Functional foods: the case for closer evaluation

BMJ 2007; 334 doi: (Published 17 May 2007) Cite this as: BMJ 2007;334:1037
  1. Nynke de Jong, project director functional foods, postlaunch monitoring, risk-benefit analyses1,
  2. Olaf H Klungel, associate professor2,
  3. Hans Verhagen, head of centre for nutrition and health1,
  4. Marion C J Wolfs, scientific coworker1,
  5. Marga C Ocké, project director, food consumption surveys1,
  6. Hubert G M Leufkens, professor of pharmacoepidemiology2
  1. 1National Institute for Public Health and the Environment (RIVM), PO Box 1, 3720 BA, Bilthoven, Netherlands
  2. 2Utrecht University, Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht, Netherlands
  1. Correspondence to: N de Jong{at}

    Current regulations focus on the mandatory safety evaluation of functional foods before they come to market, but Nynke de Jongand colleagues argue that the effects of such foods should also be evaluated after they have been launched

    Functional foods are modified foods that claim to improve health, quality of life, or wellbeing. These foods are intended for use in the context of a healthy lifestyle or as a means to compensate for an unhealthy one. From society's point of view, there are several potential problems—the medicalisation of our daily food intake, the long term safety and effectiveness of these foods, and the aggressive marketing and advertising of these highly profitable products.1 However, functional foods need to be fully evaluated to make sure they meet current scientific and regulatory standards.

    EU regulations

    Several European Union regulations and directives on functional foods are currently being developed. Current rules focus mainly on the mandatory safety evaluation of new foods before they come to market; minimum and maximum safe upper values for micronutrients used for fortification; lists of permitted substances for fortification; the registration of herbal products; and acceptable nutritional and health claims.2

    One positive development has been the recent publication of regulations on nutrition and health claims. Nutritional claims can now be made only if the food fits a certain nutrient profile (such as below a predefined fat content if “low fat”). New claims can be issued only after being assessed and authorised by the European Food Safety Authority (EFSA) on the basis of good nutritional science.3 4 Most of the regulations and directives focus on evaluating safety before foods reach the supermarket, however—no regulations deal with aspects that arise after this point.

    Market positioning of functional foods versus drugs

    Similar to so called lifestyle drugs—drugs at the boundary between lifestyle wishes and health needs, such as erectile …

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