OTC Homeopathic Asthma Products aren't Tested by FDA, Says Agency
Image: Michael J. Ermarth / FDA
March 20, 2015

The U.S. Food and Drug Administration (FDA) is warning consumers against relying on over-the-counter (OTC) homeopathic asthma products because they aren't evaluated by the FDA.

The products are sold in retail stores and online and are promoted as natural, safe and effective. The FDA does not evaluate supplements or homeopathic treatments for their safety or effectiveness, requiring only that the maker use good manufacturing practices ensuring the product's safety.

Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization.

According to the FDA, there is no cure for asthma, but there are many approved prescription asthma treatments that are considered  safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph.

Homeopathic products include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms.  The product's active ingredient(s) are listed in terms of dilution (e.g., "LM1""6X" or "30C").

The FDA advises that parents or caregivers contact to their healthcare provider if they think their children may have asthma.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: