More than a handful of U.S. senators from the Democratic party are pressuring FDA to ban the sale of bulk caffeinated powder, citing the deaths of two men last year who accidentally ingested too much of the product.
In a Jan. 22 letter addressed to FDA Commissioner Margaret Hamburg, lawmakers acknowledged the agency has issued a consumer advisory on caffeinated powder, but they said FDA needed to take additional action to protect the public.
“As long as this dangerous substance remains legal and readily available online and in retail stores, consumers will be exposed to its unreasonable risks," Sens. Sherrod Brown (Ohio) and Richard Blumenthal (Connecticut) wrote in the Jan. 22 letter. Also signing the letter: Sens. Charles Schumer (New York), Richard Durbin (Illinois), Edward Markey (Massachusetts) and Kristin Gillibrand (New York).
This is at least the second time members of Congress have called on the agency to ban the product. In October, Brown and Blumenthal wrote to Hamburg, noting 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. Two months later, the senators met with the parents of Logan Stiner, an 18-year-old who died just days before his high school graduation in LaGrange, Ohio.
Wade Sweatt, a 24-year-old Georgia resident, also died from ingesting caffeine powder. In December, the Stiner family planned to join Sweatt’s parents and advocates from the Center for Science in the Public Interest to deliver to FDA a citizen petition. The petition urged the agency to ban the product.
A single teaspoon of pure caffeine is roughly equivalent to the amount of caffeine in 25 cups of coffee, and there is a “very small" difference between an amount of powdered caffeine that is considered safe and one that is fatal, according to FDA.
FDA Sending Mixed Message
Daniel Fabricant, executive director and CEO of the Natural Products Association (NPA), pointed out in a December phone interview that FDA has issued a consumer advisory recommending consumers don't purchase powdered caffeine. Yet he said FDA hasn't made a finding that the products are adulterated and should be removed from the market. That sends somewhat of a "mixed message to consumers," said Fabricant, who previously led the dietary supplement division at FDA.
FDA did not immediately respond Wednesday to a request for comment on the senators’ most recent letter. In December, an FDA spokeswoman, Jennifer Corbett Dooren, said in an emailed statement, “The agency is working to collect additional information about powdered pure caffeine products and will consider taking regulatory action, as appropriate, to protect consumers."
I agree with Fabricant that FDA is sending a mixed message.
FDA should not recommend that consumers refrain from purchasing a product that is presumably lawful. That leaves room for consumers to ignore the agency’s advice and endanger their health. It also is unfair to caffeine marketers because it threatens sales of pure caffeine and creates uncertainty on whether or not the government will ban their products in the near-term future.
This is not the time to dilly-dally. Either ban caffeinated powder based on a finding that it is unsafe or advise consumers that the product does not pose a danger to them if they follow the directions for use. The latter, hypothetical advisory would most certainly contradict FDA’s actual advisory.
The consumer advisory warns, in part, “Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents should be aware that these products may be attractive to young people. Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death."
Adds FDA: “It is nearly impossible to accurately measure powdered pure caffeine with common kitchen measuring tools and you can easily consume a lethal amount."
In light of FDA’s view that consumers can “easily consume a lethal amount," I don’t see what the agency is waiting for. Declare that pure caffeine is adulterated and take it off the market before we have to read a third obituary.