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Announced on February 7, the US FDA notification is aimed at alerting consumers around presence of sildenafil and tadalafil in PrimeZen Black 6000, which the agency purports could pose a significant risk for people using nitrates for other chronic conditions, such as diabetes and cardiovascular disease.
The US Food and Drug Administration (FDA) has released a notification for consumers regarding the revelation a consumer product being promoted for sexual enhancement was found to contain hidden ingredients and could pose a significant health risk.1
Announced on February 7, the product, PrimeZen Black 6000, was found to contain hidden ingredients after an FDA laboratory analysis confirmed the product contained sildenafil and tadalafil, which are active ingredients in FDA-approved agents used to treat erectile dysfunction.1
“FDA approvals of Viagra and Cialis 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," reads the FDA notification
Promoted and sold on various website, including VoltCandy.com, as well as in some retail stores, the product is marketed as a sexual enhancement for men. Of note, the webpage for the product was no longer displayed on VoltCandy.com at the time this article was published.2 On the product’s packaging, the 2 primary ingredients listed are “Proprietary PremierZEN Blend” and “Prime ZEN Enhancement Blend”. The release of a public notification marks the second time such a notification has been published by the FDA in 2023, with the earlier instance concerning a hidden drug ingredient in the MANNERS Energy Boost product.3
On the backside of the packaging for PrimeZen Black 6000, the manufacturer notes no statements on the packaging had been evaluated by the FDA and the product was not intended to diagnose, treat, cure, or prevent any disease.1
On their webpage detailing information related to their Medication Health Fraud program, specifically as it pertains to stained sexual enhancement products, the FDA encouraged consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program. On the same page, the FDA provided a list of potentially dangerous products, including the PrimeZen Black 6000, but noted consumers should exercise caution before using these types of sexual enhancement products even if it is not listed on the FDA site as the agency cannot test all products on the market that contain potentially harmful hidden ingredients.3