FDA seeks Feedback on Opiate Alkaloid Content of Poppy Seeds

The FDA issued a Request for Information (RFI) on industry practices related to opiate alkaloid content of poppy seeds. The agency is particularly interested in information about Good Agricultural Practices (GAP). Because these practices may vary depending on the grower or manufacturer and the intended use of the poppy plant (e.g., whether it is grown for food or pharmaceutical purposes), the FDA would like more detailed information about the specific practices and processes from growth of the poppy plant and harvesting of poppy seeds to the processing and manufacturing of poppy seeds and products thereof.

To date, the FDA has received nine reports of deaths purportedly associated with the consumption of homemade poppy seed tea. The cause of death for eight cases was morphine intoxication, often with codeine from poppy seeds and other substances (prescription opioids, benzodiazepines, anticonvulsants, mitragynine (kratom), and cannabis) also involved.

Therefore, the agency is interested in better understanding the agricultural (i.e., growing, harvesting), processing, and distribution practices currently being used, and whether certain practices increase or reduce the presence of opiate alkaloids on poppy seeds.

Moreover, the FDA seeks detailed information on the processes used for poppy plant crops, including types of equipment used and cleaning practices. The agency has also requested information on methods to monitor and control opiate alkaloid levels, such as testing and treatments, and details about the supply chain, including activities conducted during distribution that could reduce or otherwise affect opiate alkaloid content.

The comment period ends on 15 April 2025. For more information please see the Request for Information on Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids.