The short answer
Oral care is one of the clearest cosmetic-or-drug splits in US law. Cleaning and freshening = cosmetic. Fluoride or anti-cavity claims = drug as well. Get this right before you print a single tube.
| Requirement | What it means | Who |
|---|---|---|
| Facility registration (MoCRA) | Facilities that manufacture or process cosmetics for the US register with FDA and renew every two years | The manufacturing facility |
| Product listing | Each product is listed with its ingredients, and updated every year | The Responsible Person |
| Label | English label: identity, net quantity, ingredients in descending order, name and place of business, warnings, and a contact for adverse event reports | The brand |
| Cosmetic or OTC drug? | Fluoride or anti-cavity claims add drug registration, listing (NDC) and Drug Facts | The brand / manufacturer |
| Safety substantiation | Records showing the product is safe as used | The Responsible Person |
| Adverse event reporting | Serious adverse events reported to FDA within 15 business days | The Responsible Person |
Cosmetic or drug?
| Product / claim | Status | What you need |
|---|---|---|
| Cleans teeth, freshens breath | Cosmetic | MoCRA registration and listing; cosmetic label |
| Fluoride / prevents cavities | Cosmetic + OTC drug | Also drug establishment registration, drug listing with NDC, Drug Facts, OTC monograph compliance |
| Treats gum disease or sensitivity | Drug | Drug requirements for that claim |
| Mouthwash for fresh breath | Cosmetic | MoCRA steps |
FDA gives fluoride toothpaste as a standard example of a product that is both a cosmetic and a drug. Even without words like “anti-cavity”, a well-known therapeutic ingredient such as fluoride can establish drug use.
What the drug route adds
- OTC monograph compliance (or an approved application) for the active ingredient and claims.
- Drug establishment registration and drug listing with an NDC.
- Drug Facts label, with active ingredients listed first and the cosmetic ingredients as inactive ingredients.
- Drug manufacturing rules (current good manufacturing practice for drugs).
Example
An oral care brand in Japan sells two US products. Its fluoride-free “fresh mint” toothpaste tablets are cosmetics — registered and listed under MoCRA. Its fluoride toothpaste is an OTC drug: made in a registered drug establishment, listed with an NDC, and labeled with Drug Facts showing sodium fluoride as the active ingredient.
What FDA does — and does not do — for cosmetics
FDA does not approve cosmetic products or their labels before they are sold (color additives are the exception). Registration and listing are not an approval, so never write “FDA approved” or “FDA certified” on a cosmetic label or website. Under MoCRA, the brand carries the responsibility: it must be able to show the product is safe as used, and FDA can inspect records, ask for safety information and, in serious cases, suspend a facility's registration or order a recall.
At the US border, FDA reviews imported cosmetics and can detain a shipment that appears adulterated or misbranded — for example a wrong or missing English label, an unapproved color, a prohibited ingredient or drug claims. Detained goods must be brought into compliance, exported or destroyed, so it pays to fix problems before the first shipment.
Small businesses: what MoCRA exempts
MoCRA exempts certain small businesses from facility registration, product listing and GMP. The exemption does not cover products that regularly touch the eye's mucous membrane, injected products, products for internal use, or products meant to change appearance for more than 24 hours. Labeling, safety substantiation and adverse event reporting are not on the exempt list — and many US retailers and marketplaces ask for registration and listing anyway.
Step by step: selling your oral care products in the US
- 1Decide: cosmetic, drug or bothYour claims and ingredients decide it. A drug needs drug registration, listing and Drug Facts labeling.
- 2Register the manufacturing facilityUnder MoCRA, and renew every two years. Foreign facilities name a U.S. Agent.
- 3List every productThe Responsible Person lists each product with its ingredients and updates the listing every year.
- 4Make the label US-readyEnglish text, ingredient list, warnings, contact for adverse events — and the product-specific points above.
- 5Keep safety records and an adverse event processSafety substantiation on file; serious adverse events reported within 15 business days.
Checklist
- Decide cosmetic or drug for each product, based on ingredients and claims
- Cosmetics: MoCRA registration, listing, cosmetic label
- Fluoride / anti-cavity: drug registration, listing (NDC), Drug Facts, monograph compliance
- Whitening and gum claims reviewed
- Safety records and adverse event process in place
Tell us your products — we send your MoCRA and FDA requirements in writing, free.
Frequently asked questions
Is toothpaste a cosmetic or a drug in the US?
A toothpaste that only cleans teeth and freshens breath is a cosmetic. Fluoride toothpaste, or any toothpaste claiming to prevent cavities, is both a cosmetic and a drug and must meet drug requirements too.
What does a fluoride toothpaste need?
As an OTC drug, it must follow the applicable OTC monograph (or have an approved application), be made in a registered drug establishment, be listed with FDA with an NDC, and carry Drug Facts labeling with fluoride as the active ingredient.
Is a fluoride-free toothpaste tablet a cosmetic?
It can be, if it makes only cosmetic claims (cleaning, freshening) and contains no active drug ingredient. Claims like “prevents cavities” or “treats gum disease” would make it a drug.
Is mouthwash a cosmetic?
A mouthwash for fresh breath only is a cosmetic. Claims to kill germs that cause gum disease, prevent cavities or treat a condition make it a drug.
Who is the Responsible Person under MoCRA?
The manufacturer, packer or distributor whose name appears on the label. The Responsible Person lists the products, keeps safety records and reports serious adverse events to FDA within 15 business days.
Are small cosmetic businesses exempt from MoCRA?
Certain small businesses are exempt from facility registration, product listing and GMP — but not for products that touch the eye’s mucous membrane, injected products, products for internal use or products that change appearance for more than 24 hours. Labeling, safety records and adverse event reporting still apply.
Sources
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (content current as of Oct 29, 2026)
- FDA — Summary of Cosmetics Labeling Requirements
- FDA — Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.