In an announcement of the guidance, the agency lays out its concerns: “In recent years, we have seen the emergence of powdered and liquid dietary supplement products containing high concentrations of caffeine marketed directly to consumers. These products are often sold in bulk containers with hundreds or thousands of servings in the container, and even a small dose can be toxic or deadly,” the agency said.
FDA said in the guidance that the use of bulk caffeine has been associated with two deaths.
The bulk caffeine products call for consumers to measure out doses of 200 mg or less. This equates to 1/16 teaspoon. FDA doubts consumers could measure this amount correctly.
“Because consumers are unlikely to have the correct tools to accurately measure these amounts, even a consumer who reads the warning statement and attempts to measure a safe serving might inadvertently consume an unsafe amount. A simple mistake, such as measuring a serving in grams rather than milligrams, could result in a toxic dose being consumed,” the agency wrote in the guidance.
FDA’s move drew mixed reactions in the industry. Steve Mister, president and CEO of the Council for Responsible Nutrition, said caffeine is an ingredient with a long history of safety, when used correctly. But he concurred with FDA’s position that the powdered products make it difficult to do so.
“Extremely concentrated or pure caffeine has no place in the consumer marketplace, and CRN fully supports FDA’s commitment to taking immediate steps to remove products from the marketplace that present public health concerns. Today’s announcement from FDA puts all dietary supplement stakeholders, including online retailers, on notice that highly concentrated caffeine sold in bulk to consumers is dangerous and illegal,” he said.
But Dan Fabricant, PhD, president and CEO of the Natural Product Association, said while he does not support the marketing of pure powdered caffeine per se, he is concerned about FDA making an end run around the rule-making procedure.
“If FDA has a real public health concern with caffeine, fine. They are obligated to go after it. But they should go through the appropriate public process and they didn’t do that here,” he said.
Fabricant has said in the past that FDA has presented no evidence that shows consumers are incapable of properly measuring the amounts called for by the caffeine products. He said that should be basis of the decision, not an assumption on the part of the agency, however reasonable it might seem on the surface.
“If FDA is a science-based agency and they should go about this in a scientific manner,” he said.
To read the full text of the guidance, click here.