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Sunday 22 December 2024
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US – FDA faces mounting pressure to ban powdered caffeine

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WASHINGTON—Two U.S. senators planned to meet Tuesday afternoon with the parents of a deceased teenager who had ingested powdered caffeine, coinciding with a plan to step up pressure on the FDA to ban the substance.
Advocates plan to submit a citizen petition, urging FDA to ban the sale of powdered caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount of caffeine in 25 cups of coffee, according to FDA.

“The agency is working to collect additional information about powdered pure caffeine products and will consider taking regulatory action, as appropriate, to protect consumers,” an FDA spokeswoman, Jennifer Corbett Dooren, said Monday in an emailed statement.

“In the interim, the FDA recommends that consumers avoid these products. Parents should be aware that powdered caffeine products may be attractive to young people.”

Sens. Sherrod Brown (D-Ohio) and Richard Blumenthal (D-Connecticut) will meet Tuesday with the parents of Logan Stiner, an 18-year-old who died just days before his high school graduation in LaGrange, Ohio.

In October, Brown and Blumenthal wrote to FDA Commissioner Margaret Hamburg, calling on FDA to ban powdered caffeine. The senators said the substance was still being sold on the Internet and at stores in spite of an alert from FDA, which recommended consumers avoid the products.

FDA said at the time it was aware of at least one teenage death—presumably referring to Stiner—in connection with powdered caffeine. The agency expressed particular concern that powdered caffeine was being sold in bulk bags over the Internet. The labeling on the products may be inadequate, and consumers may be unaware that small amounts can cause an overdose, according to FDA.

Perhaps most alarming is FDA’s view that there is a “very small” difference between an amount of powdered caffeine that is considered safe and one that is fatal.

“Given that very small amounts of powdered caffeine can cause severe adverse events including death, it is time for the FDA to use its authority to ban the sale and marketing of this dangerous product,” the senators wrote in the letter to Hamburg.

Daniel Fabricant, executive director and CEO of the Natural Products Association (NPA), pointed out that FDA has issued a consumer advisory recommending consumers don’t purchase powdered caffeine, yet the agency hasn’t made a finding that the products are adulterated and should be removed from the market. He said that sends somewhat of a “mixed message to consumers.”

Stiner, “a gifted athlete and a strong student” from Keystone High School who had been named prom king, died from consuming too much powdered caffeine, according to the senators’ letter.

The county coroner reported the teen had more than 70 micrograms of caffeine per milliliter of blood in his body, as much as 23 times the amount of a typical coffee or soda drinker, according to The Associated Press.

Wade Sweatt, a 24-year-old Georgia resident, also died from ingesting caffeine powder, Brown’s office said Monday in a news release.

The Stiner family will join Sweatt’s parents and advocates from the Center for Science in the Public Interest to deliver the citizen petition to FDA, according to the news release. The meeting with Stiner’s family will take place at Brown’s office.

In Ohio, Brown’s home state, more than 200 people have been admitted to the hospital after overdosing on caffeine, the news release said. FDA has cautioned that the effects of caffeine can be exacerbated if a person suffers from a preexisting heart condition.

In a USA Today article that was published on Sept. 16, the director of the Central Ohio Poison Center, Henry Spiller, likened powdered caffeine to purchasing “firecrackers and someone handing you a stick of dynamite.”
“This is frighteningly dangerous. You can’t have 16- and 17-year-olds buying something off the Internet and playing with dynamite,” Spiller told the newspaper.

Last year, FDA said it intended to explore the effects of foods containing caffeine on adolescents and children. The agency previously launched a review into the safety of energy drinks and shots following reports that link the products to a number of deaths and other serious medical problems.

Agency officials have reiterated the “adverse event reports” don’t prove the caffeinated products caused the reported illnesses.

According to the agency, healthy adults who consume four to five cups of coffee a day — 400 milligrams of the substance — generally are not endangering their health. But FDA has not specified a safe limit for children.

“Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death,” FDA warned in its consumer alert regarding powdered caffeine. “Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity.”

If consumers deviate from warnings or directions for use on a label, that is not a public health issue, said Fabricant, the former top supplement official at FDA.

“If people are going to suggest banning something everytime somebody overdoes, we’re not going to have much to eat,” he said.

Consumers can report to FDA negative side effects associated with powdered caffeine by calling 240-402-2405 or e-mailing CAERS@cfsan.fda.gov.

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