Sustain® contains hidden drug ingredients
[Update 1-30-2024] FDA continues to advise consumers not to purchase or use Sustain products. FDA has found the products available for purchase at www.sustainformula.com, in addition to amazon.com and possibly in some retail stores.
[12-26-2023] The Food and Drug Administration is advising consumers not to purchase or use Sustain®, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.
FDA laboratory analysis confirmed that Sustain® contains tadalafil and avanafil, the active ingredients in the FDA-approved prescription drugs Cialis and Stendra, respectively, used to treat erectile dysfunction. FDA approvals of Cialis and Stendra are 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:
- 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.
For more information:
Tainted Sexual Enhancement and Energy Products
Health Fraud Public Notifications