About 160 people this summer reportedly fell ill after eating mushroom-laced candy and chocolate bars that are widely available at vape and smoke shops, underscoring the dangers of a sprawling market of psychoactive products that pop up on store shelves without any review or regulation. . United States.
Two deaths now under investigation may be related to the candy, samples of which were found to contain an illegal form of psilocin, an ingredient in so-called magic mushrooms, according to federal health officials.
More than a third of those who became ill required hospitalization, suffering symptoms ranging from vomiting to loss of consciousness, seizures and hallucinations.
The illnesses were found in Diamond Schrumz chocolates and gummies, which the company recalled on June 28, officials said. Since then, the Food and Drug Administration has said That it was aware that the candy continued to be sold, and the agency released a list of about 2,300 stores it said carried the products.
Those items and other snacks, supplements and teas that promise a mind-altering experience often contain ingredients like the synthetic delta-8-THC, or kratom, botanical, which the FDA considers dangerous.
They are usually sold in stores and do not have to meet quality standards, nor do they prohibit sales to minors.
For decades, the FDA has had limited oversight of food and dietary supplement ingredients.
And officials are faced with increasingly limited resources — and a cumbersome process for identifying dangerous drugs — as social forces, including the widespread acceptance of marijuana, are creating more interest in potentially dangerous treatments.
“People go in and get these products out there, they’re like, ‘Well, it’s legal, it’s for sale, and should be safe, right?’ Caitlin Brown, clinical managing director of the Poison Centers of America, which traced the first cluster of illnesses to Diamond Schrumz candy, added that many of the products “are not what they say they are.”
Centers for Disease Control and Prevention Two samples were tested Found a mixture of gummies and mushrooms as described on the product label. But it turned up an illegal drug that wasn’t listed: psilocin, a powerful hallucinogen that. Classified by No Accepted medical use and high potential for abuse.
The FDA said it found psilocinIn four of the 22 Diamond Schrumz chocolate bars, an ingredient found in mushrooms along with psilocybin. In three bars, the agency also said it had identified pregablin, a drug sold as Lyrica that is prescribed to treat nerve pain and seizures, but can make people sleepy or dizzy. The FDA said it is not known how these and other substances in the candy interact inside the human body.
Prophet Premium Blends, the California company that recalled the candy, Its website states that the product contains High levels of an ingredient found in a type of mushroom. The company did not respond to requests for comment.
Some people who focus on safety in the smoke shop-snack business have raised other concerns. Christopher Hudala, a chemist and president of Proverde Laboratories, which tests products for the cannabis industry, said he has become increasingly concerned by the number of companies selling Delta 8 products with unknown molecular compositions.
After his reports issued warnings that those products were “not safe for human consumption,” his cannabis customers left his company, he said.
“The younger population, they think these synthetic drugs are safe because they come from safe starting materials,” such as hemp, Dr. Hudalla said. Contaminants can be dangerous, he said, but “most of them won’t kill you.”
An FDA spokeswoman said the agency is “also concerned that companies are manufacturing delta-8-THC in ways that could result in products with harmful contaminants.”
Sellers of kratom maintain that herbal products containing plant-based ingredients are safe. But Mac Haddow, senior fellow for public policy for the American Kratom Association, said he would like to see federal restrictions imposed on synthetic products that amplify the active ingredient in kratom, known as 7-hydroxymitragnine.
“It absolutely puts you in a situation where it’s potentially addictive and has the potential for respiratory depression,” Mr Haydow said.
The FDA stated that kratom, whether botanical or synthetic, “is not legally marketed in the US as a drug product, dietary supplement, or traditional food ingredient.”
Delta 8 is also not approved by the FDA for use in any context, including food, the spokesperson said.
The FDA has limitations in its authority to regulate dietary supplements — including candy. For example, food companies are not required to notify the agency when they introduce new ingredients. Instead, companies are allowed to convene a panel of experts to certify that a new ingredient is generally considered safe.
But Dr. Peter Cohen, a Harvard Medicine associate professor who studies agency oversight of dietary supplements, pointed out that even the expert panel step could be skipped. FDA Guidance documents say A single expert can certify an ingredient as safe in many cases, he noted.
“It’s crazy,” he said. “I don’t know how this position aligns with the FDA’s public health mission.”
The FDA said food manufacturers are “responsible for marketing safe foods” and must support the safety of their ingredients with science. Also said The agency rejected the application Delta 8 is known to be safe.
Food ingredient standards have carried over into regulations governing dietary supplements, said Scott Bass, chairman of the Sidley Austin Life Sciences Group, which helped draft the 1994 dietary supplement law.
He intended to create a system where the FDA would conduct a substantive review of a new ingredient, with rare exceptions, such as when an ingredient is already present in a food. But he said consultants for manufacturers of dietary supplements tell companies that if they put an ingredient in food for six or more months, they can argue that it is generally safe.
Then they bypass agency review, use the ingredient in a dietary supplement, and start increasing sales. “I call it the exemption that swallowed the rule,” Mr. Bass said.
The FDA said it does not have the authority to approve dietary supplements, but it can address unsafe products by recalling products or removing dangerous products from the market.
Against that backdrop, some companies introduce new ingredients into products with little evidence of their safety. Others are willing to use questionable ingredients and face the risk that the FDA will later issue warning letters, said Jensen Joss, a lawyer at the Center for Science in the Public Interest, a nonprofit advocacy group.
“Now the mindset is: ‘Do this, get caught, get a letter’,” he said. “‘Make as much money as we can and then do something else.'”
Prophet Premium Blends, which makes Diamond Shrumz bars, traces its roots to the e-cigarette business before it started selling candy.
Jeff Anne, 38, of Co Chief Executive, As described in the podcast 2020 presented how he became a business owner by selling and brokering marijuana and using cocaine. He described surviving a violent stay in a California prison after robbing a pharmacy; State corrections confirmed he received a two-year prison sentence in 2012 on a second-degree robbery conviction.
Mr. An described his company’s rapid growth in e-cigarette sales after other businesses pulled back in 2019, During an outbreak Lung injuries and deaths have been linked to the ingredient in vaping products. Expanding the company’s sales force at the time was a gamble, he said. “We take very big risks, because there’s a big risk with a very big reward,” Mr. Anne said on the podcast.
The company began shifting to new products, including THC vapes. Mr. An did not respond to emails or calls.
The legalization of marijuana, and, in some places, psychedelic mushrooms, has created a growing comfort with drug use and experimentation, said Dr. Joseph Palamar said.
A A survey of adult substance use A report released last month predicted an increase in cannabis and hallucinogen use in 2023. According to the Monitoring the Future survey, about 9 percent of adults ages 19 to 30 had used hallucinogens, including psilocybin, in the past year. That’s more than double the 4 percent who reported use in 2013.
For the same age group, past-year cannabis use reached 42 percent in 2023, up from about 30 percent a decade earlier.
Dr. Palmer also did considerable documentation Increase Law enforcement seized psilocybin, a powerful hallucinogenic and illegal drug. Their study found that the number of seizures in 2022 was three times higher than in 2017.
The growing diversity of psychoactive drugs in New York City Unlicensed weed shops That, he said, has caught him off guard and called for more regulation.
“Pandora’s box has been opened, and that’s it,” he said. “I think we can only fix this if someone can invent a time machine.”
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