Guidance and Precautions for FDA Registration of Cosmetics Exporting to the United States

Guidance and Precautions for FDA Registration of Cosmetics Exported to the United States

FDA registration for cosmetics includes facility registration and product registration. On December 16, 2023, the FDA officially launched the Cosmetics Direct registration system, transitioning FDA cosmetic facility and product registration from a voluntary program to a mandatory requirement. Facility registration must be renewed every two years; product registration must be renewed annually.

(1) Definition:

Products intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the human body... for the purposes of cleansing, beautifying, enhancing attractiveness, or altering appearance.

Moisturizing lotions, perfumes, lipsticks, nail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair dyes, toothpastes, deodorants, and any substance intended for use as a component of a cosmetic product. 

Note: Some products may be both cosmetics and over-the-counter (OTC) drugs.

(2) Required Documents for FDA Cosmetic Registration

1. FEI Registration Application Form

2. FDA Cosmetic Registration Application Form (Product registration also requires product name, ingredients, CAS numbers, labeling, etc.)

3. DUNS Number (Required in some cases, currently not mandatory)

(3) Precautions

1. Color additives used in U.S. cosmetics must come from batches certified by the FDA, unless specific color additives are exempt from certification.

A "List of Color Additives for Cosmetics and Their Approved Uses" can be found on the FDA website.

Related content such as "Ingredients and Pigments Prohibited or Restricted in Cosmetics" can also be found on the FDA website.

2. Any variation in formulation is considered a separate product.

(4) How Can a Product Be Both a Cosmetic and a Drug?

Over-the-counter drugs are often marketed alongside cosmetics, and some products meet the definitions of both cosmetics and OTC drugs. This occurs when a product has two intended uses and contains ingredients with two different intended purposes. For example, shampoo is a cosmetic because its intended use is to clean hair. An anti-dandruff preparation is a drug because its intended use is to treat dandruff. Thus, anti-dandruff shampoo is both a cosmetic and a drug.

Other cosmetic/drug combinations include: fluoride toothpaste, deodorants that are also antiperspirants, and moisturizers and cosmetics marketed with sun protection claims.