FDA Cosmetics Regulations for Small Makers — What MoCRA Means for Your Business
The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 significantly changed FDA oversight for cosmetic makers. Here's what changed, what still applies, and what you need to do to stay compliant.
As a handmade cosmetics maker, compliance might feel like territory reserved for big labs and corporate beauty brands. But if you’re selling lip balms, body lotions, scrubs, or any other beauty product to customers, FDA regulations apply to you too — and since December 2022, the rules changed significantly.
The Modernization of Cosmetics Regulation Act (MoCRA) was the first major overhaul of US cosmetics law in over 80 years. If you started your business before 2023, there’s a good chance your current practices predate these new requirements. As of 2026, the small business registration and product listing deadlines have both passed. If you haven’t registered your facility or listed your products with the FDA yet, that’s the first thing to address — the FDA’s enforcement posture on MoCRA is continuing to develop, and getting registered now is the simplest way to demonstrate good faith compliance. This guide covers what the FDA regulates, what MoCRA changed, and what you still need to do as a small cosmetics maker.
If you’re also looking for software to help you stay on top of compliance records and batch traceability, see how cosmetic manufacturing software and cosmetic inventory software can help simplify that side of the business.
What is the FDA?
The Food and Drug Administration (FDA) develops regulations based on laws set by the Federal Food, Drug, and Cosmetic Act (FD&C Act). Its role is to protect public health by ensuring that food, drugs, devices — and cosmetics — are safe for consumers.
For cosmetics specifically, the FDA’s authority has historically been limited compared to drugs. That changed with MoCRA, which gave the FDA new enforcement powers and created mandatory compliance requirements for cosmetics manufacturers for the first time.
Is Your Product a Soap or a Cosmetic?
This distinction matters more than most makers realise, because it determines which regulatory body oversees your product.
If your product meets the FDA’s definition of soap — made primarily of alkali salts of fatty acids, with cleaning as its only claim — it’s regulated by the Consumer Product Safety Commission (CPSC), not the FDA.
If your product is a cosmetic — intended to be applied to the body to alter appearance, cleanse, or promote attractiveness — it falls under FDA jurisdiction. This includes moisturisers, lip products, body scrubs, shampoos, and most bath and beauty products.
The label claims you make determine the classification. A plain bar of soap that only claims to clean falls under CPSC. A bar that claims to “moisturise”, “exfoliate”, or “soften skin” is a cosmetic under FDA rules.
Keep Your Cosmetics Business Compliant and Organised
MoCRA compliance means keeping accurate batch records, ingredient traceability, and production histories — and that's hard to do in a spreadsheet. Craftybase cosmetic inventory software and cosmetic manufacturing software make it simple to track every batch, ingredient lot, and production run — exactly what you need for GMP and adverse event documentation.
MoCRA: What Changed in 2022
Signed into law on December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) was the biggest change to US cosmetics oversight since 1938. Here’s what it introduced and what it means for your business.
Facility Registration
Under MoCRA, facilities that manufacture or process cosmetics for US consumers must register with the FDA. Registration must be renewed every two years.
Timeline:
- Large companies had until December 29, 2023 to register
- Small businesses (less than $1 million in average annual US cosmetics sales over the prior 3 years) had until December 29, 2024
If you’re a small maker under the $1 million threshold, you’ve already passed the registration deadline. If you haven’t registered your facility yet, this should be your first step. Registration is free and done through the FDA’s Cosmetics Direct portal.
Product Listing
All cosmetic products marketed in the US must now be listed with the FDA. This includes the product name, applicable cosmetic category, ingredient list, and the facility where it’s manufactured.
The same timelines apply — large companies by December 2023, small businesses by December 2024. Listings must be updated annually or whenever a new product is launched.
Good Manufacturing Practices (GMP)
MoCRA requires that cosmetics be manufactured, processed, packed, and held under adequate GMP conditions. The FDA is responsible for establishing specific GMP regulations.
Small businesses get extra time to comply once the FDA publishes its final GMP rule — three additional years compared to large companies. Even so, it’s worth building GMP-friendly habits now: consistent batch records, clean workspaces, labeled containers, and documented processes. These practices protect your customers and make the eventual compliance step much easier.
Serious Adverse Event Reporting (SAER)
This applies to all cosmetics businesses, regardless of size. If a consumer reports a serious adverse event — defined as an event that results in hospitalisation, serious injury, persistent disability, or death — you must report it to the FDA within 15 business days.
You’re also required to maintain records of any adverse event reports (serious or not) for six years.
This is one MoCRA requirement that doesn’t have a small business exemption. If a customer contacts you about a serious reaction to one of your products, you need to act on it promptly.
Mandatory Recall Authority
Before MoCRA, the FDA could only request voluntary recalls of unsafe cosmetics. Now it has mandatory recall authority — meaning the FDA can order a cosmetics recall if it determines a product is likely to cause serious adverse health consequences.
This reinforces why ingredient safety substantiation matters. Keep records of the safety testing, supplier certificates of analysis, and ingredient safety data that support your products.
What This Means for Small Makers
If your average annual US cosmetics sales are under $1 million, you’re classified as a “small business” under MoCRA. This gets you extended timelines on facility registration, product listing, and GMP compliance — but it doesn’t exempt you from everything.
Small businesses must still:
- Register their facility (extended deadline already passed)
- List their products with FDA (extended deadline already passed)
- Report serious adverse events within 15 business days
- Maintain adverse event records for 6 years
- Ensure products are safe and properly labelled
If you haven’t taken these steps yet, it’s worth addressing them now. The FDA’s enforcement posture on MoCRA is still developing, but voluntary compliance demonstrates good faith — and more importantly, protects your customers.
For a practical walkthrough of what MoCRA compliance looks like step by step, see our guide to MoCRA compliance for small cosmetic makers.
Hybrid Regulations: When Your Product is Both a Cosmetic and a Drug
Some products are classified as both a cosmetic and a drug by the FDA — when a product both alters appearance and causes a physiological change in the body.
Common examples include:
- Anti-dandruff shampoos (treat a scalp condition and cleanse)
- SPF moisturisers (sun protection is a drug claim; moisturising is cosmetic)
- Teeth-whitening products
- Antiperspirants (preventing sweating is a drug function)
These hybrid products must comply with both cosmetics and drug regulations — which is a significantly higher bar. If any of your marketing materials or labels make drug-type claims (“treats”, “prevents”, “cures”), your product may be regulated as a drug even if you intend it as a cosmetic.
Note that the FD&C Act doesn’t recognise “cosmeceuticals” as a category. Your product is either a drug, a cosmetic, or both.
Organic Cosmetics
Using the word “organic” on a cosmetic product triggers two sets of requirements.
The FDA regulates cosmetics that make organic claims, but the USDA’s National Organic Program (NOP) standards apply to the agricultural ingredients used. If you want to label your product as “organic”, your formulation must comply with USDA organic certification requirements — different from FDA’s general cosmetics standards.
There are four organic labelling tiers under USDA rules:
- 100% Organic — all ingredients must be certified organic
- Organic — at least 95% organic ingredients by weight
- Made with Organic [ingredients] — at least 70% organic ingredients
- Less than 70% organic — can only list organic ingredients in the ingredient panel, cannot make organic claims on main label
Regardless of organic status, all FDA cosmetics requirements still apply. An ingredient’s natural or organic origin doesn’t automatically make it safe — you’re still responsible for safety substantiation.
Product Labels
All cosmetics marketed in the US must comply with both the FD&C Act and the Fair Packaging and Labelling Act (FP&L Act). This applies whether your product is made locally or overseas.
Required label elements for cosmetics include:
- Product identity (what it is)
- Net contents (weight or volume)
- Name and address of the responsible person (manufacturer, packer, or distributor)
- Ingredient list in descending order of predominance
- Any required warnings
MoCRA added a new labelling consideration: the FDA is working on requirements to disclose fragrance allergens on cosmetics labels. This rule is still being developed, but if you use fragrance blends or essential oils, keep an eye on FDA guidance as it’s published.
Any label that is false or misleading renders the product misbranded, which can result in FDA enforcement action.
Safety of Ingredients
Cosmetics must be safe for consumers under normal or reasonably foreseeable conditions of use. There’s no FDA pre-approval required before launching a cosmetic — but you are legally responsible for ensuring your products are safe.
MoCRA strengthened this requirement by giving FDA the authority to request safety records. You should maintain documentation that substantiates the safety of your products and ingredients, including:
- Supplier certificates of analysis for raw materials
- Toxicological data on individual ingredients
- Safety data sheets (SDS) for each ingredient
- Any testing results you’ve conducted or commissioned
- Records of adverse event reports (maintained for 6 years)
Pay particular attention to documentation for complex formulations with multiple active ingredients, or for products intended for use on sensitive skin, children, or around the eyes.
Import and Export
If you’re exporting your products, you’ll need to comply with the destination country’s regulations — which may be quite different from FDA requirements. The EU, for instance, has a positive list of approved preservatives and a longer list of prohibited ingredients than the US.
An exported product won’t be considered misbranded under US law if it:
- Meets the requirements of the foreign country
- Is not in conflict with that country’s laws
- Is labelled as a product intended for export
- Is not offered for sale in domestic commerce
If you plan to sell exported products back in the US at any point, they must also comply with FDA regulations.
For imports, all cosmetics entering the US market are subject to FDA requirements regardless of origin. If you import any cosmetic ingredients or finished products, ensure your suppliers can provide appropriate documentation.
Frequently Asked Questions
Do I need to register my cosmetics facility with the FDA as a small maker?
Yes. Under MoCRA, all facilities that manufacture or process cosmetics for US consumers must register with the FDA — including small makers. If your average annual US cosmetics sales are under $1 million, you had an extended deadline of December 29, 2024 to register. If you haven't done so yet, registration is free through the FDA's Cosmetics Direct portal and should be completed as soon as possible.
What is MoCRA and why does it matter for handmade cosmetics makers?
MoCRA — the Modernization of Cosmetics Regulation Act — was signed into law in December 2022 and is the most significant update to US cosmetics law in over 80 years. It introduced mandatory facility registration, product listing, GMP compliance, and serious adverse event reporting for all cosmetics businesses, including small makers. If you started your handmade cosmetics business before 2023, your practices likely predate these requirements and may need updating.
What is serious adverse event reporting and does it apply to my small business?
Yes — serious adverse event reporting applies to all cosmetics businesses regardless of size, with no small business exemption. If a customer reports a serious health event linked to one of your products (hospitalisation, serious injury, persistent disability, or death), you must report it to the FDA within 15 business days. You're also required to keep records of all adverse event reports — serious or not — for six years. Craftybase's batch tracking features can help you maintain the production records you'd need to respond to such an event.
What's the difference between a soap and a cosmetic under FDA rules?
Under FDA rules, true soap is made primarily from alkali salts of fatty acids and makes only cleaning claims — it's regulated by the CPSC, not FDA. If your bar product also claims to "moisturise", "exfoliate", or "soften skin", it crosses into cosmetic territory and falls under FDA jurisdiction. The claims on your label determine the category, so it's worth reviewing your product descriptions carefully — especially if you sell on Etsy or your own website where label copy can drift from what's on the physical product.
Does Craftybase help with FDA cosmetics compliance record-keeping?
Craftybase is designed specifically for small-batch makers and supports the kind of record-keeping that MoCRA compliance requires. With cosmetic manufacturing software, you can track batch numbers, ingredient lots, quantities used, and production dates — giving you the traceability trail you'd need for a serious adverse event investigation or GMP audit. It's not a substitute for legal compliance advice, but it gives you a reliable paper trail that a spreadsheet simply can't provide at scale.
