FDA Cosmetics Labeling and FPLA Compliance for US Market Entry

In the US, cosmetics are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), both administered by FDA. The Modernization of Cosmetics Regulation Act (MoCRA) signed into law in December 2022 added facility registration, product listing and safety substantiation requirements.

Unlike drugs, cosmetics do not require FDA pre-market approval. However, they must be safe for use, properly labeled and, post-MoCRA, registered. Taiwan brands exporting to the US must redesign labels to comply with FDA and FPLA before shipment.

A US-compliant cosmetic label must include: (1) Product identity statement on the principal display panel (PDP) — the name and function of the product. (2) Name and address of the US responsible person (manufacturer, packer or distributor). (3) Net quantity in both metric and US customary units on the PDP. (4) Ingredients listed in INCI (International Nomenclature of Cosmetic Ingredients) order of predominance on the information panel.

(5) Warnings where required by regulation (e.g. flammability warnings for aerosols, "keep out of reach of children" for products not intended for children). (6) Country of origin may be required under CBP rules. All text must be in English (bilingual is acceptable, but English is mandatory).

Ingredients must be listed using INCI names, not trade names or IUPAC names. Water is always listed as "Water (Aqua)." Fragrance may be listed as "Fragrance" or "Parfum" without disclosure of individual fragrance components (though MoCRA may change this for allergen disclosure in future rulemaking).

Ingredients at concentrations of 1% or greater must be listed in descending order. Ingredients below 1% may be listed in any order after those at 1% or greater. Color additives must be listed by their FD&C or D&C designation (e.g. "Red 40" not "CI 16035").

Since July 2024, cosmetic facilities that manufacture or process cosmetics for US distribution must register with FDA. Product listings (including each product name and ingredient list) must also be submitted. Small businesses with less than $1M in average gross annual sales are temporarily exempt from listing but not from safety requirements.

Registration is done via the Cosmetics Direct portal on FDA's website. The Responsible Person (the US importer or distributor) makes the product listing. Taiwan manufacturers can register their facilities directly. Registrations must be renewed biennially.

FDA prohibits certain ingredients in cosmetics including mercury compounds (except as preservatives in eye makeup at specific limits), vinyl chloride, hexachlorophene, halogenated salicylanilides, chlorofluorocarbons and certain coal tar colors. Review 21 CFR Parts 700-740 for the current list.

Color additives must be FDA-approved for their intended use. Approved colors for cosmetics are listed in 21 CFR Parts 73, 74 and 82. A color certified for food use is not automatically approved for lip products or products applied near the eye.

If a cosmetic claim crosses into drug territory — claims to treat, prevent, cure or mitigate a condition — the product is regulated as a drug and requires a New Drug Application or OTC monograph compliance. Common boundary issues: sunscreens (drug), anti-dandruff shampoos (drug), whitening toothpaste with fluoride (drug), anti-acne products (drug), hair growth products.

Marketing "anti-aging," "brightening" or "hydrating" claims is generally acceptable as cosmetic. Claims such as "treats hyperpigmentation," "clinically reduces wrinkles by 80%" or "repairs cell damage" push into drug territory. Review FDA guidance on structure-function claims before finalising your marketing copy.