The Federal Food, Drug, and Cosmetic Act makes it illegal to introduce into interstate commerce a cosmetic that is adulterated. A cosmetic may be adulterated because: (1) it may cause harm to a consumer when used as directed or as customarily used; (2) it contains filth; (3) it contains a non-permitted, or in some instances non-certified, color additive; or (4) it is manufactured or held under insanitary conditions.
FDA has the authority to inspect companies that manufacture, hold or deliver cosmetic products intended for interstate commerce. It is during these inspections that FDA determines whether or not a cosmetic is potentially adulterated.
A company that complies with good manufacturing practices for cosmetics rigorously can minimize the potential for adulterated cosmetics.
FDA will review various areas of a company to determine its compliance with good manufacturing practices during an inspection. These areas include
Building and Facilities
Ingredients, including color additives
Participation in voluntary registration
Buildings are of suitable size, design, and construction.
Floors, walls, and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair
Fixtures, ducts, and pipes are installed to minimize contamination from condensation or drip.
Lighting and ventilation are sufficient.
Water supply, washing and toilet facilities, floor drainage, and sewage system are adequate for sanitary operation and cleaning of facilities, equipment, and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.
Equipment and utensils used in processing, holding, transferring, and filling are of appropriate design, material, and workmanship.
Utensils, transfer piping, and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized.
Equipment and contact surfaced not in use are stored in a manner that protects them from splash, dust, or other contamination.
The personnel supervising or performing the manufacture or control of cosmetics has the education, training, and/or experience to perform the assigned functions.
Persons coming into direct contact with cosmetic materials, finished products, or cosmetic contact surfaces wear appropriate outer garments and maintain personal cleanliness.
Consumption of food or drink or use of tobacco is restricted to designated areas.
Raw materials and primary packaging materials are stored and handled in a manner that prevents their mix-up, contamination, or decomposition.
Containers are closed and bagged or boxed materials are stored off the floor.
Containers are labeled.
Materials are sampled and tested or examined in conformance with procedures.
Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.
FDA verifies whether or not the company has written policies and procedures in place to ensure good manufacturing practices
FDA verifies the equipment used are clean and in good condition
Verifies that only approved materials are used in the production of cosmetics
Samples are taken, as appropriate
Weights and measurements are verified by two people
Labels are examined before labeling a product
Returned cosmetics are examined
Raw materials, in-process samples, and finished products are tested or examined.
Reserve samples of approved lots or batches of raw materials and finished products are retained.
The water supply is tested regularly for conformance with chemical-analytical and microbiological specifications.
Fresh as well as retained samples of finished products are tested.
Records are being produced for every batch.
Records are being maintained for the necessary time period.
Records for the following events exist.
On the principal display panel:
Name of the product
statements of identity
The statement "Warning--The safety of this product has not been determined" if the safety of the respective product has not adequately been substantiated
On the information panel:
Distributor or manufacturer information.
The warning statements, where appropriate
FDA verifies that complaints are documented, reviewed, and investigated
Where appropriate, reported
FDA will verify whether the company is participating in the voluntary registration.
FDA will verify color additives being used.
FDA will verify that the ingredients are not prohibited from use.