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FDA NEWS RELEASE

For Immediate Release: Oct. 23, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

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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.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

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