The Regulatory Framework: FD&C Act

Hair dye products are regulated as cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Three principles shape that framework:

• No pre-market approval is required for cosmetic products or ingredients, except color additives.
• Manufacturers are responsible for ensuring the safety of their products before they go to market.
• FDA can take action against adulterated or misbranded products once they are found on the market.

The FDA defines a cosmetic as a product applied to the human body by rubbing, pouring, sprinkling, or spraying that is intended for cleansing, beautifying, promoting attractiveness, or altering the appearance. Hair dye falls squarely within that definition.

Color Additives: The Critical Exception

While most cosmetic ingredients do not require pre-market approval, color additives must be approved by FDA for their intended use before they are used in FDA-regulated products.

The Color Additive Approval Requirement

Under the FD&C Act, any substance that is a dye, pigment, or other material made by synthesis or a similar process in order to impart color is classified as a color additive. The key requirements are:

• Color additives intended for use in cosmetic products need pre-approval from FDA.
• Batch certification: Color additives listed in 21 CFR part 74 and 21 CFR part 82 must undergo analysis and batch certification by the FDA before they can be used to produce any FDA-regulated product for sale in the United States.
• This requirement applies to products imported into the US as well as those manufactured domestically.
• All color additives must be labeled with sufficient information to assure their safe use and to allow a determination of compliance.

The Coal-Tar Hair Dye Exemption

There is one significant exception to the color additive pre-approval requirement: coal-tar hair dye products.

The FD&C Act provides an exemption for coal-tar hair dye products, which do not require FDA approval or batch certification if they meet specific conditions. However, this exemption:

• Applies only to coal-tar hair dyes — a narrow carve-out covering certain permanent dye intermediates
• Does not apply to other types of hair-coloring products
• Does not exempt the product from other labeling requirements, including the mandatory caution statement

Lead Acetate: Removed from the Color Additive List

FDA amended its color additive regulations to remove lead acetate from cosmetics intended for coloring hair on the scalp. The final rule was published on October 31, 2018 and took effect on January 6, 2022, after objections were reviewed. Hair dye manufacturers should confirm that lead acetate does not appear in any formulation they produce, import, or sell.

Henna: A Permitted Color Additive

The color additive henna may be safely used for coloring hair only — it may not be used for coloring eyelashes or eyebrows, or generally in the area of the eye (21 CFR 73.2190).

MoCRA: The New Regulatory Landscape

MoCRA, signed into law in 2022, is the broadest overhaul of US cosmetics regulation since the FD&C Act of 1938. It widens FDA's authority, adds new duties for companies across the supply chain, and changes how cosmetic products are brought to market, monitored once they are there, and — where necessary — removed from it.

Mandatory Facility Registration

Under MoCRA, both domestic and foreign manufacturers and processors of cosmetics distributed in the US must register each facility with FDA. Key requirements include:

• Registration deadline: Facilities must register within 60 days of starting manufacturing or processing.
• Foreign facilities must designate a US agent.
• Biennial renewal: Facility registrations must be renewed every two years, with the renewal date set two years from the date of the facility's initial registration.

As of January 6, 2026, FDA's system reflects 14,299 unique, active facility registrations and 992,907 unique, active product listings. Before MoCRA, the FDA received just 5,176 cosmetic establishment registrations through the Voluntary Cosmetic Registration Program.

Product Listing Requirements

Under FDA requirements, a hair dye manufacturer must submit a product listing that includes key information about ingredients and where the product is manufactured. These listings must be updated whenever that information changes.

First Renewal Cycle (2026)

2026 marks the first biennial renewal cycle under MoCRA. Facilities that met the original July 1, 2024 registration deadline have until July 1, 2026 to renew. More than 14,000 cosmetic facilities are now on FDA's register.

Safety Substantiation and Serious Adverse Event Reporting

MoCRA also requires:

• Safety substantiation: Manufacturers must hold adequate substantiation that their products are safe.
• Serious adverse event reporting: Any serious adverse event associated with a cosmetic product must be reported to FDA.

FDA launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products on September 12, 2025, which gives the public real-time access to adverse event data. The system makes cosmetic safety issues much more visible and provides a direct window into product-specific safety concerns.

GMP Requirements (Pending)

MoCRA requires FDA to establish Good Manufacturing Practice (GMP) regulations for cosmetic facilities. As of January 2026, FDA has not yet issued final GMP regulations; however, draft regulations or guidance are expected. Final GMP requirements are likely to become a cornerstone of FDA's inspection and enforcement efforts.

Import Requirements for Hair Dye Products

For hair dye manufacturers and suppliers outside the US, importing products into the American market requires:

• FDA facility registration: The foreign manufacturing facility must be registered with FDA.
• US agent designation: A US-based agent must be designated.
• Product listing: Each product must be listed with FDA.
• Color additive compliance: Any color additives must be FDA-approved or exempt.
• Labeling compliance: Labels must comply with 21 CFR requirements.
• Prior notice: Import shipments require prior notice to FDA through the Prior Notice System Interface (PNSI).

Incomplete or inaccurate product listings can expose a company to FDA enforcement action, and can also lead to shipments being delayed or refused at the border.

Summary

The US FDA regulatory framework for hair dyes is fundamentally different from the EU system. While most cosmetic ingredients do not require pre-market approval, color additives are strictly regulated and require FDA approval or certification. The coal-tar hair dye exemption provides some relief but does not eliminate all requirements.

MoCRA has introduced mandatory facility registration and product listing, significantly increasing FDA's visibility into the cosmetic supply chain. For hair dye manufacturers, suppliers, and wholesalers, compliance requires:

• FDA facility registration (with biennial renewal)
• Product listing for each hair dye product
• Color additive compliance — FDA approval or certification as applicable
• Correct labeling, including the coal-tar hair dye caution statement where applicable
• Safety substantiation and adverse event monitoring

Sources

1. IndexBox, “Northern America Hair Color Treatment — Market Analysis, Forecast, Size, Trends and Insights,” May 14, 2026
2. US Food and Drug Administration, “Hair Dyes,” September 25, 2025
3. US Food and Drug Administration, “Color Additives and Cosmetics: Fact Sheet,” June 28, 2022
4. Foley & Lardner LLP, “How MoCRA Is Reshaping FDA Oversight of Cosmetics in 2026,” March 12, 2026
5. US Food and Drug Administration, “Registration & Listing of Cosmetic Product Facilities and Products,” July 2, 2026
6. US Food and Drug Administration, “Cosmetics Direct,” February 11, 2026
7. The National Law Review, “How MoCRA Is Reshaping FDA Oversight of Cosmetics in 2026,” May 1, 2026
8. US Food and Drug Administration, “Regulatory Status of Color Additives”