US FDA Bill includes health warning and packaging regulations

Aug 5, 2009

President Obama signed a new legislation on June 22, 2009 granting the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products(click here to download a copy of the bill passed by the US Senate). The law includes a wide range of measures, including more comprehensive marketing restrictions, producttesting and reporting, as well as the tobacco packaging regulations in three main areas:
Health Warnings
The Act requires health warning labels to appear on cigarette and smokeless products, as described below:

* The Act requires 1 of 9 “color graphic” health warnings to cover at least 30% of upper portion of the “front” and “rear” of cigarette packages no later than 24 months after enactment of the Act (p.184). The Secretary also has the authority to: “adjust the format, type size, color graphics, and text of any of the label requirements, or establish the format, type size, and text of any other disclosures required under the Federal Food, Drug, and Cosmetic Act, if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products.” (p.185)

* The law also requires one of four health warnings on smokeless tobacco products that would cover 30% of the front and rear, and appear with contrasting background colors. (p.187). The Secretary has the authority to revise the smokeless health warnings, including increases in size to 50% and the use of color graphics if such a change would “promote greater public understanding of the risks associated with the use of smokeless tobacco products.” (p.193-94)

Productconstituentlabels
The Act includes the following requirements for the labeling of constituent information on packages:

* The Secretary is given the discretion to determine whether quantitative information in the form of tar and nicotine “yields” should be displayed on packs.
* The Secretary can also prescribe disclosure requirements regarding the level of any cigarette or other tobacco product constituent including any smoke constituent if the Secretary determines that disclosure would be of benefit to the public health, or otherwise would increase consumer awareness of the health consequences of the use of tobacco products.
* Product constituents other than tar and nicotine will not appear on the face of any cigarette. (p.189)

Ban on misleading package information
The Act includes the following requirements with respect to potentially misleading packaging information:

* Unless a product meets the requirements of being a “modified risk” product, the law prohibits labeling that: 1) “represents explicitly or implicitly that the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other tobacco products; 2) contains a reduced level of a substance or presents a reduced exposure to a substance; 3) the tobacco product or its smoke does not contain or is free of a substance; or 4) uses the descriptors ‘light’, ‘mild’,or ‘low’ or similar descriptors. (p.96)