More than one option
Messages on health, performance or well-being can come in many forms. In some cases, if a health claim is not allowed, other options may be available.
Content claim on food
For a claim on content of a nutrient or another substance on the label of, for instance, a food or a food supplement, criteria have to be met as laid down in national or supranational regulations (for example, EU regulations).
Health claim on food
In some countries, including the USA, there are possibilities for making a health claim on the label of a food or a food supplement without pre-market approval. When challenged, substantiation of the claim is required.
In other countries, it is different. The EU, for instance, has allowed several health claims on vitamins and minerals, based on consensus in the scientific literature, as noted by EFSA’s NDA Panel. Provided that the conditions are met, these health claims can be used. Many more health claims based on scientific publications were proposed, but rejected. No agreement exists at EU level on bioactive substances from plants (botanicals) used in foods.
New health claim (EU)
For a new health claim on food in the EU, pre-market approval is required. In the application dossier, all publications relevant to the health effect to be claimed must be addressed, in particular all publications on intervention studies. Ideally, a clear picture emerges, which is confirmed in a ‘pivotal study’ conducted according to current standards demonstrating the beneficial effect. In some cases, a meta-analysis of intervention studies that fulfil the criteria for inclusion can be of help.
Approval of a new health claim will only be granted on basis of a dossier fulfilling all criteria of the EU Nutrition and Health Claims Regulation, as judged by EFSA and by the Commission. This has proven not to be easy.
Previous applications, whether successsful or not, as well as guidance provided should be taken into account in order to maximize the chance of approval. The effect to be claimed must be considered beneficial to health and sufficiently proven, within the scope of the Regulation. Characterization of the product, the wording of the claim as well as the consumer instructions are also critical.
Often, questions are asked about an application dossier. Some question scan be answered by a quick clarification or explanation. Other questions, provided that they can be answered in a satisfying way at all, may require further elaboration.
Considering the product, its use, the pertaining regulations as well as the marketing and communication strategy, it may be decided if, when and how results of studies should be submitted for publication in a peer-reviewed scientific journal.
As an alternative or a complement to a content claim or a health claim on a food, other options are available to get your message across, also within the EU. The internet as well as conventional media offer various opportunities.
Think of communication of benefits towards health professionals, for instance. Business-to-business communication of a consumer benefit may also be effective. If data supporting the product are persuasive, they may fuel the public or the scientific debate.
A guarantee of final acceptance cannot be given. But previous experience with health claims and with other messages on benefits helps to avoid unnecessary complications.
Services provided in this phase may include, for instance, one or more of the following:
- preparing a dossier for registration
- consulting with authorities and representing the manufacturer
- submitting of a dossier for registration
- consulting with external experts to address specific issues
- handling questions received from authorities
- adapting the wording of a claim
- adapting consumer instructions
- developing a plan for post-launch monitoring
- monitoring the preparation of manuscripts for publication
- developing alternative or supplementary messages and communication strategies
- providing commercial support