Cosmetics Regulation — MoCRA and the Modernization of FDA Cosmetics Authority

For 85 years — from the Federal Food, Drug, and Cosmetic Act of 1938 until December 2022 — FDA had almost no authority to ensure that cosmetics were safe before they reached consumers. For comparison, FDA's drug approval authority — which requires rigorous premarket safety and efficacy demonstration — is described at FDA drug approval. For food labeling requirements under the same FDCA umbrella, see FDA food labeling. No ingredient approval, no facility registration, no mandatory adverse event reporting. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enacted as part of the Consolidated Appropriations Act of 2023, fundamentally changed this. MoCRA gave FDA its first meaningful cosmetics authority in nearly a century, requiring facility registration, product listing, safety substantiation, serious adverse event reporting, and (for the first time) mandatory recall authority. MoCRA applies to the entire $90+ billion U.S. cosmetics and personal care products market — covering shampoos, soaps, makeup, moisturizers, perfumes, nail products, deodorants, and thousands of other products used daily by virtually every American. The new requirements are being phased in through 2025–2027, so many are actively taking effect right now. Understanding MoCRA matters both for consumers trying to assess product safety and for the cosmetics industry navigating a compliance landscape that did not exist three years ago.

What Is a Cosmetic?

Under 21 U.S.C. § 321(i), a cosmetic is any article "intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance." This includes:

Skin care products (moisturizers, sunscreens at certain SPF levels, anti-aging creams)
Hair products (shampoos, conditioners, hair dyes, relaxers)
Makeup (foundation, lipstick, eyeshadow, mascara, blush)
Fragrances and perfumes
Nail polishes and nail care products
Deodorants (not antiperspirants, which are regulated as drugs)
Toothpaste (not cavity-prevention fluoride versions, which are drugs)
Baby products (lotions, oils, powders)

The drug/cosmetic line: Products that make drug claims — sunscreens (SPF), anti-dandruff shampoos (pyrithione zinc), fluoride toothpaste, antiperspirants — are regulated as both drugs and cosmetics, subject to FDA drug requirements as well as cosmetics requirements. This dual category is common and affects labeling, ingredient approval, and manufacturing standards.

Pre-MoCRA: The Regulatory Gap

Before MoCRA, FDA's cosmetics authority was strikingly minimal:

No premarket approval for cosmetic products or ingredients (except color additives)
No registration required for cosmetics manufacturers or facilities
No mandatory adverse event reporting
No mandatory recall authority — FDA could request a recall but could not order one
No requirement that manufacturers substantiate safety before marketing

The practical result: ingredients that were known or suspected to be harmful could remain in products indefinitely unless FDA could prove in court that a product was "adulterated" under the very limited pre-MoCRA standards. The European Union banned or restricted more than 1,300 cosmetic ingredients; FDA had restricted or banned fewer than 15.

MoCRA's Key Requirements

Facility Registration (21 U.S.C. § 364b)

All facilities that manufacture or process cosmetics for U.S. distribution must register with FDA
Registration must include: facility name, address, contact information, and a list of cosmetic product categories manufactured
Initial registration deadline: December 29, 2023
Renewal: every two years
Foreign facilities must also register; importers must certify that products come from registered facilities

Product Listing (21 U.S.C. § 364c)

Responsible persons (brand owners or U.S. importers) must list each cosmetic product with FDA
Listing must include: product name, applicable cosmetic category, list of ingredients, facility where manufactured
Deadline: December 29, 2023 (initial); updates within 180 days of any change
FDA will make the product listing publicly available, creating a searchable database of marketed cosmetics

Safety Substantiation (21 U.S.C. § 364a)

Responsible persons must ensure each product is safe for its intended use
Must maintain safety substantiation records (testing data, literature reviews, formulation data)
FDA can inspect these records; failure to maintain adequate substantiation is a violation
Does not require premarket submission to FDA — but records must be available if FDA requests them

Serious Adverse Event Reporting (21 U.S.C. § 364e)

Responsible persons must report serious adverse events associated with cosmetic use in the United States to FDA within 15 business days
"Serious adverse event" means: death, life-threatening event, inpatient hospitalization, significant disability, birth defect, or event requiring medical or surgical intervention to prevent permanent harm
Must submit MedWatch 3500A form with product information
Must maintain records of all adverse events (serious and non-serious) for 6 years

Mandatory Recall Authority (21 U.S.C. § 364k)

FDA now has explicit authority to order a mandatory recall of a cosmetic product that poses a reasonable probability of serious adverse health consequences
Before MoCRA, FDA could only request voluntary recalls; manufacturers could refuse
Recall authority makes enforcement meaningfully more effective

Fragrance Allergen Disclosure (21 U.S.C. § 364i)

MoCRA required FDA to propose a rule by June 29, 2024 and finalize by December 29, 2025 requiring disclosure of fragrance allergens on cosmetic labels; FDA missed both deadlines and as of early 2026 the rule has not been proposed
Fragrance is currently listed only as "fragrance" or "parfum" — a single ingredient that may represent dozens of chemical compounds, some known allergens
This requirement responds to a long-standing advocacy campaign by dermatologists and allergy organizations

Good Manufacturing Practice (GMP) (21 U.S.C. § 364d)

MoCRA required FDA to issue a proposed GMP rule by December 29, 2024 and a final rule by December 29, 2025; FDA missed both statutory deadlines and as of early 2026 has not yet issued the NPRM (the rule is now on the FDA Spring 2025 Unified Agenda's "Long-Term Actions" list with NPRM "to be determined")
Draft GMP guidance is expected to be based on international ISO standard 22716 (Cosmetics Good Manufacturing Practices)
Small businesses (under $1M annual net sales of cosmetics) are statutorily entitled to an extra year to comply with GMP requirements once the rule is issued

Small Business Exemptions

"Small businesses" with average annual gross sales of $1M or less (over 3 years) from cosmetics sold in the U.S. are exempt from registration, product listing, GMP, and recordkeeping requirements if they do not manufacture products for infants, children under 11, or "professional use only" products
Smaller exemption for businesses under $1M threshold that do manufacture those products: exempt from product listing only

Color Additives — Pre-MoCRA Approval

Even before MoCRA, color additives used in cosmetics required FDA approval. This is the one cosmetics ingredient category where premarket review exists:

Certified colors (synthetic dyes): must be batch-certified by FDA; approved under specific use conditions
Exempt colors (natural pigments): approved but not batch-certified
Color additives not on FDA's approved list cannot be used in cosmetics; using an unapproved color additive makes a product adulterated

This pre-existing approval framework for color additives is why the cosmetics industry already has some familiarity with FDA oversight — but it covers only a small subset of cosmetic ingredients.

Implementing Regulations

The FDA regulations implementing the cosmetics framework under the FD&C Act include 21 CFR Part 700 — Cosmetics General, and 21 CFR Part 740 — Cosmetic Product Warning Statements.

21 CFR Part 700 — Cosmetics: Prohibited Ingredients and Restrictions

Part 700 is the FDA's core list of substances that are categorically prohibited in cosmetics or subject to specific use restrictions. Using any of these substances makes a cosmetic product "adulterated" under the FD&C Act, triggering seizure and recall authority:

§ 700.11 — Bithionol: prohibited in cosmetics; a bacteriostatic agent formerly used in soaps and skin creams, banned after FDA found it causes photocontact sensitization (skin rashes triggered by light exposure after contact) — a severe and persistent allergic reaction that can render the individual sensitive to related compounds for life
§ 700.13 — Mercury compounds: prohibited in cosmetics except for trace amounts as a preservative in eye-area cosmetics (up to 65 ppm) where no effective mercury-free alternative exists; mercury is a neurotoxin absorbed through skin; products marketed as skin-lightening creams containing mercury as an active ingredient (a problem primarily with unlicensed imports) are adulterated
§ 700.14 — Vinyl chloride in aerosol propellants: prohibited as an aerosol propellant in cosmetics; vinyl chloride is a known human carcinogen (hepatic angiosarcoma); used historically in hairsprays before the ban; now prohibited entirely in consumer cosmetic aerosols
§ 700.15 — Halogenated salicylanilides: tribromsalan (TBS), dibromsalan, metabromsalan, and tetrachlorosalicylanilide (TCSA) are prohibited as cosmetic ingredients; these are strong photosensitizers — causing severe skin reactions in sunlight — that were previously used in soaps, deodorants, and skin creams
§ 700.16 — Zirconium-containing complexes in aerosol cosmetics: zirconium compounds (e.g., aluminum zirconium tetrachlorohydrex, common in aerosol antiperspirants) are prohibited in aerosol cosmetics intended to be inhaled; inhaled zirconium can cause granuloma formation in lung tissue; zirconium in non-aerosol products (roll-on or stick antiperspirants) is permitted
§ 700.18 — Chloroform: prohibited as an ingredient in cosmetics; chloroform was used as a fragrance ingredient and solvent before evidence of carcinogenicity (liver cancer in animal studies); products with residual chloroform from manufacturing (below action levels) are evaluated case by case, but intentional addition is prohibited
§ 700.19 — Methylene chloride: prohibited as an ingredient in cosmetics; formerly used in hair-waving products and aerosols; a probable human carcinogen with CNS effects from inhalation
§ 700.23 — Chlorofluorocarbon propellants: prohibited as aerosol propellants for environmental reasons (ozone depletion); aligned with the Montreal Protocol; cosmetic aerosols must use alternative propellants (hydrocarbons, dimethyl ether, compressed gases)
§ 700.27 — Use of prohibited cattle materials: prohibits use of prohibited cattle materials (brain, skull, trigeminal ganglia, spinal cord) in cosmetics to prevent transmission of bovine spongiform encephalopathy (BSE/mad cow disease) — relevant primarily for products using bovine-derived ingredients

The Part 700 prohibitions represent FDA's limited pre-MoCRA ingredient authority. Unlike drugs (which require premarket approval of each active ingredient), the historical cosmetics framework allowed any ingredient unless FDA could prove it caused harm and moved to prohibit it — a reactive rather than precautionary system. MoCRA's safety substantiation requirement adds prospective responsibility on manufacturers, but Part 700 remains the categorical floor: these specific substances are out regardless of safety claims.

21 CFR Part 740 — Cosmetic Product Warning Statements. Key provisions:

§ 740.1 — Establishment of warning statements: the label of a cosmetic product must bear a warning statement whenever necessary or appropriate to prevent a health hazard associated with the product; FDA may publish proposals to establish or amend required warnings on its own initiative or in response to petitions from interested parties
§ 740.10 — Safety substantiation warning: cosmetic products whose safety has not been adequately substantiated prior to marketing must bear the label statement: "Warning — The safety of this product has not been determined"; this is the regulatory mechanism that makes safety substantiation enforceable — failure to substantiate means either including the warning or withdrawing the product from market
§ 740.11 — Self-pressurized (aerosol) containers: all aerosol cosmetics must carry the warning "Warning — Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children"; products with hydrocarbon or halocarbon propellants require an additional inhalation warning ("Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal"); these warnings address the specific risks of aerosol cosmetics — eye injury from spray, explosion from incineration, and propellant inhalation
§ 740.12 — Feminine deodorant sprays: must carry a warning to spray at least 8 inches from skin, to avoid contact with broken, irritated, or itching skin, and to stop use if rash, irritation, or discomfort occurs; failure to warn with this specific language makes the product misbranded
§ 740.17 — Coal tar hair dye products: must include a patch test protocol warning and the statement "Caution — This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing eyelashes or eyebrows; to do so may cause blindness."
§ 740.18 — Feminine deodorant spray on products also bearing a drug claim: products that straddle the cosmetic/drug line must carry both the cosmetic warning under § 740.12 and any required OTC drug labeling

Under MoCRA, FDA's authority to require cosmetic warnings extends to the new facility registration and product listing requirements — companies that fail to adequately substantiate product safety now face both § 740.10 misbranding exposure and potential MoCRA enforcement. FDA may impose civil penalties for misbranded cosmetics under 21 U.S.C. § 333. The most commonly encountered Part 740 compliance issue for modern brands is the aerosol warning under § 740.11 — hairsprays, dry shampoos, body sprays, and setting sprays must all carry the full aerosol warning text even if the format requires very small type. Recent rulemakings: 88 FR 45067 (July 2023) — technical corrections; no substantive changes to warning statement requirements since the 1990s.

How It Affects You

If you use cosmetics and personal care products: MoCRA's product listing requirement (phased in since late 2023) means FDA will increasingly have a searchable database of cosmetics products and their ingredients. Once fully implemented, consumers will be able to search for specific products and see their ingredient lists. For now, the most practical resources for ingredient safety are EWG's Skin Deep database (ewg.org/skindeep) and the CosDNA database, which rate ingredients based on published safety data. Neither is an FDA resource, but both synthesize the available evidence. For fragrance sensitivity or allergies, the new fragrance allergen disclosure requirement (taking effect by December 2025) will make it easier to identify specific allergens in products once the FDA regulation is finalized.

If you have had a reaction to a cosmetic product: Report it to FDA's MedWatch (fda.gov/safety/medwatch). Under MoCRA, manufacturers must now report serious adverse events, but voluntary consumer reporting helps FDA identify patterns that may not surface through manufacturer-only reporting. If the reaction is serious — requiring medical care, involving your eyes, causing significant skin damage — see a dermatologist who can document the reaction and, if appropriate, conduct patch testing to identify the specific causative ingredient. Keep the product and its full ingredient list; this is essential for identifying the allergen or irritant.

If you work in the cosmetics industry: MoCRA compliance obligations are now in effect. Facility registration and product listing were due December 29, 2023. Safety substantiation records must be maintained and available for FDA inspection. Serious adverse event reporting (15-business-day timeline) requires an internal process for receiving, evaluating, and reporting consumer adverse event reports. Small businesses should verify whether they meet the $1M threshold for exemption — and note that the exemption does not apply to products intended for children under 11 or professional-use-only products. GMP regulations issued by FDA will require compliance by the applicable deadline; review draft GMP guidance at fda.gov/cosmetics.

If you are pregnant or buying products for infants: Products marketed for infants and young children are not exempt from MoCRA's facility registration and product listing requirements regardless of the seller's size, reflecting heightened safety concerns for these populations. Talc-based baby powder has been subject to significant litigation over asbestos contamination (a naturally-occurring contaminant in talc mining); several brands have reformulated to cornstarch-based alternatives. FDA has set action levels for asbestos in talc-containing cosmetics; check whether any talc-based products you use have been tested by the manufacturer and whether testing results are available.

The Drug/Cosmetic Boundary in Practice

Some of the most common consumer products straddle the drug/cosmetic line and face requirements from both frameworks:

Sunscreens: Regulated as OTC drugs; FDA sets SPF testing standards, requires specific active ingredient approvals, and sets labeling requirements (SPF rating, broad-spectrum designation, water resistance claims). FDA has proposed but not finalized updated sunscreen active ingredient safety classifications that would require additional data for some commonly-used chemical UV filters.
Anti-dandruff shampoos: OTC drug + cosmetic; active ingredient (pyrithione zinc, selenium sulfide, ketoconazole) subject to drug monograph
Antiperspirants: OTC drug (sweat reduction is a drug effect); deodorants without antiperspirant effect are cosmetics
Fluoride toothpaste: OTC drug (cavity prevention); non-fluoride toothpaste is cosmetic

Pending Regulations and Recent Developments

Fragrance allergen disclosure rule: MoCRA required FDA to propose this rule by June 2024 and finalize by December 2025; as of early 2026 the rule has been delayed and is still in pre-proposal stage (expected to mirror the EU fragrance allergen labeling list)
GMP regulations: FDA missed the statutory deadlines (proposed rule by Dec. 29, 2024; final rule by Dec. 29, 2025); as of early 2026 the proposed rule has not been issued and is on FDA's Long-Term Actions list, partly because EO 14192's "one-in, ten-out" framework has slowed new rulemaking
Asbestos in talc: FDA continues monitoring talc-containing cosmetics for asbestos contamination following testing that identified asbestos in some products; enforcement actions and voluntary reformulations ongoing
PFAS in cosmetics: FDA has not set specific limits on PFAS (per- and polyfluoroalkyl substances) in cosmetics; several states have enacted or are enacting state-level restrictions; advocacy groups have pushed for FDA action under MoCRA's safety substantiation authority
Hair straightening products: NIH research published in 2022 found an association between use of chemical hair straightening products and increased uterine cancer risk; FDA is reviewing the evidence and considering regulatory action under MoCRA's safety authority