Caffeine in Food and Dietary Supplements Examining Safety: Workshop Summary (2014) / Chapter Skim
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3 Safety Signals and Surveillance
3 Safety Signals and Surveillance
Pages 31-50
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From page 31... ...
Bronstein described the type of data collected during those calls and presented results from a descriptive analysis of caffeine exposure calls from January 2000 through July 2013 and energy drink exposure calls from June 2010 to July 2013.
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From page 32... ...
NPDS can provide critical insight into early recognition of trends in chemical, pharmaceutical, and commercial products including caffeine and energy drink exposures. Bronstein presented the methods and results of a descriptive analysis of poison center calls showing an initial increase but recent stabilization in caffeinated energy product calls between 2010 and 2013.
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From page 33... ...
An Analysis of Caffeine-Related and Energy-Product Exposure Calls, 2000–2013 Bronstein described the methods and results from an analysis of single substance, closed, human exposure calls related to either caffeine (from January 1, 2000, through July 22, 2013) or energy products (from June 18, 2010, through July 22, 2013)
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From page 34... ...
Data on the total number of poison center calls received related to caffeine exposure were collected from January 1, 2000, through July 22, 2013, and calls related to energy product consumption from June 18, 2010, through July 22, 2013. Data were analyzed as change over time with linear regression, and correlation with clinical effect frequency.
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Presented to the Planning Committee for a Workshop on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements on August 4, 2013. aged 20 to 59 years (42.00 mean exposures/month)
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From page 36... ...
When Bronstein and colleagues compared the rank order of energy drink central nervous system clinical effects versus the rank order of central nervous system effects for all caffeine-related exposures, calls that did not involve energy products, they noticed similar patterns. For example, the most common central nervous system clinical effect, "agitated/irritable," for both types of calls ranked third among all clinical effects for energy drinks and fifth for other caffeine-related calls.
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. Bronstein remarked that he and his colleagues would like to investigate this trend more thoroughly in an effort to identify which components of energy products are responsible for the clinical effects so similar to those being seen with caffeine exposure calls.
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Poison centers can assist with data gathering on energy product and caffeine exposure calls by (1) developing a prospective-focused system for data collection in collaboration with the FDA and the IOM; (2)
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The highest estimated daily intake for caffeine from background diet plus energy drinks and dietary supplements at the 90th percentile is for male adults: 444 mg caffeine/day. Roberts observed that, compared to estimates for background exposures, adding energy drinks and dietary supplements to the diet results in a minimal increase in caffeine intake.
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From page 40... ...
, both conducted in Canada, collected data on up to 70,000 teenagers, showing that energy drink consumption 4 times or more weekly was found in about 2 percent of subjects, consistent with what the NHANES survey found. Safety Data The GRAS determining process for the safe use of caffeine as an added ingredient of food and beverages takes into account a range of data and information from metabolic, pharmacokinetic, animal, and human studies, including data on carcinogenicity, cardiovascular effects, seizures, and other specific effects and data on children and adolescents.
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From page 41... ...
Human studies suggest that toxic doses of caffeine range from 3 g in young children to 10 g in adults (Iserson, 1990; Nawrot et al., 2003) , which is equivalent to the consumption of between 28 and 93 8-ounce servings of energy drinks per day.
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From page 42... ...
In the case of caffeine use in energy drinks, GRAS determinations have also taken into consideration potential interactions with alcohol. Although some researchers have hypothesized that caffeine may antagonize the effects of alcohol, resulting in greater alcohol consumption, the European Scientific Committee on Food and the UK Committee on Toxicity of Chemicals in Food Consumer Products and the Environment have reported that the totality of evidence is currently insufficient to conclude that co-consumption of energy drinks with alcohol is unsafe (SCF, 2003; COT, 2012)
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From page 43... ...
Nor is the premise that adolescents react differently than adults following caffeine consumption supported by the scientific evidence. Roberts noted that the caffeine content in energy drinks is similar to or below that of a number of marketed coffee products and the incremental use of caffeine in energy drinks combined with other sources of caffeine results in total human caffeine exposures below 400 mg/day in all age groups besides adult males.
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Questions About Poison Center Data There was some confusion about the reasons for poison center calls being categorized as intentional (misuse or abuse) versus unintentional.
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A national registry would be especially helpful for obtaining information on the effects of chronic exposures. The Interaction Between Caffeine and Other Ingredients in Caffeine-Containing Energy Drinks Roberts was asked to describe studies on interactions between caffeine and taurine, which the questioner noted seems to be a popular ingredient in energy drinks, or with any of the other chemical and herbal ingredients in energy drinks.
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From page 46... ...
Bronstein replied, "Let the data speak for themselves." Whether the level of analysis he and his colleagues conducted for the purposes of this workshop, with the data they had, presents a "total picture" is unclear at this point. Furthermore, he noted that more studies are needed to determine what, if any, clinical effects are related to caffeine-containing energy drink exposures.
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From page 47... ...
over an estimated 130 million emergency room visits per year suggests that the evidence for serious side effects is lacking. Lipshultz opined that, to the contrary, the DAWN data, as well as NHANES, ILSI, and poison center data, all point to the need for a more formal assessment.
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From page 48... ...
2007. New-onset seizures in adults: Possible association with consumption of popular energy drinks.
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2013. Energy drinks: An assessment of the potential health risks in the Canadian context.
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2011. Caffeinated energy drink intoxi cation.
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