FDA has issued a consumer warning for Rock-It Man, a sexual enhancement product which has been marketed as a dietary supplement but contains a hidden drug ingredient. The product contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra.
AHPA maintains a website to keep the dietary supplement industry and consumers informed on issues related to illegal tainted products being sold as "dietary supplements." The site, KeepSupplementsClean.org, provides detailed resources and information, including what both industry and consumers need to know about this important issue.
Food and Drug Administration
March 21, 2013
The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Rock-It Man,” a product promoted and sold for sexual enhancement on various websites, including shopinprivate.com and in some retail stores.
FDA laboratory analysis confirmed that Rock-It Man contains the undeclared ingredient hydroxythiohomosildenafil. Hydroxythiohomosildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs 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 on the market that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.