FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.



T97-12                         Susan Cruzan:    (301) 443-3285
March 5, 1997                  Jason Brodsky:   (301) 827-3417
                               
                               Consumer Hotline:(800) 532-4440

          FDA SEEK PUBLIC COMMENT REGARDING METER DOSE INHALERS   
               CONTAINING OZONE-DEPLETING PROPELLANTS  

     FDA today published a notice in the Federal Register seeking
public comment on a suggested approach for withdrawing 
"essential-use" status for products using chlorofluorocarbon
(CFC) propellants.  This notice is being issued because non-CFC-
based, proven alternative aerosol medications are now available. 
Withdrawal of this status for these products would end their
exemption from laws which prohibit CFC propellants.
     The following information can be used to answer questions:
     CFC has been commonly used as a propellant for various
pressurized products including metered dose inhalant treatments
for asthma, Chronic Obstructive Pulmonary Diseases (COPD) such as
emphysema and other respiratory conditions.  Since 1978, the use
of CFC-emitting products in the United States has been sharply
curtailed because of increasing evidence that CFC's contribute to
the depletion of the earth's protective ozone layer.
     As a result of international agreement established through
the Montreal Protocol on Ozone Depleting Substances (which the
United States signed) and the U.S. Clean Air Act, CFC production 
                            -MORE-

                            Page 2, T97-12, Meter Dose Inhalers
and importation have been banned for all commercial purposes in
the United States since January 1996.  The only exceptions to
this ban are products which are considered medically essential
with no suitable alternatives, which include metered dose
inhalers for asthma and COPD.  These essential-use determinations
are part of FDA regulations and are accepted under the Clean Air
Act. 
    In August 1996, FDA approved the first alternative propellant
metered-dose-inhalers.  With the advent of this product, and the
promise of other alternative products becoming available in the
future, FDA is now proposing a strategy for the future transition
from CFC-based products to alternative aerosol delivery products. 
     This notice outlines the proposed strategy for withdrawing
"essential use" status for CFC-based products as proven
alternative products meeting patient needs become widely
available and accepted.  The proposed strategy would require
post-marketing data proving safety, efficacy and patient
acceptance before a non-CFC based product could be considered to
be an acceptable alternative. 
     The agency is providing a 60-day public comment period on
this matter.  Written comments can be submitted to:
                    Dockets Management Branch (HFA-305)
                    Food and Drug Administration
                    12420 Parklawn Drive, Room 1-23
                    Rockville, MD  20857      

                           ####

FDA TALK PAPER

FDA
TALK PAPER