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February 19, 2004
The Honorable Ge Zhirong
Vice Minister
Administration for Quality Supervision,
Inspection & Quarantine
9 Madian East Road
Beijing, China
100088
Dear Mr. Minister:
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 Independent Cosmetic Manufacturers and Distributors, Inc. (ICMAD) has been recognized as a competent body to issue certificates acceptable to the government of the foreign country.
We, therefore, hope that U.S. cosmetics would be permitted entry into the People's Republic of China if accompanied by an ICMAD certificate that complies with current Chinese regulations. Because of the importance of resuming the normal movement of such products, I am prepared to meet with you and your colleagues in China at the earliest, mutually convenient time to achieve that goal.
Sincerely yours,
/S/
Lester M. Crawford, DVM, PhD
Deputy Commissioner
