ARCHIVED - Caffeine and Carbonated Soft Drinks (July 2010)

For many years, caffeine and caffeine citrate have been permitted in cola-type beverages to a maximum level of 200 ppm caffeine. In March, 2010, after an extensive review of all available science, Health Canada authorized the broader use of caffeine and caffeine citrate in all carbonated soft drinks (both cola-type and non-cola-type carbonated soft drinks). The maximum level of use in cola-type beverages remains 200 ppm and the maximum level of use in all other types of carbonated soft drinks is 150 ppm.

When caffeine is added to carbonated soft drinks, caffeine must be declared on the ingredient list. The food industry has been asked by Health Canada to also voluntarily declare the actual amount of caffeine added to caffeinated soft drinks (amount of caffeine per stated serving size). Such label information provides Canadians with the tools to make informed choices.

Health Canada encourages Canadians in general to moderate their daily caffeine intakes and to avoid elevated levels of consumption. Indeed, Eating Well with Canada's Food Guide recommends that Canadians drink water as their beverage of choice and look for other healthy beverage options, such as milk, fortified soy beverages or 100 per cent juices. Consumption of other beverages, including soft drinks, should be limited.

The following Questions and Answers were prepared based on the questions posed by the public after the March 2010 announcement that caffeine would be permitted to be added, within limits, to carbonated soft drinks in general.

Questions and Answers

Question 1. Why is Health Canada allowing caffeine in non-cola carbonated beverages?
Answer 1. In Canada, caffeine is regulated as a food additive, and there are restrictions in the Food and Drug Regulations on which food additives can be added to certain foods and at what level. When Health Canada receives requests for new food additive uses, it is obligated to consider those requests and to conduct a full safety assessment of the available scientific data. Once Health Canada has determined that all food additive submission requirements listed in the Regulations are satisfactorily met, consideration must be given to amending the Regulations to allow the food additive in specified food at levels that have been deemed to be safe by the Department.

Health Canada has determined that adding the food additive caffeine to non-cola soft drinks at concentrations no higher than 150 parts per million (ppm) poses no health risk to consumers who consume caffeine in moderation; that is, when they follow Health Canada's recommendations for maximum daily caffeine intake. In this regard, Health Canada encourages Canadians to monitor their daily caffeine intakes in order to avoid excessive consumption.

Current labelling regulations require that added caffeine be declared on the ingredient list. However, Health Canada has issued a letter urging the food industry to go beyond these food additive labelling requirements and declare on the product label the total amount of caffeine contained in their caffeinated product (amount of caffeine per stated serving size). Preliminary guidance for the industry suggests that the amount of caffeine should reflect total caffeine from its direct addition as a food additive and from natural ingredients such as guarana. Further, Health Canada has asked that industry voluntarily identify the presence of caffeine on the principal display panel (front of package labelling) of any beverages that are generally recognised as being caffeine-free but that will be newly formulated to contain caffeine. The front of package labelling will help consumers to clearly identify those products whose formulations now contain caffeine.

Question 2. Is caffeine addictive?
Answer 2. Caffeine is not considered to be an addictive substance. It is a mild stimulant that can have transient effects on mood, performance, and behaviour. Individuals who consume higher amounts of caffeine for a long period of time may exhibit some aspects of dependence and experience effects such as headaches, irritability, and tiredness upon abruptly stopping caffeine consumption. However, these effects tend to be mild and/or transient and do not persist more than a week. Further, caffeine consumption does not lead to an inability to stop consuming it. As such, it is not considered to be addictive.

Question 3. Does caffeine produce side effects?
Answer 3. There is a great deal of individual variation with regard to the side effects produced by caffeine consumption. A modest amount of caffeine present in a single cup of coffee may increase alertness in one person and in another may produce nervousness, headache and irritability. Individuals should be aware of their own limitations when it comes to caffeine consumption. Health Canada has issued recommendations concerning the maximum amount of caffeine that can be consumed over a day by different population groups. However, individuals who are very sensitive to caffeine may still experience effects even if they stay within the maximum recommended amount of caffeine.

Question 4. Does caffeine act as a stimulant?
Answer 4. Yes, caffeine can increase alertness and reduce drowsiness, but it also has diuretic properties (it increases the output of urine). As well, individuals who are sensitive to caffeine may experience side effects such as insomnia, headaches, irritability and nervousness when consuming caffeine. While there can be other contributing factors to symptoms such as these, Health Canada advises that limiting caffeine consumption is a wise precaution.

Question 5. Are caffeinated soft drinks safe for pregnant women?
Answer 5. Pregnant women who consume too much caffeine are at a higher risk of miscarriage and can give birth to babies with a lower birth weight. Health Canada considers up to 300 mg of caffeine on a daily basis to be safe for pregnant women. This amount is equal to approximately six cans of soft drink (355 ml per can). However,  Health Canada recommends that pregnant women limit the consumption of soft drinks which can displace foods of greater nutritional value.

Question 6. Does caffeine affect kidney function?
Answer 6. The available data suggest that increased caffeine intake is associated with a slight deterioration in calcium balance. The majority of evidence indicates that this occurs through caffeine-induced hypercalciuria (excessive excretion of calcium in the urine). It is acknowledged that hypercalciuria is associated with the formation of kidney stones. However, there is little evidence that caffeine leads to kidney stone formation. On the contrary, several studies have found it to have a protective effect.

Question 7. Will allowing the addition of caffeine to any carbonated soft drink limit the availability of non-caffeinated soft drinks for consumers who must or wish to avoid caffeine?
Answer 7. Published studies show that in the United States marketplace, where caffeine has been allowed in non-cola soft drinks for many years, not all non-cola soft drinks are caffeinated. For example, all lemon-lime soft drinks and the majority of root beer and citrus-orange soft drink brands do not contain added caffeine. Similarly, it is anticipated that the distribution in Canada of caffeinated and non-caffeinated soft drinks will be somewhat similar to that of the U.S.

Question 8. How will soft drink consumers who are sensitive to caffeine be able to avoid caffeine? Is it mandatory to declare the presence of caffeine?
Answer 8. In Canada, it is mandatory that food manufacturers identify the presence of food additives, including caffeine, in the ingredient list of most prepackaged food labels. So caffeinated soft drinks must list caffeine in the ingredient list. Health Canada is urging the food industry to also: (1) declare on the product label the total amount of caffeine contained in their caffeinated product (amount of caffeine per stated serving size); and (2), identify the presence of caffeine on the principal display panel of newly caffeinated beverage formulations. These are both voluntary measures. The second voluntary measure will help consumers to clearly identify those products whose formulations now contain caffeine. A preliminary guidance document on caffeine labelling is available on Health Canada's Web site. Health Canada will be monitoring industry practice in this regard to determine whether regulation will be required to ensure greater consistency in how caffeine labelling information is provided to consumers.

Question 9. Will identifying the presence of caffeine on the front package label be permanent for caffeinated beverage formulations that have not previously contained caffeine?
Answer 9. Health Canada's preliminary guidance document on caffeine labelling recommends that newly caffeinated products that previously did not contain caffeine should carry a statement on the front package label for a sufficient period of time to alert consumers to the fact that the product is now caffeinated. Therefore, this aspect of caffeine labelling is not intended to be a permanent labelling measure. Once these newly caffeinated products have been in the marketplace for some time, consumers will be aware that these products contain caffeine, much as there is now a general awareness that cola beverages contain caffeine. Declaration of caffeine in the ingredient list is a permanent requirement. Listing the amount of caffeine on the product label, which is currently voluntary, is a permanent expectation.

Question 10. How will labelling protect children and teenagers who can freely purchase soft drinks and are unlikely to monitor their caffeine intake themselves?
Answer 10. Health Canada encourages parents to educate children about healthy eating habits and the consumption of foods containing caffeine. Health Canada recommends that all Canadians follow a balanced diet that includes a variety of foods according to Eating Well with Canada's Food Guide. The Food Guide recommends that Canadians drink water as their beverage of choice and look for other healthy beverage options, such as milk, fortified soy beverages or 100 per cent juices. Consumption of other beverages, including soft drinks, should be limited.

Information specific to caffeine is found on Health Canada's Web site. For example, there is an It's Your Health document and a caffeine fact sheet which provide information on caffeine consumption, including typical naturally occurring levels of caffeine in foods such as coffee, tea and chocolate.

Question 11. How does adding caffeine to soft drinks help HC to accomplish its mandate to help Canadians maintain and improve their health?
Answer 11. Food additives are used for various reasons. Some uses, such as those that prevent the growth of food-borne pathogens, have a clear health benefit to Canadians. Other food additives, for example, alter the texture or colour of foods. While there may not always be a health benefit associated with the use of food additives, Health Canada is mandated under the Food and Drug Regulations to consider requests for new food additive uses and to conduct a full safety assessment of the available scientific data relating to those requests. Health Canada's evaluation of such products allows the food industry to use food additives to prepare many of the processed foods that are currently in demand, and at the same time, ensures that food additives are used in a safe manner, that does not pose a risk to Canadians. Canadians have the freedom to make their own food choices but Health Canada does ensure, in cooperation with the Canadian Food Inspection Agency, that foods available for purchase are safe to consume. Health Canada also provides educational information and food consumption advice to help Canadians make the informed dietary choices necessary to maintain and improve health.

Question 12. Has Health Canada considered all available scientific studies on the safety of caffeine?
Answer 12. As with all food additives, including caffeine, Health Canada is mandated under the Food and Drug Regulations to conduct a full safety assessment of the available scientific data for new food additive submissions. In 2000, a complete review of the scientific literature on caffeine was initiated by Health Canada and a final peer-reviewed report encompassing reviews of more than 300 papers was published in 2003 in the scientific journal Food Additives and Contaminants. Since then, Health Canada has continued to assess new scientific publications on caffeine as they become available.

Question 13. Will the possibility of having more caffeinated soft drinks available for purchase put children and caffeine sensitive individuals over the maximum recommended daily intake of caffeine?
Answer 13. There are no safety concerns with the amount of caffeine that may be added to non-cola carbonated soft drinks, which is comparable to the amount of caffeine that can be found in current cola soft drinks. Concern with caffeine is related to the possible over-consumption of caffeinated products in general, particularly for vulnerable groups such as children and pregnant women. Health Canada encourages all Canadians to follow a balanced diet that includes a variety of foods according to Eating Well with Canada's Food Guide. The Food Guide recommends that Canadians drink water as their beverage of choice and look for other healthy beverage options, such as milk, fortified soy beverages or 100 per cent juices. Consumption of other beverages, including soft drinks, should be limited.

Question 14. What is the purpose of adding caffeine to soft drink beverages?
Answer 14. Many countries of the world, including the United States, the United Kingdom and members of the European Union recognise caffeine as a flavouring ingredient when it is used at levels that are typically added to carbonated soft drinks. As such, they allow its broad use in these beverages. Internationally recognized bodies such as the Flavour and Extracts Manufacturer's Association Expert Panel and the US Pharmacopeia Expert Committee (which publishes the Food Chemicals Codex) also recognise caffeine as a flavouring agent. In Canada, regulatory oversight of the addition of caffeine to carbonated soft drinks to "characterize the product" falls under the food additive provisions of the Food and Drug Regulations. Canada is one of the few countries that controls the use of caffeine so closely.

Question 15. Does Health Canada know how well its caffeine guidelines are followed?
Answer 15. Health Canada intends to conduct surveys of consumer knowledge of caffeine in order to determine whether current recommendations on caffeine consumption are reaching Canadians.

Question 16. Is Health Canada also allowing the addition of caffeine to juice boxes or any non-carbonated drinks?
Answer 16. No, the Department's recent decision does not permit the addition of caffeine to juice, regardless of how it is packaged (e.g., juice boxes, plastic or glass bottles). The wording of the  Interim Marketing Authorization that permits the expanded food additive use of caffeine is very specific to non-cola carbonated soft drinks, which are commonly referred to as "pop" or "soda pop". The addition of caffeine to non-carbonated beverages, including juices, is not allowed.

Question 17. Will Health Canada be increasing the allowed amount of caffeine in cola products?
Answer 17. The Food and Drug Regulations have for many years permitted the addition of the food additive caffeine to cola-type beverages at a maximum level of 200 parts per million (ppm). This has not changed. The current  Interim Marketing Authorization allows for the addition of the food additive caffeine to non-cola carbonated soft drinks at a lower maximum level of 150 ppm. Health Canada is not considering increasing the level of caffeine permitted in cola-type beverages.