The Best FDA Approved Male Enhancement Products
Reviewed by Kristin Hall, FNP
Written by Our Editorial Team
Ads for male enhancement supplements are everywhere. Don’t believe us? By all means — turn off your AdBlock software and explore online pornography for, say, ten seconds or so.
Be prepared to be bombarded with spots for “the best sex pills for men” or “the best penis enlargement pills,” typically touting ridiculous claims about growing your penis 12 inches in two minutes or giving you the sexual stamina of a wildebeest.
And they can look tempting. But be warned: there currently aren't any FDA-approved male enhancement pills on the market. Literally none.
But there are other options.
Below, we’ve discussed some of the issues with over-the-counter male enhancement pills and supplements, from lack of efficacy data to hidden, potentially harmful ingredients.
What are Male Enhancement Pills?
Some of the most popular male enhancement pills are marketed as these magic capsules that can cure any sex-related issue. They say they can do things like::
Increase your penis size
Increase sexual satisfaction
In general, these male sexual enhancement pills are often promoted as the solution to all your sexual worries, whether you’re concerned about your penis size, your erections or your general ability to please your partner.
Seems legit, right?
These penis enhancement pills aren’t held to the same standards as FDA-approved medications, which means that the manufacturers can make all sorts of vague claims without having to prove them.
Technically, they’re all considered “dietary supplements.” And most of these dietary supplements claim that natural ingredients like horny goat weed, ginseng or maca root are all that’s needed to boost your sexual desire, have greater orgasms and reverse low libido. But again, this is far from the truth.
Worse yet, investigations have found that some of these products — including the famous Rhino pill brand — contain hidden ingredients that are potentially dangerous.
Are There Any FDA-Approved Male Enhancement Pills?
Currently, there aren’t any “male enhancement” or “sexual enhancement” pills that are approved by the FDA.
One thing that’s important to keep in mind about these pills is that, as herbal health supplements and dietary supplements, they aren’t regulated in the same way as over-the-counter or prescription medications.
This means that they don’t need to go through the FDA’s strict approval process, which involves numerous phases of clinical trials. Unlike FDA-approved medications, they aren’t required to be tested for safety or effectiveness.
They get to skirt all the FDA regulations, which means they don’t really have to answer to anyone — at least to nowhere near the same degree as FDA-approved medications. Which, as you can imagine, creates a lot of space for disingenuous business practices and less-than-truthful advertising.
Health Risks of Unsafe, Unapproved Sexual Enhancement Pills
Unscrupulous business practices are so commonplace in the over-the-counter male enhancement pill racket that the FDA actually maintains a list of tainted sexual enhancement products with hundreds — literally hundreds — of entries, all for over-the-counter male enhancement supplements that contain potentially harmful substances.
The FDA also investigated numerous male enhancement pills available in gas stations, sex stores and online marketplaces and found that over-the-counter male enhancement products contain hidden ingredients.
That’s concerning, sure. But some of those investigations also found that some of these products contain illegal amounts of legitimate pharmaceutical drugs and unlabeled stimulants. It’s one thing to consume a little too much caffeine every once in a while, but it’s another thing entirely to take an unprescribed, unregulated and unknown dose of say, sildenafil or tadalafil.
They’re the main ingredients in Viagra® and Cialis®, respectively, and they’ve both been found in some of these over-the-counter boner pills.
While that may sound like you’re getting more bang for your buck, remember: a big reason why ED medications are available by prescription only is because dosages should be tailored to your individual needs.
Plus, pharmaceutical-grade medications are required to be made in pharmaceutical-quality laboratories. Let’s just say that diet pills don’t have nearly the same rigorous and regulated manufacturing quality standards.
So yeah. Probably best to err on the side of caution here.
FDA-Approved Alternatives to Male Sexual Enhancement Pills
The good news is that just because over-the-counter male enhancement pills probably suck and aren’t worth the risk, that doesn’t mean you don’t have options. In fact, you have plenty.
ED medications that are designed specifically to treat sexual health conditions like erectile dysfunction have gone through a rigorous FDA testing and approval process, making them safe to use when properly prescribed.
These include PDE5 inhibitors, which work by increasing blood flow to your penis, making it easier for you to get and maintain an erection when you feel sexually aroused.
A list of FDA-approved male enhancement pill alternatives include:
Vardenafil (the active ingredient in Levitra®)
Avanafil (a newer medication for erectile dysfunction sold as Stendra®).
FDA-Approved Treatment: Sildenafil
Sildenafil, the generic form of Viagra, is a widely-used medication for ED that’s been approved since the late 1990s by the FDA.
A single dose of sildenafil starts working in approximately one hour and can provide relief from erectile dysfunction for around four hours.
In clinical trials that were performed as part of the drug’s FDA approval process, more than 80 percent of men reported improvements in penile erections at the highest dose (100mg of sildenafil).
Even at a lower sildenafil dosage, such as 25mg and 50mg, between 63 and 74 percent of men with erectile dysfunction reported improvements.
This makes sildenafil a great pill to use if you’re concerned about losing your erection during sex.
Sildenafil is generally a safe and effective medication. However, as with all medications, it does have the potential to cause side effects. To learn more about the potential sildenafil side effects, check out our complete guide.
FDA-Approved Treatment: Tadalafil
Tadalafil is a long-lasting ED medication that can deliver relief from erectile dysfunction for up to 36 hours per dose. In fact, it’s sometimes referred to as “the weekend pill.” It’s sold as a generic medication and under the brand name Cialis in several different strengths.
Because of its longer half-life, you might prefer tadalafil to other ED medications if you like to have sex more than once a day (yewww!) or if you prefer not to have to time your medication around the possibility of sexual activity. It’s very much a “set it and forget it” type of medication.
Daily tadalafil that’s prescribed at a reduced dose can provide ongoing relief from ED symptoms.
Because tadalafil works in the same way as sildenafil, it produces similar side effects. You can learn more about the side effects of tadalafil here.
FDA-Approved Treatment: Vardenafil
Next up on the list is vardenafil. A single dose of vardenafil, sold under the brand name Levitra®, starts working in one hour and lasts for up to six hours — which actually gives it a slight advantage over sildenafil.
It’s important to inform your healthcare provider about any medications you currently use or have recently used before considering vardenafil.
ED treatments, delivered
No matter the treatment plan, the best place to start is somewhere.
FDA-Approved Treatment: Avanafil
Available as Stendra, avanafil is the newest FDA-approved ED med on the market.
It’s more selective than other ED medications, meaning it targets the specific enzymes responsible for controlling blood flow to your penis. This means that it has a lower risk of causing certain side effects compared to medications like sildenafil, tadalafil and vardenafil.
It also gets to work faster. A single dose of avanafil produces improvements in erections in as little as 15 to 30 minutes in some men. So, if things are going better than you anticipated and your partner wants to head straight back to your place, you don’t have to hit the panic button.
Like with other ED medications, avanafil can still cause adverse effects and interact with other drugs, meaning it’s important to discuss these issues with your healthcare provider before you start treatment.
We offer sildenafil, tadalafil, Viagra and Cialis® as part of our range of ED treatments, following a consultation with a licensed healthcare provider who will determine if a prescription is appropriate.
However, it’s also important to note that PDE5 inhibitors can interact with certain medications, including nitrates used to treat angina and/or high blood pressure. That’s why it’s crucial to speak to a healthcare professional before you start using them.
Are There Male Enhancement Pills That Increase Penis Size?
Hate to break it to you gents, but there currently aren’t any dietary supplements or sexual enhancement pills that increase the size of your package. In fact, there aren’t any FDA-approved pills that’ll do it, either.
As we’ve discussed in our guide to penis growth pills, increasing your penis length or girth with a pill just isn’t possible. Not yet, anyway.
That said, there are alternatives to consider like jelqing, penis sleeves, vacuum pumps and even penile enlargement surgery. But even then, either these methods are either unproven, temporary, negligible or hilariously expensive.
We’re not in the business of telling people what to do, but if it were us, we’d stick to making the best with what we got.
The Bottom Line on FDA-Approved Male Enhancement Pills
If you are still wondering, “Do male enhancement pills work?” The answer is no — at least, not to the degree that they promise on their labels. In fact, some of them are outright dangerous. When it comes to over-the-counter male enhancement pills, here’s the key info you should take away:
They’re not regulated by the FDA. Because they’re technically considered “dietary supplements” or “herbal supplements,” they’re not regulated by the FDA in the same way prescription medications are. Which means they’re not required to undergo rigorous efficacy and safety testing. Which means these companies can pretty much say whatever they want on their labels and packaging.
They often contain hidden ingredients. There are so many half-assed male enhancement pills out there that the FDA actually maintains a public database of all the confirmed sketchy male enhancement pills you may find on the shelves. When the FDA have investigated these pills, they’ve found hidden ingredients not listed on the label, including stimulants and prescription-only drugs like sildenafil and tadalafil.
There are proven, safer alternatives. If you’re not happy with your performance in the bedroom or are experiencing erectile dysfunction, there are several FDA-approved options out there for you to consider, including sildenafil, tadalafil, vardenafil and avanafil.
If you’re interested in improving your erections, lasting for longer in bed or just ramping up your sex life, you’ll get far better results by consulting your healthcare provider than by relying on male enhancement products.
Take the time, address the problem and do it the right way. Not only will you get better results than you would from any unregulated sexual enhancement supplement — you’ll also put your health first.
Want to find out more before you start? Our guide to the most common ED medications goes into more detail about your options for dealing with erectile dysfunction, improving your sexual health, and feeling more confident in bed.