Q.01

How does the FDA regulate cosmetics?

The FDA does not approve cosmetics or their ingredients before sale, with one exception: colour additives. Instead, the company named on the label must make sure the product is safe and correctly labeled, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's rules in 21 CFR Parts 700-740, and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA added mandatory facility registration, product listing, adverse event reporting, safety records, and FDA powers to access records and order recalls.

Approach: I read the current 21 CFR Parts 700, 701, 710, 720 and 740, the FDA's list of prohibited and restricted cosmetic ingredients, its colour additive status list and its MoCRA registration figures. I took the MoCRA duties from the FDA's own pages, because they are in the statute and not in those CFR parts.

1. Cosmetic, drug, or both

  • Definition: a cosmetic is an article "intended to be rubbed, poured, sprinkled, or sprayed on... for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FD&C Act sec. 201(i)). A product intended to treat or prevent disease, or to affect the structure or function of the body, is a drug (sec. 201(g)(1)) (FDA).
  • Intended use decides: this comes from the claims made, how consumers see the product, and its ingredients. Antidandruff shampoo, fluoride toothpaste and antiperspirants are both cosmetics and drugs, and must meet both sets of rules. Soap that meets FDA's narrow definition is regulated by the Consumer Product Safety Commission (CPSC), not FDA (FDA).
  • In the CFR: a cosmetic that is also a drug or device is also subject to Chapter V of the Act [1]. On the label, its active drug ingredients are declared under § 201.66 [2].
  • Sunscreen wording: "sunscreen" claims generally make a product a drug. A sunscreen ingredient used only to protect the product's colour must be explained on the label, for example "Contains a sunscreen to protect product color" (21 CFR 700.35) [3].

2. No pre-approval; the firm is responsible

FDA does not pre-approve cosmetic products or ingredients, except colour additives. Firms "are responsible for marketing safe, properly labeled products; using no prohibited ingredients; and adhering to limits on restricted ingredients" (FDA, Cosmetics & U.S. Law).

The rules also require safety substantiation:

  • Each ingredient and each finished product "shall be adequately substantiated for safety prior to marketing." Otherwise the product is misbranded unless its principal display panel carries "Warning—The safety of this product has not been determined" (21 CFR 740.10(a)) [4].
  • MoCRA adds that the responsible person "shall ensure, and maintain records supporting" adequate safety substantiation (FDA). Animal testing is not required (FDA MoCRA page).

3. MoCRA duties and new FDA powers

All of the following are from the FDA MoCRA page.

  • Responsible person: the manufacturer, packer or distributor whose name appears on the label.
  • Serious adverse events: must be reported to FDA within 15 business days, with a copy of the label. New medical or other information received within 1 year of the report must be sent within 15 business days.
  • Facility registration: manufacturers and processors must register their facilities and renew every two years. FDA can suspend a registration, after which distributing from that facility is a prohibited act.
  • Product listing: each marketed product must be listed, with its ingredients, and updated annually.
  • FDA powers: it can access and copy safety records. It can order a mandatory recall where there is a "reasonable probability" that a cosmetic is adulterated or misbranded and will cause serious adverse health consequences or death. Its latest guidance is a mandatory recall Q&A dated October 29, 2026.
  • Rules FDA must still write: good manufacturing practice (GMP), fragrance allergen labeling, and asbestos testing for talc products. The talc proposed rule was issued in December 2024 and withdrawn in November 2025. FDA published a report on PFAS in cosmetics on December 29, 2025.
  • Small businesses: exempt from GMP, registration and listing. The exemption does not cover products that contact the eye's mucous membrane, are injected, are for internal use, or alter appearance for more than 24 hours.
  • Scale: as of June 30, 2026, FDA reports 16,398 active facility registrations [5] and 1,298,361 active product listings [6].

The older registration rules in 21 CFR Parts 710 and 720 remain in the CFR but use voluntary wording. Establishments are "requested to register" on Form FD-2511 [7], and firms are "requested to file" Form FDA 2512 [8]. Neither registration nor a number "in any way denote[s] approval," and implying otherwise is misleading [9][us_21_cfr_parts_700_740_cosmetics_regulations_ec:fb4bbaf96a82:p0].

4. Labeling (21 CFR Part 701)

  • Principal display panel (front panel): must carry a statement of identity [10] and be large enough for all mandatory information [11].
  • Net quantity: liquids by fluid measure, solids, semisolids and viscous products by weight [12].
  • Name and place of business: of the manufacturer, packer or distributor [13].
  • Ingredient list:
    • Ingredients go in descending order of predominance. Fragrance or flavor may be listed as such, and FDA-accepted trade secrets may appear as "and other ingredients" [14].
    • Letters must be at least 1/16 inch high [15]. Packages with less than 12 square inches of label space may use 1/32 inch [16].
    • Grouping is allowed instead: ingredients above 1 percent in descending order, then those at not more than 1 percent in any order, then colour additives [17][18][19].
    • Incidental ingredients and processing aids need not be declared [20].

5. Warnings (21 CFR Part 740)

  • General duty: the label "shall bear a warning statement whenever necessary or appropriate to prevent a health hazard" [21]. Warnings must be prominent, bold, and at least 1/16 inch high [22].
  • Product-specific warnings:
    • Feminine deodorant sprays [23].
    • Foaming bath products [24].
    • Coal tar hair dyes containing 2,4-diaminoanisole [25].
    • Suntanning products without sunscreen [26].
  • Tamper-resistant packaging: required for liquid oral hygiene and vaginal cosmetic products (21 CFR 700.25) [27].

6. Prohibited and restricted ingredients (FDA list, 11 items)

IngredientRuleCite
BithionolProhibited[28]
Chlorofluorocarbon propellantsProhibited in aerosols for domestic consumption[29]
ChloroformProhibited, except residues from processing or synthesis[30]
Halogenated salicylanilidesProhibited[31]
HexachloropheneNot more than 0.1 percent; only if no equally effective preservative; not on mucous membranes such as lips[32]
Mercury compoundsEye-area products only, not more than 65 ppm, only if no other safe and effective preservative; elsewhere only unavoidable traces under 1 ppm[33]
Methylene chlorideProhibited[34]
Prohibited cattle materials (BSE risk)Prohibited; certain tallow, derivatives, hides and milk products excluded[35]
Sunscreens in cosmeticsPurpose must be stated on the label[3]
Vinyl chlorideProhibited in aerosols[36]
Zirconium complexesProhibited in aerosols[37]

7. Colour additives

Colour additives are the one area where FDA approval is needed. Each must be approved for its intended use, and many need batch certification (FDA). FDA's colour additive status list gives each additive's status and limits:

  • D&C Yellow No. 10 is "Permanently listed, certification required" (§§ 74.1710/74.2710) [38].
  • D&C Orange No. 5 is limited to 5% in lipsticks and other lip cosmetics [39].

8. Enforcement basis

  • A cosmetic that breaks these rules is "adulterated" (unsafe or contaminated, sec. 601) or "misbranded" (falsely or inadequately labeled, sec. 602). The tamper-resistant packaging rule shows how they work together [40].
  • Labeling is misbranding if it is false or misleading, including a product name that suggests only some of its ingredients [41][42].
  • MoCRA adds registration suspension, records access and mandatory recall on top of these.

I did not cover state cosmetics laws (for example California's reportable ingredients list or Minnesota's restrictions) or the details of FDA's MoCRA guidance documents.

Sources:

Q.02

What changed under MoCRA?

MoCRA, signed on December 29, 2022 as part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), was the largest change to FDA's cosmetics powers since 1938. It made registration and listing mandatory where they had been voluntary, and created duties to report serious adverse events and keep safety records. It also gave FDA new powers: records access, suspending a facility's registration, and mandatory recall (FDA registration guidance, p.3; FDA MoCRA page).

Approach: I checked the current 21 CFR Parts 700-740 and FDA's MoCRA registration statistics. The CFR holds no MoCRA provisions, so the statutory changes below come from FDA's own pages, its registration and listing guidance, and the Federal Register.

Before and after

AreaBefore MoCRAUnder MoCRA
Facility registrationVoluntary: establishments were "requested to register" on Form FD-2511 [7]Mandatory under new FD&C Act section 607(a) for every facility that manufactures or processes cosmetics for US distribution. Registration must be renewed every two years. Failing to register is a prohibited act under section 301(hhh) (guidance pp.3-4)
Product listingVoluntary: firms were "requested to file" Form FDA 2512 [8]The responsible person must list each marketed product, with its ingredients, under section 607(c), and "provide any updates annually" (FDA registration page)
Serious adverse eventsNo reporting dutyMust be reported within 15 business days, with a copy of the label. New medical information received within 1 year must also be sent (FDA MoCRA page)
Safety substantiationWithout substantiation, the product needs a warning statement on its front panel (21 CFR 740.10) [4]The responsible person must also "maintain records supporting" adequate substantiation. Animal testing is not required (FDA MoCRA page; FDA Voices, 05/04/2026)
FDA powersEnforcement relied on the adulteration and misbranding provisionsAdded: records access, registration suspension (after which distributing from that facility is prohibited), and mandatory recall where there is a "reasonable probability" of adulteration or misbranding causing serious harm (FDA MoCRA page)

Key definitions (section 604, as stated in FDA's guidance)

  • Responsible person: the manufacturer, packer or distributor whose name appears on the label (guidance p.6).
  • Facility: includes importers' establishments.
  • Not a facility: salons, retailers, hospitals, hotels, trade shows, research-only sites, and sites that only label, relabel, package, repackage, hold or distribute. Packaging does not include filling a container (guidance pp.5-6).
  • Contract manufacturers: a contract facility needs only one registration, and the responsible person may file it (guidance p.7).

Exemptions

  • Small businesses (section 612): average US cosmetic sales over the previous 3 years must be less than $1,000,000, adjusted for inflation. These businesses are exempt from registration and listing (guidance p.6). FDA's MoCRA page says they are also exempt from GMP (FDA MoCRA page).
  • When the small-business exemption does not apply: businesses making these products are covered whatever their sales (guidance pp.6-7):
    • products that regularly contact the mucous membrane of the eye;
    • injected products;
    • products for internal use;
    • products that alter appearance for more than 24 hours, where removal by the consumer is not part of normal use.
  • Products also regulated as drugs or devices (section 613): they are outside cosmetic registration and listing. A facility that also makes pure cosmetics must still register (guidance p.7).

Key dates

DateEvent
March 27, 2023FDA ended the old voluntary registration program. Earlier submissions do not count under MoCRA (guidance p.4)
December 18, 2023Cosmetics Direct, the online submission portal, launched (FDA registration page)
December 29, 2023Deadline for initial registration and listing
July 1, 2024FDA began enforcing registration and listing (FDA registration page)
December 2024FDA's registration and listing guidance issued (guidance p.1)
December 27, 2024Proposed rule on asbestos testing for talc products published (89 FR 105490)
November 28, 2025Talc proposed rule withdrawn. FDA says it "will issue a proposed rule to meet its statutory obligations under section 3505 of MoCRA" (90 FR 54604)
December 29, 2025FDA's PFAS in cosmetics report published
October 29, 2026FDA's Q&A guidance on mandatory recalls issued (FDA MoCRA page)

Rules FDA still has to finish

  • Good manufacturing practice (GMP): FDA has issued draft GMP guidance.
  • Fragrance allergen labeling: rule still to be written.
  • Talc asbestos testing: a new proposed rule is still to come after the withdrawal (FDA MoCRA page; FDA Voices).

What has not changed

  • The CFR still has the old voluntary wording. Parts 710 and 720 still use "requested to" language, and § 710.8 still says registration does not "denote approval" [9]. MoCRA's duties sit in the statute (new sections 604-613), not in these CFR parts.
  • Pre-market approval is still limited to colour additives.

How it has played out

  • Registrations and listings: as of June 30, 2026, FDA reports 16,398 active facility registrations [5] and 1,298,361 active product listings [6].
  • Adverse event reports: FDA says industry reports have risen "by more than three-fold" (FDA Voices).

Not covered here: MoCRA's labeling changes in section 609 (for example, a label contact for receiving adverse event reports, and professional-use labeling) and its effect on state law. I could not open an official FDA page or the statute text that sets these out.

Sources:

Q.03