Caffeine in Foods and the Changing Regulatory Landscape

On 3 May 2013, the US Food and Drug Administration (FDA) announced plans to investigate the safety of caffeine in food products with a focus on children and adolescents. The announcement followed the release of a new brand of caffeinated gum, joining the US market alongside other atypical foods: caffeine-boosted jelly beans and potato chips, for example. The regulation of caffeine presents a compelling modern challenge. Caffeine is a stimulant with broad cultural acceptance worldwide. Caffeine and other bioactive xanthines are produced by many plants consumed by humans daily in the form of coffee, tea, guarana and yerba maté. Other plants, such as cocoa, contain smaller amounts. The presence of natural caffeine in foods is not generally at issue, though there is some debate about the duties to label that content, particularly when combined with synthetic sources. The main concern surrounds an expansion of caffeinated products in the market, with the presumption that caffeine intake will rise accordingly (both the FDA and Health Canada recommend no more than 400 mg/day). For some, the concern is more particularly on the innocent or accidental stacking of caffeinated products by consumers in a market newly saturated with the stimulant, especially in children. According to US law, a food is adulterated in contravention of the US Food, Drug and Cosmetics Act if it includes a food additive that is unsafe. A food additive is any substance added to food with the intention that it becomes a component of the food, but any substances receiving prior sanction for use or that are “generally recognized as safe” (GRAS) are specifically excluded. Food additives are deemed unsafe at law unless a regulation prescribing specific conditions of use is in force. Notably, as a food additive, caffeine has not been recognized with a US regulation prescribing its essential conditions of use. In fact, the only truly sanctioned use of caffeine in food is the recognition of its GRAS status for use in cola-type beverages at no more than 200 mg/L – law which has been in place since the 1950s. It seems that only recently have problematic examples of non-compliance been pursued by the FDA, despite many uses being “unsafe” by definition (eg. the crackdown on caffeinated alcoholic beverages). In Canada, the regulation of caffeine in foods is in flux. As in the US, caffeine is regulated as a food additive under federal law (the Canadian Food and Drugs Regulations [the Regulations]). Canada had, until recently, a similar limitation on caffeine to cola-type beverages at 200 mg/L, as well as additional limitations on vitamin, herb and amino acid content. In 2010, Health Canada issued an Interim Marketing Authorization allowing the immediate use of caffeine (at 150 mg/L) in “non-alcoholic carbonated water-based flavoured and sweetened beverages other than cola beverages” while an official amendment to the Regulations is being processed. Though this made the regulation of caffeine in standard ‘sodas and pops’ more well-rounded, it failed to address the presence of energy drinks with much higher caffeine content on the market. The Canadian regulatory landscape was complicated by the fact that caffeine can alternatively be included in natural health products (NHPs), which can include energy drinks, for example. However, instead of suffering the same regulatory fate as foods, NHPs are regulated as a subset of drugs (the US kin to NHPs are dietary supplements, which are regulated in the US as a food). It is of no surprise, then, that highly caffeinated products like energy drinks preferred to expand into Canada as NHPs, avoiding the application of food regulatory law. Health Canada has since implemented a significant shift in policy, determining that caffeinated energy drinks, and any other NHP that is represented, packaged and sold as a food, will be regulated as a food. As of January 2013, all caffeinated energy drinks that posed no immediate safety concerns have been transitioned to regulation as foods. To the extent that many of them are now in contravention of food law, they were issued Temporary Marketing Authorization Letters (TMALs) – a temporary permission to market a non-compliant product so that market data can be collected, and ultimately, a submission to amend the Regulations allowing for the product can be made.b With the transition of energy drinks complete, Health Canada has begun transitioning other food-like NHPs – vitamin waters, supplement bars and many powders and chewables must now operate under a TMAL pending regulation amendment. Notably, among the TMALs recently issued by Health Canada were two-year authorizations for brands of caffeinated gum and chocolate, which are now available in Canada – legally. In the coming years, it will be fascinating to note the progression of caffeinated foods in the US and Canada. Certain Canadian products will be able to support a regulatory amendment and stay on the market indefinitely, while other products will lose their market privileges with the expiry of their TMAL. Summary by: John Lucas