Federal health officials are warning consumers to stop using certain chocolate products marketed as dietary supplements after testing revealed they contain undeclared prescription drug ingredients commonly used to treat erectile dysfunction.
The U.S. Food and Drug Administration announced that California-based adult novelty company Gear Isle has recalled two products after they were found to contain sildenafil and tadalafil, the active ingredients in Viagra and Cialis respectively. The affected products are the Gold Lion Aphrodisiac Chocolate Male Enhancement Sachet and the Ilum Sex Chocolate Male Sexual Enhancement Booster, both sold nationwide primarily through online channels and labelled as dietary supplements.
The FDA said the undeclared ingredients pose a serious health risk to certain consumers. “Use of products with undeclared active ingredients sildenafil and tadalafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may cause a significant drop in blood pressure that may be life-threatening,” the agency said in a news release. The FDA identified adult males who take nitrates for cardiac conditions as the group most at risk. Gear Isle said it has not received any reports of adverse events related to the recall as of the announcement.
Sildenafil and tadalafil are both prescription medications that work by increasing blood flow. Both can be dangerous when taken without medical supervision, according to the Mayo Clinic. Their presence in products labelled as dietary supplements raises concerns about consumers unknowingly ingesting pharmaceutical compounds without awareness of the potential interactions.
The FDA is urging consumers to immediately stop using the products and return them for a refund. Anyone who has experienced health problems potentially related to these products is advised to contact their physician. Consumers with questions about the recall can reach Gear Isle customer service at 888-387-4753 or info@gearisle.com, Monday through Friday from 10 a.m. to 4 p.m. PST.
