FDA-approved ingredients for hair growth

Hair growth products require more than marketing claims; they need FDA-approved active ingredients to ensure compliance, safety, and proven results. For formulators, this means relying solely on substances recognized by the FDA for efficacy in hair growth.

Currently, only two ingredients are FDA-approved for hair growth: Minoxidil and Finasteride. Extensive clinical studies back both and remain the foundation of successful hair loss treatments on the market.

In this guide, we'll be presenting the two FDA-approved cutting-edge hair growth ingredients, how they function, real-world brand examples, and why adding them to your product will help it succeed.

1. Understanding FDA-Approval for (Hair Growth) 

Unlike typical cosmetic claims, hair growth is a medicinal claim, which means that any product promising to grow or treat hair loss must contain FDA-approved ingredients and adhere to OTC (Over-the-Counter) medication laws. 

The following distinction is crucial: 

Cosmetic: Safe to use, enhances appearance (e.g., looks healthier, shinier, and thicker). 

OTC/drugs: Addresses or prevents a condition directly (e.g., lowers hair loss, grows hair). 

To enter the hair growth market with authority and stay out of trouble with the law, you must use FDA-approved hair growth ingredients.

2. Minoxidil–The Vasodilator Standard

In over-the-counter (OTC)  hair regrowth, Minoxidil is the most well-known ingredient, marketed under brands like Rogaine®. 

Mode of action

By widening blood arteries in the scalp, it acts as a vasodilator, improving the flow of nutrients to hair follicles and extending the anagen period of hair growth. This implies fresh growth in many users as well as thicker, stronger strands.

Use of the ingredient

Customers demonstrate strong trust in Minoxidil products, with many users praising noticeable regrowth and a reduction in thinning. While results differ, consistent demand has positioned Minoxidil as the cornerstone of the global hair regrowth market.

Why Do Brands Choose It?

Brands consistently choose Minoxidil because it offers:

• Regulatory assurance: Being the only FDA-approved OTC hair regrowth ingredient makes it a low-risk choice for compliance.

• Established consumer awareness: Customers already recognize and trust Minoxidil, lowering barriers to market entry.

• Strong demand: The global Minoxidil market continues to grow, with both men and women actively seeking products containing it.

• Versatile formulation opportunities:  It can be formulated into foams, topical solutions, and serums, allowing brands to differentiate their products while staying FDA-compliant.

3. Finasteride – The Hormone Blocker (Oral Only)

The second FDA-approved treatment for male pattern hair loss is Finasteride (Propecia®), although it is only available orally at this time. 

Mode of action

It prevents the conversion of testosterone to DHT, the hormone that causes androgenic alopecia by shrinking follicles. 

Use of the ingredient

Propecia® is the most popular oral brand; topical forms are still in the experimental stage and are not yet FDA-approved, but they are being researched.

Customer feedback highlights that Finasteride restores confidence. Many men report not just physical improvements, but also emotional benefits—bridging the gap between cosmetic concerns and psychological well-being.

Why Do Brands Choose It?

Brands opt for Finasteride for the following reasons:

• Prescription exclusivity:  Its FDA approval as a prescription drug creates strong brand differentiation in the medical market.

• Targeted male audience: It directly addresses androgenetic alopecia, a condition affecting millions of men worldwide.

• Long-term treatment demand: Especially for clinical or prescription-focused brands, combining finasteride and minoxidil is frequently the most effective way to treat male pattern baldness.

• High consumer loyalty: Success stories and emotional outcomes translate into repeat prescriptions and strong brand trust.

• Gap-filling role: While Minoxidil is OTC, Finasteride captures the prescription side of the market, ensuring no segment is left unserved.

4. Formulation Insights for Brands:

If you are seeking to formulate and are already aware of problems, take into account these perspectives, including possible formulations and why now is the time. 

Possible formulations 

A prescription medication that contains 2% or 5% minoxidil and is labelled with drug facts. 

For males, take into account combinations or upcoming formulations that might contain prescription-backed oral finasteride. 

The reason it matters now

Minoxidil is clinically proven, widely used by dermatologists and consumers, and simple to produce as a foam or solution. 

Although finasteride is strictly regulated and only available with a prescription, it is a key addition for male-pattern hair loss if you are creating a brand with a strong clinical foundation.

Let’s Formulate Hair Growth Products

At Freelance Formulations, we specialize in cosmetic and OTC topical drugs that deliver real results. Our expert chemists partner with you to create safe, effective, and custom formulations that align with your vision. Whether you’re launching a new product or expanding your line, we provide the guidance and expertise needed to bring your ideas to market successfully. Contact us today to schedule a discovery call and begin formulating your FDA-approved hair growth products.