1. Regulatory Authority and Framework

Cosmetics in the U.S. are regulated under:

• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• MoCRA (Modernization of Cosmetics Regulation Act 2022)
• 21 CFR Parts 700–740
• FDA’s Cosmetics Office under CFSAN

MoCRA introduced mandatory registration, mandatory facility listing, mandatory product listing, mandatory safety substantiation, and mandatory adverse event reporting for the first time in U.S. history.

2. Key Definitions Under U.S. Law

Cosmetic

A product intended for:

• Cleansing
• Beautifying
• Promoting attractiveness
• Altering appearance

NOT allowed to have therapeutic, treatment, or cure claims.

Drug-Cosmetic (OTC)

If a product claims to:

• Treat acne
• Grow hair
• Treat melasma / hyperpigmentation
• Anti-dandruff
• Heal skin
  → Must follow OTC Drug Monograph regulations, NOT cosmetics.

U.S. does not have a “cosmeceutical” category — such claims automatically classify as drug.

3. Registration Under MoCRA (Mandatory)

MoCRA requires TWO mandatory filings:

3.1 Facility Registration (Every 2 Years)

Required for:

• Manufacturers
• Processors
• Contract manufacturers

Foreign manufacturers must appoint a U.S. Agent (similar to medical device & drug rules).

Data required:

• Facility name & address
• Brand names manufactured
• U.S. Agent (for foreign facilities)

Deadline:

• Initial registration: Dec 2023
• Renewal: Every 2 years

3.2 Cosmetic Product Listing (Annual)

Each cosmetic product must be listed with FDA:

• Product category
• Brand name
• Full ingredient list
• Place of manufacture
• Responsible Person information

Deadline:

• Initial listing: Dec 2023
• Annual updates: Required

4. Responsible Person (RP) – NEW Requirement

MoCRA introduced the concept of a Responsible Person (RP):

RP appears on the product label and must:

• Submit Product Listing
• Maintain safety substantiation
• Maintain PIF-like documentation
• Manage adverse event reporting
• Conduct recalls if needed

RP = U.S.-based manufacturer, packer, or distributor.
Foreign companies must designate a U.S.-based RP.

5. Cosmetic Safety Substantiation (Mandatory)

MoCRA requires adequate safety substantiation, similar to EU PIF:

Safety evidence may include:

• Toxicology review
• Ingredient safety assessments
• Microbiology challenge test
• Stability data
• Heavy metal analysis
• Clinical or consumer-use studies

FDA can ask for substantiation during inspections.

This is essentially a U.S. version of EU PIF Part III.

6. Labeling Requirements (Updated Under MoCRA)

All U.S. cosmetics must include:

• Product identity
• Net quantity of contents
• Ingredient list (INCI)
• Name & address of RP
• Warning statements (if applicable)
• Fragrance allergens (MoCRA requirement — enforcement delayed to 2025)
• Professional-use labeling (new requirement)

Language: English
Bilingual English/Spanish labels allowed.

7. Adverse Event Reporting (Mandatory)

Under MoCRA, RP must:

• Report serious adverse events to FDA within 15 days
• Maintain records for 6 years
• Provide product sample or ingredient data if FDA requests

Serious events include:

• Infection
• Disfigurement
• Hospitalization
• Significant hair loss
• Allergic reactions requiring medical intervention

8. Good Manufacturing Practice (GMP)

FDA is finalizing mandatory GMP standards for cosmetics, expected to be aligned with:

• ISO 22716
• 21 CFR manufacturing controls

Compliance will become mandatory when the rule is finalized (anticipated 2025).

9. Claims & Borderline Rules (Important)

The U.S. is claim-driven. Claims determine classification.

Examples of Drug Claims (NOT Cosmetic):

• Anti-acne (“treats acne,” “clears breakouts”)
• Anti-dandruff
• Hair growth / anti-hair loss
• Sunscreen (broad-spectrum SPF)
• Eczema treatment
• Hyperpigmentation / melasma “treatment”
• “Heals damaged skin,” “repairs barrier”
• Anti-inflammatory

These products must follow OTC drug regulations.

10. Fees & Timelines

FDA does not charge fees for cosmetic facility registration or product listing.

• Facility Registration Fee: $0
• Product Listing Fee: $0
• Timeline: Usually 1–5 days to receive confirmation

OTC drugs, however, have separate fees.

11. Importation Requirements

To import cosmetics into the U.S.:

• Facility registered under MoCRA
• Product listed on FDA portal
• U.S. Agent for foreign manufacturers
• Label must comply with U.S. regulations
• No banned ingredients (e.g., chloroform, bithionol, mercury)
• FDA may detain shipments for non-compliance

No CFS required, unlike ASEAN/GCC.

12. Post-Market Surveillance & FDA Enforcement

FDA has increased enforcement under MoCRA:

• Inspections of cosmetic manufacturers
• Warning letters
• Voluntary or mandatory recalls
• Detention of imported goods
• Testing for microbiology/heavy metals
• Claim-policing (especially on social media)

Failure to comply can lead to serious sanctions.

13. Borderline Product Classification

14. Consulting Notes for Your Portfolio

15. Advantages of the U.S. Cosmetic Market

• No government fees
• No pre-market technical review
• Fast entry (immediate once listed)
• Very large, high-value premium skincare market
• Flexible for innovation if claims are carefully controlled
• Good for cross-border e-commerce (Amazon, DTC, etc.)