For Immediate Release: Oct. 23, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA to complete phase-out of chlorofluorocarbon inhalers
The U.S. Food and Drug Administration will complete its phase-out of all inhaler
medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013.
This effort is to comply with an international treaty to protect the ozone layer
by phasing out the worldwide production of numerous substances, including CFCs,
which contribute to ozone depletion.
While most inhaler products containing CFCs have already been phased
out by the FDA, two products currently remain on the market: Combivent
Inhalation Aerosol and Maxair Autohaler. However, these products will no
longer be available after the end of this year. People with asthma or chronic
obstructive pulmonary disease (COPD) who use these inhalers should talk
to their health care professional about a prescription for an alternative treatment.
Inhalers are critical products for those persons suffering from asthma or COPD.
In the United States, more than 25 million people suffer from asthma, a disease
that affects the airways in the lungs and can cause coughing, trouble breathing,
wheezing and tightness or pain in the chest. Additionally, 15 million people have
been diagnosed with COPD, a serious lung disease that worsens over time.
Symptoms can include chest tightness, chronic cough and excessive phlegm.
“CFCs were used as propellants to move the drug out of inhalers so that patients
can inhale the medicine,” said Badrul Chowdhury, M.D., director of the Division of
Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation
and Research. “For more than two decades, the FDA and EPA have collaborated
to phase-out CFCs in inhalers – a process that included input from the public,
advisory committees, manufacturers, and stakeholders.”
Most inhalers that used CFCs have already been phased out by the FDA.
The inhaler that was most widely used—albuterol CFC inhaler—was phased
out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes
(HFAs). There are many safe and effective inhalers available to treat asthma and
COPD symptoms. All of these inhalers require a prescription, which must come
from a licensed health care professional (a physician, physician’s assistant or
nurse practitioner).
“The EPA and FDA's partnership has facilitated a safe, gradual transition
to CFC-free inhalers in the United States,” said Drusilla Hufford, director
of EPA’s Stratospheric Protection Division of the Office of Air and Radiation.
“This action is an important contribution to the global effort to repair the
Earth’s protective ozone layer and save millions of lives through the
prevention of skin cancer.”
CFCs damage the ozone layer, a thin, outer layer in the stratosphere
that acts as earth's shield against the sun's radiation. The United States
and most other countries signed an agreement in 1987 called the Montreal
Protocol on Substances that Deplete the Ozone Layer to phase out the
worldwide production and use of CFCs. In the United States, CFCs have
been removed from such products as hairsprays, deodorants and air conditioning.
For more information:
medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013.
This effort is to comply with an international treaty to protect the ozone layer
by phasing out the worldwide production of numerous substances, including CFCs,
which contribute to ozone depletion.
While most inhaler products containing CFCs have already been phased
out by the FDA, two products currently remain on the market: Combivent
Inhalation Aerosol and Maxair Autohaler. However, these products will no
longer be available after the end of this year. People with asthma or chronic
obstructive pulmonary disease (COPD) who use these inhalers should talk
to their health care professional about a prescription for an alternative treatment.
Inhalers are critical products for those persons suffering from asthma or COPD.
In the United States, more than 25 million people suffer from asthma, a disease
that affects the airways in the lungs and can cause coughing, trouble breathing,
wheezing and tightness or pain in the chest. Additionally, 15 million people have
been diagnosed with COPD, a serious lung disease that worsens over time.
Symptoms can include chest tightness, chronic cough and excessive phlegm.
“CFCs were used as propellants to move the drug out of inhalers so that patients
can inhale the medicine,” said Badrul Chowdhury, M.D., director of the Division of
Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation
and Research. “For more than two decades, the FDA and EPA have collaborated
to phase-out CFCs in inhalers – a process that included input from the public,
advisory committees, manufacturers, and stakeholders.”
Most inhalers that used CFCs have already been phased out by the FDA.
The inhaler that was most widely used—albuterol CFC inhaler—was phased
out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes
(HFAs). There are many safe and effective inhalers available to treat asthma and
COPD symptoms. All of these inhalers require a prescription, which must come
from a licensed health care professional (a physician, physician’s assistant or
nurse practitioner).
“The EPA and FDA's partnership has facilitated a safe, gradual transition
to CFC-free inhalers in the United States,” said Drusilla Hufford, director
of EPA’s Stratospheric Protection Division of the Office of Air and Radiation.
“This action is an important contribution to the global effort to repair the
Earth’s protective ozone layer and save millions of lives through the
prevention of skin cancer.”
CFCs damage the ozone layer, a thin, outer layer in the stratosphere
that acts as earth's shield against the sun's radiation. The United States
and most other countries signed an agreement in 1987 called the Montreal
Protocol on Substances that Deplete the Ozone Layer to phase out the
worldwide production and use of CFCs. In the United States, CFCs have
been removed from such products as hairsprays, deodorants and air conditioning.
For more information:
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