Caffeine in Foods and the Changing Regulatory Landscape

On 03 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 only explicitly sanctioned use of synthetic caffeine in US food is the recognition of its ‘generally recognized as safe’ (GRAS) status for use in cola-type beverages at no more than 200 mg/L – law which has been in place since the 1950s. However, it seems that only recently have problematic examples of non-compliance been pursued by the FDA (for example, the crackdown on caffeinated alcoholic beverages). In Canada, the regulation of caffeine in foods is in flux. First, until recently, Canada had a similar limitation on caffeine to cola-type beverages at 200 mg/L; but in 2012, Health Canada issued an Interim Marketing Authorization allowing the immediate use of caffeine (at 150 mg/L) in other non-alcoholic carbonated beverages. Second, the Canadian regulatory landscape is complicated by the fact that caffeine can alternatively be included in natural health products (NHPs), which can include energy drinks, for example. Instead of suffering the same regulatory fate as foods, NHPs are regulated as a subset of drugs, which are not specifically limited as to dose. Not surprisingly, highly caffeinated products like energy drinks preferred to expand into Canada as NHPs, avoiding the application of food law. However, in a recent shift in policy, Health Canada has ruled that caffeinated energy drinks, and any other NHP that is represented, packaged and sold as a food, will now be regulated as a food. Temporary Marketing Authorization Letters (TMALs) will authorize products transitioning from NHPs to food to be sold on a limited basis in Canada despite non-compliance with food law (e.g. for caffeine higher than 200 mg/L). 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. These products can be sold according to the terms of the TMAL in order to generate data to support a submission for regulatory amendment, allowing indefinite marketing in Canada if successful. For a longer version of this mini-article containing many more links and references, click here. Summary by: John Lucas