FDA Compliance Solutions for Cosmetics
The B2B TradeCenter offers complete FDA compliance solutions for companies in the cosmetics sector looking to sell in the U.S. market. Our team of regulatory specialists and former FDA staff ensures a safe and efficient process to meet the requirements of MoCRA (Modernization of Cosmetics Regulation Act of 2022).
FDA Registration
U.S. Agent Services
Product Review
Product Compliance
MoCRA Registration made Simple
FDA cosmetics establishment registration can be a complex process, but we make it simple and stress-free. Our team of experts will guide you through each step to ensure your facility is properly registered with the FDA.
Here’s how our process works:
1
Fill out our comprehensive intake form abrangente. Submit your company details and our team will assist you with completing the form and providing the necessary documentatio.
2
Obtain your MoCRA registration! We handle the submission of all required information and documents to the FDA, addressing any potential issues along the way
3
Receive the certificate and official proof of registration. We provide all account details and the official confirmation required under MoCRA.
Get FDA Registration Now!U.S. Agent Services for FDA Communication
If your cosmetics facility is located outside the U.S., the FDA requires you to designate a U.S. Agent. We serve as your direct point of contact with the agency.
Speak with a U.S. Agent
Accurate reports on your facility’s unique identifiers (UFI, UDI, or FEI)
Timely updates to your FDA registration
Forwarding of FDA communications and support for regulatory responses
Review of Cosmetic Labels
Avoid issues with noncompliant labels. We review your labels in accordance with MoCRA and FDA requirements.
Verification of mandatory sections (e.g., contact information and fragrance allergens)
Detailed compliance report with practical recommendations
Translation into English with improvement suggestions
Print-ready labels that reflect your preferences and meet FDA standards
Cosmetic Ingredient Review
We ensure your product’s ingredients comply with MoCRA, FDA rules, and other relevant legislation.
Includes:
Verification of ingredient legality and permitted use in cosmetics
Compliance analysis of restricted substances and concentration limits
Provision of supporting documentation, such as safety reports
Verification of proper ingredient names and identification
California Proposition 65 Assessment
California law (Prop 65) requires warnings for products containing certain listed substances. We assess your formula for these risks.
Identification of ingredients that trigger mandatory Proposition 65 labeling
Recommendations for changes or alternative formulations
Still have questions about our services?
Read the most common questions
from
B2B TradeCenter
clients
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What is the FDA?
The FDA (Food & Drug Administration) is the U.S. federal agency responsible for regulating food, drugs, cosmetics, and other products to ensure public safety and health in the United States. To market cosmetics in the U.S., compliance with FDA regulations is required.
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What is FDA registration and product listing?
Under MoCRA, cosmetic manufacturers must register their facilities and list each marketed product with the FDA. This includes providing detailed product information and updating it as necessary.
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Do I need a U.S. Agent?
Yes. If your facility is outside the United States, the FDA requires a designated U.S. Agent for all regulatory communications.
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What is considered a cosmetic by the FDA?
The FDA defines cosmetics as products intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance—such as creams, lotions, perfumes, makeup, shampoos, and deodorants.
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Do you help with labeling?
Yes. We review cosmetic labels to ensure they meet MoCRA and FDA requirements, including mandatory declarations and formatting rules.
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How do I know if my ingredients are allowed in the U.S.?
We analyze your ingredients for compliance with FDA and MoCRA regulations, restricted substances, and Proposition 65 warnings, and verify documentation such as CIR or international safety assessments.
