MoCRA Compliance for Small Cosmetic Makers — What You Actually Need to Know
MoCRA is now law. Here's what the Modernization of Cosmetics Regulation Act means for your small soap or skincare business — facility registration, labeling, adverse event reporting, and how batch tracking helps.
If you make soap, skincare, or body care products and sell them to the public, federal law changed significantly in late 2022 — and the deadlines to act started hitting in 2023 and 2024.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant update to US cosmetics law in nearly 90 years. The previous framework dated back to 1938. For most of that time, cosmetics were essentially self-regulated: no mandatory registration, no required adverse event reports, minimal FDA oversight. That era is over.
This post is not legal advice. But it is a plain-English breakdown of what MoCRA requires, who’s exempt, and what practical steps small batch makers should take — especially around batch records and lot tracking, which turn out to matter more than most makers realise.
Last updated: March 2026
What is MoCRA and why does it matter for small makers?
MoCRA was signed into law on December 29, 2022. It gave the FDA new authority over cosmetics: the power to require facility registration, mandate safety substantiation, order recalls, and receive reports of serious adverse events.
For context, the FDA previously had almost no mandatory oversight of cosmetics beyond basic labeling rules. A company could (and many did) sell products without ever notifying the FDA they existed. MoCRA changed that fundamentally.
Small batch makers are squarely in scope. The law applies to anyone who manufactures or processes cosmetics for US consumers — which includes Etsy sellers, farmers market vendors, and anyone with a Shopify store. The size of your operation affects some thresholds (more on that below), but does not give you a free pass on everything.
The key requirements that apply broadly:
- Facility registration — where you make your products
- Product listing — what products you make and their ingredients
- Safety substantiation — documented evidence your products are safe
- Adverse event reporting — reporting serious problems to the FDA
- Labeling updates — new requirements for allergens and contact information
The five MoCRA requirements you need to understand
1. Facility registration
Every facility that manufactures or processes cosmetics sold in the US must register with the FDA. “Facility” means wherever you’re making your products — your home studio, your rented commercial kitchen, your workshop.
The initial registration deadline for existing facilities was December 29, 2023. New facilities must register within 60 days of starting operations. Registration renews every two years (in odd-numbered years).
Registration happens through the FDA’s Voluntary Cosmetic Registration Program (VCRP) portal, which has been updated to handle MoCRA registrations. The process itself isn’t complicated — it’s essentially paperwork — but you do need to have your facility details organised before you start.
Small business note: The FDA has defined a “small business” exemption for facility registration as companies with fewer than $1 million in average annual gross sales of cosmetics. If you’re under that threshold, you don’t need to register your facility. But you do still need to comply with product listing and labeling requirements. The exemption is narrower than it sounds.
2. Product listing
Separate from facility registration, MoCRA requires that each cosmetic product sold in the US be listed with the FDA. This includes the product name, applicable cosmetic category, list of ingredients (in descending order of concentration), and the name and contact information of the responsible person.
The initial listing deadline was also December 29, 2023 for products already on the market. New products must be listed within 120 days of first marketing.
Product listing is tied to facility registration — you can’t list products without a registered facility (unless you’re under the small business threshold for facility registration, in which case product listing still applies but is handled slightly differently).
3. Safety substantiation
MoCRA requires that cosmetics be “adequately substantiated for safety.” This isn’t new in spirit — you were always supposed to be making safe products — but it’s now a legal requirement with teeth.
What counts as substantiation? The FDA hasn’t issued full final guidance yet, but the general expectation is that you have documented evidence: ingredient safety data, stability testing results, challenge testing for preservation, and challenge records for products applied near the eyes or used on children.
For many small makers, the practical implication is: keep your records. Your supplier safety data sheets (SDS), your formulation notes, your stability observations — these form the foundation of your substantiation file. If the FDA ever asks, you want to be able to show your work.
4. Adverse event reporting
This is the requirement that catches most small makers off guard. Under MoCRA, responsible parties (that’s you, the maker) must report serious adverse events to the FDA within 15 business days of receiving the report. You also need to keep records of all adverse events — serious or not — for six years.
A “serious adverse event” is defined as one that results in: death, a life-threatening situation, inpatient hospitalisation, a persistent or significant disability, a congenital anomaly, or a medical or surgical intervention to prevent one of the above. It also includes any serious unexpected side effects.
A customer complaining that a lotion made their skin temporarily dry does not trigger mandatory reporting. A customer reporting a severe allergic reaction requiring an ER visit does.
The practical implications here are real. You need:
- A way to receive and log customer complaints
- A process to assess severity
- Records that show you received the complaint, when, and what you did with it
- A paper trail going back six years
This is where lot numbers and batch records matter much more than most makers think. If a customer reports an adverse event, you need to know exactly which batch they were using, what was in it, and who else received products from that batch. Without that information, you can’t investigate or respond effectively.
5. Labeling changes
MoCRA added two new labeling requirements:
Fragrance allergens: The FDA is developing a rule requiring disclosure of specific fragrance allergens above defined thresholds. Final rulemaking was still in progress as of early 2026, but makers should watch for updates. If you use fragrances or essential oils with known allergens (linalool, limonene, eugenol, etc.), start thinking about how you’ll handle disclosure.
Responsible person contact: Labels must include a way for consumers to report adverse events — typically a phone number, website, or address where they can reach you.
Are you exempt? The soap exemption explained
The soap exemption is real, but narrower than most soap makers assume.
Under both the old law and MoCRA, a product qualifies as “soap” — and is therefore not regulated as a cosmetic — only if it meets all three of these conditions:
- The bulk of the non-water ingredients are alkali salts of fatty acids (i.e., saponified oils)
- The product is labeled, sold, and represented only as soap
- The product is not intended to moisturise, deodorise, or perform any other cosmetic function
If you make cold-process or hot-process soap from oils and lye, label it only as soap, and make no other cosmetic claims — you’re probably exempt. Full stop.
But the moment you say “moisturising soap,” “antibacterial soap,” “acne-fighting soap,” or make any claim about what the product does to your skin beyond cleaning it — you’ve lost the exemption. Your product is now both a soap (under that definition) AND a cosmetic, or possibly a drug. MoCRA applies.
Similarly, liquid “soaps” made with synthetic detergents rather than saponified oils don’t qualify for the exemption, even if you call them soap.
Shampoo bars, shaving soap, facial cleansers, and most bath bombs don’t qualify. Neither does lotion, body butter, lip balm, or anything that moisturises, fragrances, or otherwise affects the appearance of skin.
If you’re at all unsure, assume MoCRA applies to your products.
How to set up batch tracking and lot numbering for MoCRA compliance
The adverse event reporting requirement isn’t just about paperwork — it’s about traceability. If something goes wrong with a product, you need to be able to answer: when was it made, from which materials, and who has it?
That’s exactly what batch records and lot numbers are for.
What a batch record should include:
- Lot number (unique identifier for each production run)
- Date of manufacture
- Formula used (ingredients, quantities, percentages)
- Batch size
- Supplier and lot number for each raw material (so you can trace back to source)
- Equipment used
- Any observations during manufacturing (colour, scent, consistency)
- Finished product yield
- Quality checks or testing performed
- Disposition (how much sold, where, to whom)
How lot numbering works in practice:
A lot number is just a code that links a finished product batch to its records. Common formats include date-based codes (e.g., 20260312-LB-001 for a lip balm batch made March 12, 2026) or sequential numbering per product. The specific format doesn’t matter. What matters is that it’s unique, it’s on the label, and you can look it up in your records.
When a customer buys a product, that lot number ties their purchase to a specific batch. If they report a problem, you know exactly what was in it and who else might have received products from the same run.
Linking lot numbers to raw material batches:
This is where small makers often skip a step. If you record the lot number for your finished product but not the supplier lot numbers for the ingredients that went into it — you can trace forward (who has this batch?) but not backward (what if there’s a problem with a specific raw material?).
A good batch record links both directions.
Craftybase and batch tracking:
Craftybase handles exactly this kind of batch-level tracking. When you record a manufacturing run, you can assign a lot number, capture which materials and quantities went into it, and track where the finished products went. If a customer reports an issue and gives you a lot number, you can pull the full batch record in seconds — what was in it, when it was made, and which orders included products from that batch.
That’s not just useful for compliance. It’s the difference between a manageable situation and a very stressful one.
You can also keep track of raw material inventory and supplier information, which means you can record supplier lot numbers for your inputs as part of your normal workflow — not as a separate compliance task. For more on why detailed raw material tracking matters, see our post on what raw materials mean for your business.
Labeling requirements under MoCRA — a quick checklist
Beyond the new MoCRA-specific additions, it’s worth making sure your labels already meet baseline FDA cosmetics requirements. Many small makers are surprised to find they’re missing standard elements.
Required on every cosmetic label:
- Product identity (what the product is)
- Net quantity of contents (weight or volume)
- Distributor statement — your business name and address, or “distributed by [name]” with contact details
- Ingredient declaration — all ingredients in descending order of concentration, using INCI (International Nomenclature of Cosmetic Ingredients) names
- Warnings as applicable (for certain ingredients or product types)
Required under MoCRA (new or clarified):
- Adverse event reporting contact (phone, website, or address)
- Fragrance allergen disclosure (rule still being finalized as of 2026 — watch for updates)
Practical note on INCI names: “Shea butter” on a label is not technically correct — it should be “Butyrospermum Parkii (Shea) Butter.” Most customers don’t read INCI names closely, but the FDA requirement is clear. Ingredient suppliers can usually provide INCI names, and many formulation resources have searchable databases.
For a deeper look at the FDA’s prior framework and how MoCRA builds on it, see our post Are Cosmetics Regulated by the FDA? — it covers the foundational rules that MoCRA now sits on top of.
Frequently Asked Questions
Does MoCRA apply to small Etsy sellers and home-based makers?
Yes. MoCRA applies to anyone who manufactures or processes cosmetics for US consumers, regardless of business size or sales channel. Small businesses with under $1 million in average annual gross cosmetics sales are exempt from facility registration, but product listing, safety substantiation, labeling requirements, and adverse event reporting still apply. If you sell lip balm, lotion, or skincare on Etsy — MoCRA is relevant to you.
Is cold process soap exempt from MoCRA?
It can be — but only if it meets the full legal definition. True soap (bulk ingredients are saponified oils, labeled and sold only as soap, no cosmetic claims) is exempt from FDA cosmetic regulation under both the old rules and MoCRA. The moment you describe your soap as "moisturising," "antibacterial," or make any claim about what it does to skin beyond cleaning — the exemption is gone. When in doubt, assume MoCRA applies.
What counts as a serious adverse event under MoCRA?
A serious adverse event is one that results in death, a life-threatening situation, inpatient hospitalisation, persistent or significant disability, a congenital anomaly, or required medical or surgical intervention to prevent one of those outcomes. A customer reporting dry skin or mild irritation does not meet this threshold. A severe allergic reaction requiring an emergency room visit does. You must report serious events to the FDA within 15 business days and keep records of all adverse events (serious or not) for six years.
Why do lot numbers matter for MoCRA compliance?
Lot numbers create a traceable link between a finished product and its complete batch record — ingredients, quantities, supplier lot numbers, manufacturing date, and who received products from that batch. If a customer reports an adverse event, you need to identify exactly what was in the product they used and whether other customers might be affected. Without lot numbers in your records and on your labels, that investigation becomes guesswork. Craftybase tracks batch records and lot numbers as part of normal manufacturing workflow, so traceability doesn't require a separate compliance system.
When did MoCRA compliance deadlines start?
MoCRA was signed into law on December 29, 2022. The initial deadlines for existing facilities and products were December 29, 2023 — one year after enactment. New facilities must register within 60 days of starting operations. New products must be listed within 120 days of first marketing. Adverse event reporting requirements and the mandatory recall authority took effect at enactment. If you haven't registered or listed yet, you're late — but getting compliant now is still better than continuing without it.
Does MoCRA affect how I need to label my cosmetics?
Yes, in two ways. First, labels must include a way for consumers to report adverse events — a phone number, website, or mailing address for your business. Second, MoCRA directed the FDA to develop rules on fragrance allergen disclosure; that rulemaking was still in progress as of early 2026, but final rules are expected and makers who use fragrances should watch for updates. Existing requirements (INCI ingredient list, net weight, distributor name and address) remain in place and unchanged.
Where to go from here
MoCRA isn’t going away. The FDA now has real authority over cosmetics — mandatory registration, recall powers, adverse event reporting, and more. Small makers are not exempt from the core requirements.
The good news: most of what MoCRA asks for is documentation you should already be doing. Keeping batch records, tracking ingredients and suppliers, noting what went into each production run — these are sound business practices regardless of compliance requirements. They help you price accurately, identify quality problems, and know exactly what you made and when.
If you’ve been meaning to get your batch records in order, this is the moment. Start with your current products: assign lot numbers, document your formulas, and keep records of which materials went into each batch. A free cosmetics inventory spreadsheet is a decent starting point — download our free cosmetics inventory spreadsheet to get set up.
When your production volume grows beyond what a spreadsheet can track well, Craftybase handles batch tracking, lot numbers, raw material inventory, and COGS reporting as part of a single workflow — without a separate compliance system bolted on.
Start a free 14-day trial of Craftybase — no credit card required.
