If you manufacture or sell cosmetics outside the United States and you’re eyeing the American market for the first time, the rules can feel like a maze. But, importing cosmetics into the U.S. is more straightforward than importing a drug or medical device, because the FDA does not pre-approve cosmetic products before they go on sale. However, “no premarket approval” doesn’t mean “no rules.” Since the Modernization of Cosmetics Regulation Act (MoCRA) took effect, foreign cosmetics companies have real, enforceable compliance steps to complete before a shipment ever reaches a U.S. port.
This guide walks through the basics: what counts as a cosmetic under U.S. law, what doesn’t need FDA oversight at all, what MoCRA actually requires of you, and how a shipment moves through customs. It’s written for someone doing this for the first time, not for a regulatory specialist.
What Counts as a “Cosmetic” Under FDA Law
The FDA’s definition is broader than most people expect. A cosmetic is any article intended to be rubbed, poured, sprinkled, sprayed on, or otherwise applied to the human body to cleanse, beautify, promote attractiveness, or alter appearance. In practice, that covers makeup, skincare creams and serums, shampoo and conditioner, perfume and cologne, nail polish, hair dye, and most deodorants.
Cosmetics fall under FDA’s Center for Food Safety and Applied Nutrition (CFSAN), the same center that oversees food. That matters because cosmetics are not regulated the way drugs or medical devices are. There is no FDA “approval” stamp for a cosmetic formula, no clinical trial requirement, and no pre-market review of your product before it launches, with one notable exception covered below.
When a “Cosmetic” Is Actually a Drug
This is the most common point of confusion for first-time exporters, and it has nothing to do with the ingredients. It’s about the claims on your label and marketing.
If your product simply cleanses or beautifies, it’s a cosmetic. If it claims to treat, prevent, mitigate, or cure a condition, or to change the body’s structure or function, it’s legally a drug, even if it looks and sells like a cosmetic. Common examples that cross the line: sunscreen (an SPF claim makes it a drug), antiperspirant (the active ingredient that stops sweat is a drug ingredient, while a deodorant that only masks odor stays a cosmetic), anti-dandruff shampoo, acne treatments, and any anti-aging product claiming to repair or rebuild skin rather than just improve its appearance.
Products that make both kinds of claims, like a moisturizer with SPF, are regulated as both a cosmetic and a drug at once, which means the stricter drug rules (separate FDA drug facility registration, OTC monograph compliance, an NDC listing) apply on top of the cosmetic ones. If your label makes a therapeutic claim, get a regulatory read on it before you build your import plan. It changes the entire compliance path.
What Doesn’t Require FDA Cosmetic Oversight
Not everything that touches skin is FDA’s problem. The most common exemption is true soap. The FDA’s definition is narrow and specific: the product qualifies as soap, and falls outside FDA’s cosmetic rules, only if (1) the bulk of its cleansing ingredients are alkali salts of fatty acids, (2) its detergent action comes from those fatty-acid compounds, and (3) it’s labeled, sold, and marketed only as soap, with no claims about moisturizing, deodorizing, or otherwise beautifying the skin. Products that pass this test are instead regulated by the Consumer Product Safety Commission (CPSC) under general consumer product safety law, not by the FDA.
The catch: the moment a soap label adds a cosmetic claim (“moisturizing,” “softens skin,” “leaves you smelling fresh”), it stops being soap in FDA’s eyes and becomes a cosmetic, with all the obligations described below. A lot of handmade and artisanal soap brands trip over this without realizing it.
Beyond soap, items like makeup applicators, brushes, and similar tools generally aren’t cosmetics themselves (though they may fall under other consumer product rules), and anything with zero cosmetic or drug claim, marketed purely as a household or industrial product, sits outside FDA’s cosmetic authority entirely. When in doubt, the test is always the same: what does the label say the product does?
The Core MoCRA Requirements
MoCRA, signed into law in December 2022, gave FDA real authority over cosmetics for the first time. If your product is a cosmetic distributed in the U.S., here’s what you need in place:
Facility registration. Every facility that manufactures or processes cosmetics for the U.S. market must register with FDA through the Cosmetics Direct electronic portal and renew that registration every two years.
Product listing. The Responsible Person (defined below) must list each individual product with FDA, including its ingredients, and update that listing every year. Registration and listing run on different clocks: registration is biennial, listing is annual. Don’t conflate the two.
A designated Responsible Person. The Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label, and they carry the legal accountability for product safety, adverse event reporting, and keeping the product listing current. A foreign company can serve as its own Responsible Person; U.S. residency isn’t required for that role.
A U.S. Agent for foreign facilities. This is a separate role from the Responsible Person, not an interchangeable one. If your manufacturing facility is located outside the U.S., you must designate a U.S. Agent to serve as FDA’s point of contact for facility-related communication. The Responsible Person owns product compliance; the U.S. Agent is FDA’s liaison to the facility. Many companies use the same provider for both, but they are legally distinct roles with distinct obligations.
Safety substantiation. The Responsible Person must maintain records that support a reasonable basis for concluding the product is safe under its labeled or customary use, available for FDA to review.
Adverse event recordkeeping and reporting. Serious adverse events tied to a product must be reported to FDA within 15 business days, and records must be kept for six years (three years for small businesses).
Mandatory recall authority. For the first time, FDA can order a mandatory recall of a cosmetic it determines poses a reasonable probability of harm, rather than relying solely on voluntary recalls.
Two related rules are still in progress as of mid-2026 and worth watching rather than acting on yet: a fragrance allergen disclosure rule (which would require naming specific allergens individually instead of grouping them under “fragrance”) and cosmetic-specific Good Manufacturing Practice (GMP) regulations. Neither is final yet, but both signal where FDA is heading, so building documentation and ingredient transparency into your process now will save rework later.
Reach out to us if you need further clarification or would like to avail us for any of these services.
Premarket Approval: The One Exception
Cosmetics as a category don’t need FDA approval before they’re sold, but color additives are the exception. Other than coal-tar hair dyes, every color additive used in a cosmetic must already be approved by FDA for that specific use, and many require batch certification for purity. Before you finalize a formula bound for the U.S., check your colorants against FDA’s approved list. This is the one place where “cosmetics don’t need premarket approval” has a real asterisk.
A small number of ingredients are also outright prohibited or restricted in any quantity, including bithionol, chloroflurocarbon propellants, certain halogenated salicylanilides, and methylene chloride, with a few others like mercury compounds and hexachlorophene allowed only under tight restrictions. It’s a short list, but worth checking your formula against it early.
Labeling Rules You Can’t Skip
Every cosmetic sold in the U.S. needs a label that’s in English, lists ingredients by their INCI names in descending order of concentration, states the net quantity of contents, names the Responsible Person, and includes any required warning statements for the product type. For imported goods specifically, customs paperwork has its own separate requirement to mark the country of origin on the product or packaging. That’s a U.S. Customs and Border Protection (CBP) requirement under customs law, not an FDA cosmetic labeling rule, so it sits alongside your FDA label content rather than inside it.
How a Shipment Actually Moves Through Customs
Once your product, facility registration, and listing are squared away, the physical import works like this: your customs broker or you, as the importer, files an entry with U.S. Customs and Border Protection. CBP electronically flags FDA-regulated products and routes the entry data to FDA’s screening systems. If the registration and listing are current and the entry data is accurate and complete, most shipments clear electronically without a manual hold. If something doesn’t match, or registration and listing are missing, CBP can detain the shipment for FDA to examine, sample, or refuse.
Unlike food imports, cosmetics don’t require a separate Prior Notice filing before the shipment arrives. The main pre-arrival work for cosmetics is getting your facility registration and product listing right well in advance, not a per-shipment notice.
A product that isn’t properly registered or listed is treated by FDA as misbranded or adulterated, the same legal category used for genuinely unsafe products, which is exactly why a paperwork gap can hold a shipment at the border just as effectively as a safety problem can.
A Simple First-Time Checklist
- Confirm your product is actually a cosmetic under FDA’s definition, not a drug in disguise based on its claims.
- Check whether it qualifies for the soap exemption; if it makes any cosmetic claim, it doesn’t.
- Register your manufacturing facility with FDA through Cosmetics Direct.
- List each product with FDA and update that listing annually.
- Designate a Responsible Person and, if your facility is outside the U.S., a separate U.S. Agent.
- Build and keep a safety substantiation file for each product.
- Check your formula against FDA’s approved color additive list and prohibited/restricted ingredients list.
- Finalize English-language labeling with INCI ingredient names, net quantity, and Responsible Person information.
- Confirm country-of-origin marking for customs, separate from your FDA label content.
- File your customs entry with accurate, complete data to avoid a manual hold.
Getting Help
None of this requires a law degree, but it does require getting the Responsible Person and U.S. Agent roles right, keeping registration and listing on their separate two-year and one-year clocks, and not assuming a product is exempt just because it’s gentle or natural. FDA Entry works with international manufacturers and importers as their U.S. Agent and compliance partner for exactly this process. If you’re preparing your first shipment, get in touch and we’ll walk through what your specific product needs before it ships.
Frequently Asked Questions
No. Cosmetics don’t go through FDA premarket approval, with one exception: color additives (other than coal-tar hair dyes) must already be FDA-approved for that use.
No. They’re separate, legally distinct roles. The Responsible Person is accountable for product safety and listing; the U.S. Agent is FDA’s point of contact for a foreign facility. The same company can fill both roles, but they aren’t interchangeable.
Facility registration renews every two years. Product listing updates annually. They run on different schedules, which is a common source of confusion.
Only if it meets FDA’s narrow definition of soap (mostly alkali salts of fatty acids, marketed only as soap) and makes no cosmetic claims like moisturizing or deodorizing. Add a cosmetic claim and it becomes a cosmetic.
No. Prior Notice is a food-import requirement. For cosmetics, the equivalent advance work is having your facility registration and product listing in place before the shipment arrives.
Ready to Bring Your Cosmetics to the U.S. Market?
Registration, listing, and labeling are easy to get wrong from a distance, and a single gap is enough to hold your shipment at the border. FDA Entry serves as the U.S. Agent and compliance partner for international cosmetics manufacturers and importers, managing facility registration, product listing, and FDA communication so your team can focus on the product, not the paperwork.