Hims & Hers, known for offering telehealth services and products for hair loss, erectile dysfunction, and skincare, has recently entered the weight-loss medication market. There’s a high demand for these medications, and existing FDA-approved options like Wegovy and Zepbound can be very expensive.
This raises an important question: Are Hims & Hers’ weight-loss drugs FDA-approved? The answer isn’t straightforward, especially with the controversy around compounded GLP-1 medications.
We’ll explore whether Hims & Hers’ offerings have received FDA approval, delve into the controversies surrounding compounded GLP-1s, and discuss what this all means for consumers trying to find affordable and effective weight-loss solutions. You may have questions about FDA-approved weight-loss drugs in general, and whether Hims and Hers is a safe option for you.
Understanding GLP-1 Medications and the FDA Approval Process
To figure out whether Hims offers FDA-approved medications, it’s helpful to understand a little bit about GLP-1 drugs and the FDA approval process.
What are GLP-1 Drugs?
GLP-1 drugs, also known as incretin mimetics, have been getting a lot of buzz lately, and for good reason. They’ve been shown to be very effective for weight loss.
GLP-1s mimic a natural hormone in your body that helps control blood sugar levels and also slows down digestion. This can lead to feeling fuller for longer and, ultimately, eating less.
Some popular GLP-1 drugs include semaglutide (Wegovy) and tirzepatide (Zepbound).
The FDA Approval Process
The FDA has a very thorough process for approving new drugs. It involves a lot of clinical trials and safety evaluations to make sure the drug is safe and effective for what it’s supposed to do.
When the FDA approves a drug, it means they’ve looked at all the evidence and decided that the benefits of the drug outweigh the risks.
Hims & Hers’ Weight-Loss Offerings: Compounded GLP-1s
Hims & Hers has entered the weight-loss market by offering compounded versions of GLP-1 medications, which can raise questions about the connection between obesity and testosterone. The company touts the lower cost of these medications compared to FDA-approved brand names, with prices starting at $165 per month for the standard program and $99 per month for certain qualifying groups.
What Does “Compounded” Mean?
It’s important to understand what “compounded” actually means in this context. Drug compounding is the practice of combining, mixing, or altering drug ingredients to create a medication tailored to the specific needs of an individual patient. This can involve adjusting dosages, changing the form of the medication (e.g., from a pill to a liquid), or combining multiple medications into one.
The crucial point to remember is that compounded drugs are not FDA-approved. They don’t go through the same rigorous testing and evaluation process as FDA-approved drugs. This means that the FDA hasn’t verified their safety, effectiveness, or manufacturing quality.
Transparency and Certificates of Analysis
Hims & Hers emphasizes transparency in its compounding process. They state that they provide Certificates of Analysis with each order, presumably to demonstrate the quality and purity of their compounded medications.
On their website, Hims & Hers states that they are “committed to patient health and safety,” which is a sentiment you’d expect from any healthcare provider, particularly given the importance of understanding insurance coverage, such as whether United Healthcare covers hormone therapy.
The FDA’s Stance on Compounded GLP-1 Medications
It’s important to know that the FDA has issued warnings against using compounded GLP-1 drugs like semaglutide and tirzepatide, which are the active ingredients in medications like Ozempic and Mounjaro.
The FDA has serious concerns about the safety, effectiveness, and quality of these compounded drugs, primarily because the compounding industry lacks sufficient FDA oversight. This means there’s less assurance that these medications are what they claim to be and are manufactured under safe conditions.
The FDA has reported that they’ve received hundreds of reports of adverse events related to compounded semaglutide and tirzepatide. As of the date of this writing, there have been 392 reports related to compounded semaglutide and 215 related to compounded tirzepatide.
Compounding pharmacies are only legally allowed to produce medications under very specific, limited circumstances. One of these circumstances is when there’s a documented drug shortage. However, even in these situations, the FDA emphasizes that compounded drugs haven’t undergone the same rigorous review process as FDA-approved drugs and may carry significant risks.
Controversies Surrounding Hims & Hers’ Marketing and Advertising
Hims & Hers hasn’t avoided controversy, especially when it comes to advertising.
The Super Bowl Ad Controversy
The brand’s Super Bowl ad, titled “Sick of the System,” created quite a stir. The ad took aim at the high cost of weight-loss medications and what Hims & Hers sees as the healthcare industry’s focus on profits instead of patient well-being.
Criticisms of the Ad
Health advocacy groups didn’t hold back. They urged the FDA to block the ad from airing, arguing that it could mislead consumers and potentially violate advertising regulations. Some critics also felt that the ad portrayed obesity in a negative light.
Violations of FDCA?
The Campaign for Accountability, a nonprofit watchdog group, sent a letter to the FDA in February 2024 requesting an investigation into Hims & Hers for potential violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The letter alleged that Hims & Hers failed to disclose the risks associated with prescription drugs in its advertisements.
Weighing the Risks and Benefits: FDA-Approved vs. Compounded
It’s really important to know the difference between FDA-approved medications and compounded versions, especially when it comes to something like GLP-1 drugs. FDA-approved drugs go through a ton of testing to make sure they’re safe and actually work. Compounded drugs? Not so much.
That lack of testing can mean some serious risks. You might get a product that isn’t consistent in quality, or one with ingredients you don’t even know about. That opens the door to side effects and other problems you just wouldn’t expect. It’s a gamble.
The best advice? Talk to your doctor before making any decisions about weight-loss medications. They can help you sort through all this and figure out what’s safest and most effective for you.
Frequently Asked Questions
How much is Hims per month?
The cost of Hims products varies depending on the specific treatment plan and medication prescribed. Generally, you can expect to pay anywhere from $20 to $80 per month, or more, for ongoing subscriptions. A consultation fee may also apply.
Which pill is best to last longer in bed?
Several medications can help with premature ejaculation. Some of the common oral medications that Hims may prescribe include selective serotonin reuptake inhibitors (SSRIs) and topical anesthetic creams or sprays. The “best” option depends on individual needs and medical history, so it’s important to consult with a healthcare professional to determine the most appropriate choice for you.
Is Hims safe to use?
Hims offers access to prescription medications, and their safety depends on factors such as individual health conditions, potential drug interactions, and adherence to the prescribed dosage. A legitimate medical provider must evaluate your health history and current medications during the online consultation to ensure the prescribed treatment is safe for you. It’s crucial to be honest and transparent with the healthcare provider during the consultation process.
Are Hims like Viagra?
Hims offers access to Sildenafil, the active ingredient in Viagra, as well as other medications for erectile dysfunction. While they achieve the same outcome—improved blood flow to the penis—Hims operates as a telehealth platform facilitating online consultations and prescription fulfillment.
How often can you use Hims?
You can engage with the Hims platform as often as needed to manage your health concerns, provided you follow the guidance of the healthcare professionals you interact with through the service. However, the frequency with which you can use specific medications obtained through Hims depends entirely on the prescribed dosage and your doctor’s instructions.
Closing Thoughts
It’s important to remember that the compounded GLP-1 medications sold by Hims & Hers are not FDA-approved. This doesn’t necessarily make them unsafe or ineffective, but it does mean they haven’t undergone the same rigorous testing as FDA-approved drugs.
Before deciding whether to use an FDA-approved medication or a compounded one, be sure you understand the risks and benefits of both. The right choice for you will depend on your needs, your health history, and your comfort level.
Talk to a qualified healthcare professional who can help you weigh the pros and cons and make an informed decision.