Caffeine in Food and Dietary Supplements Examining Safety: Workshop Summary (2014) / Chapter Skim
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But the changing caffeine landscape raises concerns about safety and whether any of these new products might be targeting populations not normally associated with caffeine consumption, namely, children and adolescents, and whether caffeine poses a greater health risk to those populations than it does to healthy adults. At the request of the FDA, on August 5–6, 2013, the Institute of Medicine (IOM)
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Workshop participants included scientists with expertise in food safety, nutrition, pharmacology, psychology, toxicology, and related disciplines; medical professionals with pediatric and adult patient experience in cardiology, neurology, and psychiatry; public health professionals; food industry representatives; regulatory experts; and consumer advocates. The information presented in this workshop summary reflects only what was spoken or visually presented (on slides)
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Describe caffeine exposure and the risk of cardiovascular and other health effects on vulnerable populations, including additive effects with other ingredients and effects related to preexisting conditions. Explore safe caffeine exposure levels for general and vulnerable pop ulations.
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. Nevertheless, even early on, according to FDA commissioner Margaret Hamburg, there were concerns about the effects of caffeine consumption beyond moderate levels and in children, pregnant women, and other potentially vulnerable populations.2 In a 1978 report, the Select Committee on GRAS Substances raised questions about whether the chronic consumption of caffeine in cola-type beverages by children during a period of brain growth and development might affect behavior (FDA, 1989)
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While most of the discussion of vulnerable populations focused on children, adolescents, and pregnant women, some participants ex pressed concern that not enough scientific evidence has been col lected to clearly identify vulnerability. Participants identified children with underlying heart medical conditions as a separate potentially vul nerable population and identified individuals with certain genetic pre dispositions as another.
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, have expressed concern about making caffeine more readily accessible and attractive to children and adolescents. The FDA needs to know what the research suggests about caffeine exposure, particularly the additive effects and the conditions under which it is used, including in energy drinks and similar sources, and whether the FDA should be more closely monitoring and regulating these products, especially in vulnerable populations.
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She said, "I really do believe that the deliberations that you will be undertaking over the next 2 days, the discussions that you will be having, the data presented, [and] the issues raised will all help to guide us as we consider the right steps forward to protect public health." On the second day of the workshop, Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, emphasized the need to "get the science right" in determining whether there are safety concerns regarding the new uses of caffeine that warrant steps by the FDA.
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Under the food additive law, the burden is on industry to prove safety, and there is a prescribed pre-market approval process for food additives. The GRAS concept provides an alternative pathway to the marketplace, one that does not require FDA pre-market approval.
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gov/Food/DietarySupplements/QADietarySupplements/default.htm#what_is. Despite differences between the two regulatory frameworks, both provide similar options potentially available to the FDA.
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Food Additives and Contami nants 20:1–30.
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