ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:
■ OTC Drug Establishment Registration
■ Drug Product Listing
■ New Drug Application (NDA)
■ U.S. Agent Service
■ Label Review
■ Label Design
Sunscreens, Fluoride Toothpaste, Antiperspirants, Dandruff Shampoos, Skin Protectants, and Topical Analgesics are among more than 300,000 Over-the-Counter (OTC) drug products that are marketed in the U.S. without the need for FDA pre-approval.
OTC drug products are available to consumers without a doctor’s prescription.
A cosmetic product manufactured according to an FDA Monograph.
Monographs define the safety, effectiveness, and labeling of all active ingredients.
All otc cosmetic products must include standard “Drug Facts” information on the back and/or side of the container.
A New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required when a product does not conform to a final monograph.
Of 16 currently marketed active ingredients
2 ingredients, Zinc Oxide and Titanium Dioxide, are generally recognized as safe and effective (GRASE) and not misbranded for use in sunscreens
2 ingredients, PABA and Trolamine Salicylate, are not GRASE for use in sunscreens due to safety issues
12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time.
Dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.
All Drug Establishments must renew their registration between October 1 and December 31, 2021.
A cosmetic may become misbranded when:
its labeling is false or misleading
its label fails to provide required information
its required label information is not properly displayed, and
its labeling violates requirements of the Poison Prevention Packaging Act of 1970.
A determination that labeling is “misleading” includes considering both what the label says and what it fails to reveal.
Required label information includes, among others,
(1) the name and physical address of the manufacturer, packer, or distributor
(2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.
Ready to register your company and list your products? Contact ITB HOLDINGS LLC, today.
- Company registration
- Product listing
- U.S. Agent Service for foreign companies
$20,322.00 | Over-The-Counter Monograph Drug User Fee Program (OMUFA) (FY 2021) is required for OTC drug products. Expect this fee to increase over the years.
User Fees are paid to the U.S. Treasury.