MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022. It is the most significant update to US cosmetics regulation in over 80 years, requiring facility registration, product listing, safety substantiation, adverse event reporting, and Good Manufacturing Practice (GMP) compliance for cosmetics manufacturers.

Do small cosmetics businesses need to register with the FDA under MoCRA?

It depends on your size. Facilities manufacturing cosmetics for US distribution must register with FDA via Form FDA 5066. However, businesses with average annual US cosmetics sales under $1M are permanently exempt from facility registration — unless they manufacture eye area cosmetics or injectables. Prolonged-contact products such as hair dye and nail treatments do not remove the exemption, but may receive additional FDA scrutiny on safety substantiation.

Who qualifies for the MoCRA small business exemption?

Businesses with average annual US cosmetics sales under $1 million over the last 3 years may qualify for the small business exemption. However, even exempt businesses must comply with safety substantiation, labeling, adverse event reporting, and record retention. Businesses making eye products or injectables do not qualify regardless of revenue.

Does the MoCRA small business exemption cover safety substantiation?

No. Safety substantiation applies to all cosmetics businesses regardless of size. There is no small business exemption for this obligation. Every cosmetics business must maintain adequate safety documentation — including Certificates of Analysis, Safety Data Sheets, and formulation records — for every product they sell.

What counts as a serious adverse event under MoCRA?

A serious adverse event includes death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, a congenital anomaly, or a medical or surgical intervention required to prevent such outcomes. All of these events must be reported to the FDA within 15 business days of receiving the consumer report.

How long do I have to report a serious adverse event to the FDA?

Serious adverse events must be reported to the FDA within 15 business days of receiving the report from a consumer. You must also submit a follow-up report within 15 business days if you receive new medical information about a previously reported event.

When must a cosmetics facility renew its FDA registration?

FDA facility registrations must be renewed every two years from the date of initial registration. You must also update your registration within 60 days of any changes to your facility or operations. Small businesses under $1M in average annual US cosmetics sales are permanently exempt from this requirement unless they make restricted product types.

What is the MoCRA product listing deadline?

The initial product listing deadline under MoCRA passed on July 1, 2024 for existing marketed products. The FDA Cosmetics Direct portal is open and actively accepting submissions — businesses that have not yet listed should do so promptly to reduce their compliance risk. The Responsible Person (the company or individual whose name appears on the product label) must list every marketed cosmetic via Form FDA 5067, confirm or update listings at least once per year, and update within 60 days of any formula or label change. Small businesses with average annual US cosmetics sales under $1M are permanently exempt from this requirement unless they make eye area cosmetics or injectables.

When does the MoCRA GMP rule take effect?

As of June 2026, FDA has not published its final GMP rule. Once finalized, most cosmetics businesses will have 2 years to comply. Small businesses receive an additional 3-year grace period — up to 5 years total. However, FDA has already issued Warning Letters citing GMP deficiencies before the final rule, signaling active enforcement intent.

Can I sell hair dye or nail treatments and still qualify for the small business exemption?

Prolonged-contact products like hair dye and nail treatments do not automatically remove the small business exemption under MoCRA. However, if you sell eye area cosmetics (mascara, eyeliner, eyeshadow, lash adhesive) or any injectable product, the exemption is removed entirely regardless of your revenue.

How long must adverse event records be retained under MoCRA?

Adverse event records must be retained for 6 years. Businesses that qualify for the small business exemption may retain records for 3 years. Records must be organized and retrievable — records that exist but cannot be located are treated the same as records that do not exist.

Does the MoCRA small business exemption mean I don't have to do anything?

No. Exempt businesses are still required to comply with safety substantiation, labeling, adverse event reporting, and record retention (with a 3-year retention period instead of 6 years). The exemption only makes facility registration and product listing optional — all other MoCRA obligations apply regardless of revenue.

What happens if my cosmetics sales go over $1 million?

Your small business exemption is lost once your average annual US cosmetics sales over the prior 3 calendar years exceed $1 million. At that point, you must register your facility with FDA via Form FDA 5066 and list your products via Form FDA 5067 within the applicable deadlines. The 3-year rolling average means a single high-revenue year does not immediately remove the exemption — but sustained growth past the threshold does.

Can I use the MoCRA small business exemption if I sell through Amazon or Etsy?

Yes. The exemption applies based on your total average annual US cosmetics sales across all sales channels — including Amazon, Etsy, your own website, craft fairs, and wholesale accounts. As long as the combined total is under $1 million per year (averaged over 3 years), the platform does not affect your eligibility. Only US cosmetics sales count; international sales are excluded from the calculation.

MoCRA Compliance Checklist for Small Cosmetics Businesses (2026)

Let’s understand your obligations

⏱ ~8–12 minutes to complete · Progress saved automatically

Last updated: June 2026 · Always verify current requirements at FDA.gov.

Two quick questions to determine which MoCRA requirements apply to your business. Your answers affect the Required vs. Recommended labels throughout the checklist.

Written by Elise Hammond, Batchforja · Content reviewed against FDA.gov and MoCRA statutory text · Last updated June 2026 · Not legal advice — consult a regulatory attorney for your specific situation.

1. What were your average annual US cosmetics sales over the last 3 years?

Count only US gross sales of cosmetic products, averaged across the last 3 calendar years. Exclude non-cosmetic products and international sales.

Under $1 million $1 million or more Not sure / just starting out

2. Do you make any of these product types?

Part A — Remove the small business exemption regardless of revenue:

Eye area cosmetics (mascara, eyeliner, eyeshadow, lash adhesive)

I’m not sure — my product is used near the eye area

Injectables or products intended for internal use

Injectables and orally ingested products are generally regulated as drugs under the Federal Food, Drug, and Cosmetic Act — not as cosmetics under MoCRA. If you make these products, consult an FDA regulatory attorney, as this checklist does not cover your drug-related obligations.

Neither of the above

Part B — Don’t affect your exemption but require extra safety documentation:

Prolonged-contact products (semi-permanent makeup, hair dye, nail treatments)

Doesn’t remove the small business exemption. FDA may scrutinize safety substantiation more closely due to extended skin contact. Selecting this adds a reminder in the Safety Substantiation section.

Are you a contract manufacturer?

Under MoCRA, obligations are shared between the Responsible Person (the brand whose name is on the label) and the contract manufacturer (the facility doing the making).

Facility registration (Form FDA 5066) must be filed by the manufacturer — even if you only make for other brands.
Product listing (Form FDA 5067) is the brand owner’s responsibility, but you may need to provide them facility and ingredient information.
Adverse event reporting applies to whoever receives the consumer report — typically the brand.
GMP and safety substantiation are shared obligations. Your facility must comply with GMP. The brand is responsible for product safety documentation.

If you are both the manufacturer and the brand owner (your name is on the label), all obligations apply to you directly. This checklist assumes that scenario.

Step 2 of 10

Small Business Status

ⓘ Informational — applies to all businesses

Understanding your exemption status is the starting point. Even exempt businesses have obligations — knowing exactly which ones prevents gaps.

I have calculated my average gross annual US cosmetics sales for the past 3 years I understand whether I qualify for the small business exemption (under $1M average) I have accounted for revenue growth that could push me over the $1M threshold I know that adverse event reporting applies to ALL businesses — there is no small business exemption for this obligation I know that safety substantiation applies to ALL businesses regardless of size I understand that selling even one eye area cosmetic or injectable removes my small business exemption entirely — regardless of revenue. Prolonged-contact products (hair dye, nail treatments, semi-permanent makeup) do not automatically remove the exemption but may receive additional safety scrutiny.

Step 3 of 10

Facility Registration

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Establishments manufacturing cosmetics for US distribution are required to register with FDA via Form FDA 5066 and renew every two years. Small businesses with average annual US cosmetics sales under $1M are permanently exempt from this requirement — unless they make eye area cosmetics or injectables.

⚠ What’s at stake

Unregistered facilities are subject to FDA Warning Letters, import alerts, and potential injunctions under MoCRA §607. Registration deadlines for existing facilities have passed — if you exceed the $1M threshold or make high-risk products, you are currently out of compliance and should register immediately.

Tip No fees are required to register. The process is free through the FDA Cosmetics Direct portal.

Multiple facilities If you manufacture cosmetics in more than one physical location, each facility must be registered separately with its own FEI number. A single brand with two manufacturing locations needs two registrations.

I have obtained an FDA Establishment Identifier (FEI) number — required before registering I have created an FDA Industry Systems (FIS) account at FDA.gov I have submitted Form FDA 5066 via the FDA Cosmetics Direct portal My registration includes: facility name, address, contact information, product categories, and FEI number I have recorded my registration date so I can renew on time (renewal required every 2 years from initial registration) I have a reminder set to update my registration within 60 days of any changes to my facility or operations

Helpful links

FDA Cosmetics Direct portal → FEI Portal — Look Up or Request Your FEI Number → Note: Creating an account is required. If you don’t have an FEI yet, click “Create Account” on the portal login page. FEI Portal FAQ →

Step 4 of 10

Product Listing

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The Responsible Person — whoever’s name is on the product label — must list every marketed cosmetic product with FDA via Form FDA 5067, updated or confirmed at least annually. Small businesses with average annual US cosmetics sales under $1M are permanently exempt from this requirement — unless they make eye area cosmetics or injectables.

⚠ What’s at stake

Unlisted products may be subject to FDA enforcement actions including Warning Letters and product seizure. Like facility registration, product listing deadlines have passed. If you are not exempt and have unlisted products on the market, each product is a separate compliance gap.

Tip If your brand name is on the label, you are the Responsible Person — even if a contract manufacturer made the product. The compliance obligation follows the label.

What if I use a contract manufacturer?

If a contract manufacturer makes your products under your brand name, you are the Responsible Person — product listing (Form FDA 5067) is your obligation, not theirs. Your contract manufacturer is responsible for facility registration (Form FDA 5066) under their own name and FEI number. You may need to request their FEI number to include in your product listing submission. If both you and your contract manufacturer sell under separate brands, you each have your own listing obligations.

I have identified the Responsible Person for each product (the manufacturer, packer, or distributor named on the label) I have submitted Form FDA 5067 for each marketed product via FDA Cosmetics Direct Each listing includes: product name, label copy, complete ingredient list in INCI format, and the facility’s FEI number Fragrance and flavor ingredients are listed individually in my FDA product listing submission (Form FDA 5067) — not just as “fragrance” or “flavor” — Note: consumer-facing labels may still use the collective “Fragrance” declaration under current rules I confirm or update my product listings at least once per year I update a listing within 60 days of any formula change or label change

Step 5 of 10

Safety Substantiation

● Required — applies to all businesses

You must be able to demonstrate that each product is safe. This does not require clinical trials. It requires organized documentation showing your ingredients are safe at the concentrations you use them.

⚠ What’s at stake

Under MoCRA §606, a cosmetic is considered unsafe and adulterated if it is not adequately substantiated for safety. FDA can issue Warning Letters, demand product recalls, or seek injunctions. There is no small business exemption for safety substantiation — it applies to all cosmetics manufacturers regardless of size or revenue.

Tip FDA’s January 2026 draft guidance suggested that records access during inspection may include safety documentation — though draft guidance is not legally binding until finalized. Monitor FDA.gov for the final rule. Organized documentation is not optional — it is the compliance.

I have a Certificate of Analysis (CoA) on file for every raw material I have Safety Data Sheets (SDS) on file for every ingredient I have formulation records for each product showing the percentage of every ingredient I have documentation supporting the safety of preservatives, essential oils, and active ingredients at the concentrations I use My safety documentation is organized and retrievable — not scattered across email folders or paper notebooks I can produce my safety records for an FDA inspection if requested

Step 6 of 10

Labeling

● Required — applies to all businesses

Your product labels must meet FDA requirements under MoCRA and existing cosmetic labeling law. Drug claims on labels are the most common mistake — they reclassify your product and trigger a much stricter regulatory framework.

⚠ What’s at stake

Mislabeled products can be seized under the FD&C Act as misbranded. A product bearing a drug claim becomes subject to the OTC drug framework — a significantly more burdensome regulatory pathway. Missing the Responsible Person contact address (required since 2023) is a straightforward violation FDA has already cited in Warning Letters.

Pending rule: FDA’s fragrance allergen labeling rule is not yet finalized as of June 2026. When it takes effect, many products will require label updates. Monitor FDA.gov for the final rule.

Tip Claiming your moisturizer “repairs the skin barrier” or “treats eczema” is not a marketing choice — it is a drug claim under FDA rules. If any product label makes a therapeutic claim, consult a regulatory attorney.

Who is the “Responsible Person”? Under MoCRA, the Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label — typically the brand owner, not the contract manufacturer. If you brand the product and put your name on the label, you are the Responsible Person, even if someone else makes it for you. This entity must register the facility, list the product with FDA, and maintain adverse event records.

Product name is clearly displayed on the label Net quantity of contents is present Full ingredient list appears in descending order of predominance using INCI (International Nomenclature of Cosmetic Ingredients) names Color additives are listed individually by their FDA-approved names (e.g., “Red 40,” “Iron Oxides”) — fragrance may still be declared collectively as “Fragrance” or “Parfum” under current law (see item 7) Label includes the Responsible Person’s domestic address, domestic phone number, or website URL where consumers can report adverse events — this is a new MoCRA requirement (§604) No drug claims are made — words like “treats,” “repairs,” “heals,” “reduces inflammation,” or “anti-aging” can reclassify a product as an OTC drug I am tracking FDA’s pending fragrance allergen labeling rule for future label changes The Responsible Person named on my label is the same entity identified in my FDA product listing (Form FDA 5067)

Step 7 of 10

Adverse Event Reporting

● Required — applies to all businesses

If a customer reports a serious adverse event linked to your product, you must report it to FDA within 15 business days. There is no small business exemption for this requirement.

⚠ What’s at stake

Failure to report a serious adverse event within 15 business days is a prohibited act under MoCRA §605 and subject to civil penalties. This applies to every cosmetics manufacturer regardless of revenue. Failing to maintain adverse event records is a separate violation. If your product is linked to a serious event and you haven’t reported it, FDA can take enforcement action at any time.

FDA definition: serious adverse event Death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement (serious or persistent rashes, second or third degree burns, hair loss, or persistent or significant alteration of appearance), or any event requiring medical intervention to prevent these outcomes.

I have a way for customers to report adverse events — contact information is on my label and/or website I know that serious adverse events must be reported to FDA within 15 business days of receiving the report I know that if new medical information emerges within 1 year of an initial report, I must submit it to FDA within 15 business days I have a process for receiving, documenting, and assessing customer complaints I am set up to submit reports via FDA’s AEMS Safety Reporting Portal (SRP) or by paper form (Form FDA 3500A)

Submitting by email or paper?

The FDA Safety Reporting Portal (SRP) is the preferred method. If you cannot use the SRP, small businesses may submit Form FDA 3500A by email to CosmeticAERS@fda.hhs.gov. Use the subject line: “MoCRA Cosmetic Adverse Event Report — [Your Business Name].” Paper submissions sent by mail are also accepted but slower to process. Keep a copy of every report submitted.

I am retaining adverse event records for the required period — 6 years for most businesses, or 3 years if I qualify for the small business exemption. Note: The reporting obligation itself (15 business days) applies to ALL businesses regardless of size. I periodically check the FDA AEMS Public Dashboard for Cosmetic Products for trends relevant to my product types

Helpful links

Report a Cosmetic Adverse Event to FDA →

Step 8 of 10

GMP Preparation

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Good Manufacturing Practice documentation is the foundation of MoCRA compliance. Even before the final rule, building these habits protects your customers, positions you for growth into wholesale and retail, and prevents costly reformulation and repackaging later. Even with extended grace periods, early compliance is the lower-risk path.

Pending rule — act now anyway: As of June 2026, FDA has not published its final GMP rule for cosmetics. Once finalized, most cosmetics businesses will have 2 years to comply. Small businesses (under $1M average annual sales) receive an additional 3-year grace period — meaning up to 5 years total after the rule is finalized. However, FDA has already issued Warning Letters based on GMP principles, signaling active enforcement intent before the rule is final. Building GMP-compliant habits now protects your business regardless of the grace period timeline. Monitor FDA.gov for the final rule publication date.

Helpful links

FDA Draft Guidance — Cosmetic GMPs → How Batchforja handles batch records & lot tracking →

Step 9 of 10

Record Retention

● Required — applies to all businesses

FDA’s 2026 draft guidance indicated that it may access your records during inspection — including manufacturing records, ingredient receipt records, distribution records, complaint records, and safety substantiation. Draft guidance is not legally binding until finalized, but organizing records now is prudent. Records that exist but can’t be found are the same as records that don’t exist.

⚠ What’s at stake

Under MoCRA §614, FDA may access records — including formulation and safety records — during an inspection or when investigating a safety concern. If you cannot produce records on request, FDA may treat it as evidence of non-compliance even if you are otherwise doing everything right. A recall without traceability records is significantly more costly and disruptive than one with them.

Tip Spreadsheets are a compliance liability. If your records live across multiple spreadsheets, email folders, and paper notebooks, that is a gap — not a system.

Adverse event records are retained for the required period — 6 years (standard) or 3 years (small business exemption). The reporting deadline itself (15 business days) is the same for all businesses regardless of size. Batch records are organized by lot number and easily retrievable Ingredient CoAs and SDS documents are filed and accessible Formulation records are current and stored securely Distribution records are maintained so I can identify which customers received which batches Records are stored in a format that can be produced for FDA inspection on request

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Your compliance snapshot

MoCRA requirements last reviewed: June 2026

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This tool is for informational purposes only and does not constitute legal or regulatory advice. MoCRA requirements are subject to change as FDA issues new guidance and final rules. Always verify current requirements at FDA.gov and consult a regulatory attorney for advice specific to your business.

MoCRA Compliance Checklist for Small Cosmetics Businesses (2026)

Small Business Status

Facility Registration

Product Listing

Safety Substantiation

Labeling

Adverse Event Reporting

GMP Preparation

Record Retention

Your compliance snapshot

Don’t lose your results

Priority gaps

Keep your FDA records inspection-ready

MoCRA compliance requirements at a glance

1. Small Business Status

2. Facility Registration

3. Product Listing

4. Safety Substantiation

5. Labeling

6. Adverse Event Reporting

7. GMP Preparation

8. Record Retention

Frequently asked questions about MoCRA compliance

Complete MoCRA Compliance Checklist: All Requirements by Category (2026)

Small Business Status (applies to all)

Facility Registration (required for businesses over $1M or with restricted product types)

Product Listing (required for businesses over $1M or with restricted product types)

Safety Substantiation (required for all businesses)

Labeling (required for all businesses)

Adverse Event Reporting (required for all businesses)

GMP Preparation (final rule pending; small businesses get extended lead time)

Record Retention (required for all businesses)

MoCRA Compliance Checklist for Small Cosmetics Businesses (2026)

Small Business Status

Facility Registration

Product Listing

Safety Substantiation

Labeling

Adverse Event Reporting

GMP Preparation

Record Retention

Your compliance snapshot

Don’t lose your results

Priority gaps

Keep your FDA records inspection-ready

MoCRA compliance requirements at a glance

1. Small Business Status

2. Facility Registration

3. Product Listing

4. Safety Substantiation

5. Labeling

6. Adverse Event Reporting

7. GMP Preparation

8. Record Retention

Frequently asked questions about MoCRA compliance

Related resources from Batchforja

MoCRA Small Business Exemption: What It Actually Covers

How to Register Your Cosmetics Facility with FDA

MoCRA Safety Substantiation: What Documents You Need

More compliance tools for cosmetics makers

Batchforja: Compliance software for cosmetics makers

Complete MoCRA Compliance Checklist: All Requirements by Category (2026)

Small Business Status (applies to all)

Facility Registration (required for businesses over $1M or with restricted product types)

Product Listing (required for businesses over $1M or with restricted product types)

Safety Substantiation (required for all businesses)

Labeling (required for all businesses)

Adverse Event Reporting (required for all businesses)

GMP Preparation (final rule pending; small businesses get extended lead time)

Record Retention (required for all businesses)