FDA Extends Comment Period on Poppy Seeds to June 16

The U.S. Food and Drug Administration (FDA) is extending the comment period for the Request for Information (RFI) on industry practices related to poppy seeds that appeared in the Federal Register on Jan. 15.

The FDA is extending the comment period by 60 days, until June 16, to allow interested persons additional time to submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2021-P-0168.

The agency is interested in better understanding the agricultural, industry, manufacturing and supply chain practices currently being used, and whether certain practices increase or reduce the presence of opiate alkaloids on poppy seeds.

The FDA is taking action in part because it has received reports of adverse events related to the use of poppy seed products. The scientific literature and FDA’s preliminary surveillance sampling show that poppy seeds may have varying amounts of opiate alkaloids and that opiate alkaloids may be present on poppy seeds or in poppy seed-containing foods. Opiate alkaloid exposure has been associated with a range of adverse effects, including unusual dizziness or lightheadedness, respiratory arrest, and, in some cases, even death. 

The FDA seeks detailed information on the growing, harvesting and post-harvest 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.