Energy pouch products are small sachets designed to be placed in the mouth to deliver caffeine alongside food-grade ingredients. The ingredients are absorbed in the stomach, through the tissues in the cheek, and sublingually, through the blood vessels under the tongue.
As the ingredients include flavourings, questions have arisen over how these products should be classified – should they be considered a food product or a medicinal product?
This is a question that Dr Mark Tallon, managing partner of the food law consultancy Legal Foods, has examined, concluding that the current regulatory approach across Europe is not fit for consumers or manufacturers.
“The concern is that the regulatory frameworks they sit within are open to broad interpretation,” said Tallon. “This results in market fragmentation, inhibited free movement, and poor risk management.”
How this plays out in the future can only be interpreted by looking at similar cases that have arisen in Europe, he stated.
Learning from the past?
The issue facing regulators across Europe is not a new one. The emergence of vape products, nicotine gum, highly caffeinated drinks, and nicotine pouches has posed challenges to regulators because these products entered into a regulatory grey area.
Such products had the time to quickly become popular before regulators could analyse their appropriate classification and any potential health risks.
Nicotine pouches have been ruled by a number of EU member states to be nicotine-based products that should fall under tobacco and related product rules, Tallon said. However, these revisions do not extend to the pouches fortified by caffeine.
In the case of the UK, regulators have been hesitant to act on nicotine-based smoking products, and the same should be expected for the caffeine pouches, he added.
This is in marked contrast to the Danish Veterinary and Food Administration, which has already commissioned a safety assessment of the products, and issued a draft executive order targeting caffeinated sachets.
On the risk of a developing fragmented regulatory approach across Europe, Tallon stated that this has already happened.
“Few member states [are] grasping this classification nettle,” he said. “An exception being Denmark classifying them as foods and maybe shining a light to other states on considering how to deal with such products. Until we see harmonisation, the result remains fragmentation that results in significant stress on free movement rules, issues of enforcement risk, and increasing cost for businesses seeking to navigate across European markets.”
Children at risk
While the caffeine pouches remain in regulatory limbo across most of Europe, it remains possible for children and teenagers to purchase the products.
Much like highly caffeinated drinks, the products pose a risk because of the ease with which children and teenagers are able to exceed tolerable limits.
According to Tallon, for children aged between 13 and 17, a potential daily intake of 10 pouches (typically, 50mg of caffeine per pouch) exceeds safe limits by 400-500%. Too much caffeine in children and teens can cause increased heart rate, heart palpitations, high blood pressure, anxiety, and potentially death in extremely rare cases.
“In our view, the UK government and EU are behind the curve of possible risks of such products to our young children,” Tallon concluded. “Whilst many states and the UK restrict access to energy drinks to kids, the result will simply be a move to these pouches.”
