On January 21, 2014, the U.S. Food & Drug Administration (“FDA”) issued a Statement on the Institute of Medicine’s Report (“IOM Report”) on Caffeine in Foods. Released on January 17, 2014, the IOM Report is a culmination of the recent public workshop, which took place in August 2013 and was focused on the investigation of the continued safety of caffeine in foods and dietary supplements. The IOM Report highlights the issues surrounding the safety of caffeine in foods and concludes that continued research is necessary to determine whether caffeinated foods and dietary supplements are safe, particularly for children and adolescents. The full text of the IOM Report on Caffeine in Foods and Supplements may be accessed here.
We first reported on FDA’s interest in examining the safety of caffeine in foods and dietary supplements in May 2013, when the FDA formally announced its intentions to investigate caffeine added in foods. As previously reported, FDA decided to investigate the safety of caffeine in foods as a response to the influx of these products on the market in recent years and due what the FDA has characterized as numerous health-related complaints made in conjunction with the use of caffeine-containing beverages and dietary supplement products.
Whether caffeine in foods and dietary supplements is determined to be safe can impact the viability of numerous products on the market. In particular, the FDA may take enforcement actions against any products that it considers to be unsafe to the public. For example, in 2010, the Agency took action against several caffeinated alcoholic beverages on the market due to health-related risks. Accordingly, whether caffeine is found to be unsafe in foods has a bearing on the FDA’s course of action and whether it may step up enforcement moving forward. If you have any questions about the FDA regulation of caffeine in foods or dietary supplements or need the assistance of a FDA regulatory attorney, please contact us at: firstname.lastname@example.org.