CFCs Eliminated in Epinephrine Inhalers for Asthma

WASHINGTON, DC, September 25, 2007 (ENS) - The U.S. Food and Drug Administration Thursday proposed a change to its regulation on the use of the ozone depleting chemicals chlorofluorocarbons, CFCs, in metered dose inhalers for epinephrine. The rule would remove the “essential-use” designation that allows the use of CFCs in these medical devices.

Epinephrine metered dose inhalers are used for the temporary relief of occasional symptoms of mild asthma.

FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release CFCs.

Under the proposed rule, epinephrine inhalers containing CFCs would be removed from the market by the end of 2010.

A 60 day public comment period began September 20 following publication of the proposed rule in the Federal Register. A public meeting on the essential use of epinephrine will be held on a date to be announced later.

The Clean Air Act permits CFCs to be used in medical products, if the use is determined to be essential by the Food and Drug Administration. The use of CFCs has been generally banned in consumer aerosols, such as hairspray, in the United States since 1978 because of adverse effects on stratospheric ozone levels.

The production of CFCs is being phased out worldwide under the terms of the Montreal Protocol on Substances that Deplete the Ozone Layer.

Most inhalers available in the United States once contained CFCs, but most have been reformulated to use other substances as propellants.

Epinephrine inhalers are the only devices currently marketed over the counter. Should this rule become final, users of epinephrine inhalers will have to obtain a prescription for alternative drug products if a non-CFC epinephrine inhaler still does not exist.

Based on 2005 figures, the Centers for Disease Control and Prevention estimates that 7.7 percent of Americans, or 23 million people, currently have asthma.

Copyright Environment News Service (ENS) 2007. All rights reserved.