FDA bans CFCs in some inhalers from next year

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Thu Sep 22, 2011 11:06am EDT

(Reuters) - Health officials are banning the only asthma inhaler sold over the counter in the United States starting from next year to prevent the use of products that harm the environment.

The Food and Drug Administration said on Thursday that chlorofluorocarbons (CFCs) in metered-dose asthma inhalers that contain the drug epinephrine cannot be used, following an international agreement that bans CFCs because they deplete the Earth's ozone layer.

Right now, the only such inhaler is marketed by Armstrong Pharmaceuticals, a unit of Amphastar. The company could not be immediately reached for comment.

The inhaler, called Primatene Mist, is used for temporary relief of occasional symptoms of mild asthma, and is the only FDA-approved inhaler sold over the counter without a prescription, the FDA said.

The product uses CFCs to propel medicine out of the inhaler so patients can breathe it into their lungs. The FDA said some manufacturers now use a propellant called hydrofluoroalkane instead, which is less harmful to the environment.

The FDA first proposed phasing out the use of CFCs in asthma inhalers with epinephrine in 2006, and finalized the phase-out in November 2008.

Primatene Mist inhalers are already labeled to show they cannot be used after December 31, 2010. The FDA said some consumers may have to pay more for prescription asthma inhalers.

About 1 million to 2 million patients use Primatene Mist, although it is difficult to get an estimate of how many people use over-the-counter drugs, the FDA said.

More than 235 million people worldwide suffer from asthma and it is the most common chronic disease among children, according to the World Health Organization.

Two other prescription asthma inhalers that use CFCs are to be phased out by the end of 2013. These are Boehringer Ingelheim's Combivent Inhalation Aerosol and Graceway Pharmaceuticals' Maxair Autohaler.

The United States has generally banned CFCs in consumer products such as hairspray since 1978, but their use has been permitted in medical products when the FDA deems it essential.

(Reporting by Anna Yukhananov in Washington DC; editing by Matthew Lewis)
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Comments (3)
SurlyCurmudgen wrote:
Here we go again! Those who remember their high school or college chemistry, break out your chart of elements. Now add up how much a CFC molecule weighs. compare to the weight of O2, CO2 and nitrogen. Now silently in your head say…WTH or WTF. Does that tell you the caliber of scientists at the EPA or the FDA.

IF you still need confirmation, seek out an earth scientist at your local university. Be prepared for him or her to laugh hysterically while rolling on the ground.

CFCs are way too heavy to reach the stratosphere to damage ozone.

Sep 22, 2011 12:50am EDT  --  Report as abuse
Broadlands wrote:
Surly Curmudgen is sadly misguided. There is NO doubt at all (NONE) that CFCs reach the stratosphere and are being destroyed there. But, the point is: have they damaged the ozone layer? At the risk of being way over-scientific, the actual evidence does not support the widely-believed destruction of the global ozone layer by CFCs. The famous Molina-Rowland theory, as originally described, has NEVER been shown to actually work in the real atmosphere. They THEORIZED in 1974 that peak ozone depletion from CFC-derived chlorine would take place in the MIDDLE stratosphere between 25 and 35 km. They asserted in 1975 (Rev. Geophys. Space Phys, p. 9) that negligible CFC photodissociation of CFCs to inorganic chlorine species would take place below about 25 km. But in actual testing their theory later research showed that (1) the large decreases in ozone were taking place in the LOWER stratosphere below about 25 km  (Stolarski et al., 1992, SCIENCE, 256, 342), (2) INORGANIC chlorine (the only Cl that can interact chemically with ozone) below 25 km is primarily HCl and CLONO2. These two compounds are so-called reservoir species, and in addition were shown to be derived predominantly from NON-CFCs. See Zander et al. (1992, J. Atmos. Chem. 15, 171, Fig. 1 and tables). They showed that below 25 km (where Stolarski et al. 1992 said large ozone decreases had occurred) only 30% of the inorganic chlorine came from CFCs while the remaining 70% came from methyl chloride, methyl chloroform and carbon tetrachloride. (3) the ozone-destructive ClO molecules peak ABOVE the middle atmosphere near 40 km with little or none present below 25 km where ozone was being destroyed. In other words, after actual measurements were made. nothing much in the subsequent data fitted the Molina-Roland CFC theory very well. THINK about it. How can ClO ABOVE 25 km (and peaking near 40 km) in the mid-latitudes have been destroying ozone BELOW 25 km…. in the past or today? Indeed, the Molina-Rowland theory doesn’t even work to explain the famous ozone hole, a seasonal event which required a totally new theory.

Sep 23, 2011 2:41pm EDT  --  Report as abuse
SurlyCurmudgen wrote:
Your first sentence says I’m wrong, that CFCs destroy ozone. The rest of your paragraph says that there is little or no evidence of ozone being destroyed by CFCs. There is clear evidence that volcanic eruptions inject large quantities of chlorine into the upper atmosphere.

Both ozone molecules and the south pole have a negative charge. Like charges repel each other. This causes a hole in the ozone layer to develop over the south pole, becoming larger in the southern winter when the pole gets less energy from the sun and in the summer with more energy forming more ozone, becoming smaller.

Sep 26, 2011 11:41am EDT  --  Report as abuse
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