Points To Check When Selling Food Supplements Outside The U.S.

Major U.S. companies are expanding their vitamins, minerals, and botanicals businesses into Europe. Diane McEnroe, Anna-Shari Melin, and Nadja Schwarz explain what to consider in relation to formulation, labelling, and marketing language when targeting this market.

The demand for food supplements in the EU is significant and growing. For example, around half of Germans buy food supplements regularly, and the situation is similar in France and Austria. In Switzerland, one third of the population takes at least one dietary supplement. Unsurprisingly, many U.S. brands of food supplements are expanding, or are looking to expand, their businesses into Europe, particularly through online sales.

But even when selling online, products may need to be adapted in order to ensure compliance with the rules and regulations in local markets. All food supplements sold in the EU must comply with EU-wide regulations, including Directive 2002/46/EC as implemented into the national law of EU member states.

Compliance often requires the reformulation of the supplements. For example, under U.S. rules higher doses of vitamin B12 might be permitted in a supplement. The EU, however, might treat such a high dosage of B12 as a medicine for regulatory purposes, meaning that it would require a marketing authorization.

Non-compliance with EU regulations – which can easily be spotted and flagged by consumer groups – has the potential to cause significant damage to a company’s reputation and commercial strategy. In recent months, food supplements have come under even higher scrutiny from EU consumer groups, and are seemingly a constant topic of discussion.

For example, in the German news last June we saw a leading story in major national daily newspaper Der Spiegel on the “dangerous business with vitamins,” and we have seen similar reports by major news outlets ZDF and NDR.

In addition, in Germany government-backed consumer agencies such as Lebensmittelklarheit regularly publish information on products which they believe are not complying with local standards, or publicly discuss consumer concerns, for example that the information on a label of a specific product is “strange.”

U.S. food supplement companies which are interested in launching in the EU, or which are already targeting the EU market online, should therefore carefully review whether their food supplements comply with EU rules, in particular with respect to:

• U.S. food supplements may need to be reformulated for Europe. Harmonized legislation across the EU regulates the vitamins and minerals (and their sources) which can be used in the manufacturing of food supplements. Some EU member states have also set maximum or minimum levels of ingredients for vitamins and minerals. Botanicals are not regulated at an EU level, but some member states, for example Germany, have issued recommendations for their addition to food supplements, or even binding rules, for example in The Netherlands.
• U.S. food supplements generally need to be re-labelled so that the required information is presented in the language of each of the countries in which they are being sold.
• While mostly consistent with the U.S. restrictions, marketing in Europe must avoid associating a product with a particular disease, for example by saying that it protects against heart disease. The EU very strictly regulates what claims can be made about the relationship between an ingredient and its health benefits. Only an authorized health claim can be used, and this must be linked to an ingredient, not to a product as a whole, for example “vitamin C contributes to the reduction of tiredness and fatigue.” This differs from how claims are presented in the U.S. market. U.S. brand owners may wish to review the EU Register of Health Claims to see whether some of them provide opportunities in the U.S. that they didn’t previously consider.

It is important to note that the U.S. brand owner is responsible for ensuring compliance on these points. A company may be operating through a European distributor, but it will still be the brand that the regulatory authorities – and the media – might pursue if a concern were raised about a product.

Food supplement companies are therefore well advised to review their portfolios to ensure that all products marketed as food supplements comply with EU legislation, and that the health claims they make are authorized.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.