CSPI files FDA complaint for failing to protect consumers from opiate-contaminated poppy seeds

10 May 2024 --- The Center for Science in the Public Interest (CSPI) is suing the US Food and Drug Administration (FDA) accusing the agency of failing to act on a 2021 regulatory petition asking the FDA to protect consumers from poppy seeds contaminated with alleged dangerous levels of opiates.

CSPI petitioned the FDA in February 2021 with six families impacted by contaminated poppy seeds and two medical experts, asking the agency to set a maximum threshold for opiate contamination and to establish controls on imported poppy seeds. 

Under the US Administrative Procedure Act, the FDA is required to issue a final decision granting or denying a petition “within a reasonable amount of time.” CSPI’s lawsuit asks the court to order the FDA to provide a definitive response within 60 days of the court’s decision. CSPI filed the lawsuit in the US District Court for the District of Columbia.

“The availability of contaminated poppy seeds on the Internet and in grocery stores is contributing to addiction, overdoses and deaths, in addition to other social and economic harms from a failed drug test. Yet, the FDA remains perched on the sidelines,” says Lisa Mankofsky, CSPI senior litigation director.

An FDA spokesperson tells Nutrition Insight: “The FDA does not comment on possible, pending or ongoing litigation. The FDA is reviewing the petition and will respond directly to the petitioner.” 

Source of seed contamination 
Poppy seeds originate from the opium poppy plant — the same plant that produces opiates. Although the seeds naturally contain negligible amounts of opiate alkaloids, other parts of the plant produce substantial amounts, such as morphine, codeine and thebaine. 

Seeds can become contaminated with opiates from the plant’s sap and dust during harvest. Therefore, washing and processing are needed to reduce seeds’ opiate content to safe levels. 

Since the poppy plant cannot legally be grown in the US, all poppy seeds sold are imported from countries where cultivation is permitted. 

The CSPI notes that reputable manufacturers process poppy seeds, but some “unintentionally fail to properly process the seeds.” In contrast, others intentionally market contaminated seeds using coded words like “unwashed,” “raw,” or “unprocessed.” 

Seeds can become contaminated with opiates from the opium plant’s sap and dust during harvest.The organization cautions that these words are intended to draw the attention of consumers seeking opiates. Such seeds can be used to extract opiates with online instructions, for example, into rinses or teas. CSPI asserts that consumers may buy poppy seeds unwittingly or intentionally for intoxication or claimed health benefits, such as treating pain, anxiety or opioid withdrawal. 

The FDA has not granted or denied the 2021 petition, but the Department of Justice has conducted several criminal prosecutions for selling unwashed poppy seeds. According to the US Drug Enforcement Administration, selling opiate-contaminated poppy seeds is illegal under the Controlled Substances Act. 

Last year, the company Lone Goose Bakery was charged with an opium seed drug conspiracy, resulting in the death of a Utah woman. The company reportedly sold US$12.5 million in unwashed poppy seeds between 2017 and 2020. 

Safety risks 
At the time of its petition to the FDA, CSPI conducted a study on exposure to opiate-laced poppy seeds with the Connecticut Poison Control Center. Data from the American Association of Poison Control Centers’ National Poison Data System suggested that intentional exposures to contaminated poppy seeds increased in the US between 2000 and 2018. During that period, the study identified 591 exposure cases, including 392 in people aged 13 or older. 

The study also found that at least 19 people have died and that at least 20 people experienced a non-fatal overdose after intentionally consuming contaminated poppy seeds. 

One of the families who joined CSPI in their 2021 petition, Steve and Betty Hacala, lost their son after he drank a tea brewed from a bag of unwashed poppy seeds. 

“We hope to spare other families the pain and heartache we experienced after losing our son to a common food product most of us assume to be safe,” says Hacala. “The FDA has known about the problem of contaminated poppy seeds for many years. We are disappointed that the agency has failed to take action to protect consumers and fear that every additional day of delay increases the likelihood that more Americans will be killed or injured by these contaminated products.”

Poppy seeds are also used in baked goods, such as bagels and bread.Poppy seed baked goods 
Two women who joined the 2021 petition both tested positive for opiates before giving birth after eating poppy seed baked goods. 

Elizabeth Dominguez tested positive for morphine after having a bagel with poppy seeds the morning of the test while not having opioids during her pregnancy. After the test, she was temporarily separated from her newborn and received several visits by Child Protective Services. 

“Who could imagine that what you ate for breakfast could trigger such a terrible outcome,” says Dominguez. “I think the FDA owes it to all Americans who might have muffins, bagels or other foods with poppy seeds to ensure that these products are not contaminated with opiates.”

In its lawsuit, CSPI refers to research by the European Food Safety Authority, which tested 1,164 poppy seed samples from ten countries between 2012 and 2017, detecting morphine contamination levels of a mean of 57.8 mg per kg and a maximum of 596 mg per kg. An average consumer would only need to consume 12 g of poppy seeds at this mean level of contamination to reach the Acute Reference Dose for morphine. 

Last year, CSPI supported the reintroduction of the Stephen Hacala Poppy Seed Safety Act by three US senators, directing the FDA to set limits for opiates in the seeds. This act would direct the FDA to set contamination limits on poppy seeds. 

By Jolanda van Hal