[12/11/2018] The U.S. Food and Drug Administration is alerting consumers, particularly males, not to purchase or use two e-liquids sold by HelloCig Electronic Technology Co. Ltd. that contain undeclared prescription drugs tadalafil and/or sildenafil. FDA laboratory analysis confirmed “E-Cialis HelloCig E-Liquid” contains the undeclared drugs sildenafil and tadalafil, and “E-Rimonabant HelloCig E-Liquid” contains the undeclared drug sildenafil.
These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Sildenafil and tadalafil are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally.
FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation. Therefore, FDA urges consumers to stop using these products and to contact their Health care professional with any concerns associated with their use.
To date, FDA is not aware of any adverse events associated with the use of HelloCig’s products. FDA encourages health care professionals and consumers to report adverse reactions experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
- Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.
