What is an adulterated cosmetic?
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.
How does FDA determine if a cosmetic is adulterated?
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.
How does a company avoid adulterating its cosmetics?
A company that complies with good manufacturing practices for cosmetics rigorously can minimize the potential for adulterated cosmetics.
What does FDA review during an inspection?
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
- Raw Materials
- Laboratory Controls
- Ingredients, including color additives
- Participation in voluntary registration
What does FDA check when reviewing the building and facilities?
- 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.
What does FDA check when reviewing the equipment?
- 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 protects them from splash, dust or other contamination.
What does FDA check when reviewing personnel?
- 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.
What does FDA check when reviewing raw materials?
- Raw materials and primary packaging materials are stored and handled in a manner which 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.
What does FDA check when reviewing production?
- 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 in 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
What does FDA check when reviewing laboratory controls?
- 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.
What does FDA check when reviewing records?
- Records are being produced for every batch.
- Records are being maintained for the necessary time period.
- Records for the following events exist.
What does FDA check when reviewing labeling?
- On the principal display panel:
- Name of the product
- statements of identity
- net contents
- 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
What does FDA check when reviewing complaints?
- FDA verifies that complaints are documented, reviewed, and investigated
- Where appropriate, reported
What other aspects of a company does FDA review during an inspection?
- FDA will verify whether the company is participating int eh voluntary registration.
- FDA will verify color additives being used.
- FDA will verify that the ingredients are not prohibits from use