WASHINGTON, D.C. – Following a New York Times report that detailed the prevalent use of caffeine inhalers to deliver powdered caffeine, U.S. Sen. Sherrod Brown (D-OH) renewed his efforts to ban the sale and marketing of the deadly product before more individuals are harmed. While the State of Ohio enacted legislation to ban the sale of powdered caffeine in Ohio, the product is still readily available in neighboring states and online.

“Powdered caffeine harms and even kills individuals who accidently ingest too much of this dangerous product. And now, companies are coming up with new ways to give individuals a jolt to get through their day,” said Brown. “Left unregulated, this substance and related delivery devices pose a serious risk to public health. It’s time to get this product off shelves and out of online stores.”

Brown led a letter along with five of his Senate colleagues this week urging the U.S. Food and Drug Administration (FDA) to ban the sale and marketing of powdered caffeine for retail use. U.S. Sens. Richard Blumenthal (D-CT), Dick Durbin (D-IL), Kirsten Gillibrand (D-NY), Ed Markey (D-MA), and Chuck Schumer (D-NY) cosigned the letter.

According to the FDA, a single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee. Pure caffeine overdoses have been responsible for more than 200 hospital admissions in Ohio, including five life-threatening cases in 2014. The latest pure caffeine product to be marketed in the U.S. is an inhaler-like product, which the FDA has not reviewed for safety.

Although the FDA has alerted consumers to the dangers of powdered caffeine on its website, these products remain on the shelves and available online without any sort of regulation, warnings, or protections.

Logan Stiner – who was a senior in Lorain County – died just three days before his high school graduation in 2014 after ingesting too much powdered caffeine. Brown stood with his parents, Dennis and Kate Stiner, during a press conference last Friday to outline the risk pure caffeine poses. They were joined by Dr. Steve Allen, CEO of Nationwide Children’s Hospital, and Rick Spiller, Director of the Central Ohio Poison Control Center.

Brown has led the national fight to ban the sale and marketing of pure caffeine. In January 2015, Brown led a group of senators in urging the FDA to immediately ban the retail sale and marketing of pure caffeine in support of a Citizen Petition delivered to then-FDA Commissioner Margaret Hamburg. Brown first called on Commissioner Hamburg to act in October 2014.

 

 

August 4, 2015

 

Dr. Stephen Ostroff
Acting Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

Dear Acting Commissioner Ostroff:

We are writing to urge the Food and Drug Administration (FDA) to ban the retail sale and marketing of pure and highly-concentrated bulk powdered caffeine products sold outside of pharmaceutical and food production purposes. We further request the FDA to clarify serving sizes, potency, and risks associated with powdered caffeine use.

In January, we requested the FDA respond to a Citizen Petition filed by the Center for Science in the Public Interest (CSPI). This petition – also signed by the families of two young men who died from accidental powdered caffeine overdoses and lawmakers from Suffolk County, NY – implored the FDA to ban the retail sale and marketing of powdered caffeine. We appreciate the FDA’s response to our letter declaring the agency’s commitment to this public health issue. But now is the time for the FDA to act. Despite the calls to action from both Congress and the general public, six months have passed and there has been no discernable action taken by the agency to protect individuals from the dangers of powdered caffeine and prevent future overdoses.  In its unregulated form, powdered caffeine remains a serious public health risk and swift action must be taken to prevent needless, untimely deaths caused by inadvertent overconsumption. 

Recent reports indicate that manufacturers are becoming more creative in their marketing and manufacturing of delivery mechanisms for caffeine. For example, an article in the New York Times described the increasing prevalence of caffeine inhalers. Similar to e-cigarettes, the lack of research and regulation on these disposable, inexpensive vaporizers poses a serious threat to the safety and well-being of users, many of whom are looking for a quick energy jolt. Each inhaler contains approximately 500 puffs, yet ten to twenty puffs is equivalent to one serving of coffee.

We understand the FDA is aware of the potential risks associated with including caffeine in food and related products, and has been evaluating the safety of caffeine as a food additive since 2013. However, as reported in TIME, no new information from this investigation has been made available to the public. While the FDA has been silent on this issue, several states – including Illinois, New York, and Ohio – have passed or proposed legislation to restrict selling and marketing of powdered caffeine. The FDA’s consumer advisories warning of the risks associated with powered caffeine are necessary, yet this minimal response is inadequate given the proliferation of delivery devices and the unknown health risks associated with their usage.

We urge the FDA to expediently address the public health concerns with powdered caffeine, caffeine as an additive, and the use of various delivery devices, including inhalers. In addition to prohibiting the retail sale and marketing of powdered caffeine, the FDA should respond to the CSPI petition and propose immediate actions to ensure no more Americans are harmed by this product.  

 

Sincerely,

 

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