Caffeine in Food and Dietary Supplements Examining Safety: Workshop Summary (2014) / Chapter Skim
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9 Moving Forward: Filling the Data Gaps
9 Moving Forward: Filling the Data Gaps
Pages 153-166
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From page 153... ...
Also in Chapter 6, Amelia Arria noted a lack of valid assessment methods for energy drink consumption as a data gap, and she reinforced her comments in the final workshop session. In the final session of the workshop, panelists identified what they each considered the most important data gaps and considered ways to fill those gaps.
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From page 154... ...
She urged that the words "caffeine" and "energy" not be used synonymously when discussing energy drinks or other energy products. • Bailey identified the lack of data on the amount of caffeine in caffeine containing foods and dietary supplements as the most critical data gap.
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From page 155... ...
In response to physicians in the workshop audience who had indicated at various times during the discussion that none of their patients were attributing their medical complaints to energy drinks, Arria asked in return, "How systematically are you asking about recent consumption of energy drinks when a patient, especially an adolescent patient, presents with cardiovascular symptoms? " Better assessment and screening tools for busy physicians are needed to estimate the true proportion of cases that can be attributable to energy drink use.
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From page 156... ...
Although these datasets are useful for providing safety signals of what might be below the surface, they hugely underestimate the true proportion of medical complications that might be associated with the consumption of any one substance. A preferable approach to estimating the proportion of individuals experiencing health problems would be to ask consumers proactively about their experiences, an approach akin to the required and rigorous methods for adverse event reporting for pharmaceuticals in clinical trials.
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From page 157... ...
Many energy products in the dietary supplement label database contain no caffeine at all and are simply high-dose B vitamins. Approximately 1,500 products in the dietary supplement label database have energy listed somewhere on the label, and 157 products have "energy" in the product name.
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From page 158... ...
Christina Chambers, Ph.D., M.D. University of California, San Diego Christina Chambers reiterated that although there is quite a bit of data on low to moderate caffeine consumption in pregnant women, there are less data on high-dose exposure to traditional caffeine-containing products (i.e., coffee, tea, and cola)
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From page 159... ...
University of Miami, Florida After spending 35 years looking at first-generation survivors of many formerly fatal illnesses of early childhood and seeing late effects after transient early exposures to chemotherapy, Steven Lipshultz has learned that he and his colleagues do not really know when safety signals come up, who is at risk, what percentage of their patients are at risk, or the degree of severity. For example, about 1 percent of childhood cancer survivors experience acute heart failure, which is the leading late effect for early exposure, especially for those who were exposed early in life.
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From page 160... ...
"If you can't provide the scientific evidence [that] they are vulnerable groups," he said, "you don't have vulnerable groups." PANELIST DISCUSSION WITH THE AUDIENCE In the final panelist discussion with the audience, most questions asked of the panelists revolved around the differences between a longitudinal follow-up study and a registry, both of which were suggested at various times over the course of the workshop; the pros and cons of taking the sort of approach that Health Canada has taken with respect to setting safety standards for potentially vulnerable populations; other types of potential safety signals worth evaluating (i.e., besides sudden cardiac death)
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From page 161... ...
Lipshultz and Bronstein were asked to clarify the different roles that a longitudinal study and registry would serve with respect to tracking and analyzing potential safety signals associated with caffeine-containing foods and dietary supplements. Lipshultz replied that the two types of research are very different.
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From page 162... ...
As an example of how poison center data have been used in the past, he mentioned a product called Total Body Formula, a dietary supplement product that contained excess selenium, which caused, among other effects, nail changes and hair loss. The FDA removed the product from the market.
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From page 163... ...
Rodricks clarified that the Health Canada recommendation is not a single standard and that it includes two recognized vulnerable populations, women of childbearing age and children. Even so, Lipshultz said, among children there are potentially vulnerable subpopulations -- for example, children with cardiomyopathies and arrhythmias.
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From page 164... ...
to randomly assign children and adolescents and even young adults to high doses of caffeine." The type of naturalistic cohort study described by Lipshultz, on the other hand, where high doses are not administered but rather natural levels of consumption are measured, would be advantageous in that regard. Other Potential Safety Signals In Roland Griffiths's opinion, one of the safety signals for which the most data have been produced is physical dependence.
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From page 165... ...
He observed that about 17 years ago, when he was a voting member on the FDA Oncologic Drugs Advisory Committee, some terrible cardiac signals associated with a prescription product emerged but that there was inadequate data to study those signals. The company involved agreed to participate with the FDA and to conduct studies to gather the necessary data, so a black box warning label was issued.
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From page 166... ...
Although he applauded industry's willingness to at least consider providing data, he questioned what to do in the meantime given that there is no life-saving therapeutic reason to consume these products and that multiple independent databases have yielded safety signals. In his opinion, until safety is established, it is important to consider how to move forward in the meantime.
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