Letter to Retailers and Distributors of Cookware
December 12, 2024
Dear Retailers and Distributors of Cookware:
The U.S. Food and Drug Administration (FDA or we) is issuing this letter to inform you that certain imported cookware may leach lead (Pb) into food and that this cookware should not be distributed or sold in the U.S. market.
Specifically, some imported cookware products made from aluminum, brass, and aluminum alloys known as Hindalium/Hindolium or Indalium/Indolium demonstrated the potential to leach lead when tested under conditions designed to mimic their use in contact with food, according to information provided to the FDA by the Public Health Department of Seattle and King County (PHSKC) in Washington State.1,2 There is no known safe level of exposure to lead. The FDA is concerned that food cooked in these products could be served to small children, people of child-bearing age, and those who may be breastfeeding. Developing fetuses, infants, and children are particularly vulnerable to the potential harmful effects from lead exposure because of their smaller body sizes, metabolism, and rapid growth.
The FDA has placed a manufacturer of the cookware, Rashko Baba Co. Ltd., on an FDA import alert to help prevent the further sale of these products in the U.S. market. These products are subject to refusal of admission into the U.S. in that they appear to bear or contain an unsafe food additive. Cookware products that bear or contain an unsafe food additive are adulterated under 21 U.S.C. 342(a)(2)(C)(i). Offering an adulterated product for sale in interstate commerce is a prohibited act under the Federal Food, Drug, and Cosmetic Act, and the FDA will take action as appropriate when violative products are found on the U.S. market. Retailers and distributors of cookware should be aware that there may be similar products that leach lead, including Rashko Baba products subject to FDA’s import alert, that remain on the U.S. market. Therefore, we urge retailers and distributors of cookware products made from aluminum, brass, and aluminum alloys known as Hindalium/Hindolium or Indalium/Indolium to take the necessary steps to confirm that such products do not leach lead into food. Various testing methods for leachable lead are available, or you may use FDA’s lead leach testing protocol.3
Retailers and distributors of cookware are responsible for ensuring the products they market and/or distribute for use in contact with food are safe for their intended use and comply with all FDA regulations. As always, retailers and distributors are encouraged to consult with the FDA regarding the safety and regulatory status of any products that they market or distribute used in contact with food. Questions for FDA related to this topic can be sent to premarkt@fda.hhs.gov.
Sincerely,
/S/
Kristi Muldoon-Jacobs, Ph.D.
Director, Acting
Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI)
[1] PHSKC in collaboration with the University of Washington published two reports on their findings: https://www.nature.com/articles/s41370-022-00431-y and https://www.nature.com/articles/s41370-024-00686-7
[2] PHSKC posted a table on their website of the specific cookware products demonstrating the most significant lead leaching based on their test results. Information provided on their website includes pictures, brands, and country of origin when available.
[3] “Elemental Analysis Manual (EAM) Method 4.6 Inductively Coupled Plasma Optical Emission Spectrometric Determination of Cadmium and Lead Extracted from Ceramic Foodware” (https://www.fda.gov/media/95170/download). To modify for cookware, instead of a 24-hour extraction at 22 °C ± 2 °C, the extraction conditions include a 2-hour boil followed by cooling and holding at room temperature for a total of 24 hours. All other method details remain the same.
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https://www.fda.gov/food/environmental-contaminants-food/letter-retailers-and-distributors-cookware
Image above from EDF: https://blogs.edf.org/health/2023/08/15/fda-says-cookware-that-exhibits-any-level-of-leachable-lead-upon-testing-is-prohibited/
