Does your performance supplement contain a side of the main ingredient in Viagra? According to the FDA, it might.
Recent alerts from the Food and Drug Administration have warned that supplements widely marketed to men are testing positive for prescription drugs that could have dangerous side effects. The products are often promoted as “all natural.” Some claim to improve strength and energy, while others are promoted to help sexual performance or virility. Many claim to do both.
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Through testing, the FDA detected undeclared ingredients such as sildenafil and tadalafil, the active compounds in the erectile dysfunction prescription medications Viagra or Cialis, in ZoomMax, ZapMax, PeakMax and Vitafer-L Gold. Other drugs that have been found include diclofenac, a pharmaceutical anti-inflammatory that is similar to ibuprofen, and even medications for diabetes.
The companies didn’t immediately respond to requests for comment.
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Dr. Jesse Mills, a urologist and the director of the men’s clinic at UCLA Health, calls the dietary supplements “truck stop Viagra” and worries that people who get relief from erectile dysfunction with supplements may also be missing opportunities to catch early heart disease.
“Erectile dysfunction in a lot of men is a sentinel event that would suggest they have an increased risk of coronary artery disease,” he said. “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 before you drop dead of a heart attack.”
People taking nitrate medications for heart disease should also be careful, as blood pressure can drop dangerously when they are combined with sildenafil or tadalafil.
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Dr. Pieter Cohen, an associate professor at Harvard Medical School who studies the regulation of supplements, described the proliferation of performance supplements as a “hot mess.”
Because the FDA doesn’t approve dietary supplements to be sold and marketed in the U.S., it doesn’t regularly test and validate manufacturers’ claims about what’s in them.
“The company doesn’t have to inform the FDA before they introduce a product,” he said. “There’s no FDA approval process for any supplements, and companies can just introduce whatever they want to.”
The products frequently include words like “Max,” “Miracle” or “Macho” in their names, and they can be easily bought online or in some stores without prescriptions. It’s unclear what’s in them — sometimes packaging lists a variety of vitamins, as well as other ingredients.
“You don’t know what is in the supplement unless they start harming people or unless people report side effects and then we start investigating,” said Mahtab Jafari, a professor of pharmaceutical sciences at the University of California Irvine.
The number of supplements has soared over the last decade, especially online. The FDA has issued scores of alerts about hidden ingredients in performance products.
It can send warning letters to supplement makers, but it’s up to the companies to issue recalls. Cohen pointed to a 2018 published study he co-authored that found supplement makers recalled their products only about half the time after having received notice from the FDA, leaving many adulterated supplements on the market.
Promise of ‘good effects’ without side effects
In his practice, Mills sees men of all ages using supplements for improved energy, performance and sex drive. Patients often have a misconception that because they’re taking supplements and not pharmaceutical drugs, it’s safe, he said.
“There’s still a huge distrust of the pharmaceutical industry in this country,” he said. “So many men believe that if you’re taking a supplement it’s all natural and it has all the good effects and none of the side effects.”
Some men may be embarrassed to talk to their doctors about libido or other personal issues.
Many people turn to supplements because they don’t have health insurance, said Cohen, who works as a primary care physician.
Patients often hear about the benefits of supplements online through online marketing or male influencers in fitness and health who regularly promote supplements to build muscle, grow hair and enhance libido.
On TikTok Shop, sellers tout their positive experiences with certain supplements, earning commissions from purchases.
“I have guys that will bring in a moving box full of 15 to 30 supplements a day and want me to review them with them,” Mills said.
Duffy MacKay, senior vice president for scientific and regulatory affairs at the supplement industry’s Council for Responsible Nutrition, said the way consumers get the products has changed in recent years.
“At one point, these types of products were really limited to the dark shadows,” he said.
The proliferation of websites selling supplements has made it difficult for regulators to keep pace, he added.
Men in their 40s who have erection problems run an 80% risk of developing heart problems within 10 years, according to Johns Hopkins Medicine.
Mills isn’t opposed to all supplements, and he said there are a few that he sometimes recommends for his male patients, such as citrulline, an amino acid that helps improve blood flow and can be beneficial for workouts.
He talks with his patients about the supplements they take as a way to build trust.
“Just saying this is stupid and you’re spending $300 a month on these things that do nothing is a quick way to tune a patient out,” Mills said.
What to look for
It’s important to be wary of any product that makes over-the-top claims, Cohen said.
Mills said that while there are supplements that have shown some promise in treating erectile dysfunction, such as L-arginine, they are often studied at much higher doses than in over-the-counter products.
Cohen said: “If it’s working, we’re concerned that there’s an active pharmaceutical drug that’s not listed on the label, it might cause unknown adverse facts to our health. In this category of sexual enhancement supplements, I recommend that my patients not use them.”
Mackey said companies promote herbal ingredients that consumers believe help with vitality and virility, and “then they add the pharmaceutical so that the consumer has whatever sensation or experience that the drug might give them.”
Jafari said people should check whether a supplement has been evaluated by a third party, such as the U.S. Pharmacopia, published by a nonprofit organization that tests over-the-counter supplements for hidden ingredients and whether they contain what’s on the label. Products will often include stamps on their labels if they have been tested, she said.
Ultimately, the most important thing to do is find a doctor you trust and can work with to go over any products on the market.
“Patients would bring bags of dietary supplements and I would sit down and review them with them,” Jafari said. “At the end of each consultation, we send them home with maybe two, not 20, because they didn’t need them.”
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