Dietary supplements have their advantages. For instance, you might take vitamin C during the winter to boost your immunity or turn to magnesium to promote strong bones. Supplements, when taken as directed and needed, can help improve your overall health. But they also have their disadvantages—mainly, they don’t need approval from the U.S. Food & Drug Administration (FDA) before hitting the open market.
"The company doesn’t have to inform the FDA before they introduce a product. There’s no FDA approval process for any supplements, and companies can just introduce whatever they want to," Pieter Cohen, MD, Harvard Medical School associate professor, told NBC News.
Consumers, particularly men, are seeing this play out first-hand after the FDA issued a warning about certain men’s supplements containing "hidden" prescription drugs. Unintended consumption of these active ingredients can lead to serious health consequences, especially when mixed with other medications.
RELATED: FDA Recalls 3 Supplements That Contain "Toxic" Ingredients and "Unapproved Drugs."
A large sample of men’s supplements tested positive for undeclared ingredients.
Dietary supplements meant for sexual enhancement and improved energy levels in men are testing positive for "hidden ingredients," according to an FDA health advisory notification. Extensive rounds of testing found that many of these so-called "all-natural" products contain ingredients left off the product label.
What’s more, these active ingredients are commonly found in prescription drugs. In simpler terms, consumers are unknowingly exposing themselves to pharmaceuticals that could negatively interfere with additional medications and supplements.
"It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers," said the FDA.
The "hidden" ingredients are often found in erectile dysfunction and diabetes medications.
Traces of sildenafil, avanafil, and tadalafil (active ingredients in popular erectile dysfunction medications, including Viagra), acetaminophen, and diclofenac (which have anti-inflammatory properties) have been found in men’s supplements, despite their absence on the ingredient label.
In an interview with NBC News, urologist Jesse Mills, MD, cautioned against dietary supplements for treating erectile dysfunction. He called them "truck stop Viagra."
"Erectile dysfunction in a lot of men is a sentinel event that would suggest they have an increased risk of coronary artery disease," explained Mills, who is also the director of UCLA’s men’s clinic. "So if you go and you’re buying a supplement that actually has a pharmaceutical in it that takes care of your ED, you may have missed an opportunity to treat your heart diseases..."
Additionally, sildenafil, avanafil, and tadalafil combined with nitrate pharmaceuticals (often found in diabetes, high blood pressure, high cholesterol, or heart disease medication) can trigger dangerously low blood pressure.
RELATED: Recall of Common Anxiety Medication Expanded Over "Life-Threatening" Mistake, FDA Says.
15 supplement brands have been identified.
In 2024 alone, the FDA has identified 15 men’s supplement brands that have tested positive for off-label ingredients, those of which can cause serious adverse health effects. If men’s supplements are taking up real estate in your medicine cabinet, you might want to do a quick sweep for the following brands:
- Hone-e-ling
- Vitafer-L
- PeakMax
- VitalityXtra
- ZapMax
- ZoomMax
- Gold Hard Steel
- Gold Hard Steel Plus
- La Paix
- Arize
- Schwinnng
- Sustain
- Endurea
- ForeverMen
- Seraphim Z
Specific advisories for each brand can be found in the FDA’s letter, alongside more information.
What to do if your supplements have been affected.
If you’ve identified potentially "tainted" supplements in your home, the FDA is encouraging "consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products," per the notice.
You should also stop using the supplements and speak with your doctor before switching brands.
