WASHINGTON -- The U.S. Food and Drug Administration is accusing a Utah-based business of breaking federal law by selling poppy seed tea online for medicinal purposes.
The FDA sent a warning letter to Devin Michael Tew in South Jordan, Utah, south of Salt Lake City, telling him that his business, PoppySeedWash.com, is peddling an unlicensed drug in violation of the Federal Food, Drug, and Cosmetic Act.
Poppy Seed Wash has portrayed its product as a miracle product. Poppy seeds "reduce heart issues ... treat pain," improve skin, counteract constipation and assist with cancer treatment, it states on one of its social media accounts.
Tew did not respond to a telephone call and an email Tuesday afternoon seeking comment.
The website had recently been updated to remove many of the medical claims about the product.
News that the FDA is taking action was welcomed Tuesday by an Arkansas man whose son died after drinking poppy seed tea.
"It's my hope and expectation that this is just the first step in a series of additional actions," said Steve Hacala of Rogers.
Federal law includes poppy seeds on a list of "spices and natural seasonings" and are "generally recognized as safe for their intended use."
But Poppy Seed Wash is portraying its product as medicine, the FDA wrote in its July 12 letter.
"The claims on your product label and websites establish the product is a drug" because it is "intended for use in the cure, mitigation, treatment or prevention of disease," the letter stated.
"Your Poppy Seed Wash product is not generally recognized as safe and effective for the above referenced use and, therefore, the product is a 'new drug,'" the letter states. New drugs "may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA. ...FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective."
Unwashed poppy seeds -- in large enough quantities -- can be toxic, researchers say.
Stephen Patrick Hacala Jr., a gifted guitarist and a 2013 University of Arkansas graduate, had purchased a 5-pound bag of unwashed poppy seeds from Amazon.com shortly before his death.
He was 24 years old.
The April 3, 2016, death was attributed to a morphine overdose resulting from poppy seed tea consumption.
A 2017 paper, published in the Journal of Forensic Sciences, notes that "opium poppy and poppy straw are listed as Schedule II controlled substances in the United States, along with morphine and codeine. Opium poppy seeds are not currently scheduled. They are recognized as safe for human consumption by the FDA."
While washed seeds are safe, unwashed seeds are often contaminated, coated with morphine, codeine and other matter, it states.
Unwashed seeds can be purchased "with no current legal repercussions or regulations," the paper noted. But brewing poppy seed tea "can have fatal consequences."
In April, Steve Hacala and his wife, Betty, traveled to Washington and urged federal officials to crack down on poppy seed sales.
The Hacalas met with FDA officials and with James W. Carroll Jr., acting director of the Office of National Drug Control Policy.
They visited with U.S. Sen. Tom Cotton as well.
The Republican from Dardanelle gave a speech on the Senate floor highlighting the dangers caused by unwashed poppy seeds and calling on federal officials to address the problem.
He also reached out to Walmart Inc., urging the company to stop selling poppy seeds that are classified as "unwashed." The Bentonville retailer quickly agreed.
Since then, other companies have come on board.
Arkansas Attorney General Leslie Rutledge recently announced that eBay, Bonanza and Etsy would no longer be selling poppy seeds that are labeled as unwashed.
Hacala hopes that additional steps will follow.
"Until the industry or regulators can put in place appropriate standards ... it's our feeling that those [unwashed] poppy seeds ought to be put back on the controlled substance schedule and removed from the marketplace," he said.
The goal, he said, is to save lives.
"That's what we're all working towards," he said. "I'm hopeful and optimistic that this is just the start."
Metro on 08/15/2018