Jul. 22—Alpha Male Plus, a non-prescription supplement marketed for male enhancement, is voluntarily recalling all lots of its fruit gummies after the U.S. Food and Drug Administration found they contain tadalafil, an ingredient found in prescription medications used to treat erectile dysfunction. Anyone who has the product should stop using it.
Male sexual enhancement products are a category that has long proven troubling for regulators.
Most of them list a combination of herbs and other natural ingredients that are claimed to increase blood flow — and sometimes to boost testosterone levels or increase libido — but the FDA has repeatedly found they also contain hidden ingredients like tadalafil, the active ingredient in Cialis, or sildenafil, the active ingredient in Viagra.
Those medications require prescriptions and are restricted to use under the supervision of a licensed healthcare professional. Male enhancers are marketed over the counter or online as dietary supplements.
Supplements don't have to meet the same standards as drugs, prescription or non-prescription, which are considered unsafe until proven safe through clinical trials. Supplements are treated more like special foods and considered safe until they are shown to be unsafe.
The FDA is not authorized to review dietary supplements for safety and effectiveness before they go to market, the agency says. That responsibility rests on the manufacturers and distributors.
But manufacturers are required to ensure they don't contain contaminants or impurities and are accurately labeled.
Manufacturers and distributors of male enhancement supplements have repeatedly run afoul of this requirement.
The FDA has issued 15 public notifications about hidden drug ingredients in this type of product so far this year.
It issued 40 in December alone and has issued dozens of such notifications each year since 2012.
The distributors of at least 12 other supplements marketed as male sexual enhancers issued recalls in March and April for the same reason.
Men who have underlying medical conditions like severe cardiovascular disease could experience serious health risks from undeclared vasodilators like tadalafil, the FDA warns.
If taken by men using nitrates — often prescribed to patients with diabetes, high blood pressure or heart disease — they can cause a dangerous drop in blood pressure.
Alpha Male Plus reports it has not received any reports of adverse events related to this recall but the FDA is advising anyone who is experiencing problems related to taking this product to contact their doctor or healthcare provider.
It also encourages health professionals and consumers to report adverse events or side effects through the FDA MedWatch Safety Information and Adverse Event Reporting Program at fda.gov.