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FDA Requires Tobacco Companies to Disclose Detailed Information About New and Changed Products; Agency Can Stop Harmful Changes

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
September 27, 2011

WASHINGTON, DC — As required by the bipartisan 2009 law granting it authority over tobacco products, the U.S. Food and Drug Administration today directed tobacco companies to disclose detailed information about new products they introduce and changes they make to existing products. This requirement will for the first time give a government agency a window into every change made by a tobacco company and the ability to stop tobacco companies from making their products even more harmful, addictive or appealing to children.

The 2009 law requires tobacco companies to make detailed disclosures to the FDA before introducing new or changed products. Before companies can put these products on the market, the FDA must find either that they are 'substantially equivalent' to products that were on the market on or before February 15, 2007, or that their introduction 'is appropriate for the protection of the public health.'

Today, the FDA issued draft guidance regarding the information tobacco companies must disclose about new products that are not substantially equivalent to those already on the market. The FDA previously issued guidance on the process for a tobacco company claiming that an altered product is 'substantially equivalent' to a product already on the market. As required by the law, the draft guidance governing new products requires the tobacco companies to disclose their research about the health risks of the products; information about the components, ingredients, addictives and properties of the products; and a full description of manufacturing and processing methods. It is important that the FDA be vigilant and ensure that tobacco companies do not circumvent these requirements by claiming that every new product or change is substantially equivalent to existing products.

Until now, tobacco companies have been able to secretly change their products in ways that make them even more harmful, addictive or appealing, 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 easier for new users to start. Under 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.

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, 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.

We applaud the FDA for implementing these important disclosure provisions of the law. The FDA had done exactly what Congress required.