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Active Ingredient Safety Concerns In The Wake of Two Deaths. Powdered caffeine has raised a number of safety concerns in the wake of at least two recent deaths linked to the product. While the U.S. Food and Drug Administration (FDA) has rarely used its authority to remove dangerous natural products that pose health risks, […]
Active Ingredient Safety Concerns In The Wake of Two Deaths. Powdered caffeine has raised a number of safety concerns in the wake of at least two recent deaths linked to the product. While the U.S. Food and Drug Administration (FDA) has rarely used its authority to remove dangerous natural products that pose health risks, some regulatory experts say the FDA can do just that for powdered caffeine.
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) allowing the FDA to remove supplements from the market. According to Natural Products Insider, United Natural Products Alliance (UNPA) president Loren Israelsen can only remember one situation where the FDA used this authority; to ban ephedra products in 2004 after the substance was linked to heart attack and stroke.
Natural Products Insider reports that in December, the Center for Science in the Public Interest (CSPI) petitioned the FDA to remove pure, powdered caffeine from the market. The action was fueled by the death of teenager who died after ingesting the product, and lawmarkers who met the teen’s parents advocated for the ban. In a Jan. 22 letter to FDA Commissioner Margaret Hamburg, six senators wrote “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,”
Thomas Kraus, an FDA Official, wrote a March 16 letter to Sen. Richard Blumental stating that “the Agency is committed to addressing this important public health issue and continues to evaluate the complex legal, scientific, and policy issues associated with bulk powdered caffeine products.”
The FDA has opened a docket on the CSPI’s petition. While it is typically given 180 days to act, proceedings may actually take much longer. There are some petitions filed with the FDA that have been pending for decades, according to a chief regulatory affairs attorney for CSPI. The group wants the agency to acknowledge that pure caffeine as a dietary supplement can lead to “a significant or unreasonable risk of illness or injury under conditions of use suggested or recommended in the labeling,”
According to an FDA warning, a single teaspoon of pure caffeine is roughly equal to 25 cups of coffee. Small amounts can lead to a fatal overdose.
“Just as FDA removed ephedra from the market under authority granted by DSHEA, that option is open to FDA,” said Israelsen, according to Natural Products Insider. “I don’t know what they will do. We feel FDA has authority.”
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