FDA has the legal authority to inspect cosmetic establishments as well as cosmetics offered for import. Here are resources to learn more about FDA inspection of cosmetics.
Section 704 of the Federal Food, Drug, and Cosmetic Act (FD&C 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 (FD&C Act, section 704(a)).
- 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, deficiencies in labeling and packaging, 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, warehousing and storage of raw materials as well as in-process and finished cosmetics, and complaint files (Investigations Operations Manual, subchapter 2.1.2).
- 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 (Investigations Operations Manual, subchapter 4.3). The investigator must provide a receipt describing the samples that he or she obtained (FD&C Act, section 704(c)).
- The compliance staff at the FDA district office then determines from the information gathered, and the results of the analysis of samples collected (from the establishment or elsewhere), whether or not a product is adulterated or misbranded. Staff at FDA headquarters components are frequently consulted (Field Management Directives: Establishment Inspection Report).
- Although there are no good manufacturing practice (GMP) regulations for cosmetics, we do have Good Manufacturing Practice Guidelines (Inspection Checklist). Failure to adhere to GMP may result in an adulterated or misbranded product.
- 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.
Under the FD&C Act, imported cosmetic products must comply with all the regulatory requirements that apply to domestic products (FD&C Act, section 201(b). They are subject to examination and/or sampling through U.S. Customs and Border Protection at the time of entry. Foreign cosmetics that appear to be adulterated or misbranded (FD&C Act, sections 601 and 602) may be refused entry into the United States. 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 (FD&C Act, section 801). 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.
- Cosmetics Compliance Program: Import and Domestic (PDF 310 KB)
- GMP Guidelines/Inspection Checklist
- GMP Draft Guidance
- Information for Cosmetics Importers
- Import Alerts for Cosmetics
- Inspection Reference, Guides & Field Activities
- Materials from Webinar on Inspection Process
- Regulatory Procedures Manual