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US FDA Issues Letter to Cookware Retailers and Distributors

SafeGuardSHardgoodsJanuary 21, 2025

SG 014/25

The US Food and Drug Administration (FDA) has informed retailers and distributors of cookware that certain imported products may leach lead into food and that these should not be available on the US market. The agency will take appropriate action when violative products are found.

In December 2024, the FDA issued a letter to cookware retailers and distributors informing them that imported cookware products made from aluminum, brass and aluminum alloys, also known as Hindalium/Hindolium or Indalium/Indolium, were found to have the potential to leach lead when tested under conditions designed to mimic their use in food contact. Therefore, such cookware should not be distributed or sold in the US market.

These findings are based on two reports by the Public Health Department of Seattle and King County (PHSKC) concerning their testing of imported cookware products. Studies revealed that many aluminum cookware and cookpot products contained more than 100 ppm lead and could leach sufficient lead under simulated cooking and storage conditions to exceed recommended dietary limits. Furthermore, the PHSKC website posted a summary report with detailed information of the cookware that released lead above the FDA’s recommended daily intake levels, including the methods deployed, description and material of the products, their country of origin (CoC), purchase details, lead values and photographs.

The FDA letter also emphasizes that retailers and distributors are responsible for ensuring the safety of their food contact products and compliance with all FDA regulations. It encourages economic operators of cookware products made from aluminum, brass and aluminum alloys to confirm that their products do not leach lead into food. Various testing methods for leachable lead are available, or there is the FDA’s lead leach testing protocol. To modify for cookware, the extraction conditions include a two-hour boil followed by cooling and holding at room temperature for a total of 24 hours, instead of a 24-hour extraction at 22 °C ± 2 °C as indicated in the original protocol.

It is important to note that 21 U.S.C. 342(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits the sale of an adulterated product and the FDA will take appropriate action when products in violation of the rules are found on the US market.

SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. Our technical experts have extensive experience of testing materials and articles for many markets. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Our experience can ensure your products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance. Contact us to know more or visit our website. In the end, it’s only trusted because it’s tested.

© SGS Société Générale de Surveillance SA. This publication or website is a property of SGS Société Générale de Surveillance SA. All contents including website designs, text, and graphics contained herein are owned by or licensed to SGS Société Générale de Surveillance SA. The information provided is for technical and general information purposes only and offers no legal advice. The information is no substitute for professional legal advice to ensure compliance with the applicable laws and regulations. All information is provided in good faith “as is”, and SGS Société Générale de Surveillance SA makes no representation or warranty of any kind, express or implied, and does not warrant that the information will be error-free or meet any particular criteria of performance or quality.

For further information, please contact:

HingWo Tsang

Dr. Hingwo

Tsang

Global Information and Innovation Manager
Melanie Tamayo

Melanie

Tamayo

Senior Technical Manager, SGS NA

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