U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
February 25, 2003

INSPECTION OF COSMETICS

Section 704 of the Food, Drug, and Cosmetic Act authorizes FDA to conduct inspections of cosmetic firms at reasonable times, in a reasonable manner, and without prior notice in order to assure compliance with the applicable laws and regulations, to determine whether cosmetics are safe and properly labeled, and to identify possible health risks and other violations of the law.

A number of factors affect how FDA determines that an inspection of a cosmetic establishment may be warranted. These factors may include -- but are not limited to -- the type of products, the significance of consumer or trade complaints received, the company's compliance history, FDA surveillance and compliance initiatives, and agency resources.

Some things to know about inspections:

• The FDA investigator must present credentials and a written notice of inspection to the most responsible individual present before beginning the inspection.
• Among the things that an investigator may look for are use of prohibited ingredients, improper use of restricted ingredients, noncompliance with requirements related to color additives, microbial contamination, failure to adhere to requirements for tamper-resistant packaging where needed, and deficiencies in labeling and packaging.
• An investigator may collect samples of cosmetic ingredients or finished products as part of routine surveillance, if adulteration or misbranding is noted or suspected, or on special assignment, such as follow-up to a cosmetic-related complaint or adverse reaction. Additionally, the investigator may collect in-process product, swabs of equipment or product contact surfaces, or any other materials that might serve to document product adulteration or misbranding. The investigator must provide a receipt describing the samples that he or she obtained.
• It is the investigator's job to gather facts. The compliance staff at the FDA district office then determines from the information gathered and analysis of samples collected (from the establishment or elsewhere) whether or not a product is adulterated or misbranded.
• Although there are no good manufacturing practice (GMP) regulations for cosmetics, failure to adhere to GMP may result in an adulterated or misbranded product. Among other things, the investigator may check the adequacy of buildings and facilities, the suitability of equipment and how it is maintained, personnel training, handling of raw materials, production procedures, laboratory and other quality controls, packaging, labeling, warehousing and storage of raw materials as well as in-process and finished cosmetics, and complaint files.
• The length of an inspection varies, depending upon factors such as the size of the establishment, the reasons for the inspection, and what the investigator finds.

Imported cosmetic products must comply with all the regulatory requirements that apply to domestic products. They are subject to examination and/or sampling through the U.S. Customs Service at the time of entry. Foreign cosmetics that appear to be adulterated or misbranded may be refused entry into the U.S. Shipments found not to comply with U.S. laws and regulations are subject to detention. They must be brought into compliance, destroyed, or re-exported. Not all imported products are examined at the time of entry. Those not examined, however, are still subject to all the legal requirements of the laws we enforce.

The following resources provide additional information on the inspection of cosmetics:

• Guide to Inspections of Cosmetic Product Manufacturers
• Compliance Program Guide for Domestic Cosmetics
• Compliance Program Guide for Imported Cosmetics