Dietary Supplement - European Union

European Union

The European Union's Food Supplements Directive of 2002 - requires that supplements be demonstrated to be safe, both in dosages and in purity. Only those supplements that have been proven to be safe may be sold in the bloc without prescription. As a category of food, food supplements cannot be labeled with drug claims but can bear health claims and nutrition claims.

The dietary supplements industry in the United Kingdom (UK), one of the 27 countries in the bloc, strongly opposed the Directive. In addition, a large number of consumers throughout Europe, including over one million in the UK, and various doctors and scientists, had signed petitions by 2005 against what are viewed by the petitioners as unjustified restrictions of consumer choice. In 2004, along with two British trade associations, the Alliance for Natural Health had a legal challenge to the Food Supplements Directive referred to the European Court of Justice by the High Court in London. Although the European Court of Justice's Advocate General subsequently said that the bloc's plan to tighten rules on the sale of vitamins and food supplements should be scrapped, he was eventually overruled by the European Court, which decided that the measures in question were necessary and appropriate for the purpose of protecting public health. ANH, however, interpreted the ban as applying only to synthetically produced supplements—and not to vitamins and minerals normally found in or consumed as part of the diet. Nevertheless, the European judges did acknowledge the Advocate General's concerns, stating that there must be clear procedures to allow substances to be added to the permitted list based on scientific evidence. They also said that any refusal to add a product to the list must be open to challenge in the courts.

A survey of adults aged 18–64 years, conducted in 2001 in Ireland, suggested that, with the possible exception of niacin (flushing) and vitamin B6 (neuropathy), there appears to be little risk of the occurrence of adverse effects due to excessive consumption of vitamins in this population. However, many subsequent studies have linked supplements, such as vitamins A and E, to various diseases and conditions, sometimes ones that they are supposed to prevent.