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Brown, Blumenthal, Durbin Renew Call on FDA to Ban Retail Sale and Marketing of Deadly Pure, Bulk Powdered Caffeine



April 27, 2016 - 11:32 AM


From the Office of Senator Brown


WASHINGTON, D.C. – Standing with families whose loved ones have died after using powdered caffeine, U.S. Sens. Sherrod Brown (D-OH), Richard Blumenthal (D-CT), and Dick Durbin (D-IL), along with the Center for Science in the Public Interest (CSPI), today renewed their call on the Food and Drug Administration (FDA) to ban the retail sale and marketing of pure, bulk powdered caffeine, which even in small doses can be deadly.

Today, Brown, Blumenthal, and Durbin, along with Sens. Ed Markey (D-MA) and Chuck Schumer (D-NY), will send a letter to the FDA highlighting new data from poison control centers throughout the country, which confirms that the vast majority of cases reported to poison control centers involve individuals under the age of 18. According to CSPI, though five dietary supplement companies removed powdered caffeine from their websites, at least 19 companies continue to market and sell this deadly product without alerting consumers to the risks associated with it.

“It is disturbing that despite two unintended and untimely deaths associated with powdered caffeine, the FDA has done little to regulate these products or adequately enforce the standards in place to protect Americans from the substantial risk associated with ingesting powdered caffeine in any form,” said the Senators in their letter. “Unfortunately, in the absence of strong regulatory action, companies are continuing to develop new delivery mechanisms and creative advertising ploys to attract new powdered caffeine users and are doing so without relaying the serious health consequences of improper use.”

During the press conference, the Stiner family from Ohio and the Sweatt family from Alabama shared personal stories on the potentially deadly impact of powdered caffeine. Logan Stiner – who was a senior at Keystone High School in LaGrange, Ohio – died just three days before his high school graduation from ingesting too much powdered caffeine.Logan passed away on May 27, 2014. Wade Sweatt died at the age of 24 after being in a coma caused by powdered pure caffeine. Wade passed away on June 24, 2014.

According to the FDA, a single teaspoon of pure caffeine is roughly equivalent to the amount in 28 cups of coffee. 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.

 

 

Full text of the letter to be sent to the FDA today is below:

 

Dear Commissioner Califf:

We are writing to urge the U.S. Food and Drug Administration (FDA) to take meaningful action on pure and highly-concentrated bulk powdered caffeine products. We first shared our concerns about these products with the agency over a year ago, and the FDA has yet to ban the retail sale and marketing of pure and highly-concentrated bulk powdered caffeine products sold outside of pharmaceutical and food production purposes. Given the mounting evidence, it is clear that regulation and enforcement of these products is long overdue.

Data collected by the American Association of Poison Control Centers indicates that, since 2014, there have been 60 incidents involving powdered caffeine cases in at least 25 states. The vast majority of these cases involved individuals under 18 years of age. This is unacceptable.

In September 2015, the FDA sent warning letters to five dietary supplement companies, alerting them that their labels violate FDA regulations and do not adequately address the risks associated with consumption. These companies responded by voluntarily removing these products from their websites. Despite this fact, bulk pure, powdered caffeine and other dangerous forms of highly-concentrated caffeine remain widely available and easy to buy over the internet.

While we appreciate the FDA’s attention to these five companies, we remain concerned that, according to the Center for Science in the Public Interest (CSPI), nearly 20 other retailers – domestic and international – continue to market and sell powdered caffeine in multiple forms. Moreover, these products do not provide a way to measure a safe dosage per FDA recommendations, and are sold in quantities that could easily kill hundreds of individuals if ingested incorrectly.

It is disturbing that despite two unintended and untimely deaths associated with powdered caffeine, the FDA has done little to regulate these products or adequately enforce the standards in place to protect Americans from the substantial risk associated with ingesting powdered caffeine in any form. Unfortunately, in the absence of strong regulatory action, companies are continuing to develop new delivery mechanisms and creative advertising ploys to attract new powdered caffeine users and are doing so without relaying the serious health consequences of improper use.

We request that the FDA use its authority to scrutinize the powdered caffeine market, enforce the safety mechanisms in place, and ultimately ban pure and highly-concentrated bulk powdered caffeine products in all of its forms.

Thank you for expediently attending to this matter.

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