FDA Regulations for US Personal Care Products

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to US cosmetic law in 85 years. Key new requirements: (1) Facility registration: All facilities that manufacture or process cosmetics for US sale must register with the FDA. Foreign facilities that export to the US are included. Deadline was December 29, 2023 for most facilities. (2) Product listing: All cosmetic products sold in the US must be listed with the FDA, including ingredients. (3) Safety substantiation: Brands must maintain records substantiating product safety. (4) Serious adverse event reporting: Mandatory reporting of serious adverse events within 15 business days. (5) Recalls: FDA now has authority to mandate cosmetic recalls.

The most important regulatory decision for any personal care brand is whether its product is a cosmetic or an OTC drug. This is determined by the product's intended use, not its formulation: (1) Cosmetics are intended to beautify, cleanse, or alter appearance without affecting body structure or function. (2) OTC drugs are intended to treat, prevent, or cure conditions — sunscreens (SPF claims), anti-dandruff shampoos, anti-perspirants, acne treatments, and teeth-whitening products are all OTC drugs in the US.

OTC drugs require compliance with FDA monographs or New Drug Applications — a significantly more complex and expensive process. Misclassifying an OTC drug as a cosmetic is one of the most common compliance failures for international brands entering the US market.

The US has a relatively short prohibited ingredient list compared to the EU (11 prohibited substances vs EU's 1,300+). However, California's Toxic-Free Cosmetics Act (effective January 2025) bans 24 chemicals including mercury, lead compounds, formaldehyde, PFAS, and several others. Since California represents ~$60B in personal care sales, any brand selling nationally must comply with California's stricter list.

The EU Cosmetics Regulation's restricted ingredient list (Annexes II, III, IV, V, VI) is not enforceable in the US, but brands that formulate to EU standards will generally exceed US minimum requirements — a useful benchmark.

Personal care labels must comply with FDA's Fair Packaging and Labeling Act (FPLA) and 21 CFR Parts 701 and 740. Required elements: identity of the product, net quantity of contents (US customary units — ounces/fluid ounces), name and place of business of the distributor/manufacturer, ingredient declaration (in descending order of predominance, using INCI names), and directions for safe use if not obvious.

Unlike the EU, no 'Period After Opening' (PAO) symbol is required in the US, and the standard ingredient list order differs slightly from INCI rules. 'Fragrance' is a permitted collective term in the US — individual fragrance ingredients do not need to be disclosed, though this is a growing consumer expectation.

Many personal care ingredients trigger California Prop 65 warning requirements — titanium dioxide (in spray products), formaldehyde-releasing preservatives, certain hair dye ingredients, talc (in some forms), and retinol at high concentrations. If your product contains a Prop 65-listed chemical above the safe harbor level, you must provide a clear and reasonable warning on the product or in the purchase environment.

Because Prop 65 is enforced primarily by private plaintiff attorneys on a contingency basis, failure to include required warnings is a significant litigation risk. Many brands use a precautionary Prop 65 warning ('This product contains chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm') to reduce exposure.