The United States has banned the general use of Chlorofluorocarbons (CFCs) in consumer aerosols for decades, and eliminated the manufacture of CFCs in the United States as of January 1, 1996, except for certain limited uses. The Montreal Protocol permits continued production or importation of CFCs for use in essential medical products upon approval by the Parties (i.e., signatory countries) to the Montreal Protocol. As required by the Clean Air Act (CAA), FDA makes determinations of essentiality in consultation with the Environmental Protection Agency (EPA). Once a determination of essentiality is made, the United States, through EPA, applies annually to the Parties to the Montreal Protocol for a specific CFC production allowance. The United States has secured essential-use exemptions for the use of CFCs in Metered-Dose Inhalers (MDIs) and will continue to work to obtain these exemptions for the future.

The FDA will continue to support essential-use exemptions for the use of CFCs in MDIs for the treatment of lung diseases until non-ODS products adequately serve the needs of patients who depend on these products. As manufacturers develop new, technologically feasible alternatives to ODS products and the non-ODS products prove to be medically acceptable alternatives, ODS production and importation for these products will be eliminated in accordance with the terms of the CAA and the Montreal Protocol. The United States will then no longer request essential-use allowances from the Parties to the Montreal Protocol for these non-essential uses.

Additional information about the Montreal Protocol, the Clean Air Act, and EPA nominations is available through the links below.