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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
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Are considered drug products as well as cosmetics



OTC cosmetics are safe and effective, and consumers can freely use them without the need of a drug prescription. Keep in mind that products that are not classified as drugs in the European Union might be considered as OTC cosmetics in the United States.

Both Cosmetics and Drug products

Here is a list of Over-the-Counter (OTC) products that are considered drug products as well as cosmetics:


▪ Anti-acne products

▪ Topical analgesics

▪ Antiperspirants

▪ Dandruff products

▪ Hair growth / hair loss products

Fluoride toothpaste

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.

These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe (GRAS) and effective, and not misbranded.

Intended Use Criteria

A shampoo is a cosmetic, since its intended use is to cleanse the hair.

An anti-dandruff treatment is a drug, because its intended use is to treat dandruff.

Consequently, an antidandruff shampoo is both a cosmetic and a drug.

Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.

Organic Cosmetic Products

FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The term “organic” is not defined in either of these laws or the regulations that FDA enforces.

The Agricultural Marketing Service of the U.S. Department of Agriculture (USDA) oversees the National Organic Program (NOP). The National Organic Program (NOP) regulations include a definition of “organic”, and provide for certification that agricultural ingredients have been produced under conditions that would meet the definition. They also include labeling standards based on the percentage of organic ingredients in a product.

Cosmetic products labeled with organic claims must comply with both USDA regulations for the organic claim, and FDA regulations for labeling and safety requirements for cosmetics.

OTC Cosmetic Establishment Registration

Manufacturers, exporters, and importers of OTC cosmetics products must be registered with the FDA as Drug Establishments. ITB HOLDINGS LLC can assist.

A foreign company or registrant must provide the name, address, and phone number of its U.S. Agent such as ITB HOLDINGS LLC.

The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) Number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.


The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enacted on March 27, 2020, authorizes the FDA to assess and collect user fees dedicated to OTC monograph drug activities.

Monograph Drug Facility (MDF) Facility Fee


Contract Manufacturing Organization (CMO) Facility Fee


Payment of these annual fees to the U.S. Treasury is now required for initial registration as well as renewal. An account must first be created.