Turf Wars, Tension, Threats, Turmoil and Frustration?

Hoping for a calm year in Europe during 2008? Don’t count on it. Turf wars, tension, threats, turmoil and frustration lie ahead.

Turf wars are likely between the medicine regulators, the food authorities and those who control advertising as they vie for supremacy in interpretation and enforcement of the increasingly complex regulatory interplay between medicines law and regulations on food claims.

As EU member state level medicines regulators meet their food counterparts, the former will assert medicines law takes precedence, the latter will assert the Nutrition and Health Claims Regulation has shifted the balance with its provision for disease-risk reduction claims. Advertising authorities are overturning objections by medicines regulators that would have, in the past, been unchallenged assertions that function claims for probiotics stray into the realm of medicinal.

Tension between the fortified food sector and the dietary supplements industry will arise as they fight to arrogate to themselves the lion’s share of the “safe” intake level of vitamins and minerals established by Article 5 of the Food [Dietary] Supplements Directive and its counterpart under the Addition of Vitamins Minerals and Other Nutrients to Food Regulation. It is a misguided scrap, suggesting a failure of the fortified food sector to appreciate the sophistication of the risk management model developed by Prof. David Richardson for the European Health Products Manufacturers Association; and, by demonstrating a divided industry, it plays into the hands of the more restrictive member states.

There will also be more tension between companies that want a home for botanicals under the Food Supplements Directive, only to be opposed by others with costly licenses under the medicines legislation. This tension will be further exacerbated by the opposition of medicines regulators. Finally, look for tension over the scope of long-awaited EU legislation on sports nutrition.

The threats will come to long-established sports nutrition best sellers as medicines regulators pick over the growing evidence of effectiveness for glucosamine and creatine.

Turmoil will manifest as consumers around Europe mobilize to demand access to higher potency dietary supplements, as the process of establishing maximum permitted levels for vitamins and minerals enters the “end game” of Council Working Group meetings to find the conspicuously absent common ground.

More turmoil will surround a different set of consumer activists agitating against the use of additives in food, particularly in children’s food. What do the regulators do when consumer power rejects their science-based regulatory approach that additives are safe, and enlists political support to undermine the principles of food legislation?

And as food and public health authorities in several member states move to implement plans for compulsory folate fortification to reduce neural tube defects, both the fortified food sector and the supplements industry will find their products challenged: the fortified food businesses relishing the opportunity to reduce expensive folate levels, while still advertising its presence, and leaving the supplement sector wondering how to defend its products.

Finally, there is frustration: for poor boron, efforts to secure the inclusion of which in PARNUTs foods and food supplements have languished for years as Germany blocks its inclusion onto permitted lists in line with EFSA findings.

More tension between science and politics on all these issues is to be expected, which does not augur well for rational and credible decision-making, or confidence in European legislation as the panacea for all ills from consumer protection to market harmonization.

For once, it is not just industry players fighting their own corner; the whole of the regulatory infrastructure and consumer factions are joining in the fun.

Some businesses benefit from the greater confidence that regulation brings in the safety of its products and the removal of barriers to trade. But against a background of consumer activism, those benefits can become illusory if customers reject products, and if the cost of compliance and barriers to market entry become prohibitive for innovative businesses whose new products are the future of the sector.

Chris Whitehouse is managing director of the Whitehouse Consultancy, which specializes in strategic advice to industry. For more information, visit Whitehouse-Europe.com.