CFCs Eliminated in Epinephrine Inhalers for Asthma

CFCs Eliminated in Epinephrine Inhalers for Asthma



2007 September -   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. 

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