Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2021-P-0168]</DEPDOC> <SUBJECT>Growing, Harvesting, Processing, and Distribution of Poppy Seeds—Industry Practices Related to Opiate Alkaloids; Request for Information</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice; request for information. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is requesting information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. We are taking this action, in part, because we have received reports of adverse events related to the use of some poppy seed products. We intend to use the information to help determine what type(s) of actions, if any, we should take to help ensure that poppy seed products do not pose a health risk when consumed. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the notice must be submitted by April 15, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments and information as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 15, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2021-P-0168 for “Growing, Harvesting, Processing, and Distribution of Poppy Seeds—Industry Practices related to Opiate Alkaloids; Request for Information.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Jesse Lunzer, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2879, or Holli Kubicki, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> FDA is requesting information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. The opium poppy ( <E T="03">Papaver somniferum</E> ), or the “poppy plant,” is cultivated for food use, decorative use, ornamental use, and medicinal purposes. In the poppy plant, seeds grow inside an enclosed round fruit that is often referred to as a “capsule” or “seed capsule.” The poppy plant produces substances, including alkaloids, to maintain the biological processes needed to grow and reproduce. Morphine, codeine, and thebaine are alkaloids produced by poppy plants and are referred to as opiate alkaloids. 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 may cause a range of side effects, including unusual dizziness or lightheadedness, sedation, extreme sleepiness, slowed or difficult breathing, unresponsiveness, respiratory arrest, and, in some cases, death. Reports of adverse events associated with poppy seed consumption have also garnered concern among citizens and consumer groups such as the Center for Science in the Public Interest (Ref. 1). FDA is aware that some consumers have used poppy seeds to produce a “poppy seed tea” that has been linked to serious adverse events, including death. “Tea” is a misnomer, as the beverage is a solution that results from rinsing the opiate alkaloid-containing latex residue from the outer hull of the poppy seeds using cold water, and not an infusion created by steeping the seeds in hot water. To date, 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. FDA's efforts to expand our understanding of opiate alkaloids on poppy seeds and consumer behaviors related to poppy seed consumption include surveillance sampling and testing poppy seeds from marketed products to determine their opiate alkaloid content. Twenty-one samples taken from poppy seeds purchased online showed morphine levels between 1 milligram per kilogram (mg/kg) and 520 mg/kg (median 70 mg/kg; mean 120.4 mg/kg) and codeine levels between 0.8 mg/kg and 255 mg/kg (median 85 mg/kg; mean 113.1 mg/kg). We also have been examining agricultural and manufacturing practices related to poppy seeds and are interested in learning whether there are agricultural or manufacturing practices that might reduce the presence of the opiate alkaloids on poppy seeds. Our current understanding is that most opiate alkaloids on poppy seeds are deposited on the seeds by means of contact with liquid or dried latex that may occur through pod/capsule damage and/or particulate latex-derived dust through growing, harvesting, and processing practices (Refs. 2-4). Because these practices may vary depending on the grower or manufacturer and the intended use of the poppy plant ( <E T="03">e.g.,</E> whether it is grown for food or pharmaceutical purposes), we 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 poppy seed food products in the market ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 24k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━