The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market. Consumers should also be on alert for products that offer immediate or quick results and that sound too good to be true. Even if a product is not included in the list, consumers should be cautious about using certain products, especially those promoted for sexual enhancement, weight loss, bodybuilding and/or pain relief. However, FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. The FDA’s tainted products database can help consumers identify some of these potentially harmful products. Over the past decade, the FDA has posted on its website hundreds of public warnings and recall announcements related to these types of fraudulent products. Hidden active drug ingredients continue to be identified in products that are misrepresented as dietary supplements and promoted for sexual enhancement, weight loss, bodybuilding and/or pain relief.
People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. For example, they may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. These undeclared ingredients are phosphodiesterase type-5 (PDE-5) inhibitors, which can be associated with significant safety issues and the risk of serious adverse events.
For example, the FDA has identified various Rhino products containing sildenafil and/or tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively. The FDA has posted warnings that these Rhino products contain undeclared ingredients that are the same as or structurally similar to active ingredients found in FDA-approved prescription drugs used to treat erectile dysfunction.
The FDA continues to pursue regulatory and criminal actions against those who violate federal law. The case led to an indictment, which is being prosecuted by the U.S. Since 2015, the FDA’s Office of Criminal Investigations has been investigating a South Korean national living in the Los Angeles area for smuggling raw materials, producing Rhino capsules and distributing the misbranded drug products throughout the U.S. “We remain vigilant in our efforts to protect the American public from the sale of these potentially dangerous products.” Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. Distributing unapproved drugs, disguised as supplements, places the U.S. “Over the past few years, the FDA has been combatting the retail sale of male enhancement drug products that are frequently misrepresented as dietary supplements and that contain hidden and potentially harmful active drug ingredients. The FDA has received reports of people experiencing chest pain, severe headaches and prolonged erections after taking a Rhino product that led to surgical intervention and hospitalization due to extreme drops in blood pressure. Rhino products include names such as Platinum Rhino 25000, Krazzy Rhino 25000 and Gold Rhino 25000. These products are often sold in single-serving package sizes. More recently, these unapproved products have been discovered in international mail shipments to the U.S. These products continue to be sold at gas stations and convenience stores, as well as on websites such as eBay and Amazon. Since 2007, the FDA has identified more than 25 products marketed with variations of the name “Rhino” that contained hidden drug ingredient(s). Food and Drug Administration is warning consumers not to purchase or use Rhino male enhancement products, due to a recent rise in reported health issues.
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