FDA cosmetic regulations and MoCRA requirements explained
FDA cosmetic regulations cover safety, labeling and ingredients. MoCRA adds safety records, adverse-event reporting and registration and listing duties.
FDA cosmetic regulations cover safety, ingredients and labeling, with further duties under the Modernization of Cosmetics Regulation Act (MoCRA). Cosmetics generally need no FDA premarket approval, except for color additives. Companies must still meet applicable requirements before selling them. FDA explains the distinction between regulation and approval.
The federal framework includes the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. MoCRA added safety records, serious-adverse-event reporting and, subject to exemptions, mandatory facility registration and product listing. A registration or listing number is not FDA approval. FDA's registration and listing guidance makes that point explicit.
What is considered a cosmetic?
Intended use determines whether a product is a cosmetic, a drug or both. Cosmetics cleanse, beautify, promote attractiveness or alter appearance. Claims to treat or prevent disease, or affect body structure or function, can make a product a drug. The cosmetic definition excludes soap as legally defined, not everything sold as soap. See FDA's classification explanation.
Fluoride toothpaste, antidandruff shampoo, sunscreen preparations and antiperspirant deodorants can be both cosmetics and drugs. A cosmetic label review alone is therefore insufficient for these products. FDA identifies these examples in its labeling requirements summary.
Start a compliance review with intended use and claims, not the product's position beside makeup on a shelf.
How 21 CFR Parts 700–740 fit together
The cosmetics provisions in Title 21 remain useful, but they must be read with the newer statutory duties. In particular, the old voluntary registration provisions do not describe today's MoCRA registration system.
| Part | Main subject | What to watch |
|---|---|---|
| 700 | General requirements, particular products and ingredient restrictions | This is not a general MoCRA GMP rule. |
| 701 | Cosmetic labeling | Read it with newer statutory labeling duties. |
| 710 | Legacy voluntary establishment registration | Do not use it as the current mandatory registration route. |
| 720 | Legacy voluntary ingredient-composition filings | These filings are not MoCRA product listings. |
| 740 | Warning statements | A safety warning does not replace safety substantiation. |
Parts 710 and 720 still appear in the eCFR, which can make the registration route confusing. FDA stopped accepting Voluntary Cosmetic Registration Program submissions in March 2023. Use the current registration and listing process instead, as explained on FDA's guidance page.
Safety and ingredient compliance
The lack of general premarket approval does not establish that a formula is safe. Review ingredient restrictions and color-additive authorizations against the intended use. FDA's authority overview explains this exception to the general approval position.
MoCRA places the safety-substantiation duty on the responsible person. That person must ensure and maintain records supporting adequate substantiation of safety. The evidence must support reasonable certainty of safety in the judgment of qualified experts. The duty does not prescribe one universal testing battery or require animal testing. See the safety-substantiation statute and FDA's MoCRA overview.
Keep the supporting evidence. A warning that safety has not been determined is not a substitute for meeting this duty.
FDA cosmetic labeling requirements
A label review should cover the package layout as well as the wording. Under 21 CFR Part 701:
- Product identity and net quantity belong on the principal display panel.
- The name and place of business and an ingredient declaration are core requirements.
- Required information must be prominent and conspicuous.
- English is generally required. Foreign-language representations can trigger translation requirements.
Ingredients generally appear in descending order of predominance. Exceptions apply to ingredients present at 1% or less and to color additives. Part 701 also permits collective "fragrance" and "flavor" declarations, subject to applicable law.
For net quantity, don't rely on older summaries that describe metric units as optional. The Fair Packaging and Labeling Act generally requires both US customary and SI metric units, subject to exceptions.
MoCRA also requires a domestic address, domestic telephone number or electronic contact information through which adverse-event reports can be received. These are alternatives, not three cumulative requirements. This provision took effect on December 29, 2024. Professional-use cosmetics also have statutory labeling requirements. They do not receive a blanket labeling exemption. See section 609.
Warnings depend on the product and hazard. Part 740 requires warnings when necessary or appropriate to prevent a health hazard and contains product-specific provisions. Do not apply one standard warning to every cosmetic.
Who handles MoCRA duties?
The responsible person is the manufacturer, packer or distributor whose name appears on the label. That is not automatically the contract manufacturer. FDA's MoCRA overview uses this definition when describing the new duties.
Facility registration and product listing
For covered facilities, owners or operators handle registration and renew it biennially. Specified changes to registration information must be notified within 60 days. Foreign facilities must include a US agent contact. These requirements appear in the registration statute.
The responsible person submits, or ensures submission of, product listings, including ingredients. Listing updates are annual. The registration and listing statute generally requires new products to be listed within 120 days of marketing in interstate commerce. Facility renewal follows the initial registration date, rather than one universal calendar-year deadline. Check FDA's current registration and listing page when setting the renewal schedule.
Keep these schedules separate. A facility's biennial renewal does not replace the annual product-listing update.
Serious-adverse-event reporting
The responsible person must report serious adverse events to FDA within 15 business days of receipt, with a copy of the label. New and material medical information received within one year of the initial FDA report must also be submitted. The deadline is again 15 business days from receipt. Section 605 sets these requirements.
Under section 605, general adverse-event record retention is six years, or three years for qualifying small businesses. Assign responsibility for receiving reports and tracking deadlines. Don't leave the label contact as an unmonitored inbox.
MoCRA also gives FDA records-access, registration-suspension and conditional mandatory-recall powers. The recall authority includes a serious-harm threshold and an opportunity for voluntary recall. It does not mean FDA orders every cosmetic recall. See FDA's description of its MoCRA powers.
Small-business exemptions have limits
A qualifying small business can be exempt from the GMP and registration/listing provisions. It is not exempt from MoCRA as a whole. Safety, adverse-event and applicable labeling duties still matter. The small-business provision defines the limits.
The sales test uses average gross annual US cosmetic-product sales over the previous three years. Those sales must be below $1 million, adjusted for inflation. Do not use the unadjusted figure as a current eligibility threshold.
The exemption excludes specified products that regularly contact the eye's mucous membrane, injected products and internal-use products. It also excludes certain appearance-altering products lasting over 24 hours where consumer removal is not part of customary use. The eye provision does not cover every eye-area cosmetic. Review both sales and product eligibility before claiming an exemption.
Check rulemaking before using a new compliance date
MoCRA requires rulemaking on cosmetic GMP, fragrance-allergen labeling and talc asbestos testing. A statutory rulemaking deadline is not a manufacturer's compliance deadline. For GMP, the statute sets a final-rule publication deadline three years after December 29, 2022. Check the GMP statute alongside the rule itself.
For fragrance allergens, the mandate alone does not establish an operative list, thresholds or compliance dates. Consult FDA's implementation updates and the final rule before applying a new requirement. Do the same before setting a cosmetic GMP compliance date.
FDA withdrew its December 2024 talc-testing proposal in November 2025. Do not treat that proposal's methods as binding requirements. FDA records the withdrawal in its cosmetics news and events.
A practical cosmetic compliance review
Use this checklist to organize the federal review, not as a complete legal audit:
- Classify the product using intended use and claims.
- Review ingredient restrictions and authorized color-additive uses.
- Maintain safety-substantiation records.
- Check label content, placement, units and adverse-event contact details.
- Assess registration and listing duties, including any claimed exemption.
- Assign adverse-event reporting and record-retention responsibilities.
RegAffairs AI's answer on how FDA regulates cosmetics provides a source-linked starting point for this question.
Keep the scope of that review clear: this guide covers federal cosmetic requirements, not a complete state-law clearance.