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.
General FDA requirements and ingredient prohibitions/restrictions for cosmetics marketed in the US.
- 01Avoid prohibited/restricted ingredients listed in Part 700
- 02Ensure products are neither adulterated nor misbranded
- 03Read Part 700 together with MoCRA’s new registration and safety duties
Long-standing regulation; its practical weight increased with MoCRA (2022), which added registration, safety substantiation, and mandatory GMP to the US framework.
21 CFR Part 700: frequently asked questions
Quick answers to common questions about 21 CFR Part 700.
What is 21 CFR Part 700?
21 CFR Part 700 — Cosmetics — General — is a regulation issued by the Food and Drug Administration (United States). 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.
Who does 21 CFR Part 700 apply to?
General FDA requirements and ingredient prohibitions/restrictions for cosmetics marketed in the US.
What are the key requirements of 21 CFR Part 700?
FDA 21 CFR Part 700 requires, among other things: 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.
When was 21 CFR Part 700 last updated?
The current version of 21 CFR Part 700 dates from April 2022. Long-standing regulation; its practical weight increased with MoCRA (2022), which added registration, safety substantiation, and mandatory GMP to the US framework.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 700 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.