FDA Approved Hair Growth Products: Everything You Need To Know

Medically reviewedby Dr. Amy Revene M.B.B.S.
WrittenbyLuat Duong
Last updated

In the realm of hair growth solutions, only two treatments have earned FDA approval for hair loss: Rogaine (minoxidil), suitable for both men and women, and Propecia (finasteride), exclusively for men.

This article provides an insightful overview of these FDA-approved hair growth products, including Rogaine's topical solution available in 2% and 5% strengths.

We'll guide you through their effectiveness, usage, and what you can expect, helping you make informed decisions for your hair care journey.

What is an FDA-approved product?

FDA approved hair growth products

An FDA-approved product is one that has been evaluated and authorized for sale by the U.S. Food and Drug Administration (FDA). This approval indicates that the product has been rigorously tested for safety and effectiveness for its intended use.

The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices.  

The process for FDA approval typically involves a thorough review of clinical trial data and other relevant information to ensure that a product meets the necessary standards for quality and performance. 

This process is especially crucial for pharmaceuticals and medical devices, where safety and effectiveness are paramount.

FDA approval is a significant indicator that a product is both safe and effective for consumer use as directed.

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Which hair growth products are FDA-approved?

FDA approved hair growth products

The FDA has approved only two hair growth products: finasteride and minoxidil. Finasteride, often known by its brand name Propecia, is a prescription pill for men, while minoxidil, commonly referred to as Rogaine, is a topical solution available over-the-counter for both men and women.


Finasteride, known commercially as Propecia, is primarily used to treat male pattern baldness, particularly in the crown area. It works by reducing the body's levels of dihydrotestosterone (DHT), a hormone linked to androgenic alopecia. 

By lowering DHT, finasteride helps slow down hair loss and can be effective in early to moderate stages of hair loss. 

It is an oral medication, available only by prescription, and is generally not prescribed to women due to risks of birth defects.


Minoxidil, widely recognized by the brand name Rogaine, is a topical solution available in 2% and 5% concentrations. It functions as a vasodilator, enhancing blood flow to hair follicles, which can help slow hair loss and stimulate new hair growth. 

Minoxidil's effectiveness varies among individuals. It can be used alone or in combination with hair restoration surgery for improved results. 

Unlike finasteride, it is available over-the-counter and can be used by both men and women.

Do FDA hair growth products work

FDA-approved hair growth products like finasteride and minoxidil are proven to be relatively safe and effective for treating hair loss and thinning. Clinical trials and studies over decades have demonstrated their efficacy.

Finasteride, when taken daily, can significantly reduce DHT levels in the body by up to 70 percent. This reduction is substantial enough to protect existing hair follicles and potentially revive struggling ones. 

The decrease in DHT, a key factor in androgenic alopecia, makes finasteride a valuable tool in managing hair loss, particularly male pattern baldness.

Minoxidil, although its exact mechanism of action remains partially unclear, has shown positive results in increasing hair density, volume, and thickness. Studies indicate that minoxidil can improve hair follicle count by 12 to 18 percent over a 48-week period. 

Its ability to increase blood flow to the follicles is believed to be a crucial factor in its effectiveness. 

An interesting aspect is that experts generally agree that using both finasteride and minoxidil together is safe, potentially offering a more comprehensive approach to treating hair loss. 

This combination allows for both the reduction of DHT (finasteride) and the stimulation of hair follicles (minoxidil), covering different aspects of hair growth and preservation.

Which hair growth products are not FDA-approved?

Many hair growth products are not FDA-approved, including various home remedies and natural ingredient-based treatments. These products often lack sufficient scientific evidence or clinical trials to meet FDA standards.

Home remedies and natural treatments, such as rosemary, olive oil, pumpkin seed oil, and other pantry items, have shown some promise in preliminary studies

However, these studies are often not extensive or replicated enough to warrant FDA approval.

For example, saw palmetto is sometimes mentioned in studies for its potential to regulate DHT levels, a factor in hair loss, but there's insufficient evidence for FDA endorsement.

Additionally, mechanical devices like laser treatment combs, electric scalp massagers, and helmets that claim to promote hair growth are not currently FDA-approved. 

While some of these products may offer benefits, their effectiveness has not been conclusively proven through the rigorous, extensive testing required for FDA approval. 

As a result, their status remains uncertain, and they are not part of the FDA's recommended solutions for hair growth or hair loss treatment at this time.

A better approach for your overall hair health

Best hair growth serums

Experience a revolutionary transformation in your hair care regimen with Bio-Pilixin® Serum, a cutting-edge solution expertly formulated to help fight hair loss and encourage robust hair growth. 

Developed by leading experts, this serum utilizes advanced stem cell technology and multiple plant growth factors to nurture hair follicles and kickstart growth, setting it apart from other products in the market. 

Its efficacy is not just a claim; it has been clinically tested, showing significant improvements in as little as 45 days. 

An impressive 93% of participants in clinical studies have expressed satisfaction with the results, highlighting its effectiveness. 

What makes Bio-Pilixin Serum truly special is its safe, drug-free composition, making it suitable for daily use without the risk of side effects. 

The selection of potent active ingredients is based on a thorough review of scientific literature, each evaluated by a third-party laboratory to ensure unmatched quality. 

All ingredients are 100% vegan, aligning with a commitment to ethical and natural solutions. 

The formula includes Capilia Longa, a natural compound proven to reduce hair loss by up to 89% and increase hair density by up to 52%. Additionally, niacinamide is incorporated to strengthen hair by boosting keratin production.

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While finasteride and minoxidil remain the only FDA-approved treatments, known for their efficacy in combating hair loss, it's important to recognize the potential of emerging products that, although not FDA-approved, are showing promising results. 

Bio-Pilixin Serum, with its expert formulation and clinical backing, represents a new frontier in hair care, offering a safe, effective, and natural approach. 

Remember, when choosing a hair growth product, it's crucial to consider FDA approval as a mark of safety and efficacy. 

However, exploring products like Bio-Pilixin Serum, which are supported by clinical studies and scientific research, can also be a beneficial addition to your hair care regimen. 

Whether you opt for tried-and-tested FDA-approved options or innovative new treatments, the key is to choose a product that aligns with your specific needs and hair goals. 


What are the FDA-approved products to increase hair growth?

The FDA has approved only two products for hair growth: finasteride and minoxidil. Finasteride works by slowing down hair loss, preventing the body from harming its own hair follicles, while minoxidil, available as ROGAINE®, stimulates hair regrowth in individuals with hereditary hair loss.

Which brand of minoxidil is FDA approved?

ROGAINE is the FDA-approved brand of minoxidil. Over the years, ROGAINE has innovated its product line to provide hair regrowth benefits for both men and women experiencing hereditary hair loss.

What can promote faster hair growth?

To encourage faster hair growth, consider increasing protein intake, using caffeine-based hair products, avoiding permanent dyes, and reducing stress. These practices can contribute to healthier hair growth and overall hair health.


  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8808739/ 
  2. https://www.cuimc.columbia.edu/news/studies-uncover-new-approaches-combat-hair-loss-men-and-women 

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Luat Duong

Luat Duong is a Copenhagen-based writer and content strategist specializing in hair loss and health. His work has been featured in MyHealthGuide, The Right Hairstyles, and Woman's Era. He is a graduate of Vaasa University. You can connect with him on LinkedIn.