Saudi Food and Drug Authority 
Drug Sector  
Review of Energy Drinks  
 
Prepared By:  
National Drug and Pois on Information Center 
 
 
June 2014 
 
 
 
 
 
  1 
SFDA; NDPIC; Review of Energy Drinks 
  
1. REQUEST: 
The National Drug and Poison Information Center (NDPIC) was requested by the Vice 
President for Drug Affairs to prepare a concise review for Energy Drinks (EDs). The NDPIC, 
thus, aimed to focus on three core ob jectives for this review, as follows: 
 
 To provide an introduction and define products known as EDs. 
 To provide a regulatory background of EDs.  
 To discuss the potential health risk associated with common ingredients found in EDs. 
 
 
2. RESPONSE: 
Executive Summary:  
Energy drinks (EDs) promote mental and physical stimulation for a short period of time. The 
three most common ingredients are caffeine, taurine, and glucuronolactone. When too many 
are consumed or when they are mixed with alcohol, problems can occur. Though individuals 
may drink EDs to remain energetic during periods of intense physical activity or to quench their thirst, these drinks may actually lead to dehydration. The regulatory status of EDs is still 
unclear; in many jurisdictions, the products ar e regulated as food products, though claims of 
their physiological benefits, such as mental stimulation, would indicate that they be regulated 
as drugs. Some of the constituents of these products, such as caffeine, have no recommended 
daily dietary allowances. It is impossible to analyze these products using a risk versus benefit 
assessment because they do not fulfill any therapeutic or dietary requirements. Likewise, an 
assessment of the long-term effects of EDs is impossible because testing the safety and efficacy of these products for any length of time is not feasible. 
 
Introduction:   
Components (i.e. Ingredients) of Energy Drinks:  
Generally, EDs include methylxanthines (such as caffeine), B vitamins, and herbs. Other 
common ingredients are guarana, which has a high caffeine content, taurine, various forms of 
ginseng, maltodextrin, carbonated water, inositol, carnitine, creatine, glucuronolactone, and 
Ginkgo biloba. Some contain high levels of sugar, and many brands offer artificially 
sweetened diet versions. The central ingredient in most energy drinks is caffeine, the same 
stimulant found in coffee and tea, often in the form of guarana or yerba mate.   Table 1 illustrates the information based on the GCC standardization organization  (GSO), 
number 1926/2009 for requirements of the most commonly EDs available in Saudi Market, 
such as: POWER HORSE, RED BULL, BISON ENERGY DRINK.  2 
SFDA; NDPIC; Review of Energy Drinks 
  
Ingredients  Maximum permitted per 100ml 
Caffien  الكافيين32 mg  
inositol انيستول20 mg  
Glucuronolactone   جلوكورونلاكتون240 mg  
Taurine   تاورين400 mg  
 
Table 2 & 3 demonstrate the content of caffeine in kola-type beverage as well as Coffee and Tea Beverages   Table 2 : Comparison of the caffeine content in Kola-type beverages  
Kola-type beverages  Caffeine content (mg/100ml) 
Coke Zero%  9.5 
Coca Cola#  9.0 
Mountain Dew(NZ)^  13.5 
Mountain Dew(Aus)^  15.0 
Pepsi%^  10.7 
Pepsi Max%^  12.0 
 
 
Table 3 : Comparison of the caffeine content in coffee and tea beverages  
Coffee and Tea Beverages  Caffeine content (mg/100ml)  
Tea, black, brewed#  22.5 
Tea, green, brewed#  12.1 
Coffee, cappuccino, double shot, 285ml 
takeaway cup, café variety#  101.9 
Coffee, flat white, double shot, 285ml takeaway 
cup, café variety#  86.9 
Coffee, longblack, double shot, 285ml takeaway 
cup, café variety#  74.7 
Coffee, mocchaccino, double shot, 300ml 
takeaway cup, café variety#  97.4 
Coffee, from ground coffee beans, espresso 
style@  194.0 
Source: Table 2 & 3   adapted from Food regulation policy options paper. The regulation of caffeine in foods, Augest 
2013 available at: 
https://www.health.gov.au/interne t/main/publishing.nsf/Content/A294B740C7928C3CCA257BF0001CFFF4/$File/The
%20Regulation%20of%20Caffeine%20in%20Foods.docx- accessed on 02-06-14.  
 
 
 
Potential for Interaction between ingredients of Energy Drinks:  3 
SFDA; NDPIC; Review of Energy Drinks 
 There are extensive data on the toxicokinetics of caffeine and taurine but less information on 
glucuronolactone. Consideration of the chemical nature of the three parent compounds and their metabolites, and the fact that differing processes are involved in their absorption, distribution, metabolism and excretion did not, in the experts view, raise any a priori reasons 
to expect any toxicokinetic interactions, even at high intakes of any one constituent. The 
physiological handling and lack of toxicological effects of glucuronolactone did not, in the experts view, raise any a priori reasons to expect toxicodynamic interactions from this constituent. Caffeine and taurine, on the other hand , each affect the functioning of the central 
nervous system, kidneys and heart, thus there is a need to consider the potential for 
toxicodynamic interactions between these two constituents.  
 
Caffeine is a central nervous system stimulant whereas taurine generally act as an inhibitory 
neuromodulator. Caffeine exerts stimulatory effects by blocking the inhibitory action of 
adenosine at its binding sites, with subsequent increases in the levels in some brain regions of 
several neurotransmitters, including adrenaline, noradrenaline, tryptophan and dopamine. It 
also modulates the effects of GABA and serotonin.  
 
Taurine, on the other hand, depresses the activity of excitable membranes in the brain. 
Centrally, taurine acts as an agonist of the more sedating glycine receptors and inhibits the 
more excitatory actions of NMDA receptors and glycine neurotransmitter function. It therefore could modulate the excitatory actions of some other amino acids. While these data may appear to indicate that if there were any interactions, taurine might reduce caffeine-
mediated excitation. Taurine is found naturally in meat, fish and breast milk, and it's 
commonly available as a dietary supplement.  It is promoted to enhance athletic and mental 
performance. 
 
Both caffeine and taurine can have short-term diuretic actions, causing loss of body water 
and sodium. Taurine acts via inhibition of central release of the anti-diuretic hormone, 
vasopressin. Caffeine does not inhibit vasopres sin release but has a direct action on kidney 
tubule functions, such as ionic reabsorption and renal perfusion, probably via adenosine 
receptor blockade.   A high dose of taurine in the drinking water, equivalent to about 1500 mg/kg body weight, 
was required to elicit diuresis and natriuresis in rats, whereas 1g or more intravenously over 
15 minutes (about 15 mg/kg body weight) was su fficient in sensitive humans with liver 
cirrhosis and ascites. Bearing in mind that taurine is rapidly absorbed across the gut via an active transport mechanism, the diuretic effects in normal subjects with an acute 
consumption of 750 ml of energy drink containing 3g of taurine are difficult to predict.  
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SFDA; NDPIC; Review of Energy Drinks 
 Caffeine can increase heart rate, force of contraction of heart muscle and blood pressure. 
Taurine, on the other hand, depresses the activ ity of excitable membranes in the heart. 
Caffeine enhances catecholamine synthesis and release from adrenal cells in vitro, probably related to its effects on intracellular calcium . Numerous in vivo studies have shown oral 
caffeine at doses of 6 mg/kg body weight or more increases plasma catecholamine 
concentrations, especially adrenaline, in a dose-related manner during exercise, though one study giving 8.8 mg/kg in an energy drink found no increase. The acute consumption estimate for energy drinks of 750 ml is equivalent to a caffeine intake of 4 mg/kg body 
weight for a 60 kg adult.  
 
There is no evidence that taurine increases catecholamine release; if anything it has an 
inhibitory effect on excessive sympathetic ac tivity in rat models of hypertension, with 
reduction of plasma catecholamines . Neither does taurine given alone have any effect on 
heart rate or blood pressure in rats or humans. Both taurine and caffeine influence the activity 
of angiotensin II, an endogenously formed substance that raises arterial blood pressure and 
reduces the excretion of sodium and water by the kidney, but their action on angiotensin II is 
in opposite directions. In vivo caffeine augments the action of angiotensin II on the kidney 
and may raise plasma renin levels, whereas taurine attenuates the effects of circulating 
angiotensin II.  
 Human metabolic considerations indicate the body is likely to  handle small quantities of 
glucuronolactone without any problems. However, the intake of glucuronolactone from 
consumption of some energy drinks is possibly as much as two orders of magnitude greater 
than that from the rest of the diet. There is  very little information available for risk 
assessment of glucuronolactone at such inta kes. While there is no indication from the 
available data that there is any risk to health from consumption of high amounts of 
glucuronolactone, there is a lack of scientific evidence to support the safety of 
glucuronolactone present in beverages at concentrations that may result in intakes as much as 
two orders of magnitude greater than that obtained from the rest of the diet. 
1,2,3 
 
International regulatory status of EDs:  4,5,6 
US-FDA 
The US Food and Drug Administration (FDA; 2003) code of federal regulations, number 
21CFR182.1180, describes caffeine as being generally recognized as safe (GRAS) when 
used in cola drinks at 0.02%, or 71 mg for a 12 oz soft drink. However, this regulation does 
not apply to EDs. In the US, the amount of caffeine ED companies can include in their 
beverages is unlimited because the FDA has set no restrictions regarding this. 
 
Health Canada 5 
SFDA; NDPIC; Review of Energy Drinks 
 Health Canada recognizes EDs as food but has set safety requirements regarding their 
composition and labeling: 
 Composition Requirements  
Specific requirements will be established to better control the types and levels of ingredients added to EDs. These requirements include, for example, setting minimum and maximum 
limits for caffeine from all sources (natural and synthetic sources), vitamins and minerals as 
well as other ingredients e.g. herbal extracts.  
 
Specific to caffeine, Health Canada’s scientific assessment supports the establishment of an 
initial maximum limit for total caffeine of 400 mg per liter  with a maximum amount of 
caffeine not to exceed 180 mg per container presented  as a single-serve container . Health 
Canada has determined that any Energy Drink container that cannot be resealed will be 
treated as a single-serve container. Health Canada has determined that re-sealable containers 
equal to or less than 591 mL will be treated as single-serve containers. 
 Labeling Requirements  
‐ The amount of caffeine from all sources in mg per container or serving size. 
‐ A statement on the label identifying the product as a “high source of caffeine” given that 
a ED will be required to contain a minimum amount of caffeine that is deemed to be 
sufficiently high. 
‐ A statement indicating that the product is “Not recommended for children, pregnant or 
breastfeeding women, and individuals sensitive to caffeine” 
‐ The statement “Do not mix with alcohol” 
 
European Union  
In the European Union the use of caffeine as flavoring in foods has to be clearly indicated on 
the label. Commission Directive 2002/67/EC provides for consumers to be given clear and precise information on the presence of caffeine in a foodstuff. Caffeine must be mentioned by name in the list of ingredients i mmediately after the term “flavoring”.  
Beverages that contain a proportion of more than 150 mg of caffeine per liter must be labeled 
„High caffeine content ‟, followed by the quantity of caffeine expressed in milligrams per 
100mL. This wording must appear in the same field of vision as the name of the drink. These 
labeling requirements do not apply to products sold as “tea” and “coffee”. 
 
In the European Union, there is a requirement to label EDs on the basis of informing 
consumers about high levels of caffeine present in foods and soft drinks that would not 
normally contain caffeine. A beverage that contains caffeine in excess of 150 mg/L must place the following message on its label directly under where the product name is stated: “High caffeine content”. This message must then be followed in brackets by the caffeine 
content expressed in mg/100 ml.  
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SFDA; NDPIC; Review of Energy Drinks 
 The caffeine level of 150 mg/L is used in th e EU as the regulatory differentiator between 
energy drinks and other beverages. For other beverages caffeine is permitted as a flavoring agent up to 150 mg/L. When used in this way, caffeine must be mentioned by name in the list of ingredients immediately after the word “flavoring”. There is, however, no requirement for 
quantification of the caffeine present in the foodstuff.  
 Energy shots are addressed separately in the EU through Commission Directive 2002/46/EC, which governs food supplements. Under this Directive, food supplements may contain a wide 
range of nutrients and other ingredients including vitamins, minerals, various plants and 
herbal extracts. Whilst caffeine cannot be added in its chemical form, guarana and other 
herbal sources of caffeine could be included. There are specific labeling requirements, 
including the names and quantities of substances (including quantity per portion), which 
characterize: the product; daily recommended doses and warnings against exceeding that 
dose; and that the products should be stored out of the reach of children. This Directive notes 
that specific rules regarding other substances with nutritional or physiological effects should 
be laid down at a later stage.   
Meanwhile, EU member states can institute their own national legislation where they 
consider it is in the public health and safety interests of their population. With regard to 
energy drinks this has been exemplified by th e setting of upper caffeine levels (e.g. Denmark 
and France), reported „banning ‟ of energy drinks, or additional labeling requirements (e.g. 
Finland). 
 In February 2013, the European Commission made a request to conduct a scientific opinion on the safety of caffeine. Concern was raised by several Member States that consumption of caffeine may be encouraged following the favorable evaluation of caffeine-related health 
claims on sports performance. The European Commission has therefore asked EFSA to 
review the available data with a view to de termining intake levels which would pose no 
safety concern for the main population sub-groups ‟. The work requested is an extensive 
literature search and review as part of a safety assessment for caffeine. It is proposed that this 
work will commence in March 20 13 and take a period of six months. The deadline for 
completion of the scientific opinion has not yet been determined (European Food Safety 
Authority, 2013). 
 
Ireland   
A review of the health effects of stimulating drinks was undertaken by safe-food, a British-
Irish food safety agency. The subsequent report made a number of recommendations 
regarding labeling, marketing and promotion, further research needs, and advice for 7 
SFDA; NDPIC; Review of Energy Drinks 
 pregnant women, cautioning consumption by children less than 16 years of age and during 
sports or exercise. 
 
Other Bodies 
Regulations for EDs in other countries are quite varied and include: 
 Limits on claims that can be made on the label (e.g. Japan, which limits claims if energy 
drinks are marketed as foods but not if they have been assessed and categorised as Foods for Specified Health Uses); 
 labeling requirements that specify the quantity  of caffeine per serv ing size and per 100 
mL (e.g. South Africa); and 
 Health warning labels or advisory warning statements regarding the unsuitability of the 
product for particular population groups (e.g. South Africa, United Arab Emirates, and 
India). 
 
Safety of EDs:    
This section will highlight the most commonly  reported adverse events in the medical 
literature associated with  consumption with EDs.  
 
Cardiovascular adverse events: 
A recent systematic review by Goldfarb, et al, included 17 published cases of adverse 
cardiovascular events following ingestion of energy drinks. The following table (Table 4) 
presents a summary of cases included in the review. 
 
 
 
 
  
 
 
 
  
Authors defined an estimated acute ingestion of ≥480 mg of caffeine within 8 hours as 
“acute heavy consumption” and ≥200 mg/ day of caffeine over ≥1 weeks as “chronic heavy 
consumption”. 
 
Results, although prone to publication bias, show that the majority of affected cases 
involved teenagers and young adults, the larges t demographic of ED consumers. Results are 
Table 4: adapted from Goldfarb, Tellier, et al. Review of Published Cases of Adverse Cardiovascular Events After Ingestion of E nergy Drinks. American Journal o f
Cardiology 2014; 113:168-172. 
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SFDA; NDPIC; Review of Energy Drinks 
 in keeping with the recent US Substance Abuse Services and Mental Health Administration 
report that indicated this is the most common age group to present to the emergency department with symptoms attributed to ED consumption. On the basis of published case 
series, it cannot be concluded that any specific additive or brand appeared to be more 
frequently involved. However, it is found that heavy consumption of EDs was implicated in 
at least 7 cases, and 5 cases were associated with co-ingestion of alcohol or other drugs. Of note, in all 4 reported cases of ST-elevation, the presenting symptom was severe chest pain. 
It is also reported that 11 cases presented with serious adverse events, including cardiac 
arrest. Of these serious cases, the majority occurred either with acute heavy consumption of 
EDs or in combination with alcohol or other drugs. 
 
However, there are several limita tions to the review. First, th e rates of co-ingestions with 
EDs may be underestimated because toxicology results were not always reported. Second, 
although heavy consumption of EDs were temporally associated with these events and in 
many cases no alternative etiology could be identified, it cannot be excluded that some of 
these cases are rare spontaneous CV events not directly related to ED consumption. 
However, it is important to note that thes e types of spontaneous events are normally 
exceedingly rare in youth and young adults, who make up a large part our case series.
7 
 
Energy drink consumption in asso ciation with athletic training: 
A review article by Higgins, et al, concluded that consuming one can of energy drinks 
during a single athletic training session is safe for most healthy individuals. However, 
excess consumption and consumption with other caffeine-containing beverages or alcohol 
may lead to adverse effects and possibly death. In addition, the review article advised that 
patients with clinically relevant underlyin g medical conditions, including heart disease and 
hypertension, should consult with their physicians before drinking EDs.8 
 
Energy drinks consumption plus alcohol: 
A recent survey carried out on nearly 22,000 US secondary school students and published in 
Journal of Addiction Medicine, found that t eens who consume EDs were more likely to use 
alcohol and drugs. 9   
 On Nov. 17, 2010, the US FDA announced and warned that mixing or drinking EDs in 
which contain caffeine, with alcohol may lead to life-threatening behaviors, as caffeine can 
mask sensory cues. This means that individuals drinking these beverages may consume 
more alcohol—and become more intoxicated.     
 
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SFDA; NDPIC; Review of Energy Drinks 
  
 
 
REFERENCES:  
1. Health Canada. Safe Use of Energy Drinks at http://www.hc-sc.gc.ca/hl-vs/iyh-
vsv/prod/energy-energie-eng.php. 
 
2. Nutrition and Health Info-sheet. The UC Davis Nutrition Department. Availablr at: 
http://nutrition.ucdavis.edu/infosheets/.  
 
3. European Commission, Health & Consumer Protection Directorate-General.  Opinion of 
the Scientific Committee on Food on Additiona l information on “energy” drinks- available 
at: http://ec.europa.eu/food/f s/sc/scf/out169_en.pdf.  
 
4. Food regulation policy options paper. The regulation of caffeine in foods, Augest 2013 
available at: https://www.health.gov.au/internet/main/publishing.nsf/Content/A294B740C7928C3CCA
257BF0001CFFF4/$File/The% 20Regulation%20of%20Caf feine%20in%20Foods.docx  
 
5. Health Canada’s Proposed Approach to Ma naging Caffeinated Energy Drinks, October 
2011. Available at : http://www.hc-sc.gc.ca/fn-an/legislation/pol/energy-drinks-boissons-
energisantes-eng.php  
 
6. Hechman MA and Mejia G. Energy Drinks: An Assessment of Their Market Size, 
Consumer Demographics, Ingredient Profile, Functionality, and Regulations in the United 
States. comprehensive reviews in food science and food safety 2010 (9); 303-317. 
 
7. Goldfarb, Tellier, et al. Review of Published Cases of Adverse Cardiovascular Events 
After Ingestion of Energy Drinks. American Journal of Cardiology  2014; 113:168-172. 
 
8. Higgins, Tuttle, et al. Energy Beverages: Content and Safety. Mayo Clinic Proceeding  
2010; 85(11):1033-1041. 
 
9. McElrath YM1, O ʼMalley PM , Johnston LD. Energy drinks, soft drinks, and substance 
use among United States secondary school students. J Addict Med. 2014 Jan-Feb;8(1):6-13. 
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SFDA; NDPIC; Review of Energy Drinks 
 10. US Food and Drug Administration. Serious Concerns Over Alcoholic Beverages with Added 
Caffeine. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm233987.htm  - 
accessed on 03.06.14