FDA denies request to limit levels of opiate contamination in poppy seeds

Statement of CSPI Director of Regulatory Affairs Sarah Sorscher

In a letter sent today to Center for Science in the Public Interest (CSPI), the Food and Drug Administration is denying the group’s citizen petition asking for maximum limits on opiate contamination in poppy seeds, pointing to lack of information and resources. 

CSPI submitted the petition in 2021 on behalf of a group of consumers injured by contaminated seeds. Seeds from poppies, particularly those that have been specially bred for pharmaceutical use, can be highly contaminated with opiates like morphine and codeine that are present in the sap (but not the seeds) of the poppy plant. While not lethal in the amounts typically consumed, when large amounts of seeds are steeped in hot water as a tea, sometimes with added acidic agents like lemon juice, the concentrated opiates can reach levels high enough to trigger dependence, overdose, and death. CSPI has documented at least 19 fatalities and 20 non-fatal overdoses from poppy tea in a peer-reviewed medical journal article. 

In addition, baked goods made with contaminated seeds can lead to opiate levels in the blood high enough to trigger positive drug tests, leading the Department of Defense to warn service members to avoid eating foods that contain poppy seeds. Families have been reported to child services after mothers who consumed poppy seeds in baked goods tested positive in routine hospital screenings; others have been accused of parole violations. 

In May 2024, CSPI filed suit against FDA, alleging that the agency had unreasonably delayed responding to our petition. The suit succeeded in getting the agency to commit to respond to the petition by February 28, 2025. That response was the letter issued today. 

In its letter, the FDA cited lack of information and resources as reasons for denying the petition. But the side effects of opiates are already well understood, and, in 2021, the European Union found information adequate to establish safe limits for opiate contamination in poppy seeds and has issued a guidance advising the food industry on best practices to reduce contamination. FDA’s inability to set a standard is evidently mainly due to the dysfunction of the agency’s food program and its lack of resources, more than any shortcoming in the science. 

The denial letter noted that FDA has detected levels of morphine in poppy seeds ranging up to 520 milligrams per kilogram (median: 70 mg/kg), and codeine levels up to 255 milligrams per kilogram (median: 85 mg/kg). These are well in excess of the level of 20 milligrams per kilogram considered safe in poppy seeds by European authorities. These levels are also concerning given that doctors can prescribe a therapeutic dose of morphine starting at 10 milligrams, and codeine at 15 milligrams. 

Today’s action now can be added to the long list of examples of FDA failing to do its job by ensuring our food system is free of dangerous chemicals. It’s a sad state of affairs when our primary food regulator is so broken that it cannot do something as basic as put a limit on the amount of controlled narcotics in our food.