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January 9, 2004
Dear Sir or Madam:
In light of the recent BSE situation, we are aware that the authorities in the People's Republic of China have established a requirement that cosmetic products for export and sale in its territory must be accompanied by certification by a competent authority in the country of origin. It is our understanding that this certification must attest to compliance with the requirements of the country to which the product is being exported.
Cosmetic products marketed in the United States are regulated by the Food and Drug Administration (FDA) pursuant to the requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) and, as appropriate, the Fair Packaging and Labeling Act (FPLA). A product that meets the safety and labeling requirements of these laws may be freely marketed in the United States.
FDA has the authority and responsibility for overseeing the safety of cosmetics in the marketplace and exercises such oversight through inspections and other enforcement powers including, but not limited to, recalls, seizures and criminal penalties.
The laws and regulations in the United States do not require prior authorization by FDA for the export of cosmetic products outside of the country. Nor does the law require that manufacturers provide certification to U.S. authorities of compliance with the requirements of the foreign authority as a condition for exporting cosmetic products. It is the responsibility of the manufacturer to ensure that the product is in compliance with the requirements of the foreign authority.
Accordingly and pursuant to long standing policy (see enclosed), the FDA does not provide certification that a cosmetic product is in compliance with the requirements of the country to which it is being exported, even when a manufacturer requests the agency provide such certification. In view of this, the Cosmetic, Toiletry and Fragrance Association (CTFA) has been designated to serve as a competent authority and issue certificates acceptable to the government of the foreign country.
I hope this information is helpful to you.
Sincerely yours,
/S/
Lester M. Crawford, DVM, PhD
Deputy Commissioner
Enclosure
July 2, 1993
Ms. Sheri R. Lanza
Commercial Officer
U.S. Embassy
San Jose, Costa Rica
Dear Ms. Lanza:
This purpose of this letter is to expand on my letter of June 14, 1993 concerning "Certificates of Free Sale" for cosmetic products.
Evaluation of Requests from companies for Certificates of Free Sale is not part of FDA's law enforcement responsibilities. Because of our limited resources, such requests generally have a low priority in our day to day compliance activities. FDA response to a request may take several months to process depending on the number of products involved and other priorities of the Office of Cosmetics and Colors. In view of this, companies are free to obtain certificates from State and/or local agencies having jurisdiction over their products or from a trade association such as the Cosmetic, Toiletry and Fragrance Association (CTFA) or the Independent Cosmetic Manufacturers and Distributors (ICMD) which may be sufficient for their needs and acceptable to the government of the foreign country.
I hope this information is helpful to you.
Sincerely yours,
/S/
Marilyn E. Veek
American Desk Officer
International Affairs Staff
Office of Health Affairs
October 28, 1998
Dear Sir:
This purpose of this letter is to expand on my letter of June 14, 1993 concerning "Certificates of Free Sale" for cosmetic products.
Evaluation of Requests from companies for Certificates of Free Sale is not part of FDA's law enforcement responsibilities. Because of our limited resources, such requests generally have a low priority in our day to day compliance activities. FDA response to a request may take several months to process depending on the number of products involved and other priorities of the Office of Cosmetics and Colors. In view of this, companies are free to obtain certificates from State and/or local agencies having jurisdiction over their products or from a trade association such as the Cosmetic, Toiletry and Fragrance Association (CTFA) or the Independent Cosmetic Manufacturers and Distributors (ICMD) which may be sufficient for their needs and acceptable to the government of the foreign country.
I hope this information is helpful to you.
Sincerely yours,
/S/
Marilyn E. Veek
Associate Director for Communications
Office of International Affairs
cc: JRempe
