[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: