FDA Requires Tobacco Companies to Disclose Changes to Products, Providing Important New Information to Protect Public Health

Washington, D.C. — As required by the bipartisan new law granting it authority over tobacco products, the U.S. Food and Drug Administration today directed tobacco companies to disclose for the first time detailed information on any changes they make to tobacco products. We applaud the FDA for diligently implementing this important requirement of the new law. The agency has done exactly what the law requires.

Until now, tobacco companies have been able to secretly change their products in ways that make them even more harmful, addictive or appealing to children, and no government agency has had the information or authority to do anything about it. Now for the first time, tobacco companies will be required to disclose such changes to the FDA, and the FDA has the power to block product changes that harm public health, including changes that make it more difficult for current tobacco users to quit or increase the likelihood that new users will start. As a result of the bright spotlight of FDA scrutiny, tobacco companies will no longer be able to secretly manipulate their products in ways that make them more addictive and appealing.

The new disclosure requirement applies to all tobacco products introduced after February 15, 2007. As required by the law, tobacco companies must disclose to the FDA detailed information on any changes they make to the ingredients, harmful or potentially harmful constituents, design and other components of cigarettes, including an assessment of any such changes on the health effects of these products. For products introduced or changes made between February 15, 2007, and March 22, 2011, tobacco companies must submit this information by March 22, 2011. For new products or product changes introduced on or after March 22, 2011, the law requires tobacco companies to disclose the required information to the FDA at least 90 days before being allowed to introduce the product.

This new requirement is an important complement to other critical provisions of the new law. The law also requires tobacco manufacturers to disclose detailed information about all tobacco products to the FDA, including all ingredients and additives by brand and information about the health effects of the products. The FDA also has authority to require changes in all tobacco products — both existing and new — to protect public health, such as reduction or elimination of harmful chemicals or changes in nicotine levels.

The FDA already has implemented many important provisions of the new law that crack down on tobacco marketing and sales to kids, ban candy and fruit-flavored cigarettes that appeal to kids, prohibit misleading cigarette descriptions such as 'light' and 'low-tar,' and require larger warning labels on smokeless tobacco. The FDA is in the process of implementing large, graphic cigarette warnings that will cover half the front and back of cigarette packs.

We applaud the FDA for quickly and effectively implementing its new authority over tobacco products. The FDA has seized the opportunity presented by the new law to protect our children and reduce the death and disease caused by tobacco use, the nation's number one cause of preventable death. Tobacco use kills more than 400,000 Americans and costs the nation nearly $100 billion in health care bills each year.