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
▪ Dandruff shampoos
▪ 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.
Any firm that manufactures or packages cosmetics may submit an establishment registration. If you choose to participate in the Voluntary Cosmetic Registration Program (VCRP), you may whether register your establishment, file Cosmetic Product Ingredient Statements, or both.
However, the FDA stopped accepting and processing submissions to the voluntary registration program for cosmetics establishments and products. The FDA is developing a program for submission of the facility registrations and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), and will provide further updates on its forthcoming availability.
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)
▪ 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. These fees tend to increase substantially.
Monograph Drug Facility (MDF) Facility Fee: $26,153.
Contract Manufacturing Organization (CMO) Facility Fee: $17,435.
The FDA recognizes 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 for the FY 2023 facilities rates? Not really.