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


Skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors and deodorants


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.


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.


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.


The FDA stopped accepting and processing submissions to the Voluntary Cosmetic Registration Program (VCRP) for establishments and products.

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), manufacturers and processors must register their facilities with the FDA and renew their registration every two years. They must also list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.

Keep in mind that before you export any Over-the-Counter (OTC) cosmetic product to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.


The owner, operator, or agent in charge of an establishment, or an individual authorized by one of them, may register that establishment.

Foreign establishments must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the establishment and FDA. The U.S. Agent is authorized to register any establishment.

The U.S. Food and Drug Administration will not confirm a registration, provide a registration number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.

FDA will conduct this verification step by sending an email to ITB HOLDINGS LLC. If the FDA does not receive a response to its verification request within 30 calendar days, the registration, registration renewal, update, or cancellation submission will be removed from its database and a new submission will be required.


The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.


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)

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

▪ U.S. Agent Service

▪ Label Review

▪ Label Design

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




User Fees are paid to the U.S. Treasury, every fiscal year (FY). These fees tend to increase substantially. The facility fees for FY 2024 are due on June 3, 2024.

▪ Monograph Drug Facility (MDF) Facility Fee:
$34,166 (FY 2024).
$26,153 (FY 2023).

▪ Contract Manufacturing Organization (CMO) Facility Fee:
$22,777 (FY 2024).
$17,435 (FY 2023).

Entities that registered with the FDA during the Coronavirus Disease 2019 (COVID-19) pandemic, and whose sole activity with respect to OTC monograph drugs during the pandemic had consisted of manufacturing OTC hand sanitizer products, are not identified as OTC monograph drug facilities subject to OMUFA facility fees for FY 2024.

OTC monograph drug facilities are exempt from FY 2024 facility fees if they had ceased OTC monograph drug activities, and updated their registration with the FDA to that effect, prior to December 31, 2022.

No User Fee is required for conventional cosmetics.

The FDA recognized that the FY 2022 facility fee rates were an increase of 19 percent in comparison to the FY 2021 facility fee rates, and that increase was largely attributed to the decrease in the number of fee-liable facilities. Any lessons learned? Not really.

Following a solid recovery since the height of the pandemic, the cosmetic market is expected to reach approximately $580 billion by 2027.