Question 1

What does MoCRA stand for?

Accepted Answer

MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022.

Question 2

When was MoCRA signed into law?

Accepted Answer

MoCRA was signed into law on December 29, 2022.

Question 3

What is the main purpose of MoCRA?

Accepted Answer

MoCRA expands FDA oversight of cosmetics and introduces new compliance requirements for many cosmetic businesses.

Question 4

Does MoCRA apply to companies outside the United States?

Accepted Answer

It can. Foreign cosmetic facilities and responsible persons distributing cosmetics in the U.S. may be subject to MoCRA requirements.

Question 5

Does MoCRA mean cosmetics are FDA approved?

Accepted Answer

No. Registration/listing does not mean FDA approval or endorsement.

Question 6

What is cosmetic facility registration under MoCRA?

Accepted Answer

A required submission for many facilities that manufacture or process cosmetic products distributed in the U.S.

Question 7

What is cosmetic product listing under MoCRA?

Accepted Answer

A submission that identifies cosmetic products and related information for many products sold in the U.S.

Question 8

Is facility registration the same as product listing?

Accepted Answer

No. Facility registration covers the facility; product listing covers the cosmetic products.

Question 9

Do brand owners have MoCRA responsibilities?

Accepted Answer

Often yes, depending on whether they are the ‘responsible person’ and how the supply chain is structured.

Question 10

What is a 'responsible person' in cosmetics compliance?

Accepted Answer

Generally, the entity responsible for ensuring the cosmetic product meets U.S. requirements and labeling obligations.

Question 11

Do contract manufacturers have MoCRA responsibilities?

Accepted Answer

Often yes, especially if they operate the manufacturing/processing facility that must register.

Question 12

Do private-label cosmetic brands need MoCRA compliance?

Accepted Answer

Many do. Private-label brands often have responsible person obligations and product listing needs.

Question 13

Does MoCRA apply to handmade cosmetics?

Accepted Answer

It may, depending on your activities, product types, and any applicable exemptions. We can assess your case.

Question 14

Does MoCRA apply to salons or spas that make products?

Accepted Answer

It can, if the business manufactures/processes cosmetics for distribution. Requirements depend on the facts.

Question 15

Does MoCRA apply to importers of cosmetics?

Accepted Answer

It can. Importers may be involved in responsible person obligations depending on the brand and labeling structure.

Question 16

Do I need MoCRA compliance to sell cosmetics on Amazon?

Accepted Answer

Selling channel does not remove regulatory obligations; requirements depend on the product and your role.

Question 17

Do I need MoCRA compliance to sell on Shopify or my own website?

Accepted Answer

Yes if your product and role fall under MoCRA requirements; eCommerce does not remove FDA obligations.

Question 18

Do I need MoCRA compliance for international sales only?

Accepted Answer

MoCRA is relevant to cosmetics distributed in the U.S. If you do not sell into the U.S., MoCRA may not apply.

Question 19

Does MoCRA change cosmetic ingredient rules?

Accepted Answer

MoCRA expands oversight and compliance expectations; ingredient compliance still matters and must be evaluated by product and claims.

Question 20

Does MoCRA require product safety documentation?

Accepted Answer

Many businesses should maintain appropriate safety-related documentation and records to support compliance.

Question 21

Can MoCRA requirements vary by product type?

Accepted Answer

Yes. Product type, intended use, and claims can affect compliance needs.

Question 22

How do I know if my product is a cosmetic or a drug?

Accepted Answer

Classification often depends on intended use and claims. We can review your product and labeling to assess risk.

Question 23

Can cosmetic claims turn my product into a drug?

Accepted Answer

Yes. Certain claims can trigger drug classification risk and additional regulatory requirements.

Question 24

Is anti-acne skincare considered cosmetic or drug?

Accepted Answer

It depends on active ingredients and claims; many acne products can be regulated as drugs.

Question 25

Are sunscreens cosmetics or drugs?

Accepted Answer

Many sunscreens are regulated as OTC drugs in the U.S. Compliance depends on formulation and labeling.

Question 26

Are anti-aging claims allowed for cosmetics?

Accepted Answer

Some appearance-related claims may be acceptable, but structure/function or disease claims can increase drug risk.

Question 27

Do I need to list all ingredients on cosmetic labels?

Accepted Answer

Most cosmetics require ingredient declaration on the label. Exact requirements can vary by product and packaging.

Question 28

Do fragrances require special labeling?

Accepted Answer

Fragrance labeling can be nuanced. We can review your label and ingredient approach for U.S. compliance.

Question 29

Do essential oils count as cosmetics?

Accepted Answer

Sometimes. Intended use and claims determine whether an essential-oil product is cosmetic, drug, or other category.

Question 30

Are soaps covered by MoCRA?

Accepted Answer

Some soaps fall under different rules depending on composition and claims. We can help classify your product.

Question 31

Do hair products require MoCRA compliance?

Accepted Answer

Many do if they are cosmetic products distributed in the U.S. and subject to facility registration/product listing requirements.

Question 32

Do makeup products require MoCRA compliance?

Accepted Answer

Often yes, depending on the responsible person and supply chain roles.

Question 33

Do skincare products require MoCRA compliance?

Accepted Answer

Often yes, depending on product type, claims, and roles.

Question 34

Do body lotions and creams require MoCRA compliance?

Accepted Answer

Often yes if they are cosmetics distributed in the U.S. and the business is subject to MoCRA requirements.

Question 35

Do deodorants require MoCRA compliance?

Accepted Answer

Some deodorants are cosmetics while antiperspirants can be drugs; classification depends on claims and formulation.

Question 36

Do cosmetic kits or bundles need product listing?

Accepted Answer

Often, each product may need to be addressed appropriately. We can map listings by SKU/product.

Question 37

Do different scents of the same product need separate listing?

Accepted Answer

It depends on listing structure and product differences; we can advise on the cleanest compliant approach.

Question 38

Do different sizes of the same product need separate listing?

Accepted Answer

Often the core product can be handled consistently, but exact listing approach depends on how products are defined.

Question 39

What if my product formula changes?

Accepted Answer

Formula changes can require updates to listings and labels. We can manage updates as needed.

Question 40

What if my facility address changes?

Accepted Answer

Facility registration details should be updated to keep records accurate and current.

Question 41

What if I change my contract manufacturer?

Accepted Answer

Supply chain changes may require updates to facility registration/product listing strategy and documentation.

Question 42

What if I have multiple manufacturing facilities?

Accepted Answer

Multiple facilities may each require registration depending on what they do.

Question 43

What if I have multiple brands under one company?

Accepted Answer

We can organize compliance by entity, brand, product line, and responsible person structure.

Question 44

Do distributors need to register under MoCRA?

Accepted Answer

Typically the manufacturer/processor facility and responsible person are central, but roles vary—an assessment is best.

Question 45

Do retailers need MoCRA compliance?

Accepted Answer

Retailers may have obligations depending on their role; usually manufacturing/processing and responsible person roles drive filings.

Question 46

Does MoCRA require GMPs for cosmetics?

Accepted Answer

MoCRA increases expectations around good manufacturing practices; we can guide GMP readiness and documentation.

Question 47

Do I need written procedures for cosmetics manufacturing?

Accepted Answer

Strong documentation is recommended; exact needs depend on your operations and risk profile.

Question 48

Do I need batch records for cosmetics?

Accepted Answer

Maintaining batch/production records is a good compliance practice and supports traceability and safety programs.

Question 49

Do I need complaint handling procedures?

Accepted Answer

Complaint handling and documentation are important for compliance and risk management.

Question 50

Do I need adverse event reporting?

Accepted Answer

Certain adverse event reporting obligations can apply; we can help set up a simple process and documentation.

Question 51

Do I need a recall plan for cosmetics?

Accepted Answer

Having a recall/withdrawal plan is a strong risk-control step; requirements depend on situation and expectations.

Question 52

Do I need product stability testing?

Accepted Answer

Testing strategy depends on product type and risk; many brands use stability data to support quality and shelf-life decisions.

Question 53

Do preservatives require special attention in compliance?

Accepted Answer

Yes. Preservative systems and contamination controls are important for safety and quality.

Question 54

Do I need microbial testing for cosmetics?

Accepted Answer

Many products benefit from microbiological controls and testing based on risk; we can help define an appropriate approach.

Question 55

Do I need certificate of analysis (COA) from my manufacturer?

Accepted Answer

COAs and quality documentation can support compliance and due diligence depending on your supply chain.

Question 56

Can you help with cosmetic label compliance?

Accepted Answer

Yes. We review cosmetic labels for core required elements, ingredient declarations, and claim risk.

Question 57

Can you help reduce drug-claim risk on cosmetic labels?

Accepted Answer

Yes. We can recommend safer claim wording aligned with cosmetic positioning.

Question 58

Do I need a U.S. address on cosmetic labels?

Accepted Answer

Many products need responsible party contact information. Exact requirements depend on the product and labeling setup.

Question 59

Can I use bilingual labels for U.S. cosmetics?

Accepted Answer

Yes, but required statements should remain clear and compliant in presentation and content.

Question 60

Does packaging artwork need to match listed information exactly?

Accepted Answer

Consistency matters. Listings, labels, and product details should align to reduce risk and confusion.

Question 61

What information is needed for MoCRA facility registration?

Accepted Answer

Typically facility identity, address, contacts, and details about operations. We provide a checklist during intake.

Question 62

What information is needed for MoCRA product listing?

Accepted Answer

Typically product names, categories, ingredient information, and responsible person details; exact data depends on product.

Question 63

Can you handle MoCRA filings for multiple product lines?

Accepted Answer

Yes. We can scale listings and registrations across product lines and manufacturers.

Question 64

Can you support foreign cosmetic manufacturers exporting to the U.S.?

Accepted Answer

Yes. We support both domestic and international clients distributing cosmetics in the U.S.

MoCRA (Modernization of Cosmetics Regulation Act of 2022)

Establishment Registration: $1449 USD / Per Year

MoCRA Compliance Services

What Is MoCRA?

Why MoCRA Compliance Is Important

MoCRA Compliance Assistance Services

Frequently Asked Questions (FAQ)

What does MoCRA stand for?

When did MoCRA become law?

Who must comply with MoCRA?

What is considered a facility under MoCRA?

Does MoCRA apply to foreign cosmetic manufacturers?

What happens if a company does not comply with MoCRA?

Can FDA Registration Assistance help with MoCRA compliance?

Contact FDA Registration Assistance

© 2013 – 2026 FDA Registration Assistance. All Rights Reserved. FDA Registration Assistance is a private FDA regulatory consulting firm and is not the FDA.