Importing cosmetics and makeup into the United States of America (USA) is a complex process that demands strict adherence to various regulations. The Food and Drug Administration (FDA), U.S. Customs and Border Protection (CBP), and other agencies enforce these regulations to ensure the safety and quality of imported cosmetics.
When you import cosmetics to the USA, it’s essential to understand the nuances of import regulations, and to ensure your products comply with all requirements. Importers must be meticulous in classifying their cosmetic products and meeting all labeling and safety standards, as the U.S. definition of cosmetics may differ from other countries. Non-compliance can result in significant delays, penalties, or even refusal of entry of your cosmetic products.
The Cosmetics and Makeup Market in the United States
The cosmetics market in the USA is a dynamic and thriving industry, with a market size estimated at USD 62.97 billion in 2023. This market is expected to grow at a compound annual growth rate (CAGR) of 6.1% from 2024 to 2030, presenting significant opportunities for both domestic and international players.
This growth is likely fueled by several factors, including the rising popularity of e-commerce channels for cosmetics, increased product innovation catering to diverse consumer needs, and the influence of social media and beauty influencers on purchasing decisions.
These factors also contribute to a highly competitive landscape, where established brands and emerging players constantly vie for market share. Companies employ various strategies to stand out, including product differentiation, strategic collaborations, and targeted marketing campaigns aimed at capturing the attention of discerning consumers.
FDA Regulations For Cosmetics
The FDA plays a crucial role in regulating cosmetics under the Federal Food, Drug, and Cosmetic Act (FDCA). While most cosmetics do not require pre-market approval for import into the USA, they must be safe for consumers under customary conditions of use and must be properly labeled.
Types of Cosmetics That May Require FDA Approval:
- Products With Health Claims: These are considered drugs under the FDCA, and require FDA approval as both cosmetics and drugs. Examples include:
- Anti-aging creams that claim to reduce wrinkles or alter the skin’s structure
- Hair dyes containing specific active ingredients that alter hair growth or structure
- Sunscreens marketed with an SPF rating, as they are considered over-the-counter (OTC) drugs
- Products With Color Additives: All color additives used in cosmetics must be FDA-approved. Importers should ensure that any color additives in their products are permitted for their intended use.
- Products With Harmful Ingredients: Certain ingredients are prohibited or restricted by the FDA due to safety concerns. Examples include:
- Mercury compounds
- Certain preservatives like formaldehyde
- Lead acetate
Voluntary Registration Programs:
While not mandatory for cosmetic products, voluntary registration with the FDA can offer several benefits:
- Voluntary Cosmetic Registration Program (VCRP): This allows companies to register their products and ingredients with the FDA, providing enhanced market surveillance and the prevention of regulatory issues.
- FDA Facility Registration: This enables the FDA to swiftly contact you if there are any concerns about your products, facilitating speedy action to address potential risks and protect consumers.
Labelling Requirements For Imported Cosmetics
The FDA has specific labeling requirements for cosmetics imported into the USA, to ensure consumer safety and informed product choices. These requirements include:
- Product Identity: The label must clearly state the name of the cosmetic product.
- Net Quantity of Contents: The amount of product in the package must be accurately declared.
- Ingredient Declaration:
- All ingredients must be listed in descending order of predominance.
- Ingredients present at 1% or less may be listed in any order after the other ingredients.
- Color additives must be listed using their FDA-approved names.
- Name and Place of Business: The label must include the name and address of the manufacturer, packer, or distributor.
- Country of Origin: For imported cosmetics, the country of origin must be clearly stated.
- Warnings and Cautions:
- Allergen warnings must be included if the product contains potential allergens.
- Safety warnings are required for products containing ingredients that may pose safety concerns, such as hydroquinone.
- Other Requirements:
- The type size for label statements must be legible and meet specific requirements based on the size of the container.
- Certain products, such as liquid oral hygiene products and vaginal products, must be packaged in tamper-resistant packaging.
Fair Packaging and Labeling Act (FPLA)
The Fair Packaging and Labeling Act (FPLA) mandates that cosmetic labels must be truthful and not misleading. All information, including ingredient lists and product claims, must be accurate and not likely to deceive consumers.
The FPLA also emphasizes clarity and ease of understanding for consumers. This means labels must be legible and readily accessible, with all required information presented in English.
Customs Process
Importing cosmetics into the USA involves a customs process where products are classified under the Harmonized Tariff Schedule (HTS). The HTS code determines the applicable tariffs and duties for your goods.
Commonly Used HTS Codes for Cosmetics:
- Chapter 33: This chapter covers a broad range of essential oils, perfumes, and cosmetics.
- 3304: This includes beauty and skincare products like makeup, manicures, and pedicures.
- 3305: This covers hair care products such as shampoos, conditioners, and hair lacquers.
- Chapter 90: Optical, photographic, cinematographic, measuring, checking, precision, medical, or surgical instruments and apparatus; parts and accessories.
- 9018: This covers instruments and appliances used in medical, surgical, dental, or veterinary sciences, including scenting apparatuses used in retail spaces.
Required Documents For Cosmetic Imports into the USA
Importing cosmetics into the USA requires meticulous documentation to ensure compliance with regulations, and to facilitate smooth customs clearance. These documents include:
- Commercial Invoice: Provides a detailed description of the goods, including value, quantity, and origin.
- Bill of Lading or Air Waybill: Contract between the shipper and carrier, detailing transportation terms.
- Packing List: Outlines the contents of each package, including quantity and description.
- Prior Notice of Importation: Submitted to the FDA before arrival, providing information about the cosmetics.
- Certificate of Origin: Verifies the origin of the goods.
- Other Documents (if applicable):
- Certificate of Analysis: Verifies the chemical composition and purity of the cosmetics.
- Free Sale Certificate: Confirms legal marketing and sale in the origin country.
- Labeling Samples: May be required to verify compliance with FDA labeling regulations.
Duties and Fees
Importing cosmetics into the USA involves certain duties and fees that importers must be aware of. These may include:
- General Duty Rates: For cosmetic goods, the typical range for import duties is between 4.9% and 5.8%.
- Merchandise Processing Fee (MPF): Charged by U.S. Customs and Border Protection (CBP) to process imported goods.
- Harbor Maintenance Fee (HMF): Applies to cargo entering the U.S. by sea.
Factors Affecting Duty Rates:
- Country of Origin: Cosmetics from countries with which the U.S. has a free trade agreement (FTA) may be eligible for preferential duty rates or duty-free entry.
- Product Classification: The specific HTS subheading used to classify the product can also affect the duty rate.
Ready to Import Cosmetics to the USA?
Importing cosmetics into the USA can be complex, but CrimsonLogic offers a suite of customs software solutions — and even management services — that are designed to streamline the delivery process, while ensuring compliance with all relevant regulations.
Our FDA Prior Notice (FDA PN) solution facilitates compliance with FDA Prior Notice requirements for cosmetics classified as food products. Meanwhile, our E-Commerce Goods Clearance solution streamlines customs entry for low-value e-commerce cosmetics parcels via Section 321 Type 86, ensuring seamless compliance and expedited clearances so you can focus on growing your business.
Contact us today to learn more, and discover how CrimsonLogic can empower your U.S. cosmetics imports!
