regulations regarding remote sales |
Three years after Act passage | Manufacturers must submit listing of potentially harmful constituents |
Three years after Act passage | Regulations regarding “good manufacturing practice” |
Three years after Act passage | Regulations regarding testing of tobacco constituents |
On December 31st of each year, manufacturers must register with the FDA. In June and December of each year, manufacturers must file updates of their tobacco products.
The FDA will soon promulgate regulations implementing the legislation. Because the legislation delegates broad authority to the FDA to issue these regulations, the regulations will play a significant role in defining the scope of manufacturers' obligations under the legislation. Manufacturers are advised to participate in the process of developing these regulations. The Troutman Sanders Tobacco Team will monitor the regulatory process closely and will provide further alerts regarding its status.