Opiates and poppy seeds: CSPI sues FDA for failing to protect consumers

Agency has failed to respond to petition filed more than three years ago

The Center for Science in the Public Interest is suing the Food and Drug Administration for failing to act on a regulatory petition asking the agency to protect consumers from poppy seeds contaminated with dangerous levels of opiates.

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

Poppy seeds used in baking come from the same plant that produces opiates, including morphine and codeine. The poppy plant cannot be legally grown in the United States, so all poppy seeds sold in this country are imported from countries where cultivation is permitted. 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.

While reputable manufacturers process poppy seeds, some companies unintentionally fail to properly process the seeds and others intentionally market contaminated seeds using coded words like “unwashed,” “raw,” or “unprocessed,” evidently intended to draw the attention of consumers seeking opiates. Such seeds can then be used to extract opiates into rinses or teas using instructions found online. Consumers may purchase such products unwittingly or intentionally for intoxication or claimed health benefits, including the treatment of pain, anxiety, and opioid withdrawal. According to CSPI research, at least 19 people have died, and at least 20 people have experienced a non-fatal overdose, after intentionally consuming contaminated poppy seeds.

One 24-year-old Arkansas man, Stephen Hacala, died in 2016 after drinking a tea brewed from a bag of unwashed poppy seeds. His parents, Steve and Betty Hacala, have since been working with CSPI to raise awareness of the problem of contaminated poppy seeds with members of Congress, the Drug Enforcement Administration, state attorneys general, and the FDA. They were among the signatories of the petition filed with the FDA in 2021, and say they are mystified by why it has taken the FDA so long to act.

“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,” said Steve Hacala. “The Food and Drug Administration 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.”

While some consumers have sought out unwashed or unprocessed poppy seeds, others have been harmed by unwittingly consuming poppy seeds in baked goods. Elizabeth Dominguez of New York tested positive for morphine in the hospital in 2019 prior to giving birth. She was surprised by the result, not having used opioids during her pregnancy. But she did have an everything bagel with poppy seeds the morning of the test. As a result of the positive test, Dominguez was temporarily separated from her newborn and visited at home multiple times by Child Protective Services.

“Who could imagine that what you ate for breakfast could trigger such a terrible outcome,” Dominguez said. “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.”

Jamie Silakowski had a similar experience in the hospital in 2018 prior to giving birth to her son. She recalls having eaten lemon poppy seed bread before heading to the hospital. Silakowski and Dominguez, like the Hacalas, were also among the petitioners to FDA in 2021.

Under a federal law known as the Administrative Procedure Act, agencies such as the FDA are required within a reasonable amount of time to issue a final decision granting or denying a petition. The lawsuit filed today asks the United States District Court for the District of Columbia to order the FDA to provide a definitive response within 60 days of the court’s decision.

“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,” said CSPI senior litigation director Lisa Mankofsky.

While the FDA has not yet granted or denied the 2021 petition, the Department of Justice has conducted several criminal prosecutions for selling unwashed poppy seeds in violation of the Controlled Substances Act. One company, Lone Goose Bakery, run by a Tulsa, OK, couple, sold $12.5 million in unwashed poppy seeds between 2017 and 2020, and in 2020 alone, shipped 46,000 orders for its contaminated products, according to court documents.

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