The agency has issued a warning to consumers about the unapproved sexual products that are sometimes sold at gas stations.
Rolling up to your local corner store and trying out one of their dubious, but inexpensive, male enhancement products might seem like a bit of fun.
But these unregulated supplements pose serious health risks, a recent consumer advisory from the U.S. Food and Drug Administration (FDA) warns.
These products — which are usually marketed under the Rhino brand with names like Krazzy Rhino 25000 and Platinum Rhino 25000 — contain unlisted ingredients that are chemically similar to generic versions of sildenafil (Viagra) and tadalafil (Cialis), along with an unknown array of other hidden compounds.
That can make for dangerous interactions with other prescription drugs, especially since consumers don’t know what drugs are contained in these over-the-counter products, FDA officials said.
“Consumers should… be on alert for products that offer immediate or quick results and that sound too good to be true,” the FDA statement reads. “Use common sense. Claims that sound too good to be true probably are; search for information using noncommercial sites rather than depending on information provided by sellers.”
These male enhancement pills are unregulated, illegal, and dangerous. So how exactly do they end up on gas station and convenience store shelves?
The answer has to do with the distinction between dietary supplements and drugs.
The FDA regulates drugs before they hit store shelves. Dietary supplements are only monitored and reviewed if they’re “adulterated or misbranded” after they come to market, the agency says.
That gives the supplement market a bit of a Wild West character: Anything can happen, and you don’t always know what you’re going to get.
“Based on the large holes that are built in the regulatory regime for dietary supplements, companies feel comfortable making whatever claims they want to until they can’t anymore,” Andrew Ittleman, an FDA compliance attorney at the firm Fuerst Ittleman David & Joseph, told Healthline.
Instead, he says, it’s often up to local law enforcement, municipalities, or states to identify and track dangerous supplements hitting the market.
“In a lot of cases, that information gets to the FDA through those local efforts,” he said.
Most men probably aren’t expecting sexual miracles from gas station supplements. But the success of these products — 25 of which the FDA identifies under the Rhino name as having suspicious, unlisted ingredients — suggests the appeal is more than mere curiosity.
There are two main reasons, Dr. Don Grant of the U.K.-based online pharmacy The Independent Pharmacy, explains.
“Consumers turn to unlicensed erectile dysfunction (ED) products, like Rhino, primarily due to their low price. Licensed ED products, like Viagra, are often more expensive than their unlicensed counterparts,” Grant told Healthline.
“[But] another reason why unlicensed ED products are so popular is because consumers often don’t need to interact with medical professionals to receive the drugs,” he added.
For many men, the shame factor could make the prospect of an easy transaction at a gas station more appealing than a doctor’s visit.
Then there’s the high cost of healthcare in the United States.
Paying to see a doctor or a specialist if you’re under- or uninsured to get a prescription for Viagra or Cialis might simply be too expensive or onerous. For these consumers, products like Rhino gain extra appeal.
Another issue with these gray market supplements is that their chemical composition can be changing all the time.
They may “work” for a short time, but not in a directed or safe way, says Dr. David Shusterman, the medical director of urology at NY Urology.
Some of these drugs will increase overall blood flow and blood pressure, which is good for erections, but can also be bad for your brain, heart, and other organs.
“What a urologist would do for you is not give you drugs that are over the counter. He’ll give you drugs that are actually working directly on your penis and do not increase blood pressure and do not increase energy levels but improves just where you need it — which is in your erection,” Shusterman told Healthline.
In short, “nondoctor-prescribed supplements and enhancements should never be used at any time,” he said. “A doctor should always be able to look at the drugs in the supplement to make sure none of the drugs are toxic.”
In the meantime, consumers can empower themselves by checking any dietary supplements — not just the male enhancement kind — against the FDA’s running list of tainted products.
It’s by no means complete. But the list can help people make a more informed decision.
Independent third-party websites, such as Trustpilot, can also help fill in the gap in vetting online retailers of supplements and medical products.
“The exploitation of legal loopholes by drug manufacturers and illegitimate online prescribing sites is prompting governments around the world to amend regulation procedures. However, it is also down to the consumer to research and educate themselves before purchasing a potentially dangerous product,” Grant said.
“Any ED product that promises impossible results… is probably too good to be true,” he said.