Immune sector in rude health despite regulator attacks

Sector giants like probiotic players have had to weather regulatory storms as new laws have raised claim-backing requirements to pharma levels – especially in Europe – in the process severely altering the way products can be marketed.

US agencies have gone after spurious claim making and emerging markets like latin America and Asia are implementing rules that look set to be equally tough.

But analysts still predict that sector to surge to €21bn by 2015 globally, from about €13bn in 2011.

But immunity is not just about probiotics and even prebiotics. Vitamin C is probably the most famous nutrient when it comes to battling colds and flus and other vitamins and minerals are important too.

Under the European Union’s tough nutrition and health claims regulation (NHCR) 10 ingredients have won immunity claims: Copper, folate, iron, selenium, vitamins A, B12, B6, C, D and zinc. No pre- or probiotic claim has yet had success, even though many have tried - and continue to try - with an interesting beta-glucan claim by German firm Leiber awaiting assessment as we speak.

The company said it had learned much from European Food Safety Authority (EFSA) guidance in building its dossier.

While there has been much screaming and moaning about the restrictive, business throttling nature of the EU regulations, and their influence beyond Europe, particularly in Asia, for the 10 ingredients above, new potential opens.

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This is particularly so because products need only contain 15% of the RDA of one of those ingredients to carry the relevant immunity claim.

Already products like GlaxoSmithKline’s Ribena Plus has added vitamins A, C and E targeting immune support for children in the UK.

In Poland, Agrosnova’s Dr. Witt ActivDrink has used newly approved claims to target different health platforms including immunity via the addition of vitamin C into its premium range of drinks, functional gum and nectars.

Danone’s probiotic Actimel drink has been reformulated in some EU countries with vitamin D and B6, allowing to reinstate immunity claims it has in recent years removed due to the EU laws.

“Through the use of article 13.1 general health claims manufacturers who see the potential in immune support products either through reformulation or through repositioning their product could see success,”​ Euromonitor health and wellness analyst, Diana Cowland, told us recently.

For a look at the situation in the US, read Hank Schultz’s interview with Washington DC-based attorney, Ivan Wasserman here​.