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[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3873-3876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00757]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-P-0168]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: 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.

DATES: Either electronic or written comments on the notice must be 
submitted by April 15, 2025.

ADDRESSES: You may submit comments and information as follows. Please 
note that late, untimely filed comments will not be considered. The 
https://www.regulations.gov 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.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): 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.''
    Instructions: 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 ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov 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 https://www.regulations.gov. 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: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION:

I. Background

    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 (Papaver 
somniferum), or the ``poppy plant,'' is cultivated for food use, 
decorative use, ornamental use, and

[[Page 3874]]

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.g., 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 marketplace.
    Accordingly, we are seeking additional information on industry 
practices, such as information about the poppy seed supply chain and 
harvesting, handling, and testing practices, as well as manufacturing, 
processing, or other practices available and in use by industry to 
reduce or otherwise affect the opiate alkaloid content of poppy seeds. 
This information would help FDA understand existing industry practices 
and determine what type(s) of actions, if any, we should take to help 
to ensure that poppy seed products do not pose a health risk when 
consumed.

II. Issues for Consideration and Request for Information

    We invite comment in response to the questions below. Please 
explain your answers and provide references and data, if possible. 
Including contextual information about your role(s) in the poppy seed 
industry (e.g., grower, importer, retailer) would also be helpful.

A. Questions About Growing, Harvesting, and Post-Harvest Processes of 
Poppy Plant Crops and Poppy Seeds

    As background, a poppy plant's production of opiate alkaloids 
varies based on certain environmental, biological, and inter-cultivar 
genetic variation. In addition, we are aware that agricultural 
practices that occur during poppy plant growth may impact opportunities 
for opiate alkaloid-containing latex to be deposited on seeds (Refs. 2-
5 and 9).
    Dried mature poppy plants are commonly harvested by using 
mechanized harvesting machinery that cuts and removes the above-ground 
plants after the plants have died and dried out in the field (Refs. 6-
9). We want to learn about the types of harvesting practices and 
machinery used, because harvesting dried plants can result in the 
production of opiate alkaloid-containing dust or particulate plant 
tissue that may be deposited on the seeds (Ref. 9).
    We also are aware of some practices that are used to separate seeds 
from the seed capsules. For example, firms might use threshing 
machines, which crush the capsules and release the seeds. Other 
practices involve use of sieves, gravity tables, or other cleaning 
machines intended to separate the seeds from debris (such as small 
fragments of capsules, stems, or rocks) by shaking or blowing air 
through a permeable surface and separating plant material by size (Ref. 
8). Opiate alkaloids might be transferred to the outer surface of poppy 
seeds during various harvesting and post-harvesting steps.
    Question 1: Please tell us about the growing, harvesting, and post-
harvest processes used to produce poppy plant crops and seeds and what 
types of equipment are used for these processes. What, if any, are the 
different processes used for different geographic areas where the 
plant(s) are grown and why are the different processes used? We are 
particularly interested in information about good agricultural 
practices, scoring or nicking pods, harvesting procedures, cleaning and 
separation of plant parts, opiate alkaloid testing method and 
frequency, thermal treatments (e.g., to degrade opiate alkaloids), 
packaging, cleaning of equipment, frequency of cleaning, and storage.
    Question 2: Do buyers of poppy plants request specific varieties or 
cultivars based on the amount of opiate alkaloid produced by the 
variety or cultivar? If so, what are the specific varieties or 
cultivars and, if known, what are the preferred uses for these 
varieties or cultivars, and why are those varieties or cultivars 
preferred?
    Question 3: What types of equipment (e.g., agricultural threshers, 
combines, cultivators, other equipment) are used for harvesting poppy 
plants? FDA is aware that machine harvesting can result in opiate 
alkaloids being deposited on poppy seeds (Ref. 9). Please elaborate on 
style, model, settings, etc.
    Question 4: What practices are used to monitor, control, reduce, or 
otherwise affect poppy seed opiate alkaloid content, such as opiate 
alkaloid testing or poppy seed heat treatments (Refs. 10-12)? We are 
particularly interested in information on the types of practices to 
reduce opiate alkaloids and frequency of

[[Page 3875]]

use of the practices, as well as any evidence of their impact on the 
opiate alkaloid content of poppy seeds and the quality of the seeds.

B. Questions About Poppy Seed Supply Chain

    We also seek information about distribution chains of poppy seeds 
and activities conducted during distribution (for example, opioid 
alkaloid testing and poppy seed heat treatment). Poppy seeds might be 
sourced from poppy plants that are grown solely for food use. In 
addition, seeds from poppy plants that are grown for pharmaceutical 
purposes might be sold for human food consumption (Refs. 4 and 6). 
Thus, FDA also wants to better understand the practices of companies 
that sell poppy capsules and seeds from plants grown for pharmaceutical 
purposes to entities involved in food manufacturing and distribution, 
at all points in time from the growth of poppy plants to the sale of 
poppy seeds. Cultivars grown for pharmaceutical purposes may produce 
higher opiate alkaloids compared to cultivars grown solely for food 
use, which may result in higher opiate alkaloid content on seeds. These 
cultivars and their seeds might be more affected by the practices 
involved in growing, harvesting, processing, and distribution.
    Question 5: What are the various intermediaries and processes that 
are part of the supply chain for poppy seeds? Please include 
information about what intermediaries (such as brokers, exporters, 
importers, consolidators, manufacturers, and retailers) and processes 
(such as opiate alkaloid testing, testing frequency, packing, sale, and 
transportation) might be involved at various stages throughout the 
poppy seed supply chain.
    Question 6: What activities are performed in the distribution 
chains of poppy seeds? For example, do distributors or wholesalers 
engage in opioid alkaloid testing and heat treatments of poppy seeds? 
If so, what types of testing, treatments, or other activities are 
performed and how frequently are such activities performed?
    Question 7: Describe the role of any brokers or other intermediary 
distributors that sell poppy seeds between pharmaceutical companies (or 
poppy plants grown for pharmaceutical use) and food manufacturers. Do 
brokers or other intermediary distributors request poppy seeds from 
specific cultivars of poppy plants? If so, what are these specific 
cultivars?
    Question 8: Do brokers or other intermediary distributors typically 
sell poppy seeds direct to retailers or individual consumers? What 
additional precautions or steps are taken when selling directly to 
retailers or consumers?

C. Questions About Processing and Manufacturing From Poppy Plants to 
Poppy Seeds

    We want additional information about other post-harvest practices 
conducted by manufacturers to control or reduce, or that may otherwise 
affect, poppy seed opiate alkaloid content, such as if opiate alkaloid 
testing (at any point) or poppy seed heat treatments are performed 
(Refs. 10-12). More information on the types of practices to reduce 
opiate alkaloids and frequency of the practices, as well as any 
evidence on their impact on the opiate alkaloid content of poppy seeds 
and the quality of the seeds, would be useful.
    Question 9: What manufacturing processes are used to manufacture 
poppy seed food products and what processes are applied to reduce poppy 
seeds' opiate alkaloid content? Information about any processes, such 
as initial inspection, cleaning or separation of plant parts, mixing, 
crushing, blending, treatments such as heating or washing, drying, 
cleaning of equipment, cleaning frequency, packaging, testing, testing 
type, and transportation, used to process poppy seeds and manufacture 
poppy seed products would be useful.
    Question 10: When using contract growers or otherwise procuring 
seeds, what specific varieties, cultivars, characteristics (e.g., 
color, aroma, opiate alkaloid levels), or other specifications are 
typically required for food use?
    Question 11: If you are a manufacturer of poppy seeds or poppy seed 
products, what types of customers (e.g., manufacturers of other 
products, retailers, individual customers) do you sell to? What 
additional precautions or steps, if any, are taken when selling to 
various customers?
    Question 12: If you are a manufacturer of poppy seeds or poppy seed 
products, what types of sellers (e.g., manufacturers of other products, 
growers, other sources) do you buy poppy seeds from? What additional 
precautions or steps, if any, are taken when buying from various 
sellers?

III. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

*1. Center for Science in the Public Interest Citizen Petition, 
February 5, 2021, Docket No. FDA-2021-P-0168).
*2. BfR (Bundesinstitut f[uuml]r Risikobewertung--Federal Institute 
for Risk Assessment), 2005. ``BfR Recommends Provisional Daily Upper 
Intake Level and a Guidance Value for Morphine in Poppy Seeds.'' BfR 
Health Assessment No. 012/2006, 27 December 2005. Available at 
http://www.bfr.bund.de/cm/245/bfr_recommends_provisional_daily_upper_intake_level_and_a_guidance_value_for_morphine_in_poppy_seeds.pdf (accessed September 13, 2024).
*3. European Food Safety Authority (EFSA) Panel on Contaminants in 
the Food Chain (CONTAM). ``Scientific Opinion on the Risks for 
Public Health Related to the Presence of Opium Alkaloids in Poppy 
Seeds.'' EFSA Journal, 9(11):2405, 2011. Available at https://doi.org/10.2903/j.efsa.2011.2405 (accessed September 13, 2024).
*4. EFSA Panel on Contaminants in the Food Chain (CONTAM), et al. 
``Update of the Scientific Opinion on Opium Alkaloids in Poppy 
Seeds.'' EFSA Journal, 16(5):e05243, 2018. Available at https://doi.org/10.2903/j.efsa.2018.5243 (accessed September 13, 2024).
*5. European Union ``Commission Recommendation of 10 September 2014 
on Good Practices to Prevent and to Reduce the Presence of Opium 
Alkaloids in Poppy Seeds and Poppy Seed Products.'' 2014/662/EU. 
Official Journal of the European Union, L271/96. Available at 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2014.271.01.0096.01.ENG&toc=OJ%3AL%3A2014%3A271%3ATOC (accessed September 13, 2024).
*6. Fist, A.J. ``The Tasmanian Poppy Industry: A Case Study of the 
Application of Science and Technology.'' Proceedings of the 
Australian Agronomy Conference. 2001. Available at https://nla.gov.au/nla.obj-1382338968/view (accessed September 13, 2024).
7. Martinov, M. and M. Konstantinovic. ``Chapter 2: Harvesting,'' in 
Medicinal and Aromatic Crops: Harvesting, Drying, and Processing. 
[Ouml]ztekin, S., Martino, M., The Hawthorn Press, Inc. 2007.
8. Fej[eacute]r, J. and I. Salamon. ``Agro-Technology of the Poppy: 
Large-Scale Cultivation in Slovakia.'' International Symposium on

[[Page 3876]]

Papaver 1036. 2014.
9. Montgomery, M.T., X.A. Conlan, A.G. Theakstone, et al. 
``Extraction and Determination of Morphine Present on the Surface of 
Australian Food Grade Poppy Seeds Using Acidic Potassium 
Permanganate Chemiluminescence Detection.'' Food Analytical Methods, 
13(5):1159-1165, 2020. Available at https://doi.org/10.1007/s12161-020-01729-z (accessed December 8, 2024).
10. Lo, D. and T. Chua. ``Poppy Seeds: Implications of 
Consumption.'' Medicine, Science and the Law, 32(4):296-302, 1992. 
Available at https://doi.org/10.1177/002580249203200403 (accessed 
December 8, 2024).
11. Sproll, C., R.C. Perz, R. Buschmann, et al. ``Guidelines for 
Reduction of Morphine in Poppy Seed Intended for Food Purposes.'' 
European Food Research and Technology, 226(1):307-310, 2007. 
Available at https://doi.org/10.1007/s00217-006-0522-7 (accessed 
December. 8, 2024).
12. Shetge, S.A., M.P. Dzakovich, J.L. Cooperstone, et al. 
``Concentrations of the Opium Alkaloids Morphine, Codeine, and 
Thebaine in Poppy Seeds are Reduced After Thermal and Washing 
Treatments But Are Not Affected When Incorporated in a Model Baked 
Product.'' Journal of Agricultural and Food Chemistry, 68(18):5241-
5248, 2020. Available at https://doi.org/10.1021/acs.jafc.0c01681 
(accessed December 8, 2024).

    Dated: January 8, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00757 Filed 1-14-25; 8:45 am]
BILLING CODE 4164-01-P
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