FDA Requests Information on Poppy Seeds

The U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on industry practices related to poppy seeds. The FDA 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 this action, in part, because the agency has received reports of adverse events related to the use of some 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.

The FDA intends to use information to help determine what type(s) of actions, if any, the agency should take to help ensure that poppy seed products do not pose a health risk when consumed. The FDA said it is committed to helping to ensure that poppy seeds are not harmful when consumed.

Comments can be submitted via the Federal eRulemaking Portal to Docket No. FDA-2021-P-0168. Follow the instructions for submitting comments. All comments must be submitted 90 days after the date of publication in the Federal Register. 

Written comments may be mailed to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Ensure that all comments include Docket No. FDA-2021-P-0168. Confidential submissions should be appropriately marked.