Editor’s note: This article is the second of a three-part series on energy drink regulation, which covers the regulatory framework and outlook for this sector in the United States and Europe, as well as the potential legal vulnerabilities that exist. Part two will focus on the regulation of energy drinks in Europe.
The energy drinks market is one of the most rapidly expanding in the food sector, with consumption growth in Europe and sales increasing by 45 percent between 2006 and 2011 globally, according to Euromonitor International. Energy drink consumption in the UK has grown from 175 million liters in 2000 (1.5 percent of total soft drink consumption) to 495 million liters in 2011 (3.4 percent of total soft drink consumption), an increase of 183 percent in terms of volume, according to Zenith International data featured in the annual reports of the British Soft Drinks Association. As in the United States, the European energy drinks market has been accompanied by increasing media and regulatory attention concerning potential harmful effects while conclusive evidence of harm remains elusive.
Current Legislation in Europe
There is as yet no harmonized European legislation applying across the 28 European Union (EU) member states, which defines energy drinks or specifically regulates them as a product class.
Energy drinks are subject to the EU legislation applying to foods generally, including the prohibition on placing unsafe food on the European market and requirements concerning labelling of caffeine content and product claims.
Manufacturers are obliged to indicate high caffeine content and the precise content of caffeine where contained in a product in excess of 150 mg/L. From Dec. 13, 2014 (under the new Food Information Regulation), the label for such products must further state “not recommended for children, or pregnant or breast-feeding women."
The scope for beneficial claims on energy drinks is also significantly restricted. Since December 2012, only so-called “bodily function" claims, which have been scientifically substantiated and approved by the European Commission and either appear on an EU positive list or have been individually authorized, may be used on energy drinks. Significantly, no claims regarding caffeine or amino acid claims are currently on the positive list, and such claims are therefore not permitted.
National Legislation on Energy Drinks
At the national level, some EU member states have attempted to directly or de facto prohibit the marketing of energy drinks in their territories or require pre-market approval of key ingredients on the basis of alleged public health grounds.
In a number of European court judgments in which the Commission has challenged such regimes, the European Court has found that, while member states enjoy a “margin of discretion" in deciding the level at which they protect public health in the face of scientific uncertainty (regarding risks from energy drink consumption), restrictions against the marketing of energy drinks must nevertheless be underpinned by some plausible and demonstrable scientific concern. In the absence of this, prohibitions or prior notification systems which de facto operate to prevent access to the national market may be considered unjustified trade barriers. For example, in Commission v. Italian Republic, the European Court of Justice found an Italian law prohibiting marketing of energy drinks in Italy whose caffeine content exceeded 125 mg/l was, in the absence of scientific evidence demonstrating a public health risk above that level, an illegal measure with effect equivalent to a quantitative restriction on imports.
In other member states, certain ingredients found in energy drinks such as guarana or ginseng are considered to have medicinal properties and may require pre-market licensing of the product as a drug.
Status of Scientific Evidence of Risk
None of the risk assessments of energy drinks or of their key ingredients carried out at European level have conclusively identified any harm from their consumption. Previous Opinions from the European Scientific Committee for Food concluded that the contribution of energy drinks to caffeine consumption was “not a matter of concern" (with a reservation for pregnant women and children), and were unable to conclude whether levels of amino acids in energy drinks were safe or unsafe. Similarly, the European Food Safety Authority (EFSA) concluded in a 2009 scientific opinion that “exposure to taurine and D-glucurono-γ-lactone at the levels presently used in ‘energy’ drinks…is not of safety concern."
The Media and Political Environment
Despite the lack of conclusive evidence of harm, political and media pressure is growing toward further regulation of energy drinks or their key ingredients. Deaths from cardiac arrests allegedly linked to consumption of energy drinks have been reported on both sides of the Atlantic. Such incidents may well trigger further legislation going forward. EFSA last year prioritized energy drinks for further investigation as a “potential emerging risk," and an EFSA report on energy drink consumption habits found the principal consumer group to be adolescents doing physical exercise. In addition, the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) called for restrictions on advertising of energy drinks at festive and sport events, and warned against their consumption with alcohol or during physical exercise. The German Federal Institute for Risk Assessment (BfR) has expressed similar concerns.
Future European Harmonized Legislation?
It remains to be seen whether the Commission will bow to public and political pressure and restrict marketing of energy drinks or introduce additional labelling requirements in the absence of conclusive evidence of an associated health risk.
One of the factors to be weighed in the balance will be whether industry self-regulation through voluntary codes of practice on the marketing of energy drinks is deemed sufficient to protect principal consume groups. For example, the Code for the Labelling and Marketing of Energy Drinks developed by the Union of European Soft Drinks Associations (UNESDA) prohibits product claims that energy drinks have a rehydration effect similar to isotonic sport drinks as well as the targeted marketing of energy drinks to children or near to schools.
As to the likely form of any future European harmonized legislation, it appears more likely this would focus on typical key ingredients of energy drinks, such as caffeine or amino-acids, rather than restricting energy drinks as a product class. An existing legal basis for further restrictions or requirements already exists in the form of the EU regulation on the addition of vitamins and minerals and other substances to food. This enables the Commission to place on a “community scrutiny" list any ingredient where “the possibility of harmful effects on health is identified, but scientific uncertainty persists" and where that ingredient is added to food “under conditions that would result in the ingestion of this substance in excess of amounts." The onus is then placed on industry to provide scientific data proving the safety of that ingredient, and the Commission must ultimately decide (within four years of the substance being listed and on the basis of an EFSA opinion) whether to restrict or prohibit the use of the substance or to take no further action. It is significant that in the draft legislative proposal for Regulation 1925/2006 (although not in the finally adopted legislation), taurine was specifically listed by the Commission as a “substance under community scrutiny" and caffeine was included as a “restricted substance" subject to a maximum limit in soft drinks.
Industry would be well advised to ensure that in listing key ingredients for “community scrutiny," or in making any decision to restrict or prohibit a relevant substance, the Commission respects the general principle of EU law (stated in the regulation) that such a requirement be based on a risk assessment that has identified “the possibility of harmful effects on health" and is not based on “a purely hypothetical approach to the risk, founded on mere assumptions which have not yet been scientifically verified." More specifically, there would appear to be scope to challenge any restriction or prohibition based merely on the absence of industry data “demonstrating the safety of a substance" (which is difficult to prove conclusively), as opposed to data suggesting the possibility of harm. Such measures would also need to be provisional (limited in time) pending a more comprehensive risk assessment and proportionate to the potential risk identified (for example, appropriate labelling rather than an absolute ban on marketing). Industry should also bear in mind that a mere decision to include key ingredients on the community scrutiny list, irrespective of whether this ultimately leads to any restriction, may have negative commercial blacklisting supply chain implications.
For help with understanding laws regulating the dietary supplement and functional foods industry, visit INSIDER’s Regulatory Content Library.
Craig Simpson is a senior European legal advisor (Brussels office), Mark Fitzsimmons is a partner (Washington office) and Mitch Cheeseman is managing director, regulatory and industry affairs department (Washington office) at Steptoe & Johnson LLP. The authors acknowledge the valuable assistance and ideas of Blandine Gayral, paralegal in the Brussels office of Steptoe & Johnson, in preparing this article.