November 19, 2010
This guidance is being issued because the FDA has received reports from local and state agencies that traditional pottery from several manufacturers in Mexico labeled as "lead free" in fact contains levels of extractable lead comparable to levels that may be found in lead-glazed pottery. In some cases, the levels of extractable lead exceed limits specified in FDA guidelines. FDA's own investigations have confirmed some of these reports.
The lead contamination may arise when potters convert from using lead glaze to using non-lead glaze and do not implement measures to ensure that their equipment and production facilities, which may be contaminated with lead from longstanding use, do not contaminate their new pottery.
In the guidance, the FDA lists several key production practices to ensure that lead contamination of new production ware will not occur and recommends that those involved in the manufacture, importation and distribution of traditional pottery for sale in the United States ensure that the pottery has been produced in a manner that is free from contamination with avoidable lead.
Recommended production practices include:
Using separate facilities for the production of lead glazed and non-lead glazed ware
Establishing good manufacturing practices to ensure that lead is not introduced into a production area used to produce non-lead glazed ware
Ensuring that kilns being converted for firing non-lead glazed ware have been retrofitted; for example, insulation has been replaced to eliminate lead contamination from past use of the kiln to fire lead-glazed ware
Training employees in good manufacturing practices applicable to the production of pottery to avoid lead contamination
The FDA also states in the guidance that if either lead glazed or non-lead glazed pottery contains extractable lead and is labeled as "Lead Free," FDA may regard the ware to be subject to regulatory action under the misbranding provisions of law.
In the guidance, the FDA also reminds manufacturers of the existing requirements that ornamental and decorative ceramicware not intended for food use that contain unsafe levels of extractable lead be permanently labeled using a specified statement such as "Not for Food Use – May Poison Food."
Though FDA's guidance addresses issues that have arisen with traditional pottery made with non-lead glaze, most traditional pottery is still made with lead glaze and if improperly made, can be a source of excessive lead exposure for consumers. The FDA has partnered with several federal and state health agencies to make information available to the public in English and Spanish about reducing risks for lead poisoning associated with traditional ceramicware. This information is available at:
- Consumer Update: Some "Lead-Free" Pottery Can Still Taint Food
- Questions and Answers on Lead-Glazed Traditional Pottery