The Food and Drug Administration is advising consumers not to purchase or use HON-E-LING, a product promoted for sexual enhancement on various websites, and possibly in some retail stores. This product was identified during an examination of imported goods.
FDA laboratory analysis confirmed that HON-E-LING contains sibutramine and sildenafil, which are not listed on the product label.
Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. This product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or heart rate in some people and may present a significant risk for people with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. This undeclared ingredient 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.
Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA’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.
Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
