Quick answer: the FDA does not issue a licence to sell skincare — but since MoCRA took effect, “no licence” no longer means “no obligations.” The Modernization of Cosmetics Regulation Act of 2022 introduced mandatory facility registration, mandatory product listing, safety substantiation, adverse event reporting, and — for the first time — mandatory recall powers. Most people selling from home will fall under the small business exemption, but that exemption is narrower than it sounds, and it does not exempt you from everything.
Jurisdiction: this article covers the United States. If you are selling into the EU or UK, those systems work differently — both require product notification before sale and a designated Responsible Person, and neither is covered here. Get local guidance for those markets.
What Changed: MoCRA
For decades, US cosmetics were among the most lightly regulated consumer products. Advice written before 2023 — including the earlier version of this article — reflected that world, and much of it is now wrong.
The Modernization of Cosmetics Regulation Act of 2022 was signed into law on 29 December 2022 as part of the Consolidated Appropriations Act, 2023. It added to the FD&C Act:
- Mandatory facility registration. Anyone who owns or operates a facility manufacturing or processing cosmetics for US distribution must register it with the FDA, update within 60 days of any change, and renew every two years.
- Mandatory product listing. The “responsible person” — the entity named on the product label — must submit an annual listing for each product, including its ingredients.
- Safety substantiation. You must hold records adequately supporting that your product is safe.
- Serious adverse event reporting. Reports must be submitted to the FDA within defined timeframes, and records retained.
- Mandatory recall authority. The FDA can now order a recall where a company does not act voluntarily on an adulterated or unsafe product.
- Records access and expanded labeling requirements.
Registration and listing are handled through the FDA’s electronic portal, Cosmetics Direct, with paper forms available as an alternative.
The VCRP no longer exists
Older guides — this one included — recommended voluntarily registering under the Voluntary Cosmetic Registration Program. The FDA stopped accepting VCRP submissions on 27 March 2023. The programme is retired, information previously submitted to it was not carried over, and a past VCRP submission does nothing for MoCRA compliance. If you registered under VCRP years ago, treat that as void.
The Small Business Exemption — and Its Limits
This is the part that actually matters if you are making products at your kitchen table.
MoCRA exempts small businesses — broadly, those whose average gross annual sales in cosmetics over the previous three years fall below one million dollars — from facility registration, product listing, and good manufacturing practice requirements. Most home-based sellers will qualify.
But the exemption does not cover everything. Even as an exempt small business you remain subject to:
- Safety substantiation — you still need records supporting that your product is safe
- Serious adverse event reporting
- Labeling requirements
- The long-standing prohibitions on adulterated and misbranded products
And the exemption is lost entirely for certain product types, regardless of how small your business is. It does not apply to products that:
- regularly come into contact with the mucous membrane of the eye in normal use
- are injected
- are intended for internal use
- are intended to alter appearance for more than 24 hours, where removal by the consumer is not part of normal use
An eye cream or an eyeliner can therefore pull a very small operation into full registration and listing. Check your product category before assuming you are exempt.
Cosmetic or Drug? The Line That Catches People Out
Under the FD&C Act, a product is a cosmetic if it is intended for cleansing, beautifying, promoting attractiveness, or altering appearance. It becomes a drug if it is intended to treat or prevent disease, or to affect the structure or function of the body.
Crucially, intent is established by your marketing claims. The same jar of cream sold as “hydrating and softening” is a cosmetic; sold as “treats eczema” or “reduces inflammation” it becomes an unapproved drug — a far heavier regulatory burden, and the most common way small skincare brands land in trouble. Claims made on your website, your packaging, and your social media all count.
Sunscreens are regulated as over-the-counter drugs in the US, not cosmetics. Do not add SPF claims to a homemade product.
What the FDA Still Does Not Do
Some of the older picture remains accurate, and it is worth being clear about:
- There is no FDA licence for selling cosmetics. Registration is not a licence, and it is not approval.
- The FDA does not approve cosmetic products or ingredients, with the exception of colour additives.
- There is no mandated pre-market testing regime for cosmetics. The obligation is that your product is safe and honestly labeled, not that a particular test was run.
- Responsibility runs down the chain. Manufacturers, distributors and retailers all carry accountability for products not being adulterated or misbranded.
The Licences You Probably Do Need
People asking “do I need a licence” usually mean the whole picture, not just the FDA. The FDA is the part that does not require one. Everything else might.
- A general business licence from your city or county, in most jurisdictions.
- A sales tax permit from your state, if it collects sales tax.
- Home occupation permits and zoning clearance — many residential areas restrict manufacturing at home, and this catches people out more often than anything federal.
- State-level cosmetic manufacturing rules, which vary and in some states are meaningful.
- Product liability insurance — not a legal requirement in most cases, but most marketplaces and retailers will ask for it.
Note that MoCRA preempts certain state laws specifically on registration, listing, GMP, records, recalls, adverse event reporting and safety substantiation — but not on business licensing, zoning or tax, which remain entirely local.
What We Corrected on This Page
The previous version described the pre-MoCRA regime as current. Specifically:
- “The FDA does not have the power to recall any cosmetics from the market.” No longer true. MoCRA gave the FDA mandatory recall authority.
- “It is advisable to voluntarily register under the FDA’s Voluntary Cosmetic Registration Program (VCRP).” The VCRP was discontinued in March 2023. This was advice to use a programme that no longer exists.
- “It is not required of any cosmetic company to register or share their product formulation.” Registration and product listing are now mandatory for businesses that do not qualify for the small business exemption.
- A quotation attributed to a named industry figure, whose citation linked to one of our own product review articles. We could not verify it. Removed.
- A claim that cosmetic side effects extend to “severe cases that may lead to cancer”, sitting on a link that pointed nowhere. Unsupported and alarmist. Removed.
- No jurisdiction was stated anywhere on a page giving regulatory guidance, despite describing US federal law throughout. Now stated at the top.
Frequently Asked Questions
No — the FDA does not issue a licence for selling cosmetics, and it never has. But since the Modernization of Cosmetics Regulation Act of 2022, the absence of a licence no longer means the absence of obligations. Facility registration and product listing are now mandatory for businesses that do not qualify for the small business exemption, and safety substantiation, adverse event reporting and labeling rules apply regardless of size.
Businesses whose average gross annual cosmetics sales over the previous three years fall below roughly one million dollars are exempt from facility registration, product listing and good manufacturing practice requirements. Most home-based sellers qualify. The exemption does not remove safety substantiation, adverse event reporting or labeling obligations, and it does not apply at all to products that contact the mucous membrane of the eye, are injected, are for internal use, or alter appearance for more than 24 hours without consumer removal.
No. The FDA stopped accepting submissions to the Voluntary Cosmetic Registration Program on 27 March 2023, and the programme has been retired. Information previously submitted to it was not transferred to the new system, and a past VCRP submission does not count towards MoCRA compliance. Registration and listing now go through the FDA’s Cosmetics Direct portal.
When its intended use is to treat or prevent disease, or to affect the structure or function of the body — and intent is judged largely by your marketing claims. A cream sold as hydrating is a cosmetic; the same cream sold as treating eczema or reducing inflammation is an unapproved drug. Claims on your website, packaging and social media all count. Sunscreens are regulated as over-the-counter drugs in the US, so SPF claims should not be added to a homemade product.
Yes, since MoCRA. Previously recalls were voluntary and the FDA could only request one. The agency now has mandatory recall authority where a responsible person does not act voluntarily on a product it determines to be adulterated or misbranded and likely to cause serious harm. Any guide still stating that the FDA cannot order a cosmetics recall was written before 2023.
Usually a general business licence from your city or county, a sales tax permit if your state collects sales tax, and zoning or home occupation clearance — residential areas often restrict manufacturing at home, and that catches people out more often than anything federal does. Some states have their own cosmetic manufacturing rules. Product liability insurance is rarely a legal requirement but most marketplaces and retailers will ask for it.
Sources
- FDA — Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.
- FDA — Voluntary Cosmetic Registration Program (discontinued).
- Congressional Research Service — FDA Regulation of Cosmetics and Personal Care Products Under MoCRA.
Last updated: August 2026. This is general information, not legal advice, and it has not been reviewed by a lawyer. Regulations change and enforcement dates shift — verify current requirements directly with the FDA and with your state and local authorities, and consult a regulatory attorney before launching a product.
