FDA warns consumers about the potential health risks of over-the-counter asthma products labeled as homeopathic
en Español (PDF - 73KB)
The U.S. Food and Drug Administration is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.
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. Although there is no cure for asthma, there are many prescription asthma treatments approved by FDA as safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph.
Speak to your health care provider if you think you or your child may have asthma. Consumers with asthma can take an active role in managing their condition by making certain they have appropriate treatments on hand in the event they experience an asthma attack or a worsening of asthma symptoms, and by consulting with a health care provider when needed.
OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1” "6X" or "30C").
The FDA encourages health care professionals and consumers to report any adverse reactions related to OTC asthma care products labeled as homeopathic to the agency’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online at MedWatch Online Voluntary Reporting Form; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
For more information on the FDA’s regulatory policies related to drugs labeled as homeopathic, see its Compliance Policy Guide titled “Conditions Under Which Homeopathic Drugs May be Marketed.”