Temporary Tattoos & Henna: What Cosmetic Professionals Need to Know About FDA Compliance

From summer festivals to bridal parties, temporary tattoos and henna designs are a popular way to express creativity without the permanence of ink.

But beneath the artistry lies a complex regulatory framework, especially when it comes to black henna, a product that’s drawing increasing scrutiny from the FDA.

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If you’re a cosmetic brand, salon, or vendor offering temporary tattoo services, understanding the legal boundaries and safety risks is essential.

This blog breaks down the FDA’s position on decal tattoos, henna/mehndi, and black henna, and what you need to do to stay compliant.

Decal Tattoos: Popular, But Not Always Safe

Decal-type temporary tattoos — the kind applied with water and a backing sheet — are widely used, especially by children. While many contain FDA-approved color additives, others do not.

The FDA has received reports of adverse reactions, including skin irritation and allergic responses, particularly when unapproved dyes are used.

Key Compliance Points:

• Products must list all ingredients on the label.

• Color additives must be approved for skin application.

• Products labeled “FDA approved” without proper authorization may be detained under Import Alert 53-19.

  
  

If you’re importing or selling decal tattoos, verify that the dyes are approved for dermal use, not just general cosmetic use. And never rely on vague “FDA approved” claims without documentation.

Henna & Mehndi: Cultural Tradition Meets Regulatory Limits

Henna, derived from the Lawsonia inermis plant, has been used for centuries in ceremonial body art. But in the U.S., the FDA has only approved henna for use as a hair dye, not for direct application to the skin.

This means that henna used for body decoration is considered an unapproved use of a color additive, rendering the product adulterated under the Federal Food, Drug, and Cosmetic Act.

Even natural henna is not exempt from FDA oversight. If you’re offering mehndi services or selling henna kits, you’re operating in a legally gray area. Consider consulting with a regulatory attorney to assess your risk exposure.

Black Henna: A Serious Compliance Red Flag

Black henna is often marketed as a faster-drying, longer-lasting alternative to traditional henna. But its dark color typically comes from p-phenylenediamine (PPD) — a coal-tar derivative used in hair dyes that can cause severe allergic reactions, including blistering, scarring, and permanent skin damage.

PPD is not approved for use in cosmetics applied to the skin, and its inclusion in black henna products makes them illegal under FDA regulations.

FDA Enforcement Actions Include:

• Warning Letters to companies marketing black henna products

• Import Alerts for foreign-made henna intended for skin use

• Consumer advisories warning of serious health risks

If your product contains PPD or is labeled as “black henna,” it’s not just a compliance issue; it’s a liability risk. Immediate reformulation or withdrawal from the market may be necessary.

Labeling & Ingredient Disclosure: What’s Required

Under the Fair Packaging and Labeling Act (FPLA), cosmetic products sold at retail must include a full ingredient declaration. Products without this are considered misbranded and cannot be legally sold in interstate commerce.

However, this requirement does not apply to:

• Samples

• Products used only by professionals (e.g., at salons or fairs)

  
  

Still, professional-use products must be safe for intended use, and manufacturers are responsible for ensuring compliance.

Don’t assume that professional-use exemptions protect you from liability. If a client experiences an adverse reaction, a lack of labeling won’t shield you from FDA scrutiny or civil claims.

Final Thoughts: Compliance Is More Than a Checklist

Temporary tattoos and henna may seem low risk, but they sit at the intersection of cosmetic law, color additive regulation, and consumer safety. Whether you’re a manufacturer, importer, or service provider, it’s critical to:

• Audit your product ingredients

• Verify color additive approvals

• Avoid PPD and other restricted substances

• Ensure proper labeling and documentation

Bustos Law Group is here to help you navigate these complexities. From product reviews to regulatory strategy, we offer tailored legal guidance to keep your business compliant and your customers safe.