How to export cosmetics to the USA?

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This is the million-dollar question for many brands. The process requires more than just a good product; it demands compliance with FDA regulations (now updated by the MoCRA law), a precise technical labeling strategy, and impeccable international logistics. To succeed in the world's largest consumer market, your company needs to master facility registration, the correct classification between cosmetic and drug (OTC), and ensure that the supply chain supports the rigorous requirements of the United States. 

The MoCRA Revolution 

If you researched exporting cosmetics a few years ago, you probably heard that FDA registration was "voluntary."  Forget that. The scenario has changed. In December 2022, the USA sanctioned MoCRA (Modernization of Cosmetics Regulation Act), which was the largest reform in the country's cosmetics legislation since 1938. The goal is to increase consumer safety and give the FDA more enforcement power. 

For you, the exporter, this means new obligations: 

• Facility Registration: Every factory (domestic or foreign) that manufactures cosmetics for sale in the USA must be registered with the FDA. If you outsource production, your partner's factory must have this registration. And note: it must be renewed every two years. 
• Product Listing: It is not enough to register the factory; you need to list each product individually in the FDA system, stating the composition, place of manufacture, and category. 
• Traceability and Safety: You are required to keep records proving the safety of your products.  "I think it won't hurt" no longer works. It is necessary to have technical safety dossiers for the ingredients. 
• Expert Tip: Do not try to cheat the system. The FDA now has the authority to suspend your facility's registration if there is a risk to public health, which immediately blocks all your imports. 

The OTC Trap: Cosmetic or Drug? 

This is one of the most common mistakes. Product classification in the USA is different. 

The basic FDA rule focuses on the product's "claim": 

• If the product only cleanses, perfumes, or beautifies: It is a Cosmetic. 
• If the product treats, cures, prevents diseases, or alters the body's structure: It is a Drug. 

Why does this matter? Because the requirements for exporting an OTC are much higher. You will need a pharmaceutical factory registration, will have to comply with specific monographs for active ingredients, and obtain an NDC (National Drug Code) number. If you try to ship a sunscreen labeled only as a cosmetic, your cargo will be barred and possibly destroyed. 

That is why reviewing marketing texts and packaging is important. Sometimes, softening a label ("helps improve the appearance of acne" instead of "cures acne") can keep your product in the cosmetic category and simplify your market entry. 

International Labeling: Much beyond translation 

Taking your label and throwing it into Google Translate is a recipe for failure. Labeling in the USA is technical and rigid. Some points our consultants always highlight: 

• Principal Display Panel (PDP): Must contain the product name, identity (what is it? e.g., "Hair Conditioner"), and net quantity. The latter must be expressed in both the metric system (ml, g) and the imperial system (fl oz, oz). The position and font size of these numbers are regulated by law. 
• Ingredient List: Although INCI is a global standard, there are divergences. Some plant names or chemical compounds are described differently in the USA. 
• Color Additives: The FDA is paranoid (rightly so) about dyes. Every batch of dye used must be certified unless it is on an exemption list. A common mistake is using a dye approved but banned in the USA for the eye area. 
• "Warning Statements": Certain products require specific warning phrases mandatory by law, with visual prominence on the label. 

"US Agent" and the Responsible Person 

MoCRA instituted the requirement for a "Responsible Person" on the label. Who is this person? It is the entity that will legally answer for the product in the USA. The label must contain an American address, phone number, or website for contact. 

Furthermore, for foreign companies (like yours), it is mandatory to appoint a US Agent. This agent acts as a communication bridge between the FDA and your factory. They must be available to answer the FDA during business hours and are the ones who will receive official notifications. 

Do not try to use the address of a friend living in Florida. The responsibility involves maintaining records of adverse effects and reporting serious problems to authorities within short deadlines. It is a professional service that should be hired as part of your export cost. 

Logistics and Quality Preservation 

You invested time and money in regulation. Now, you need to ensure the product arrives intact. International logistics for cosmetics has particular challenges. 

• Temperature: A closed container in the port of Santos or crossing the Equator can turn into an oven.  Creams can melt, separate phases, or oxidize. Evaluate the need for reefer (refrigerated) containers or, for smaller air shipments, the use of thermal blankets and Styrofoam boxes. 
• Transport Packaging: Boxes (secondary and tertiary) need to be robust.  Cargo handling in the USA is mechanized and fast. If the box is fragile, your product will be damaged. 
• Documentation: For customs clearance, you will need the Commercial Invoice, Packing List, and, crucially for chemicals, the MSDS (Material Safety Data Sheet) or SDS, translated into English. Without the MSDS, the airline or shipping company may refuse shipment because they do not know if the product is flammable or dangerous. 

Smart Entry Strategies: Amazon and B2Brazil 

With the technical and logistics part solved, how to sell? The best strategy combines B2B and B2C, utilizing platforms that already have qualified traffic. 

1. Digital Retail:

Amazon and the SPN Partnership Amazon is the most coveted gateway to test American public acceptance (B2C) without the prohibitive costs of opening physical stores.  However, Amazon is relentless with compliance. If your product is not perfectly adequate to FDA standards, they block your account and withhold your stock. 

The B2B Trade Center is an official partner of the Amazon SPN (Service Provider Network). This means we are certified by Amazon itself to help your company navigate this ecosystem. We assist in regulatory adequacy, logistics, and structuring your account to ensure your entry into the world's largest marketplace is safe and free of blocks. 

2. Global Wholesale:

B2Brazil If your focus is volume and selling to distributors or retailers (B2B), the strategy must include B2Brazil. As the leading B2B marketplace in the Americas, B2Brazil connects your industry directly to international buyers looking for qualified suppliers. Having an active showcase on B2Brazil, integrated into your export strategy, expands your visibility to importers looking for exactly what you have, allowing for larger negotiations. 

The Next Step 

Exporting cosmetics to the USA is a journey of business maturation. By adapting your company to the American market, you raise the standard of your operation as a whole, becoming more competitive even in the domestic market. 

The secret is not to do everything alone. Having partners who understand customs procedures, exchange rates, and international legislation saves time and avoids fines in dollars.  Your company has global potential. The question is: are you ready to professionalize your international operation? 

If you want to structure your export safely, contact the team of specialists at the B2B Trade Center and let's design your company's cosmetic export plan to the USA together!