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FDA’s New GLP-1 Compounding Guidelines: What Clinical Research Reveals

The U.S. Food and Drug Administration (FDA) has introduced updated guidance regarding the compounding of GLP-1 receptor agonists such as tirzepatide and semaglutide. With increasing demand for these medications, the rise of compounded alternatives has led to regulatory scrutiny, legal challenges, and evolving policies to ensure patient safety. This article, authored by the research team at MedClinRes.org, explores the latest FDA updates on GLP-1 drug compounding, evaluates the clinical implications, and highlights the importance of regulatory oversight in maintaining drug efficacy and safety.

The Importance of FDA Oversight in GLP-1 Drug Compounding

GLP-1 receptor agonists, including semaglutide and tirzepatide, have become widely sought-after treatments for obesity and type 2 diabetes. However, due to increased demand, shortages of these medications have prompted the use of compounded alternatives. Compounded drugs are formulations made by specialized pharmacies or outsourcing facilities, often to address drug shortages or patient-specific needs. However, these drugs do not undergo the same rigorous FDA approval process as commercially available pharmaceuticals, raising concerns about their quality, efficacy, and potential risks.

FDA-approved GLP-1 drugs are subject to stringent clinical trials to confirm their safety and effectiveness. In contrast, compounded versions, while sometimes necessary in cases of shortages, lack comprehensive regulatory oversight. This has led to a series of FDA updates and legal proceedings to establish clear guidelines on the circumstances under which compounding is permissible.

Key FDA Updates on GLP-1 Drug Compounding

March 10, 2025: Tirzepatide and Semaglutide Compounding Enforcement Discretion Periods

Following legal proceedings in Outsourcing Facilities Association v. FDA, the FDA clarified enforcement discretion for compounding tirzepatide and semaglutide:

  • Tirzepatide: As of March 19, 2025, the FDA will no longer exercise enforcement discretion for outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act unless tirzepatide remains on the drug shortage list.
  • Semaglutide: Enforcement discretion for state-licensed pharmacies and physicians under Section 503A will continue until April 22, 2025, or until a district court decision determines otherwise.
  • Outsourcing facilities under Section 503B can continue compounding semaglutide until May 22, 2025, or until further legal rulings are made.

These updates mean that compounders must adhere to strict guidelines, and FDA enforcement may increase for those producing compounded versions without proper authorization.

February 21, 2025: FDA Declares Semaglutide Shortage Resolved

The FDA determined that the shortage of semaglutide has been resolved. However, due to supply chain logistics, patients and providers may still experience localized shortages as distribution normalizes. In response, the FDA has allowed:

  • State-licensed pharmacies and physicians to continue compounding semaglutide under Section 503A for 60 days (until April 22, 2025).
  • Outsourcing facilities to compound semaglutide under Section 503B for 90 days (until May 22, 2025).

This decision is significant, as it sets a timeline for the transition away from compounded semaglutide towards FDA-approved formulations.

December 19, 2024: Tirzepatide Shortage Resolution

The FDA announced that the tirzepatide shortage has been resolved after evaluating manufacturing capacity and national supply levels. However, legal proceedings led to an extension of enforcement discretion periods for compounding tirzepatide:

  • State-licensed pharmacies under Section 503A could compound tirzepatide until February 18, 2025.
  • Outsourcing facilities under Section 503B could compound tirzepatide until March 19, 2025.

These timeframes marked the beginning of a shift toward stricter enforcement against unauthorized compounded tirzepatide.

Current Shortage Status of GLP-1 Drugs (as of February 2025)

The FDA continues to monitor GLP-1 drug availability, working closely with manufacturers to determine supply stability. The following GLP-1 medications remain in shortage:

  • Dulaglutide (Trulicity®): In shortage, though manufacturers report all presentations are available.
  • Liraglutide (Saxenda® and Victoza®): In shortage, with two presentations available and three experiencing limited availability.

FDA's determination of drug shortages depends on various factors, including manufacturer-reported supply levels, market demand, and the ability of alternate manufacturers to fill supply gaps.

Legal Considerations for Compounded GLP-1 Medications

Restrictions Under the FD&C Act

  • Section 503A: Prohibits compounding drugs that are essentially copies of FDA-approved medications unless there is a documented medical need that cannot be met with available commercial products.
  • Section 503B: Prevents outsourcing facilities from compounding drugs that are identical or nearly identical to FDA-approved medications unless they are officially listed on the FDA drug shortage list.

These regulations aim to prevent unnecessary compounding when FDA-approved versions are available, ensuring that patients receive high-quality and effective medications.

FDA Actions Against Noncompliant Compounders

The FDA has indicated that while enforcement discretion was temporarily allowed during shortages, any compounded GLP-1 products found to be of substandard quality or otherwise unsafe will be subject to regulatory action. This includes:

  • Misbranded or adulterated compounded medications.
  • Unauthorized compounding beyond enforcement discretion timelines.
  • Compounded GLP-1 products using semaglutide salt forms (e.g., semaglutide sodium, semaglutide acetate), which are not the same as FDA-approved semaglutide.

Implications for Healthcare Providers and Patients

Healthcare Providers

  • Should prioritize FDA-approved GLP-1 drugs when available.
  • Must be aware of legal restrictions on prescribing compounded GLP-1 medications.
  • Should educate patients about supply chain variability and encourage proper medication adherence during transitional periods.

Patients

  • Should only obtain GLP-1 medications from licensed healthcare providers and state-licensed pharmacies.
  • Must be cautious about online retailers selling compounded versions of GLP-1 drugs that may not meet quality standards.
  • Should report any adverse effects from compounded GLP-1 medications to the FDA via the MedWatch Adverse Event Reporting Program.

Final Thoughts: Why FDA Regulation Matters

The recent updates on GLP-1 drug compounding reflect the FDA’s commitment to balancing medication access with safety. While compounded versions provided a temporary solution during shortages, their continued use outside of regulatory guidelines poses risks. The scientific evidence supports that FDA-approved GLP-1 medications remain the safest and most effective option for patients needing these treatments.

At MedClinRes.org, our research-driven approach underscores the importance of clinical validation, regulatory compliance, and patient safety. As the availability of GLP-1 drugs stabilizes, we strongly advocate for evidence-based prescribing practices that align with FDA standards. For healthcare providers and patients alike, informed decision-making is the key to achieving optimal health outcomes.

Also Read: FDA’s Concerns Over Unapproved GLP-1 Weight Loss Drugs

FDA’s Concerns Over Unapproved GLP-1 Weight Loss Drugs: What the Research Says

The use of GLP-1 receptor agonists, such as semaglutide and tirzepatide, has surged in recent years due to their effectiveness in weight management. However, the increasing availability of unapproved and compounded versions of these drugs presents significant risks. The U.S. Food and Drug Administration (FDA) has raised concerns over the safety, effectiveness, and quality of these unregulated versions, urging both healthcare professionals and patients to exercise caution.

Understanding GLP-1 Receptor Agonists and Their Approved Use

GLP-1 (glucagon-like peptide-1) receptor agonists function by mimicking natural hormones that regulate appetite and glucose metabolism. The FDA has approved specific formulations of semaglutide and tirzepatide for weight management and diabetes treatment under strict regulatory guidelines. These approved drugs have undergone extensive clinical trials to ensure their safety, efficacy, and consistency in dosage.

However, the demand for these medications has led to the rise of unapproved compounded versions, often marketed as alternatives when the FDA-approved drugs are in short supply or expensive. While compounding pharmacies play a vital role in healthcare, producing customized medications for unique patient needs, the absence of FDA oversight on compounded GLP-1 drugs introduces risks that warrant close scrutiny.

The Risks of Unapproved GLP-1 Drugs

Lack of FDA Review for Safety and Efficacy

Unlike FDA-approved drugs, compounded versions of semaglutide and tirzepatide do not undergo rigorous clinical evaluation. This means that their safety profile, effectiveness, and overall quality remain uncertain. Without FDA review, there is no guarantee that these versions contain the correct active ingredients or appropriate dosages.

Dosing Concerns and Adverse Events

The FDA has received numerous reports of adverse events linked to compounded semaglutide and tirzepatide, including:

  • Incorrect dosing due to miscalculated measurements by healthcare providers and patients.
  • More frequent or excessive dosing beyond the FDA-approved guidelines, leading to severe side effects.
  • Symptoms such as nausea, vomiting, diarrhea, abdominal pain, and constipation, some of which have required hospitalization.

From a research perspective, these adverse reactions highlight the importance of precise dosing and pharmacokinetic stability, which compounded drugs may not consistently achieve.

The Issue with Salt Forms of Semaglutide

One of the most pressing concerns involves compounded semaglutide products made from salt forms, including semaglutide sodium and semaglutide acetate. These chemical variations differ from the active ingredient used in FDA-approved formulations. Currently, there is no conclusive research indicating whether these salt forms possess the same pharmacological properties, raising questions about their safety and effectiveness.

The Growing Threat of Counterfeit and Illegally Marketed GLP-1 Drugs

The FDA has also identified counterfeit versions of Ozempic, a popular brand of semaglutide. Counterfeit drugs present severe health risks because they may:

  • Contain incorrect or harmful ingredients.
  • Have inaccurate dosages, potentially causing toxicity or therapeutic failure.
  • Be manufactured under substandard conditions with no quality control measures.

Similarly, the agency has issued multiple warnings to online sellers distributing semaglutide, tirzepatide, and retatrutide under misleading labels such as “for research purposes” or “not for human consumption.” Many of these products are being marketed directly to consumers, bypassing prescription requirements and medical supervision.

Why Retatrutide Cannot Be Compounded

Retatrutide, an investigational GLP-1 receptor agonist, cannot legally be used in compounding. It is neither an FDA-approved drug nor has it been established as safe or effective for any medical condition. Any compounded product claiming to contain retatrutide is inherently unregulated and poses unknown risks.

FDA’s Recommendations for Patients and Healthcare Providers

Given these concerns, the FDA strongly advises patients and healthcare professionals to take the following precautions:

  • Obtain prescriptions from licensed healthcare providers and only fill them at state-licensed pharmacies.
  • Avoid purchasing medications online unless from a verified and state-licensed pharmacy.
  • Consult a doctor about medication safety before considering compounded versions.
  • Be aware of dosing precision and proper administration techniques to prevent serious health complications.

Reporting Adverse Events and Quality Issues

Healthcare providers, patients, and compounders are encouraged to report adverse events or quality concerns related to compounded semaglutide and tirzepatide products. Reports can be submitted through the FDA’s MedWatch Adverse Event Reporting program online or via fax at 1-800-FDA-0178. Additional inquiries can be directed to the CDER Division of Drug Information at druginfo@fda.hhs.gov or 855-543-3784.

Conclusion

As the demand for GLP-1 receptor agonists grows, so do concerns regarding the safety and regulation of compounded and counterfeit versions. The research underscores the importance of FDA oversight in ensuring drug quality, efficacy, and patient safety. While compounded medications can serve an essential function in healthcare, the risks associated with unregulated GLP-1 drugs highlight the need for vigilance among patients, healthcare providers, and regulatory agencies. By prioritizing FDA-approved treatments and reporting any suspicious or adverse effects, patients can better protect their health while benefiting from these breakthrough therapies.

Also Read: FDA’s New GLP-1 Compounding Guidelines

Hims Hard Mints for Erectile Dysfunction: A Medical & Wellness Perspective

Available exclusively through ForHims.com, Hard Mints contain the same active ingredients in Viagra, Cialis, Levitra, and Staxyn.

Do Hims Hard Mints really work? How do Hard Mints work? Keep reading our review to learn everything you need about the Hims Hard Mints today.

What Are Hard Mints?

Hard Mints are chewable mints featuring a customized dose of ED medication.

You chew the mint until you can comfortably swallow it, then allow the active ingredients to enter your body to treat ED.

Hims customizes each Hard Mint based on your unique needs and physiology. Hard Mints are made from sildenafil, tadalafil, vardenafil, and other ED medication. These are the same active ingredients found in Viagra, Cialis, Levitra, and Staxyn.

As with other Hims treatments, there’s no need for an in-person visit or phone call. Instead, you sign up online and get a virtual appointment with a Hims physician licensed in your state. That physician determines the best ED treatment option and medication for your unique needs.

Hard Mints Benefits

Hard Mints are designed to offer all of the benefits of traditional ED medication – but in a chewable mint form instead of a blue pill you swallow.

Here are some of the benefits of Hard Mints:

  • No need for daily medication – just chew a mint when it’s time to perform
  • The same active ingredients as Cialis, Viagra, and other prescription ED medication
  • Get harder erections and last longer
  • Works in as little as 15 minutes and lasts up to 36 hours
  • Different medication dosages and combinations are available, customized to your unique needs and physiology
  • 100% online process with free, discreet shipping

Hard Mints: Get the benefits you've been looking for!

How Do Hard Mints Work?

Hims Hard Mints contain the same active ingredients in Viagra, Cialis, and other prescription ED medications. These ingredients have been shown to treat ED and make it easier to get an erection.

Hims offers two broad types of Hard Mints, including:

  • As-Needed Hard Mints
  • Daily Hard Mints

You can take one Hims mint daily to be ready at any time. Or, you can take mints 15 to 30 minutes before sex.

The active ingredients in Hard Mints include tadalafil, sildenafil, and vardenafil, among others. These are the generic forms of Cialis, Viagra, Levitra, and Staxyn, and they’re FDA-approved treatments for erectile dysfunction. They work in different ways to make it easier to get harder, longer-lasting erections.

All three active ingredients in Hard Mints work as PDE5 inhibitors. They work by preventing the action of a chemical called phosphodiesterase type-5 (PDE5) in your body. Hard Mints can help widen and relax blood vessels by relaxing this chemical.

Tadalafil, sildenafil, and vardenafil all work in slightly different ways and have different response times. Still, they’re all FDA-approved PDE5 inhibitors shown to help treat erectile dysfunction and improve sexual performance.

Visit official website to learn about Hard Mints >>>

Hard Mints Features

Some of the features and benefits of Hard Mints include:

Compounded Formula: In compounded substances like Hard Mints, a physician personalizes the formula based on the patient's unique needs. A physician may consider your symptoms, weight, tolerance, and other factors before deciding the ultimate combination and dosage of ingredients in your Hard Mints.

Free Consultation with Licensed Medical Professionals: All Hims purchases come with a free consultation from a medical professional licensed in your state. The cost of this consultation is included with your Hard Mints purchase, and there’s no extra charge. The physician will determine if Hard Mints or other ED drugs are the right choices for you.

No In-Person Visits or Phone Calls Required: You don’t need to schedule an in-person visit with a doctor or sit in a waiting room to get Hard Mints. You don’t even need to make a phone call. Instead, all consultations take place virtually in a telehealth environment.

Easy to Take: Just bite into and chew the Hard Mint until you can comfortably swallow it. There’s no need to take it with water like a pill.

Fast, Free & Discreet Shipping: Hard Mints arrive in discreet packaging, and all shipping is fast. You can quickly get the ED medication you need to be delivered anywhere in the US. Plus, your Hard Mints purchase includes the cost of shipping.

Available As Needed or Daily: Want to take mints daily to be ready for sex at any time? You can do that with Hard Mints. Or, you can take it as needed, chewing a mint 15 to 60 minutes before sex to be ready to go on-demand.

Affordably Priced at $7.50 Per Use and Higher: Hard Mints cost around $7.50 per use, depending on your treatment option.

Clinically Proven Ingredients: The three active ingredients in Hard Mints are all clinically proven and extensively studied. The FDA has approved all three ingredients for treating erectile dysfunction. The three active ingredients include tadalafil, vardenafil, and sildenafil. Hims is careful to explain that the FDA has not specifically approved Hard Mints for the treatment of ED, but the FDA has approved the three active ingredients inside Hard Mints.

How to Get Hard Mints

Hims makes it easy to get Hard Mints online after a free medical evaluation. Here’s how it works:

  • Step 1) Schedule a free online medical evaluation through Hims. Hims asks a few questions about your symptoms and health history, then schedules your evaluation.
  • Step 2) Speak with a licensed medical provider. A licensed medical provider determines if treatment is right for you.
  • Step 3) Enjoy free delivery. If the doctor decides Hard Mints are right for you, the ED medication arrives at your address in discreet packaging.

Types of Hard Mints

Hims created Hard Mints with different doses of active ingredients – and different types of active ingredients. Whether you want to take a daily or as-needed pill, you can get the medication you need with Hims.

Types of Hard Mints include:

As-Needed Hard Mints

Instead of taking something every day, you can take a mint every time you want to perform. Hims offers three hard mints that work within 15 to 30 minutes and last for hours, using the same active ingredients in Cialis, Viagra, and other ED medications.

As-needed hard mints include:

Tadalafil + Sildaneafil Chewables

Priced starting at $8 per treatment, the Tadalafil + Sildenafil chewable mints contain the same active ingredients in Cialis and Viagra at different dosages. Tadalafil (Cialis) can help you get harder, longer-lasting erections, and it starts to work in as little as 30 to 60 minutes and remains in your system for up to 36 hours. Hims compounds its formula based on your unique physiology, choosing different doses of tadalafil and sildenafil based on your needs.

Price: From $8 per use

Tadalafil Chewables

Hims also offers tadalafil chewables containing the same active ingredient in Cialis. The chewable mints can help you get stronger, longer-lasting erections. Like other Hard Mints, the Tadalafil Chewables are compound based on your specific needs, with some mints containing a larger or smaller dose. You can take it as needed or once daily, and the active ingredients remain in your system for up to 36 hours.

Price: From $7.50 per use

Vardenafil Chewables

Hard Mints Vardenafil Chewables contain the same active ingredient in Levitra and Staxyn, two popular ED medications. The active ingredient can help you get a stronger erection in as little as 15 minutes. Hims compounds the formula based on your unique needs, choosing different doses of vardenafil according to your physiology. Vardenafil can help you get a better erection for up to 12 hours after each mint.

Price: From $7.50 per use

Daily Hard Mints

Most Hims Hard Mints are taken as needed when you’re ready to have sex. However, Hims also offers a single daily hard mint. You take it once per day to enjoy harder, longer-lasting erections at any time.

Tadalafil (Daily)

Hard Mints Tadalafil Chewables are similar whether you’re taking the mints daily or as needed. Both versions of the formula contain tadalafil, the same active ingredient in Cialis, at different doses to give you stronger, longer-lasting erections. You take tadalafil daily, and the active ingredient stays in your system for up to 36 hours.

Price: From $94 per month

Hard Mints Versus Pills

Hims offers chewable mints and pills with ED medications. What’s the right choice for you? Why take chewable mints over traditional ED pills?

Here are some of the differences between Hard Mints and traditional ED medication:

Both mints and pills contain clinically-proven ingredients. Hard Mints contain the same active ingredients in Viagra, Cialis, and other prescription ED medications.

Compounded, customizable formulas are available. With traditional ED medication, you take pills with a specific dosage. With Hard Mints, you get a formula compounded to your unique needs and physiology. It’s made custom for you, giving you better-desired effects.

Both mints and pills are available at affordable prices, thanks to Hims. You can buy generic sildenafil and tadalafil pills through Hims for around $3 per use, for example. Or, you can buy Hard Mints starting at around $7 to $8 per use.

Chewable mints are tasty and convenient – and they freshen your breath. Instead of the awkwardness of a blue pill, you can chew a mint to get hard as needed.

How to Take Hard Mints

Hard Mints are designed to be easy and convenient to take:

  • Bite into and chew the minute until you can comfortably swallow it
  • Do not swallow the mint whole like a pill or suck on it like a cough drop
  • Take daily or before sex as needed, following the dosage recommendations on your product

Try Hard Mints today and see the difference!

Scientific Evidence for Hard Mints

There’s ample scientific evidence showing the active ingredients in Hard Mints, including sildenafil, tadalafil, and vardenafil, help with ED. Hard Mints contains a customizable dose of one or more of these ingredients, giving you harder, longer-lasting erections. We’ll review some of the scientific evidence behind Hard Mints below.

A 2008 study on tadalafil described the drug as the “most versatile PDE5 inhibitor” for treating ED. Tadalafil (Cialis) has a half-life of 17.5 hours, giving you a longer therapeutic window and easier, on-demand dosing. That study found clinical trials had proven the safety and efficacy of tadalafil, finding it effective even for difficult-to-treat ED.

A 1998 study tested sildenafil (Viagra) on a group of 532 men over a 24-week period. Men received 25, 50, or 100mg of sildenafil or a placebo. Researchers found men in the 100mg group recorded scores 100% higher after treatment, claiming it was significantly easier to achieve and maintain an erection. Men in all sildenafil groups were successful at sex 69% of the time compared to 22% in the placebo group. Men in the placebo group attempted to have sex 1.5 times per month, while men in the sildenafil groups attempted to have sex 5.9 times per month. The drug was well-tolerated, with common side effects including headache, flushing, and dyspepsia (occurring in 6% to 18% of men).

In a similar study on vardenafil, researchers gave 573 patients a 20mg dose of vardenafil or a placebo over a 4-week treatment period. Researchers found 81% of patients in the vardenafil group achieved first-time successful penetration, and 70% maintained an erection for the duration of sex. Overall, the vardenafil group had significantly better sexual performance and harder, easier-to-maintain erections than the placebo group.

Overall, the three active ingredients in Hard Mints have been proven to help treat erectile dysfunction when taken daily or as needed. Plus, with a dose customized to your unique physiology, Hard Mints can make getting the treatment you need easier.

Hard Mints Reviews: What Do Customers Say?

Hard Mints launched early in 2023, and reviews continue to be published online every day. We’ll review some of the thoughts people have about Hard Mints below.

It’s important to note Hard Mints aren’t the only chewable ED medication available today. Other options include BlueChew, Hello Cake, and Rugiet Ready. Generally, reviewers seem happy with the price, quality, and customizable dose of Hard Mints compared to other options. At $7.50 to $8 per use, Hard Mints also tend to be cheaper than other chewable mints (although BlueChew is comparable to Hard Mints for pricing and may be cheaper).

  • Reviewers on Reddit generally find Hard Mints work as advertised and are comparable to ED pills and other chewable ED treatments. Hard Mints can give you harder, longer-lasting erections, whether taken daily or as needed.
  • Industry review websites have rated Hard Mints 4.0 to 4.7 stars out of 5 based on their efficacy, quality, and pricing.
  • Customers generally like the flavor and chewability of Hard Mints. It’s like eating candy instead of swallowing traditional ED medication.
  • Some customers find they pay a premium for the Hims brand and Hard Mints formula and that you could get similar doses at a cheaper price.
  • Overall, most customers are happy with their Hims experience and the quality of Hard Mints. Whether taking ED medication for the first time or looking for alternatives to pills, Hard Mints could help.

Click here to get honest customer reviews >>>

About Hims

Hims is a subsidiary brand of Hims & Hers Health. It’s a telemedicine company founded in 2017. Today, the company offers a range of medications for men and women, including sexual treatment solutions, anxiety medication, and other solutions. You can order from Hims entirely online after a virtual consultation with a physician licensed in your state.

Hims is available in the United States and the United Kingdom and launched Hard Mints in February 2023. You can contact Hims and the company’s customer service team via the following:

  • Email: contact@forhims.com
  • Online Help Center: https://support.forhims.com/hc/en-us

Final Word

Hard Mints are a popular ED treatment from Hims. Available to order entirely online in discreet packaging, Hims Hard Mints features the same active ingredients in Viagra, Cialis, and other popular prescription ED medications.

To learn more about Hard Mints and how they work, or to buy Hard Mints online today, visit the official website.

Affiliate Disclosure:

The links contained in this product review may result in a small commission if you opt to purchase the product recommended at no additional cost to you. This goes towards supporting our research and editorial team. Please know we only recommend high-quality products.

Disclaimer:

Please understand that any advice or guidelines revealed here are not even remotely substitutes for sound medical or financial advice from a licensed healthcare provider or certified financial advisor. Make sure to consult with a professional physician or financial consultant before making any purchasing decision if you use medications or have concerns following the review details shared above. Individual results may vary and are not guaranteed as the statements regarding these products have not been evaluated by the Food and Drug Administration or Health Canada. The efficacy of these products has not been confirmed by FDA, or Health Canada approved research. These products are not intended to diagnose, treat, cure or prevent any disease and do not provide any kind of get-rich money scheme. Reviewer is not responsible for pricing inaccuracies. Check product sales page for final prices.

Hers Mental Health Treatments: A Research-Based Look at Online Anxiety & Depression Care

At MedClinRes.org, we recognize the importance of accessible mental health care, particularly for conditions like anxiety and depression, which affect millions of women worldwide. Hers, an online healthcare provider, offers a range of mental health treatment options, including FDA-approved medications tailored to support women’s well-being.

Through a streamlined virtual consultation process, users can receive personalized treatment plan recommendations within 24 to 48 hours. This approach eliminates the need for in-person visits, making it a convenient and discreet option for those seeking professional mental health support. Once prescribed, medications are shipped directly to the patient’s address in discreet packaging, ensuring privacy and accessibility.

But how does Hers’ approach to mental health treatment compare to traditional care options? Is it a reliable solution for managing anxiety and depression? In this research-based review, we analyze the effectiveness, safety, and accessibility of Hers’ mental health offerings. Keep reading to explore the latest evidence on Hers’ treatment plans and whether they align with best practices in mental health care.

What is Hers?

Hers is an online health and wellness brand for women. Hers aims to make healthcare easy, affordable, and accessible for women across the United States.

Today, Hers offers treatment plans, prescription medication, and other solutions for women with various health concerns. Popular Hers treatment options include products for anxiety, depression, hair loss, and birth control.

You can complete a free assessment with Hers online to speak with a licensed healthcare provider. That healthcare provider can prescribe certain medications or recommend other solutions based on your unique needs.

How Hers Works for Mental Health

Hers offers a range of mental health solutions, prescription medications, and treatment options.

Here’s how Hers works for mental health:

Step 1) Complete the intake process. Hers asks a few basic questions about yourself and your mental health. You can complete the questionnaire online from the comfort of your home from any device.

Step 2) Provider review. A licensed healthcare provider reviews your responses, then recommends treatment options for anxiety, depression, and other mental health concerns, if appropriate.

Step 3) Enjoy automatic refills and unlimited check-ins. Hers’ care team can answer questions and adjust the dosage if needed. Otherwise, you continue to enjoy automatic refills and complete check-ins.

According to the official website, 75% of Hers customers reported improved mental health symptoms after completing an online assessment and receiving customized treatment.

Overall, the goal of Hers is to provide mental health care on your time. You can get treatment recommendations within hours without leaving your home. You don’t need to wait in a clinic or visit a doctor in-person. You don’t even need to make a trip to the pharmacy.

Hers Mental Health Treatment Areas

Hers can treat general anxiety and depression concerns along with specific mental health issues.

Complete a free online assessment to tell Hers about your mental health concerns. Then, a licensed healthcare provider reviews your claim and recommends the best option for your personalized needs.

Specific areas of concern you can address with Hers include:

Anxiety & Worry: Are you anxious, worried, on edge, or not feeling like yourself for any reason? Hers may be able to help.

Work & Career Stress: Are you feeling burned out? Are you experiencing trouble at work? This can significantly impact mental health, and Hers may recommend solutions to help.

Trouble Getting or Staying Motivated: Do you have low energy? Do you feel fatigued? You’re not alone, and Hers may be able to recommend the best options for getting or staying motivated.

Sleep Trouble: Do you have trouble falling asleep or staying asleep? Anxiety and depression could impact your sleep, creating a negative spiral. Hers could recommend a solution.

Feeling Down or Depressed: If you’re feeling down or sad, then Hers can recommend a solution.

Major Life Events: Hers can recommend solutions to overcome significant life events. You can get support for breakups, grief, big moves, and more.

Regardless of your symptoms, a provider reviews your claim to determine the best treatment option. Then, the provider recommends the best choice for your unique needs, including prescription depression and anxiety drugs or other treatment solutions.

Note: Hers does not treat certain mental illnesses, including bipolar disorder, schizophrenia, OCD, or ADHD.

Hers Mental Health Products & Treatment Options

Hers can ship prescription mental health medication direct to your address in discreet packaging. If a doctor prescribes medication for your mental health concern, you can continue ordering this medication through Hers while enjoying unlimited refills.

Available mental health prescription drugs, over-the-counter products, and other solutions available through Hers include:

Generic for Wellbutrin XL (Bupropion XL): Hers offers generic Wellbutrin XL (bupropion XL) starting at $49 monthly. You can get psychiatric care for anxiety and depression with a convenient, FDA-approved, prescription-only medication. A licensed healthcare provider could prescribe bupropion XL for treating anxiety and depression, if appropriate. Bupropion is an NDRI affecting the balance of neurotransmitters in the brain – like norepinephrine and dopamine – to ease symptoms of depression.

Generic for Buspar (Buspirone HCl): Hers offers generic Buspar (buspirone HCl) starting at $49 monthly. Buspirone is an FDA-approved anxiolytic (anti-anxiety) medication for anxiety disorders. It works as a nonbenzodiazepine anxiolytic medication. The mechanism by which buspirone works is a bit complicated. Still, in simple terms, it belongs to a class of medications called azapirones, which interact with serotonin receptors in the brain. According to the National Institutes of Health (NIH), buspirone affects several neurotransmitters in different ways, weakly impacting certain dopamine receptors while avoiding the receptors influenced by benzodiazepines. It primarily targets the 5HT2 and 5HT1 serotonin receptors, which makes it effective in managing anxiety. Since every individual's brain chemistry is unique, buspirone's ability to affect many different things in a small way makes it an excellent option for people who do not respond well to other medications due to unwanted side effects or a lack of effectiveness. Studies have shown it can provide meaningful anxiety relief in many patients.

Generic for Celexa (Citalopram): Another FDA-approved medication for anxiety and depression, generic Celexa (citalopram), was one of the first selective serotonin reuptake inhibitors (SSRIs) on the market. Like other SSRIs, the drug raises serotonin levels in the brain, which could help with symptoms of anxiety and depression. Citalopram increases serotonin levels by lowering the level of serotonin that neurons reabsorb, leading to more free serotonin in your brain. Some use citalopram for general anxiety and depression, while others use it for mood, panic attacks, and more.

Generic for Cymbalta (Duloxetine): Hers offers a generic version of Cymbalta or duloxetine. Priced at $49 per month, duloxetine can help with depression and anxiety. Duloxetine works as an antidepressant. It’s an SNRI, or serotonin-norepinephrine reuptake inhibitor, first approved by the FDA in 2004. The FDA has approved duloxetine to treat generalized anxiety disorder (GAD) and major depressive disorder (MDD). Some doctors also prescribe duloxetine for nerve disorders, diabetic neuropathy, fibromyalgia, and musculoskeletal pain, among other conditions. However, Hers does not prescribe duloxetine for these purposes. By inhibiting the reuptake of serotonin and norepinephrine, duloxetine could help manage symptoms of anxiety and depression.

Generic for Lexapro (Escitalopram): Hers offers generic Lexapro, or escitalopram, to help with anxiety and depression. Escitalopram is a prescription drug and SSRI that reduces the amount of serotonin reabsorbed by your body, increasing the amount of free serotonin cycling through your brain. First approved by the FDA in 2002, escitalopram is sold under the brand name Lexapro. Doctors may prescribe escitalopram for generalized anxiety disorder (GAD) and major depressive disorder (MDD). Hers offers generic escitalopram starting at $49 per month.

Generic for Prozac (Fluoxetine): Hers sells generic Prozac, or fluoxetine, to help with anxiety and depression. With treatment starting at $49 per month, fluoxetine can provide antidepressant effects by acting as an SSRI. The FDA has approved using the drug for acute and maintenance treatment of the major depressive disorder (MDD). The FDA has also approved fluoxetine for obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder. Hers may not be able to treat all health conditions through its platform, and some patients may need to visit a separate healthcare provider for other treatment options. If prescribed, fluoxetine works similarly to other SSRIs to increase the amount of serotonin in the brain by limiting how much serotonin your nerve cells reabsorb.

Generic for Paxil (Paroxetine): A licensed healthcare provider may prescribe the generic Paxil, paroxetine, through the platform. Starting at $49 per month, the drug can help with anxiety and depression. Paroxetine is an antidepressant SSRI designed to balance chemicals naturally present in the brain. The FDA approved paroxetine in 1992, and you can buy the drug under brand names like Paxil, Paxil CR, Pexeva, and Brisdelle. The FDA has approved the drug for GAD, MDD, OCD, and PTSD. Some doctors also prescribe paroxetine for hot flashes.

Generic for Zoloft (Sertraline): You can get sertraline, or generic Zoloft, a popular SSRI and one of the first antidepressants on the market in the United States. First approved by the FDA in 1992, Zoloft / sertraline remains popular today. Sertraline works by controlling the amount of serotonin reabsorbed by the brain, thereby increasing free serotonin circulating in the body. Sertraline could also improve motivation, boost interest in activities, and reduce instances of panic attacks.

Generic for Effexor (Venlafaxine): You may receive a prescription for generic Effexor (venlafaxine) through a licensed healthcare provider via Hers. Then, you can buy that prescription online at $49 per month. Venlafaxine is an SNRI, or serotonin-norepinephrine reuptake inhibitor, that works as an alternative to SSRIs. The FDA first approved venlafaxine in 1992, then later approved an extended-release version of the drug (venlafaxine XR) in 1997. Today, venlafaxine is available under brand names like Effexor and works by balancing levels of two crucial chemicals within the brain: norepinephrine and serotonin.

Online Psychotherapy Services: Hers also offers online services for talk therapy, also known as psychotherapy. Patients can use the Hers website to speak with a licensed therapist. You can enjoy holistic, quality care virtually. Hers offers both telepsychiatry and online psychotherapy services.

Note: Hers does not prescribe controlled substances (like benzodiazepines or Klonopin) for psychiatric care. The company also does not treat certain mental illnesses, including bipolar disorder, schizophrenia, OCD, or ADHD. However, a medical provider reviews your symptoms and history to determine the best treatment option from Hers’ catalog.

Hers Mental Health Treatment Pricing

Hers offers a unique pricing model with its mental health treatment options. You pay a low rate for your first month, and your subscription automatically renews at the standard rate. You pay the same rate regardless of which mental health medication you buy.

Here’s how it works:

  • Medication: $25 for your first month*
  • Provider Evaluation: Unlimited
  • Medication Adjustments: Unlimited
  • Ongoing Follow-Ups: Unlimited

*After your first month, you pay $85 monthly for a monthly subscription (month-to-month) or $49 monthly for a three-month subscription ($123 for your first order, then $147 billed quarterly thereafter). Hers automatically renews your subscription until you cancel. You must cancel at least seven days before your renewal date to avoid further charges.

Hers Refund Policy

Hers does not offer a refund on any prescription drugs, supplements, or other products. Because the company cannot resell products after use, Hers does not provide a refund on its products.

However, you can contact the Hers customer service team if you’re unhappy with Hers’ products for any reason – or if you received a damaged or incorrect product.

Contact Hers

You can contact Hers and the Hers customer service team via the online help center, telephone at 1-800-368-0038, or email at support@forhims.com, or by downloading the Hers app.

Final Word

Hers is an online health and wellness brand for women. The company offers a range of healthcare products and services, including mental health solutions.

Today, you can access online therapy services through Hers or receive a consultation with a licensed US medical provider. Hers can recommend the best treatment options for your unique needs, including prescription antidepressant drugs (like SSRIs and SNRIs) or other mental health treatment solutions.

If prescribed, you can sign up for a cost-effective prescription for your antidepressant or anti-anxiety medication through Hers. Hers offers prescriptions starting at $49 per month with unlimited refills and dosage changes available.

To learn more about Hers’ mental health solutions and how they work or to sign up today, visit the official website.

Affiliate Disclosure:

The links contained in this product review may result in a small commission if you opt to purchase the product recommended at no additional cost to you. This goes towards supporting our research and editorial team. Please know we only recommend high-quality products.

Disclaimer:

Please understand that any advice or guidelines revealed here are not even remotely substitutes for sound medical or financial advice from a licensed healthcare provider or certified financial advisor. Make sure to consult with a professional physician or financial consultant before making any purchasing decision if you use medications or have concerns following the review details shared above. Individual results may vary and are not guaranteed as the statements regarding these products have not been evaluated by the Food and Drug Administration or Health Canada. The efficacy of these products has not been confirmed by FDA, or Health Canada approved research. These products are not intended to diagnose, treat, cure or prevent any disease and do not provide any kind of get-rich money scheme. Reviewer is not responsible for pricing inaccuracies. Check product sales page for final prices.

Hims Hair Loss Treatments: A Research-Based Look at Effectiveness & Safety

At MedClinRes.org, we understand that hair loss is a common concern among men, often influenced by genetics, hormonal changes, and lifestyle factors. To address this, Hims offers a range of hair loss treatments, including FDA-approved medications and over-the-counter hair care solutions designed to support hair regrowth and scalp health.

The process begins with a simple online consultation, where users complete a questionnaire regarding their hair loss history and health background. A licensed medical provider then reviews the information to determine whether a prescription treatment is appropriate or if an alternative hair care solution may be more suitable.

But is Hims the right choice for you? How does its approach to hair loss treatment compare to other available options? In this article, we examine the science behind Hims hair loss solutions, exploring their mechanisms, effectiveness, and safety profile to help you make an informed decision about your hair health. Keep reading to learn more about the latest research-backed hair loss treatments available through Hims.

What is Hims?

Hims, found online at ForHims.com, is a personal wellness brand offering a range of solutions for men.

Hims was founded to make treatment accessible and affordable for men. Today, men can access a range of products through Hims – including ED medication, anxiety and depression treatment options, hair loss treatments, and more.

Hims is a subsidiary of Hims & Hers Health, an online wellness brand founded in 2017. In addition to ForHims.com, the company operates ForHers.com, which offers similar treatment options for women.

Hims makes getting access to care simple. All you have to do is go online and answer a few questions and a provider will review your case to see if treatment is right for you. It is really that simple to start with Hims knowing a qualified medical provider reviews your personal situation, then recommends the best treatment options based on all of your unique feedback points.

Hims offers access to prescription medication and other products to support your health care goals. If a provider determines that medication is right for you, your order is shipped directly to your door for free.

Hims Hair Loss Benefits

Benefits of treating hair loss through hims:

  • Start regrowing in as little as 3-6 months (*Active ingredients have been studied separately, with each showing results of improvement in hair regrowth after 3 to 6 months of use.)
  • FDA-approved treatment options available
  • 100% online with free shipping, if prescribed
  • Free online consultation
  • Range of prescription hair loss treatment options and other products available

How Does Hair Loss Work Through Hims?

Hims provides access to prescription medication, like minoxidil (Rogaine) and finasteride to treat hair loss. The company also sells hair loss supplements like biotin and others.

Here's how to get started with Hims:

  • Step 1) Complete a short consultation to answer a few questions about your hair loss. A licensed medical professional reviews your case for free, then decides whether or not a specific hair loss product is appropriate for you.
  • Step 2) Get hair loss treatment products delivered to your door. If a doctor has prescribed a hair loss treatment product, then your prescription is sent directly to you for free.
  • Step 3) Regrow your hair. Start regrowing your hair in as little as 3-6 months. You can stop hair loss, regrow your hair, and regain confidence.

Hims Hair Loss Products

Below are some hair loss products available through Hims:

Topical Finasteride & Minoxidil Spray

Hims' most popular hair loss treatment option is the Topical Finasteride & Minoxidil Spray. This quick-drying spray could reverse hair loss and improve hair growth when applied topically to your scalp.  The topical minoxidil and finasteride spray combines two clinically-proven ingredients (finasteride and minoxidil) to help stop hair loss and regrow hair. The same active ingredients but even fewer steps than other hair loss routines. The fine-mist spray dries faster on your scalp—no dripping down the back of your neck here. You use the spray once daily to target a receding hairline and bald spots.

Features of the combination spray include:

  • Finasteride treats hair loss in men by reducing dihydrotestosterone (DHT) in your scalp. DHT is an androgen hormone linked to testosterone that appears to contribute to hair loss by shrinking hair follicles.
  • The combination spray is a fine mist that dries quickly. You apply it to your scalp and targeted thinning areas once daily, then start experiencing results in as few as three months.
  • The spray contains two active ingredients, including 0.3% finasteride and 6% minoxidil, along with alcohol (ethanol), propylene glycol, and citric acid as inactive ingredients.
  • Possible side effects of the spray include itching, irritation, and a dry, flaky scalp.

Overall, the 2-in-1 spray is Hims’ most popular hair loss treatment option. Men like it for its proven results and ease of application.

Oral Finasteride

If you have a receding hairline, a medical provider may determine that oral finasteride is the right choice for you.

Oral Finasteride is an FDA-approved, clinically-proven solution for hair loss prevention and regrowth. It's an easy, once-a-day pill proven to help reverse hair loss and improve hair growth. Just take one capsule of finasteride daily for better hair growth.

Finasteride & Minoxidil

If you have a receding hairline and bald spots, a medical provider may also recommend a combination of finasteride and minoxidil as different medications.

You take two FDA-approved, clinically proven treatments for hair loss in one Finasteride (oral pill) & Minoxidil (topical serum) package. The drugs work better when used together. They can reduce DHT levels and stimulate regrowth, making them ideal for reversing a receding hairline and fixing bald spots.

Hair Power Pack

If you're dealing with overall thinning hair, a medical provider may recommend the Hims Hair Power Pack during your initial consultation. The Hims Hair Power Pack includes finasteride and minoxidil, two FDA-approved clinically proven treatments, thickening shampoo, and biotin gummy supplements.

The Hims Hair Power Pack includes the following:

1 x Finasteride Pills

Oral finasteride pills are FDA-approved daily tablets to help increase the volume and health of your hair in as little as 3-6 months (based on studies of the active ingredients). Finasteride pills work by preventing testosterone from breaking down into DHT. DHT is a hormone linked to hair follicle damage.

1 x Minoxidil Drops

The Hims Hair Power Pack includes minoxidil drops, a topical solution applied once daily to promote hair growth. The drops work by shedding old hairs. To do that, minoxidil relaxes blood vessels, encouraging blood to flow to your scalp more easily.

1 x Thickening Shampoo

Hims' thickening shampoo, called Hims Thick Fix Shampoo, is infused with saw palmetto to stimulate hair growth. Apply the shampoo to cleanse built-up toxins, unlock hair follicles, and stimulate strands.

1 x Hims Hair Loss Gummies

Hims also offers hair loss gummies. These biotin gummies are a tasty and effective way to support hair growth. Each gummy contains natural ingredients like biotin to support hair growth, including vitamins, minerals, and nutrients linked to hair growth and thickness. These ingredients provide the building blocks for hair, and Hims developed the formula with precise nutrients for optimal hair growth.

Hims Thickening Shampoo & Conditioner

Hims offers a thickening shampoo and conditioner. Applying both solutions daily can support hair growth with easy, effective treatment.

Hims thickening shampoo ($19) features saw palmetto to stimulate strands, giving you fuller-looking hair. The formula also creates an ultra-rich lather with a fresh eucalyptus grove scent.

Hims thickening conditioner ($22) is infused with niacinamide and other ingredients to help hydrate and bolster your hair, leaving it feeling thicker. The Hims thickening conditioner can give your hair a silky smooth appearance and features a eucalyptus grove scent.

You can buy Hims Thickening Shampoo & Conditioner over the counter with no prescription. The shampoo and conditioner contain no hair loss medication. They contain natural ingredients to support hair growth.

Who Should Use Hims for Hair Loss?

Hims markets its hair loss treatment options to men with various hair loss concerns. Whether you're trying to fill in bald spots, reverse a receding hairline, or prevent hair loss entirely, you may be able to find the treatment options you need with Hims.

Some men who could benefit from Hims' hair loss treatment options include:

Men Who Want to Prevent Hair Loss

If male pattern baldness runs in the family, you may want to take preventive measures before losing your hair. You could have a full head of hair today, and hair loss preventive measures can help you maintain it for the future.

Men With Thinning at the Crown

Androgenic alopecia can lead to bald spots across the head – including at the top. This condition occurs when your hair follicles' anagen (growth phase) shortens over time, inhibiting growth. Hims has treatment options to reverse the issue. If your hair is thinning at the crown, then Hims could help.

Men With a Receding Hairline

Men with a family history of baldness and aging may experience a receding hairline. This process occurs when the anagen phase of follicles shortens with age, and Hims' treatment options may reverse it. As you get older, your forehead may become more visible.

Men With All-over Thinning

If you're thinning all over, seeing parts of your scalp, or struggling to style your hair, then a prescription from Hims could still help. Hims' treatment options can help reactivate hair follicles that have closed with age, giving new life to your thinning hair.

Hims Hair Loss Reviews

Generally, customers are satisfied with Hims' hair loss treatment options and how they work. Many customers have achieved a noticeable difference in hair thickness and overall quality using products provided by Hims..

Here is some of the feedback from Hims customers:

  • Many men have experienced significant and noticeable hair growth thanks to Hims, achieving thicker, fuller-looking hair within months of starting a Hims regimen.
  • Men have fixed noticeable issues like receding hairlines, bald crowns, general thinness, and other hair loss problems with Hims' treatment solutions.
  • One customer claims he noticed “a huge change in the overall health and fullness of my hairline” after using Hims' treatment options.
  • Another customer reported being able to style his hair in waves for the first time in 10 years after using Hims' recommended treatment for just five months.
  • Hims' treatment options are popular with men of all ages, including those who are losing hair in their 20s and 30s and men losing hair in their 40s, 50s, 60s, 70s, and beyond.
  • Others like Hims for being cost-effective and affordable.
  • Many men also like how simple it is to work with Hims to get the prescription hair loss medication they need. Hims offers a 100% online process, allowing customers to submit their intake form without an in-person doctor appointment. If prescribed, the medication is shipped directly to their door for a reasonable price. While actual price to a customer will depend on the product and subscription plan purchased, Hims' hair loss products start at less than $1/day.

Overall, Hims continues to score top marks from men seeking all types of hair loss products and solutions.

Hims Hair Loss Return Policy

Hims does not offer refunds on hair loss products (or any other medications, supplements, or products sold through the official website).

Hims does not accept refunds because the company cannot and will not reuse anything returned to them due to the nature of their products.

If you're unhappy with the results of Hims' products or did not receive what you expected, contact the company via the official website.

Hims maintains an online help center and app where you can ask questions, manage orders, and get the necessary answers.

Final Thoughts on Hims Hair Loss Solutions

Hims offers a range of hair loss solutions for men of all ages, including topical minoxidil, oral finasteride, thickening shampoo and conditioner, and more. Based on the customer feedback and the quality of products that are backed by real studies, using hair loss products from Hims is a great way to start regrowing your hair and regaining your confidence.

To learn more about the hair loss products available through Hims and how they work or get started with a free online consultation today, visit the official website.

Affiliate Disclosure:

The links contained in this product review may result in a small commission if you opt to purchase the product recommended at no additional cost to you. This goes towards supporting our research and editorial team. Please know we only recommend high-quality products.

Disclaimer:

Please understand that any advice or guidelines revealed here are not even remotely substitutes for sound medical or financial advice from a licensed healthcare provider or certified financial advisor. Make sure to consult with a professional physician or financial consultant before making any purchasing decision if you use medications or have concerns following the review details shared above. Individual results may vary and are not guaranteed as the statements regarding these products have not been evaluated by the Food and Drug Administration or Health Canada. The efficacy of these products has not been confirmed by FDA, or Health Canada approved research. These products are not intended to diagnose, treat, cure or prevent any disease and do not provide any kind of get-rich money scheme. Reviewer is not responsible for pricing inaccuracies. Check product sales page for final prices.