Which Lash Serum Is FDA-Approved? (There’s Only One!) (2025)

If you’re looking for an FDA-approved lash serum, there is only one option on the market — Latisse. All other eyelash growth serums are considered to be “cosmetic” products, which means they are not regulated by the FDA.

In this article, I will share what it means to be FDA-approved and the differences between a drug and a cosmetic.

Key Takeaways:

  • Latisse (bimatoprost ophthalmic solution 0.03%) is the first and only FDA-approved eyelash serum for the treatment of hypotrichosis, a condition of having inadequate or not enough lashes.
  • Latisse requires a prescription while other over-the-counter serums don’t require a prescription
  • OTC eyelash growth serums didn’t go through the rigorous clinical trials required by the FDA.

Let’s dive into it!

Which Lash Serum is FDA-Approved?

Latisse is the only lash serum that has been approved by the FDA for use in the United States. It contains an active ingredient called bimatoprost, which has been shown to promote lash growth and thickness over time.

Having said that, you should know that Latisse is a prescription medication and can only be used under the guidance of a doctor. It may cause side effects so it’s important to discuss them with your doctor before starting any treatment.

If you want to know more about Latisse, you can check their website here.1

What It Means to Be FDA-Approved

The FDA, or the US Food and Drug Administration, is a government agency that is responsible for protecting public health by ensuring the safety of food, drugs, and cosmetics.

In order for a drug to be FDA-approved, it needs to be reviewed by the Center for Drug Evaluation and Research (CDER). The product must provide benefits that are greater than the potential risks for the intended population.2

Latisse had to go through a rigorous testing process to ensure that it is safe and effective.

When Was Latisse Approved by the FDA?

Latisse (developed by Allergan, Inc.) was originally approved by the FDA on December 24th, 2008 for the treatment of hypotrichosis in patients 18 years old or above.3

What’s hypotrichosis?

It is a condition where the patient has little to no hair growth around the head area. This includes brows and eyelashes.

Drug vs Cosmetic

Latisse is considered a drug because it’s used to treat a medical condition with an active ingredient called bimatoprost.

Therefore, the only way you can get your hands on this product is with a doctor’s prescription.

On the other hand, all other lash serum products are considered cosmetics since they don’t have any active ingredients that treat a medical condition.

As a result, these products are available over-the-counter and don’t require a prescription.

What Eyelash Serum Is as Good as Latisse?

The truthful answer to this question is … nobody can tell for sure.

Why is that?

Because Latisse is the only eyelash growth serum approved by the FDA with clinical data to prove its benefits.

All other lash serums on the market are not FDA-regulated, which means they don’t have to go through the same clinical trials as Latisse did. Some eyelash serums are simply bad for you.

It doesn’t necessarily other serums are not as good as Latisse. It’s just that we don’t have much scientific evidence to make comparisons.

Having said that, we can make 2 suppositions.

#1 Prostaglandins-Based Serums Are as Effective as Latisse

The active ingredient found in Latisse is bimatoprost, a prostaglandin compound.

Since then, several mainstream lash serum brands have added prostaglandin analogs to their ingredient list. A prostaglandin analog is a synthetic version of prostaglandins.

Pro Tip: Find out which popular eyelash growth serums contain a prostaglandin analog compound.

Therefore, these serums should in theory be as effective as Latisse in terms of lash growth. It is also reasonably safe to assume they would have the same risk profile.

I say in theory because we don’t have any direct evidence to prove that prostaglandin-based lash serums are as effective as Latisse since they haven’t been through clinical trials.

#2 Natural Lash Serums Are Less Effective but Safer

If you’re not comfortable using a prostaglandin-based serum, then you can opt for natural lash serums that don’t contain any synthetic compounds.

Some popular ingredients found in natural lash serums are biotin, green tea, peptides, and vitamin E.

Although these serums are thought to be safer, they are also less effective since they don’t have any FDA-approved active ingredients.

This means the results will likely be much slower and less dramatic than what you would get with a prostaglandin-based serum.

Having said that, some of these ingredients have scientific evidence to support their lash-enhancing benefits.

It’s just that unfortunately we are not comparing apples to apples since one is a drug approved by the FDA and the other is a cosmetic.

The Bottom Line

If you want the most effective and FDA-approved lash serum on the market, then your only option is Latisse. There are a few places where you can buy Latisse depending on which country you live in.

But keep in mind that since it’s a drug, you will need a prescription from your doctor to get your hands on this product.

It also comes with a series of potential side effects, some of which are long-lasting and quite serious.

– Asako 🙂

Additional Readings on DivineLashes.ca: If you want to know what other options are out there, check out my list of favorite eyelash serums, which lash serums don’t have prostaglandins, and my eyelash serum 101 guide for beginners.

References

  1. Latisse. (bimatoprost ophthalmic solution) 0.03%. Retrieved from https://www.latisse.com/ [Accessed March 3rd, 2023].
  2. FDA (2022). Development & Approval Process | Drugs. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs [Accessed March 3rd, 2023].
  3. FDA (2009). Drug Approval Package. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022369_latisse_toc.cfm [Accessed March 3rd, 2023].

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Asako Ito

Asako Ito, Co-Founder of Divine Lashes and certified lash stylist, is known for her innovative techniques in the lash industry. She holds multiple certifications and licenses, including Luxury Eye, THE LASH SHOP, World Microblading, and The Lash Bible. With over a decade of experience, she stays at the forefront of lash and brow artistry by collaborating with top artists worldwide. You can read her full bio here.

Which Lash Serum Is FDA-Approved? (There’s Only One!) (2025)
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