Are Cosmetics Regulated by the FDA? What Small Manufacturers Need to Know
Cosmetics don't get FDA approval before they're sold, but the FDA still regulates them. Here's what actually applies to your business: the soap-vs-cosmetic line, labeling, ingredient safety, and where MoCRA fits in.
If you make lip balm, lotion, serums, or any other beauty product and sell it to real customers, the FDA has some level of authority over your business. That surprises a lot of small manufacturers, who assume “FDA regulated” means the kind of pharmaceutical-style approval process built for companies with a dedicated compliance department.
Cosmetics don’t work that way. There’s no FDA application to file, no lab review, and no approval stamp before you can sell a product. That doesn’t mean you’re unregulated, though. It means the responsibility for safety and compliance sits with you, the manufacturer, from the day you start selling.
Then in December 2022, the enforcement side of that picture changed. The Modernization of Cosmetics Regulation Act (MoCRA) gave the FDA registration, listing, and recall powers it had never had before. We cover MoCRA in full in our MoCRA compliance guide; this post covers the more basic question underneath it: what the FDA actually regulates in cosmetics, and where your business fits in.
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What is the FDA?
The FDA is the US federal agency responsible for protecting public health by regulating the safety of food, drugs, medical devices, and cosmetics sold to consumers.
It operates under the Federal Food, Drug, and Cosmetic Act (FD&C Act). For most of its history, cosmetics have been the lightest-touch category the FDA oversees: no mandatory registration, no pre-market approval, and enforcement that mostly kicked in after something had already gone wrong. MoCRA changed the enforcement side of that in 2022, but the basic shape held: cosmetics are still the only major FDA-regulated product category that doesn’t require approval before it reaches a shelf.
Is Your Product a Soap or a Cosmetic?
Your product counts as soap only if it makes cleaning claims alone; claim anything about moisturising, exfoliating, or appearance, and it becomes a cosmetic instead.
This distinction decides which federal agency has authority over your product. True soap, made primarily from alkali salts of fatty acids, falls under the Consumer Product Safety Commission (CPSC), not the FDA. A cosmetic (intended to cleanse, beautify, or alter appearance) falls under FDA jurisdiction instead, covering moisturisers, lip products, body scrubs, shampoos, and most other bath and beauty items.
What decides the category isn’t your ingredients, it’s your claims. A bar made of nothing but saponified oils, labelled and sold purely as soap, sits with the CPSC. The same bar labelled “moisturising” or “gentle exfoliating” crosses into cosmetic territory, and FDA rules apply. If you make actual soap and want the full legal test for staying inside the exemption, we walk through it in our MoCRA guide.
What Did MoCRA Change for Cosmetics Businesses?
MoCRA, signed into law in December 2022, gave the FDA mandatory registration, product listing, and recall powers over cosmetics for the first time.
Before MoCRA, the FDA had almost no mandatory oversight of cosmetics: a company could sell products for years without the FDA ever knowing they existed. MoCRA introduced five obligations that now apply to most cosmetics businesses, small ones included:
- Facility registration: most facilities that manufacture or process cosmetics for US consumers now have to register with the FDA. There’s a small-business exemption for companies under $1 million in average annual US cosmetics sales over the past three years, though it’s narrower than it sounds; certain higher-risk product categories don’t qualify.
- Product listing: every cosmetic product sold in the US has to be listed with the FDA, including its ingredients, category, and manufacturing facility.
- Safety substantiation: you need documented evidence, not just an assumption, that your products are safe as formulated.
- Serious adverse event reporting: a serious health event linked to your product has to be reported to the FDA within 15 business days, with no small-business exemption.
- New labelling requirements: a way for customers to report problems, plus fragrance allergen disclosure once the FDA finalises that rule.
Good manufacturing practice (GMP) habits, consistent batch records, clean workspaces, documented processes, are worth building now regardless of your compliance deadline; they also make it much easier to scale without anything falling through the cracks. For more on that, see our good manufacturing practice guide and how to scale cosmetic manufacturing.
Deadlines, exact thresholds, and what “small business” means for each individual requirement are their own topic. We’ve worked through all of it in our full guide to MoCRA compliance for small cosmetic businesses. The rest of this post sticks to the FDA rules that existed before MoCRA and still apply regardless of it.
Can a Product Be Both a Cosmetic and a Drug?
Some products are regulated as both a cosmetic and a drug: anti-dandruff shampoo, SPF moisturiser, and teeth-whitening products are common examples.
That happens whenever a product both changes appearance and causes a physiological effect in the body. Antiperspirants fall into the same bucket, since preventing sweat is legally a drug function, not a cosmetic one.
Hybrid products have to comply with both sets of rules at once, which is a meaningfully higher bar than either category alone. If your labels or marketing use drug-type language (“treats,” “prevents,” “cures”), your product can end up regulated as a drug even if you built and priced it as a cosmetic. And there’s no middle category to duck into: the FD&C Act doesn’t recognise “cosmeceutical” as a legal term. A product is a drug, a cosmetic, or both.
Labeling a Product “Organic”
Using the word “organic” on a cosmetic label pulls in a second regulator. The FDA covers the cosmetic itself; the USDA’s National Organic Program (NOP) covers whether your agricultural ingredients actually qualify. If you want “organic” on the label, your formulation needs to meet USDA certification standards, a separate bar from general FDA cosmetics compliance.
USDA rules recognise four tiers, based on the percentage of certified organic ingredients by weight:
- 100% Organic: every ingredient is certified organic
- Organic: at least 95% organic ingredients
- Made with Organic [ingredients]: at least 70% organic ingredients
- Under 70% organic: no organic claim allowed on the main label, though certified ingredients can still be named in the ingredient list
None of this changes your baseline FDA obligations. An ingredient being natural or organic doesn’t make it automatically safe. You’re still on the hook for safety substantiation either way.
What Has to Be on Your Product Label
All cosmetics sold in the US have to comply with both the FD&C Act and the Fair Packaging and Labelling Act, whether you manufacture locally or overseas. At minimum, your label needs:
- Product identity: what the product actually is
- Net contents: weight or volume
- Name and address of the responsible person (the manufacturer, packer, or distributor)
- Ingredients listed in descending order of predominance
- Any required warnings
A false or misleading label makes a product “misbranded” in FDA terms, which opens the door to enforcement action regardless of whether the product itself is safe.
MoCRA added to this baseline. Labels increasingly need a way for customers to report a problem (phone, website, or address), the FDA is still finalising a rule on fragrance allergen disclosure, and ingredient names now have to follow standardised INCI terms rather than common names. Our MoCRA compliance guide covers all three in detail, since they sit on top of the baseline above rather than replacing it.
Proving Your Ingredients Are Safe
There’s no FDA pre-approval step before you launch a cosmetic. No agency reviews your formula and signs off before it reaches a shelf, which is exactly why “FDA approved” isn’t a real designation for cosmetics; the FDA itself is explicit that it doesn’t pre-approve them. What you do carry is legal responsibility: your product has to be safe under normal or reasonably foreseeable use, and you have to be able to show why.
MoCRA gave the FDA explicit authority to request the records that back that up. In practice, that means keeping:
- Supplier certificates of analysis for raw materials, whether that’s a carrier oil like squalane or a synthetic preservative
- Safety data sheets (SDS) for each ingredient
- Toxicological data on individual ingredients where it exists
- Results from any testing you’ve run or commissioned
- Batch and lot records tying each finished product back to the ingredients and quantities used
- Adverse event records, kept for six years regardless of severity
Pay closer attention here for complex formulations with several active ingredients, and for anything meant for sensitive skin, children, or use near the eyes. For the fuller substantiation checklist, see our MoCRA compliance guide.
Do FDA Rules Change If You Import or Export Cosmetics?
FDA rules apply to every cosmetic sold into the US regardless of where it’s made, and an exported product has to meet the destination country’s rules instead.
If you export, you’re working to the destination country’s regulations first, and they can differ substantially from FDA rules. The EU, for example, keeps a positive list of approved preservatives alongside a longer prohibited-ingredients list than the US uses.
An exported product avoids being “misbranded” under US law as long as it meets the destination country’s requirements, doesn’t conflict with that country’s laws, is labelled for export, and isn’t offered for sale in the US. Sell any of it back into the US later, and FDA rules apply in full.
Imports work in the other direction: every cosmetic entering the US market is subject to FDA requirements regardless of where it was made. If you import ingredients or finished products, confirm your suppliers can produce the same certificates of analysis and safety data you’d expect from a domestic supplier.
Frequently Asked Questions
Does the FDA approve cosmetics before they're sold?
No. Unlike drugs, cosmetics don't go through FDA premarket approval: there's no application, no review, and no approval stamp. The FDA is explicit that "FDA approved" isn't a real designation for cosmetics. Responsibility for safety sits with the manufacturer, you have to be able to show your product is safe for its intended use, and the FDA can take enforcement action after the fact if it isn't.
What's the difference between a soap and a cosmetic under FDA rules?
True soap is made mostly from saponified oils and makes only cleaning claims, which puts it under the CPSC, not the FDA. The moment a bar claims to moisturise, exfoliate, or soften skin, it becomes a cosmetic and FDA rules apply instead. The claims on your label decide the category, not the ingredients, so it's worth checking your product copy actually matches what's on the bottle or bar.
Does the FDA regulate small cosmetics businesses the same way as big brands?
Mostly, yes. Baseline FDA requirements around safe ingredients, accurate labelling, and reporting serious adverse events apply regardless of business size. MoCRA layered some size-based exceptions on top of that baseline, including a facility registration exemption for businesses under $1 million in average annual US cosmetics sales, though it's narrower than it sounds. Our MoCRA compliance guide covers the exact thresholds and exceptions.
Can a cosmetic also be regulated as a drug?
Yes, when a product both changes appearance and causes a physiological effect in the body. Anti-dandruff shampoo, SPF moisturiser, teeth-whitening products, and antiperspirants are common examples, each doing a cosmetic job and a drug job at once. Hybrid products have to meet both cosmetic and drug requirements, a meaningfully higher bar. Using drug-type claims like "treats" or "cures" on a cosmetic label can trigger drug regulation even if you never intended that.
Do I need special certification to label my product "organic"?
Yes, and it's separate from FDA cosmetics compliance. The FDA regulates the cosmetic itself, but the word "organic" pulls in the USDA's National Organic Program, which sets its own certification tiers based on the percentage of certified organic ingredients by weight. An ingredient being organic doesn't make it automatically safe, you still need the same safety substantiation the FDA expects for any other cosmetic ingredient.
Does Stocksmith help with FDA cosmetics compliance record-keeping?
Stocksmith isn't a compliance or legal product, but it handles the record-keeping FDA compliance depends on. Track batch numbers, ingredient lots, and production dates as part of your normal manufacturing workflow, so if a customer reports a reaction or the FDA asks a question, you can pull the full batch history in seconds instead of digging through spreadsheets and email.
What to Do Next
The FDA’s baseline cosmetics rules (safe ingredients, honest labels, no pre-market approval required) haven’t changed much in decades. What changed in 2022 is enforcement. MoCRA gave the FDA registration, listing, and recall powers it never had before, and small businesses aren’t exempt from most of it.
If you haven’t looked at your MoCRA obligations yet, our guide to MoCRA compliance walks through facility registration, product listing, and adverse event reporting step by step.
Either way, the recordkeeping underneath all of it, batch records, ingredient lots, supplier documentation, is the same work that makes a cosmetics business easier to run day to day, compliance aside. Stocksmith’s cosmetic inventory software and cosmetic manufacturing software track this as part of your normal production workflow: assign a lot number to a batch, record what went into it, and pull the full history the moment you need it.
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