COSMETICS
Understand how U.S. Food and Drug Administration (FDA) cosmetic regulations apply to domestic and foreign brands. We help you enter the U.S. market legally, reduce enforcement risk, and align your operations with current FDA cosmetic requirements, including the Modernization of Cosmetics Regulation Act (MoCRA) of 2022.
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REGISTER A COSMETIC MANUFACTURING OR PROCESSING FACILITY
FDA cosmetic facility registration is mandatory under MoCRA. We handle accurate facility registration for manufacturers, processors, and packers to ensure compliance and avoid regulatory penalties.
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LIST COSMETIC PRODUCTS WITH THE FDA
Cosmetic product listing is required for each formulation and brand name. We prepare and submit FDA product listings correctly, ensuring ingredient accuracy and regulatory alignment.
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MEET MODERNIZATION OF COSMETICS REGULATION ACT (MoCRA) REQUIREMENTS
MoCRA significantly expanded FDA oversight of cosmetics. We help brands comply with safety substantiation, adverse event reporting, recordkeeping, and updated regulatory obligations.
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U.S. AGENT REQUIREMENT
Fulfill your legal obligation. We act as the designated U.S. Agent for foreign manufacturers, facilitating official communication with the FDA and ensuring 24/7 regulatory responsiveness
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AMAZON COSMETIC COMPLIANCE VERIFICATION
Keep your listings live. We provide the precise documentation and safety data required by Amazon to prevent listing suppression and verify your products’ compliance with platform policies.
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RESPONSIBLE PERSON DESIGNATION & SUPPORT
MoCRA requires every cosmetic product to have a designated Responsible Person. We act as or support the Responsible Person role to ensure accountability and regulatory continuity.
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INGREDIENT & FORMULATION COMPLIANCE REVIEW
We review cosmetic formulations for prohibited, restricted, or high-risk ingredients under U.S. law to prevent product seizures, recalls, or enforcement actions.
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COSMETIC LABELING & CLAIMS COMPLIANCE
Ensure your labels meet FDA and FTC cosmetic labeling requirements. We verify ingredient declarations, warnings, identity statements, and marketing claims to reduce misbranding risk.
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ADVERSE EVENT REPORTING & RECORDKEEPING
We help you establish compliant systems for capturing, documenting, and reporting adverse events to the FDA within required timelines, protecting both consumers and your brand.
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CORRECT FDA WARNING LETTERS & COMPLIANCE ISSUES
If your cosmetic brand has received an FDA inquiry or Warning Letter, we assist with remediation strategies, corrective actions, and formal FDA responses.
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IMPORTING COSMETICS INTO THE U.S.
From customs coordination to FDA clearance, we guide cosmetic importers through entry requirements to reduce shipment delays, detentions, and refusals at U.S. ports.
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PREPARE FOR FDA INSPECTIONS & AUDITS
Be ready for FDA inspections of cosmetic facilities and records. We help you prepare documentation, SOPs, and inspection response strategies to minimize enforcement risk.
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PAY FDA & REGULATORY SERVICE FEES
We manage regulatory service fees associated with cosmetic compliance submissions to ensure timely processing and uninterrupted market access.
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ONGOING COSMETIC COMPLIANCE MANAGEMENT
Cosmetic compliance is not a one-time event. We provide ongoing support to keep your registrations, listings, labels, and safety documentation current as regulations evolve.
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FREE COSMETIC COMPLIANCE TOOLS & GUIDES
Access free tools, checklists, and educational resources designed to help cosmetic brands understand FDA expectations and reduce compliance mistakes before they happen.
Conventional Cosmetic
Products intended solely for cleansing, beautifying, or altering appearance without therapeutic claims. These must comply with FDA cosmetic labeling, ingredient safety, and MoCRA facility registration requirements.
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Over-the-Counter Cosmetic
Products such as anti-dandruff shampoos or acne treatments that contain active drug ingredients. These must meet both cosmetic and FDA OTC drug monograph requirements.
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Cosmetic & Drug Combination
Combination products offering both aesthetic and therapeutic benefits. Subject to full FDA drug registration, labeling compliance, and GMP controls.
➜ REGISTER NOWCosmetic FDA Compliance & MoCRA Services
Ensuring your beauty and personal care products meet the latest U.S. regulatory standards.
1. What is MoCRA?
The Modernization of Cosmetics Regulation Act is the first major expansion of FDA authority over cosmetics since 1938.
2. Is facility registration mandatory?
Yes. Under MoCRA, every facility that manufactures or processes cosmetics for the U.S. must register with the FDA.
3. What is Product Listing?
Responsible persons must submit a list of each cosmetic product to the FDA, including its ingredients and manufacturing site.
4. Who is the "Responsible Person"?
The manufacturer, packer, or distributor whose name appears on the label and who is liable for compliance.
5. What are Cosmetic GMPs?
Good Manufacturing Practices are mandatory standards ensuring products are produced in a clean, controlled environment.
6. Does a U.S. Agent need to be appointed?
Foreign facilities must designate a U.S. Agent as a direct point of contact for FDA communications.
7. What is Adverse Event Reporting?
Serious adverse events (like severe rashes or infections) must be reported to the FDA within 15 business days.
8. Are safety substantiations required?
Yes. Manufacturers must maintain records proving that their products are safe for their intended use.
9. What are the new labeling rules?
Labels must include contact info for adverse event reporting and disclose fragrance allergens.
10. Is FDA approval required for cosmetics?
Unlike drugs, cosmetics do not require "pre-market approval," but ingredients must be safe and properly listed.
11. What about Color Additives?
Color additives are strictly regulated and must be FDA-approved for their specific intended use.
12. Can a product be both a drug and cosmetic?
Yes. Products like SPF moisturizers or anti-dandruff shampoos are regulated as both OTC drugs and cosmetics.
13. What is "Adulteration"?
A product is adulterated if it contains filthy or toxic substances, or if it was made in unsanitary conditions.
14. What is "Misbranding"?
A product is misbranded if its label is false, misleading, or fails to meet mandatory formatting requirements.
15. How do I list fragrance allergens?
MoCRA requires specific allergens to be identified on the label once the FDA finalizes the list.
16. Are small businesses exempt?
Very small businesses may be exempt from certain GMP and registration rules, but safety requirements always apply.
17. What is an FDA Inspection?
The FDA has the authority to inspect cosmetic facilities to verify GMP compliance and record-keeping.
18. What are Professional Use products?
Products used by salon professionals must now follow the same labeling and safety rules as retail cosmetics.
19. What about Talc-containing cosmetics?
New regulations require standardized testing methods to detect asbestos in talc-containing cosmetic products.
20. What is a PFAS disclosure?
The FDA is currently assessing the safety and presence of "forever chemicals" (PFAS) in cosmetic formulations.
21. How often do I renew registration?
Facility registrations must be updated or renewed biennially (every two years).
22. Can the FDA recall cosmetics?
Yes. Under MoCRA, the FDA has mandatory recall authority if a product poses a threat to public health.
23. What is the VCRP?
The Voluntary Cosmetic Registration Program has been retired and replaced by the mandatory MoCRA system.
24. Is animal testing banned?
The FDA doesn't ban it, but many states do, and MoCRA encourages the use of non-animal safety alternatives.
25. What is the INCI name?
The International Nomenclature Cosmetic Ingredient name—the standard naming convention for ingredient lists.
26. How do I handle trade secrets?
Ingredient listing is mandatory, but specific fragrance or flavor formulas can often remain proprietary.
27. Are "Natural" claims regulated?
The FDA does not have a legal definition for "natural"; such claims are subject to truth-in-advertising laws.
28. What is the role of an Importer?
Importers ensure that foreign-made cosmetics meet all MoCRA registration and safety requirements before entry.
29. Does the FDA test every product?
No. The burden of proof for safety and compliance lies entirely with the manufacturer/responsible person.
30. What happens if I don't comply?
Non-compliance can lead to import alerts, product seizures, warning letters, or mandatory recalls.
31. What is an Import Alert?
A "red list" that allows the FDA to detain products from specific companies at the border without physical inspection.
32. How do I start compliance?
Begin by registering your facility, listing your products, and conducting a safety substantiation audit.