FDA Cosmetics Import Compliance: A Complete Guide for Beauty Brands

The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Unlike drugs, cosmetics don't require pre-market approval, but they must comply with strict labeling, safety, and import documentation requirements.

What Qualifies as a Cosmetic?

FDA defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. This includes:

• Skin care: Moisturizers, cleansers, serums, masks
• Makeup: Foundation, lipstick, mascara, eyeshadow
• Hair care: Shampoo, conditioner, styling products, hair dyes
• Nail products: Polish, treatments, removers
• Fragrances: Perfumes, colognes, body sprays
• Personal care: Deodorants, toothpaste, mouthwash

The Drug-Cosmetic Distinction

Products making therapeutic claims cross into drug territory and face much stricter requirements:

• Cosmetic: "Moisturizes skin" or "Reduces appearance of wrinkles"
• Drug: "Treats acne" or "Prevents sun damage"

Sunscreens, anti-dandruff shampoos, and antiperspirants are regulated as over-the-counter (OTC) drugs, requiring drug establishment registration and product listing with FDA.

All food and cosmetics shipments to the US require prior notice submission before arrival. This is handled through FDA's Prior Notice System Interface (PNSI).

Timing Requirements

• Ocean freight: Submit no more than 15 days and no less than 8 hours before arrival
• Air freight: Submit no more than 15 days and no less than 4 hours before arrival
• Ground transport: Submit no more than 15 days and no less than 2 hours before arrival

Required Information

Your prior notice must include:

• Product description and intended use
• Manufacturer name, address, and registration number
• Shipper and consignee details
• Country of production
• Anticipated arrival information (port, date, time)
• FDA product code

Common Prior Notice Errors

These mistakes lead to shipment holds:

• Incorrect product codes: Cosmetics have specific FDA product codes that must match the actual product
• Timing violations: Submitting too early or too late
• Incomplete manufacturer information: All parties in the supply chain must be identified
• Mismatched quantities: Prior notice quantities must match shipping documents

Cosmetics labeling is one of the most common reasons for import detention. US requirements differ significantly from other markets.

Principal Display Panel (PDP)

The front label must include:

• Identity statement: What the product is (e.g., "Moisturizing Cream")
• Net quantity: In both metric and US customary units

Information Panel

The back or side panel requires:

• Ingredient declaration: Listed in descending order of predominance using INCI nomenclature
• Distributor statement: Name and address of manufacturer, packer, or distributor
• Warning statements: Required for specific ingredients or product types

Language Requirements

All required label information must be in English. Bilingual labels are permitted but English cannot be smaller or less prominent than other languages.

Ingredient Labeling Specifics

• Fragrance and flavor: Can be listed as "fragrance" or "flavor" without disclosing specific components
• Color additives: Must use FDA-approved names (e.g., "FD&C Red No. 40")
• 1% threshold: Ingredients at 1% or less can be listed in any order after higher-concentration ingredients

Common Labeling Violations

• Missing or incorrect net quantity statements
• Ingredient names not in INCI format
• Missing warning statements for products containing specific ingredients
• Claims that cross into drug territory

Color additives are one of the few areas where FDA requires pre-market approval for cosmetics. Using unapproved colors or colors from non-certified batches leads to automatic detention.

Certification Requirements

Certain color additives must come from FDA-certified batches. These "certifiable" colors include:

• FD&C colors (approved for food, drugs, and cosmetics)
• D&C colors (approved for drugs and cosmetics only)
• External D&C colors (approved for external use only)

Each batch must be certified by FDA before use, and you need documentation showing the certification number.

Exempt Colors

Some colors are exempt from batch certification but still must be approved:

• Mineral-based colors (iron oxides, titanium dioxide)
• Plant and animal-derived colors
• Synthetic organic pigments meeting specific criteria

International Differences

Colors approved in the EU, Japan, or China may not be approved in the US. Common issues include:

• EU-approved colors: Many CI (Colour Index) numbers don't have US equivalents
• Asian formulations: Often contain colors not permitted in US cosmetics
• Natural colors: May require different documentation than synthetic versions

Documentation Requirements

For each shipment, maintain:

• Color additive certificates of analysis
• Batch certification numbers for certifiable colors
• Supplier declarations for exempt colors

While cosmetics don't require pre-market approval, participating in FDA's Voluntary Cosmetic Registration Program provides significant import advantages.

Benefits of VCRP Registration

• Reduced inspections: Registered facilities and products face fewer random examinations
• Faster clearance: Customs processing is typically smoother with registration on file
• Regulatory awareness: FDA will notify you of regulatory changes affecting your products
• Industry credibility: Registration demonstrates commitment to compliance

Registration Components

VCRP has two parts:

• Facility registration: Manufacturing and packaging facilities register with FDA
• Product listing: Individual products are listed with their formulations

How to Register

Registration is done through FDA's online Cosmetics Direct system:

1. Create a FURLS (FDA Unified Registration and Listing System) account
2. Register each manufacturing/packaging facility
3. List each product with ingredient information
4. Update listings when formulations change

MoCRA Changes

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 made some registration mandatory starting in 2024:

• Facility registration is now required for most cosmetic manufacturers
• Product listing with ingredient disclosure is mandatory
• Adverse event reporting is required
• Good manufacturing practice requirements apply

Understanding the step-by-step import process helps you prepare documentation and avoid delays.

Step 1: Pre-Shipment Preparation

• Verify all products meet FDA labeling requirements
• Confirm color additives are approved and certified
• Ensure manufacturer facility is registered under MoCRA
• Prepare certificates of analysis and safety data

Step 2: Prior Notice Submission

• Submit prior notice within required timeframe
• Receive confirmation number
• Provide confirmation to customs broker

Step 3: Customs Entry

• File customs entry with correct HTS codes
• Include prior notice confirmation
• Provide commercial invoice and packing list

Step 4: FDA Review

FDA may:

• Release without examination: Most common for compliant shipments
• Request documentation: Label reviews, certificates of analysis
• Physical examination: Sample collection for lab analysis
• Detention: If violations are suspected

Step 5: Release or Detention

If detained, you have options:

• Provide evidence of compliance
• Request re-examination
• Relabel to correct violations
• Re-export or destroy non-compliant products

These are the most frequent problems we see with cosmetics imports and how to prevent them.

Issue 1: Unapproved Color Additives

Problem: Products contain colors not approved for US cosmetics use.

Solution: Review formulations against FDA's color additive list before production. Work with manufacturers to substitute approved alternatives.

Issue 2: Drug Claims on Cosmetics

Problem: Marketing claims cross into drug territory, triggering OTC drug requirements.

Solution: Review all claims with regulatory counsel. Use structure/function claims rather than treatment claims.

Issue 3: Incomplete Labeling

Problem: Labels missing required elements or using non-INCI ingredient names.

Solution: Have US-compliant labels produced before shipment. Many brands use secondary labels for US market.

Issue 4: Prior Notice Errors

Problem: Incorrect product codes, timing violations, or missing information.

Solution: Work with experienced customs brokers who specialize in FDA-regulated products.

Issue 5: Manufacturing Facility Issues

Problem: Manufacturer not registered or previous FDA violations on record.

Solution: Verify facility registration status before ordering. Request facility audit reports.

Building a Compliance Program

Consistent compliance requires:

• Pre-production formula review against FDA requirements
• Label review by qualified regulatory personnel
• Supplier qualification and documentation requirements
• Regular updates on regulatory changes
• Relationship with specialized customs broker