Three Democrats in the U.S. Senate are renewing calls for FDA to ban the retail sale and marketing of bulk powdered caffeine.
On Tuesday at the U.S. Capitol Building, the nonprofit Center for Science in the Public Interest (CSPI) joined Sens. Dick Durbin of Illinois, Richard Blumenthal of Connecticut and Sherrod Brown of Ohio in calling for the ban. Families whose loved ones have died after taking bulk powdered caffeine also joined the press conference.
The senators said data collected by the American Association of Poison Control Centers indicated that, since 2014, there have been 60 incidents involving powdered caffeine cases in at least half the states. Most of the cases involved minors, the senators noted.
“It is disturbing that despite several 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," the senators wrote Tuesday in a letter to FDA Commissioner Robert Califf, M.D. “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."
On Sept. 1, FDA announced issuing warning letters to five marketers of powdered bulk caffeine. FDA warned that it is virtually impossible to accurately measure a safe amount of bulk powdered caffeine with common kitchen measuring tools, such as a teaspoon. Four of the five products that were subject to the letters were removed from the market, and the other product is no longer marketed to consumers, noted Marianna Naum, an FDA spokesperson.
Just 1 teaspoon of pure powdered caffeine roughly corresponds to 28 cups of coffee, according to FDA’s Aug. 27 warning letters. Erratic heartbeat, a seizure and death are among the serious health effects of powdered caffeine, FDA noted in a Sept. 1 constituent update.
“The FDA remains concerned about pure powdered caffeine products and continues to consider every legal option in determining the best path forward," Naum said in a statement.
In late 2014, following the death of 18-year-old Logan Stiner, CSPI requested a ban on bulk powdered caffeine in a citizen petition filed with FDA.
“A ban on such products would allow enforcement action against any company selling it—not just the five that received a warning letter," said Laura MacCleery, director of regulatory affairs with CSPI, in a statement Tuesday. “It would mean that such products could be seized by Customs at the border."
Naum said FDA doesn’t discuss matters that are pending before the agency.
“However, we can assure you that the FDA takes concerns raised about safety of these types of products very seriously and we are considering the matters raised by the petition and giving it our careful attention," she said. “We will respond directly to the petitioner and post our response online after we review."
The American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and United Natural Products Alliance (UNPA) have adopted policies and guidelines that discouraged the sales of bulk powdered caffeine to consumers by their members.
Loren Israelsen, president of UNPA, agreed with CSPI that FDA should exercise the same authority it invoked 12 years ago under the Dietary Supplement Health and Education Act of 1994 (DSHEA)—when it banned ephedra products—to remove bulk powdered caffeine from the market.
“It is important to note that in the form marketed, [bulk powdered caffeine] is clearly a drug mislabeled as a dietary supplement," Israelsen said in a statement. “As such, its sale is both inappropriate and illegal."
Steve Mister, president and CEO of CRN, also supported an FDA ban.
“We believe that FDA should use the authority and the tools that it has to remove pure powdered caffeine from the consumer marketplace," Mister said in a phone interview. “There is no reason why consumers need to have access to large quantities of pure caffeine."
Israelsen highlighted FDA’s authority to remove products from the market under DSHEA through a finding that a product “presents a significant or unreasonable risk of illness or injury." In addition to the above option, Mister also cited a separate standard in the law through which FDA could enact a prohibition—namely through a finding that a dietary supplement poses “an imminent hazard to public health or safety."
“As FDA has said, it is unreasonable to expect consumers to be able to measure out a 1/16th of a teaspoon using the kinds of measuring equipment most of us have in our kitchens," said Mister, whose organization spoke to INSIDER this week about powdered caffeine during a podcast. “Under the conditions of labeling that would be provided, it would present a significant risk of injury or illness."
Mister added a caveat to his support for a ban. “We would be concerned to be sure that they are not doing something that inadvertently restricts wholesalers’ ability to sell in a business–to-business transaction to somebody else who is then going to make a finished product out of the caffeine."
In spite of FDA’s warning letters last year, consumers can still find for sale bulk powdered caffeine. MacCleery indicated that following a quick Google search CSPI ordered a small bottle of liquid caffeine from South Korea that contained 9,000 milligrams of caffeine.
“We easily purchased large bags of pure powder sufficient to kill several dozen people," MacCleery said, “and a gallon jug of what looks like water but is actually a highly caffeinated liquid—a cup of which would be a fatal dose."
This isn’t the first or even second time members of Congress called for a ban on BPC. On Jan. 22, 2015, six senators—including Blumenthal, Durbin and Brown—wrote to then FDA Commissioner Margaret Hamburg, M.D., citing the deaths of two men the previous year who accidentally ingested too much caffeine. And in a previous letter to Dr. Hamburg, Brown and Blumenthal cautioned bulk powdered caffeine was still being sold on the Internet and at stores in spite of an alert from FDA, which recommended consumers avoid the products.