In a Federal Register notice, the agency has asked for comments on the proposal, which is being issued because there are two alternative, non-CFC-based, albuterol MDIs available.
If the essential-use designation is removed, albuterol MDIs containing an ozone-depleting substance (ODS) could not be marketed after an appropriate transition period.
The agency has tentatively concluded that the two non-CFC based albuterol products will be satisfactory alternatives to the albuterol MDIs containing ODS.
CFCs have been commonly used as propellants for various pressurised products including MDI treatments for asthma and chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. Since 1978, the use of CFC-emitting aerosol products in the US has been generally banned because of increasing evidence that CFCs contribute to the depletion of the earth's protective ozone layer.
As a result of an international agreement established through the Montreal Protocol on Substances that Deplete the Ozone Layer and the US Clean Air Act, CFC production and importation have also been banned for all commercial purposes in the US since January 1996. The only exceptions to these bans are products that are considered medically essential with no suitable alternatives. Albuterol CFC-containing MDIs for asthma and COPD have been considered exceptions from the ban.