ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
Cosmetics
COSMETICS

Before you export any cosmetic product to the United States, register your company with the U.S. Food and Drug Administration.

FDA Registration of your Cosmetic Establishment is either voluntary or required, because a product intended for a therapeutic use, is a drug.

FDA defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

Products included in this definition are:

  • skin moisturizers, perfumes, lipsticks
  • fingernail polishes, eye and facial makeup
  • cleansing shampoos, permanent waves
  • hair colors and deodorants
  • any substance intended for use as a component of a cosmetic product

Soap is not included.

COSMETIC & DRUG PRODUCTS

If the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug.

■ Fluoride toothpaste
■ Antiperspirants
■ Dandruff shampoos
■ sunscreens
■ Soaps and cleansers marketed as “antibacterial”
■ Diaper ointments
are considered “drugs” (OTC – over-the-counter drugs), and therefore require a Drug Establishment Registration.

Please get a DUNS Number for your company.

Your labels must be FDA compliant.

INGREDIENTS IN COSMETIC PRODUCTS

Asbestos is a naturally occurring mineral that is often found near talc, an ingredient in many cosmetic products. Asbestos however, is a known carcinogen and its health risks are well-documented.

Adulterated tattoo ink: Microbial Contamination with Clostridium Clostridioforme, Clostridium Ramosum, Bacillus Cereus, Staphylococcus Equorum, Kocuria Kristinae. A cosmetic is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users.

Also, products labeled as “sterile” are expected to be free of viable microorganisms.  Therefore, use of the term “sterile” in regard to these products is false and misleading, and the tattoo inks are misbranded.

Free of high-virulence microbial pathogens: Cosmetics including shampoo, shower gel, foot scrub, and eye area products, are not expected to be aseptic. However, high Aerobic Plate Counts (APC) can increase the users’ risk of infection. APC should not be greater than 500 CFU/g for eye area cosmetics and 1,000 CFU/g for all other products.

Your firm should perform testing on incoming raw materials to ensure the absence of filth, microorganisms, and other adulterants prior to processing or using them in your products.

Routine testing of the water supply used in the facility to formulate cosmetics, clean equipment and manufacturing areas, should be conducted to assure chemical and microbiological quality, and not a source of contamination.

The declaration of ingredients must contain the common or usual names of the cosmetic ingredients as required.

COSMETIC ESTABLISHMENT REGISTRATION

ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, warehouses, importers, or distributors:

■ Cosmetic Establishment Registration

■ Cosmetic Product Listing

■ Drug Establishment Registration (OTC Cosmetics)

Voluntary Cosmetic Registration Program (VCRP)

■ U.S. Agent Service

■ Label Review

■ Label Design

OTC ESTABLISHMENT
LIMITED OFFER
  • Company registration
  • Product listing
  • U.S. Agent Service for foreign companies
  • User Fee is not included

FDA
FACILITY
REGISTRATION

$350.00

FDA USER FEES

$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 2021) is required for OTC drug products.

User Fees are paid to the U.S. Treasury.

No User Fee is required for conventional cosmetics.