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.
Please get a DUNS Number for your company.
Your labels must be FDA compliant.
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.
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
$16,119.00 – $24,178.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 2022) is required for OTC drug products.
User Fees are paid to the U.S. Treasury.
No User Fee is required for conventional cosmetics.