FDA to set standard for opiate contamination in poppy seeds

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Statement of Sarah Sorscher, Director of Regulatory Affairs
Last Monday, June 30, the Food and Drug Administration announced it is developing a guidance to set action levels limiting opiate contamination in poppy seeds, a move long urged by consumer advocates.
After years of delay, it’s good news to see the FDA finally moving forward with a commonsense standard. No one thinks it’s a good idea to have deadly pharmaceuticals in the food supply, yet it’s taken years for FDA to take action. We urge the FDA to set clear, science-based limits, as the European Union has already done.
Poppy seeds used in baking come from the same plant species that produces pharmaceutical opiates, including morphine and codeine. These opium poppies cannot be legally grown in the United States, so all poppy seeds sold in this country are imported. While the seeds themselves contain negligible amounts of opiates, they can be contaminated by other parts of the plant and require washing and processing to reduce opiate contamination to safe levels.
Tea brewed using such contaminated seeds can produce intoxication, addiction, and overdose. According to research by Center for Science in the Public Interest (CSPI), by 2021, at least 19 people had died, and at least 20 people had experienced a non-fatal overdose after intentionally consuming contaminated poppy seeds. CSPI, along with medical experts and six families injured by contaminated poppy seeds, petitioned the FDA in 2021 to set standards for opiate contamination in poppy seeds. Two of the co-signatories to that petition were Steve and Betty Hacala, whose son Stephen died from an overdose due to poppy seed tea. The agency denied that petition in January of this year after CSPI sued the agency for response, instead issuing a request for more information in February of this year. Now the agency has announced it is finally moving forward with a draft guidance that will set an action level effectively limiting opiate contamination in seeds. It expects to be completed by December 2025.
FDA has detected levels of morphine in poppy seeds ranging up to 520 milligrams per kilogram and codeine levels equivalent to up to 255 milligrams per kilogram of morphine, well in excess of the level of 20 milligrams per kilogram for opiate alkaloids considered safe in poppy seeds by European authorities.
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