Regulatory Focus™ > News Articles > FDA Prepares to Remove Last of CFC-Containing Products from Market

FDA Prepares to Remove Last of CFC-Containing Products from Market

Posted 23 October 2013 | By Alexander Gaffney, RAC

US regulators are once again warning consumers that they are nearing the end of a multi-year process to phase out all medical products containing chlorofluorocarbons (CFCs), a propellant used in some asthma inhalers that is more broadly linked to the depletion of the ozone layer.

Background

The removal of the inhalers from the market has long been planned under an environmental protocol signed by the US in 1987 known as the Montreal Protocol, an international agreement meant to preserve the ozone layer by phasing out the use of CFCs, which were then commonly used as propellants in aerosol canisters.

Despite the Protocol's phase-out plan, it took until 2006 for FDA and the Environmental Protection Agency (EPA) to develop rules to implement the CFC phase-out.

By 2008, both EPA and FDA's attempts to get all manufacturers to switch to different propellants had failed, with at least one-Amphastar, manufacturer of Primatene-underwriting a lobbying campaign against the proposed ban. Critics contended the amount of CFCs emitted by the products were insignificant and would be of no consequence to the ozone layer. Those arguments lost out, and on 1 January 2012, FDA finally acted to ban the products from the market.

Recent Developments

In May 2013, FDA issued a warning to consumers that the last two inhalers on the market containing CFCs-Combivent Inhalation Aerosol and the Maxair Autohalar, both prescription products-will be unavailable as of 1 January 2014.

Now it's repeating a similar warning, reminding consumers that the end of CFC propellants is right around the corner, and to plan accordingly.

Regulators said disruptions should largely be minimized, as there "are many safe and effective inhalers available to treat asthma and COPD symptoms [that do not contain CFCs]," FDA wrote.

FDA notes that albuterol inhalers, the most common type used to treat asthma, were removed from the market in 2008 and replaced with a hydrofluoroalkanes (HFA)-based propellant. Combivent had an alternative approved in 2011 that contains the same active ingredients but does not contain the CFCs. Alternatives to Maxair include albuterol or levalbuterol, FDA said.

However, consumers will have to obtain a new prescription for the products, which will require them to assume the cost of seeing a healthcare professional. The last over-the-counter asthma inhaler, Primatene, was taken off the market in 2011 by FDA, angering some legislators who said the lack of access could harm patients. However, other asthma groups have made the opposite argument, saying that the condition of asthma requires the oversight of a medical practitioner to ensure safe and proper use.


FDA Announcement on CFCs


Tags: Inhaler, EPA

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