The FDA and Permanent Makeup

Understanding FDA Regulations in the Permanent Makeup Industry

Over the past decade the PMU industry has seen significant growth 🚀. So many more people have become interested in procedures like microblading, nano brows, powder brows, lash enhancements, lip blush, scalp micropigmentation, and more. While this spike in PMU activity has caused a lot of excitement in the industry, it has also led to increased scrutiny from clients, and new regulations from local health departments and now even the U.S. Food and Drug Administration (FDA).

As a PMU manufacturer it is our responsibility to keep up with the latest rules so we keep our products safe for everyone, but with so much info out there (some of it misleading) it can get confusing for artists and clients to know what manufacturers like us are doing to keep them safe.

So, we’re here to help clear things up! 😊

How Does the FDA Regulate Permanent Makeup?

The FDA only recently started overseeing parts of the PMU industry. Since June 2024 all U.S. cosmetic manufacturers (including PMU manufacturers) must have their products and facilities registered with the FDA and follow the Modernization of Cosmetics Regulation Act (MOCRA).

Here’s what you need to know 🔍

1. MOCRA and Its Impact on PMU

In December 2022 MOCRA became law, expanding the FDA’s reach into cosmetic products including PMU and tattoo ink. This means manufacturers are required to:

• Register their facilities with the FDA 🏭

• List all products and their ingredients with the FDA

• Follow strict safety and quality guidelines (GMPs)

• Report serious adverse reactions linked to tattoo products ⚠️

• Clearly label products with ingredients, safety warnings, and instructions

What does this mean for artists and clients?

If you're buying PMU inks or pigments make sure they come from an FDA-registered manufacturer. This ensures the products are made in safe, inspected facilities, and adhere to MOCRA.

2. Are Some Pigment Formulas "Trade Secrets"?

Some pigment makers claim they don’t have to list ingredients because their formulas are "trade secrets" or "proprietary blends." But the FDA does not allow this ❌.

All ingredients must be disclosed so consumers can make informed choices. While companies can apply for a "trade secret" exemption, the FDA almost never grants it.

3. Pigments and Color Additives – What’s Actually Approved?

PMU pigments are made from color additives and other ingredients. The FDA regulates color additives but has not approved any for tattooing. That means there’s no official FDA-approved list of safe colorants for PMU.

So, if nothing is approved how do we know what’s safe? 🤔

Manufacturers like SofTap carefully review FDA-approved colorants for cosmetics and food along with international safety data to determine which pigments are safest.

4. Good Manufacturing Practices (GMPs) – Why They Matter

MOCRA now requires manufacturers to follow GMPs to make sure products are safe and consistent. This includes:

• Using high-quality, contamination-free ingredients

• Keeping production environments sanitary 🧼

• Testing products for stability and safety

• Making honest and accurate claims in marketing

5. Labeling and Marketing Rules

The FDA is cracking down on misleading marketing in the tattoo & PMU industries. That means:

• Every ingredient (including colorants and preservatives) must be listed 🏷️

• Products must have warnings if there are any potential risks

• No company can claim PMU pigments or tattoo inks are "FDA-approved" unless they actually are (which none currently are)

Does MOCRA Compliance Mean a Product is FDA-Approved?

Nope! While MOCRA requires manufacturers to follow FDA rules it doesn’t mean their products are FDA-approved. True FDA approval involves long clinical trials, which currently only apply to drug products, not cosmetics like PMU pigments and tattoo inks.

How SofTap Meets FDA Guidelines

SofTap is committed to full compliance with FDA regulations and MOCRA requirements. As a leading manufacturer in the PMU industry, SofTap ensures the highest safety standards by:

1. Registering our manufacturing facility with the FDA 🏭
2. Only using colorants approved for cosmetics in the USA and internationally
3. Only using globally accepted ingredients and staying within their usage limits
4. Continuing to follow Good Manufacturing Practices (GMPs)
5. Evaluating and adapting our processes as needed to maintain the highest standards for product quality, safety, and consistency
6. Ensuring our product labels are clear and list all ingredients and warnings
7. Batch testing all pigments
8. Performing internal audits to ensure safety and quality ✅

Final Thoughts

Navigating FDA regulations in our industry can feel overwhelming, but understanding them is key to building trust with our clients and ensuring safety for all.

At SofTap we take pride in leading by example, proactively ensuring our products meet the highest industry standards and keeping up with regulatory changes to make sure our products remain safe and reliable.

Want to learn more about the FDA and PMU?

Get your info straight from the source by visiting the FDA’s official website (link below), or talk to a regulatory expert to make sure you're using safe and compliant products! 💡

 

1. Modernization of Cosmetics Regulation Act (MOCRA) and Its Impact on Permanent Makeup (PMU): https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra

2. Color Additives and Permanent Makeup: https://www.fda.gov/cosmetics/cosmetic-ingredient-names/color-additives-permitted-use-cosmetics

3. FDA Fact Sheet for Tattoos & PMU: https://www.fda.gov/cosmetics/cosmetic-products/tattoos-permanent-makeup-fact-sheet