[2-10-2025] The Food and Drug Administration is advising consumers not to purchase or use VITALITY, a product promoted and sold for sexual enhancement on https://www.zen-herbs.com and possibly in some retail stores.
FDA laboratory analysis confirmed that VITALITY contains sildenafil and tadalafil not listed on the product label.
Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restricted to use under the supervision of a licensed health care professional. 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.
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:
Note: This notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, pain relief 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.
Refer to the links below for more information:
