Cosmetics — General
FDA’s general cosmetics regulations — including specific prohibitions and restrictions on certain ingredients (e.g. bithionol, mercury compounds, certain color additives) and general provisions on cosmetic products. Together with the FD&C Act’s adulteration and misbranding provisions and MoCRA, it forms the US cosmetics regulatory baseline.
What this does not cover
stated in the document's own scope- Covers cosmetics; products that meet the definition of a drug (many sunscreens, anti-dandruff shampoos, and similar) are regulated as drugs, not solely as cosmetics under Part 700.
- Sets general provisions and ingredient prohibitions/restrictions, not the color-additive approvals, which are governed by the separate color-additive regulations.
- Predates the newer facility-registration, product-listing, and safety-substantiation duties, which are added by MoCRA rather than by Part 700 itself.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 700 is the FDA general regulations for cosmetics. It carries the general provisions for the product class and, importantly, the specific ingredient prohibitions and restrictions FDA has established — for example bans or limits on bithionol, mercury compounds, halogenated salicylanilides, certain chloroform uses, methylene chloride, and certain aerosol propellants, along with warning-statement requirements for particular products. It functions as the baseline rulebook for what may and may not go into a cosmetic, working with the adulteration and misbranding provisions of the Federal Food, Drug, and Cosmetic Act and, more recently, the authorities added by MoCRA.
Scope & applicability
General FDA requirements and ingredient prohibitions/restrictions for cosmetics marketed in the US.
Legal basis & how it acquires force
Part 700 is a binding regulation in Title 21 CFR, issued by the FDA under the Federal Food, Drug, and Cosmetic Act. Its ingredient prohibitions and restrictions have the force of regulation: a cosmetic containing a prohibited ingredient, or one used outside a stated restriction, is deemed adulterated under the Act. It sits within the wider cosmetics framework alongside the color-additive regulations and the labeling rules, and its authority derives from the Act’s general provisions on cosmetics rather than from a premarket-approval scheme.
Document structure
| Part | Covers |
|---|---|
| General provisions | Definitions and general applicability for cosmetic products |
| Prohibited ingredients | Ingredients such as bithionol, mercury compounds, and halogenated salicylanilides prohibited in cosmetics |
| Restricted ingredients | Ingredients permitted only within stated limits, such as certain chloroform and methylene-chloride uses |
| Warning statements | Required warnings for particular cosmetic products, such as certain aerosol and feminine-deodorant products |
| Use of certain constituents | Provisions on specific constituents and their permitted use in cosmetics |
Key requirements
- Avoid prohibited/restricted ingredients listed in Part 700
- Ensure products are neither adulterated nor misbranded
- Read Part 700 together with MoCRA’s new registration and safety duties
Implementation tips
- Screen formulations against the Part 700 prohibitions and the color-additive rules
- Treat Part 700 as the floor; MoCRA is now the active compliance frontier
- Keep labelling compliant to avoid misbranding findings
Revision notes
Long-standing regulation; its practical weight increased with MoCRA (2022), which added registration, safety substantiation, and mandatory GMP to the US framework.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 700 is the standing FDA cosmetics rulebook that MoCRA’s newer authorities build upon: registration, listing, safety substantiation, and the forthcoming cosmetic GMP regulation add to, rather than replace, the ingredient prohibitions and general provisions here. Together with the color-additive regulations, the labeling requirements, and the adulteration/misbranding provisions of the Federal Food, Drug, and Cosmetic Act, it forms the US cosmetics regulatory baseline. Internationally, cosmetic GMP is commonly benchmarked to ISO 22716.
21 CFR Part 700: frequently asked questions
Quick answers to common questions about 21 CFR Part 700.
What does 21 CFR Part 700 cover?
The FDA general regulations for cosmetics, including specific prohibitions and restrictions on ingredients such as bithionol, mercury compounds, and certain chloroform and methylene-chloride uses, along with general provisions and warning-statement requirements.
Does Part 700 require premarket approval of cosmetics?
No. Cosmetics generally do not undergo FDA premarket approval. Part 700 instead sets baseline rules — notably prohibited and restricted ingredients — that a cosmetic must respect to avoid being adulterated under the Act.
How does Part 700 relate to MoCRA?
Part 700 is the pre-existing cosmetics rulebook. MoCRA’s newer duties — registration, product listing, safety substantiation, adverse-event reporting, and a forthcoming cosmetic GMP regulation — add to it rather than replace its ingredient prohibitions and general provisions.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.