MUSHROOM-LACED CANDY RECALL HIGHLIGHTS F.D.A.’S LIMITED SAFETY ROLE

Nearly 160 people have reportedly been sickened this summer by 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 with no review or regulation across the 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 traced to Diamond Shruumz 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 shops that it said carried the products.

Those items and other snacks, supplements and teas promising a mind-altering experience often contain ingredients like synthetic Delta-8-THC, or kratom, a botanical, that the F.D.A. considers hazardous.

They are commonly sold in stores and do not have to meet quality standards, nor do they carry restrictions on sales to minors.

For decades, the F.D.A. has had limited oversight of food and dietary supplement ingredients.

And officials are increasingly confronting limited resources — and a cumbersome process for identifying dangerous drugs — as social forces, including a wider acceptance of marijuana, are giving rise to more interest in potentially dangerous treats.

“People go in and get these products right there, they’re like, ‘Well, it’s legal, it’s for sale, and must be safe, right?’ ” said Kaitlyn Brown, clinical managing director of America’s Poison Centers, which traced the first cluster of illnesses to Diamond Shruumz candy. She added that many products are not “what they say they are.”

The Centers for Disease Control and Prevention tested two samples of gummies and detected a mix of the mushrooms described on the product label. But it found one illegal drug that was not listed: Psilocin, a potent hallucinogen that is classified by the Drug Enforcement Administration as a Schedule 1 drug, defined as having no accepted medical use and a high potential for abuse.

The F.D.A. said it had detected the psilocin, an ingredient found alongside psilocybin in mushrooms, in four of 22 Diamond Shruumz chocolate bars. In three bars, the agency also said it identified pregabalin, a drug marketed as Lyrica that is prescribed to treat nerve pain and seizures, but that can make people sleepy or dizzy. The F.D.A. said it is not known how these and the other substances in the candy interact inside the human body.

Prophet Premium Blends, the California company that recalled the candy, said on its website that the product had contained a higher level of an ingredient found in one type of mushroom. The company did not respond to requests for comment.

Some of those who focus on safety in the smoke shop-snack business have registered other concerns. Christopher Hudalla, a chemist and president of ProVerde Laboratories, which tests products for the cannabis industry, said he had grown increasingly alarmed by the number of companies selling Delta 8 products with unfamiliar molecular compositions.

After issuing warnings in his reports that those products were “not safe for human consumption,” his cannabis clients dropped his company, he said.

“The younger populations, they think that these synthetic drugs are safe because they come from safe starting materials,” like hemp, Dr. Hudalla said. The contaminants may be risky, he said, but “most of them will not kill you.”

An F.D.A. spokeswoman said the agency is “also concerned that companies are producing Delta-8-THC in ways that could result in products with harmful contaminants.”

Sellers of kratom maintain that botanic products containing plant-based ingredients are safe. But Mac Haddow, a senior fellow on 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, referred to as 7-hydroxymitragynine.

“It completely gets you into a situation where it’s potentially addictive and there’s a potential for respiratory suppression,” Mr. Haddow said.

The F.D.A. said kratom, whether botanical or synthetic, is “not lawfully marketed in the U.S. as a drug product, a dietary supplement, or an ingredient in conventional food.”

Delta 8 has also not been approved by the F.D.A. for use in any context, including in food, a spokeswoman said.

The F.D.A. has limits in its authority to regulate food — including candy — and dietary supplements. For instance, food companies are not routinely required to tell the agency when they introduce novel ingredients. Rather, companies are allowed to convene a panel of experts to certify that a new ingredient is generally regarded as safe.

But Dr. Pieter Cohen, a Harvard Medicine associate professor who studies agency oversight of dietary supplements, pointed out that even the expert panel step can be skipped. F.D.A. 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 is aligned with the F.D.A.’s public health mission.”

The F.D.A. said that food makers were “responsible for marketing safe foods” and must support the safety of their ingredients with science. It also said that the agency had denied an application for Delta 8 to be recognized as safe.

The food ingredient standard has migrated to rules governing dietary supplements, said Scott Bass, chairman of the Sidley Austin life sciences group, who helped draft the 1994 dietary supplement law.

He intended to create a system where the F.D.A. would perform a basic review of a new ingredient, aside from rare exceptions, such as when an ingredient had already been present in food. But he said consultants for makers of dietary supplements tell companies that if they put an ingredient in food for six or so months, they can argue that it’s generally safe.

Then they bypass agency review, use the ingredient in a dietary supplement and begin racking up sales. “I call it the exemption that swallowed the rule,” Mr. Bass said.

The F.D.A. said it did not have authority to approve dietary supplements, but it can address unsafe products through product recalls or by removing dangerous products from the market.

Against that backdrop, some companies introduce new ingredients in products with little evidence of their safety. Others are willing to use questionable ingredients and face the risk that the F.D.A. will later issue warning letters, said Jensen Jose, a lawyer for the Center for Science in the Public Interest, a nonprofit advocacy group.

“Now the mind-set 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 the Diamond Shruumz bars, traces its roots to the e-cigarettes business before it began selling candy.

Jeff Ane, 38, the company’s chief executive, described in a podcast released in 2020 how he became a business owner after selling marijuana and brokering and using cocaine. He recounted surviving a violent stay in a California prison after robbing a pharmacy; state corrections confirmed that he had received a two-year prison sentence in 2012 on a second-degree robbery conviction.

Mr. Ane described his company’s rapid growth selling e-cigarettes after other businesses scaled back in 2019, during an outbreak of lung injuries and deaths tied to an ingredient in vaping products. He said that expanding the company’s sales force at the time had been a gamble. “We take very large risks, because there’s very big reward in large risk,” Mr. Ane said on the podcast.

The company began shifting to new products, including THC vapes. Mr. Ane did not respond to emails or calls.

Legalization of marijuana, and, in a few places, psychedelic mushrooms, has created growing comfort with drug use and experimentation, said Dr. Joseph Palamar, an associate professor in the department of population health at NYU Langone.

A survey of adult substance use released last month found increases in the use of cannabis and hallucinogen in 2023. About 9 percent of adults ages 19 to 30 used hallucinogens, including psilocybin, in the past year, according to the Monitoring the Future Survey. That’s more than twice as many as the 4 percent who reported use in 2013.

For the same age group, cannabis use in the past year reached 42 percent in 2023, up from about 30 percent a decade earlier.

Dr. Palamar also documented a significant increase in law enforcement seizures of psilocybin, a potent hallucinogen and illegal drug. The number of confiscations was three times higher in 2022 compared to 2017, his study found.

The growing variety of psychoactive drugs in New York City’s unlicensed weed shops has alarmed him, he said, and beg for more regulation.

“Pandora’s box has been opened, and that’s that,” he said. “I think the only way we can fix this is if someone could invent a time machine.”

2024-09-07T09:04:49Z dg43tfdfdgfd