Eurotrends: European Health Claims: The First Consequences

Nutrition business in Europe is currently being affected by the new Health Claims Regulation, which came into effect fully on Dec. 14, 2012. Since that date, all health-related claims made on product labels or used in product-related advertising must either be supported by product-specific evidence approved by the European Commission, or be drawn from a positive list in accordance with the ingredients contained in the product in question. Claims include statements made on Internet sites related to the product—a fact some distributors may not have realized.

The positive list from which product messages must be drawn encompasses claims for vitamins, minerals and precious few “other substances,” but not for botanicals, whose claim applications have not yet been evaluated by the European Food Safety Authority (EFSA).

Many manufacturers, especially large companies with dozens if not hundreds of products on the line, have proactively removed all claims not covered by the new regulation from product labels and other media. Other companies, possibly shunning the costs involved with re-labeling, have adopted a wait-and-see attitude as to what exactly the consequences for carrying illegal health claims will be—specifically to see how fast watchdog organizations will be able to comb through all products currently on the market.

Many manufacturers are hoping to use the claims made on botanical products that have not yet been evaluated. As long as EFSA has not issued an opinion on a given substance, then technically the originally applied-for claims are not illegal to use, and many companies are banking on that. In fact, single-substance botanical products such as ginkgo or Echinacea can only be marketed successfully based on their traditional claims. If and when those claims become illegal to use, these useful plants would be reduced to being no more than decorative additions to generic vitamin/mineral combination products, at least where health claims are concerned.

Alternate Routes & First (Re)Actions
On the R&D side, the Health Claims Regulation has forced manufacturers to consider going the drug route (i.e., investing in clinical trials for products intended to carry more than generic health claims), since requirements for the substantiation of proprietary, product-specific claims for food products approach the costs and complexity of drug trials. Finding an experienced contract research organization (CRO) specializing in nutrition trials such as analyze & realize (a&r) is becoming a crucial issue in this context in order to stay cost-effective.

Of course, this is a route only open to companies with deep pockets. Small to medium-sized companies are more or less forced to either take their chances with the pending botanical claims, or make the best of the available proprietary health claims. For this reason, many botanical products are being re-formulated to include vitamins and minerals, so that at least their health claims can be used safely.

In the meantime, watchdog authorities have indeed begun to take action. Of its clients, a&r is aware of three separate cases that have occurred since the regulation came into effect where manufacturers of products marketed via telemarketing were contacted with regard to claims made verbally over the airwaves. Traditionally, strong claims are used in this sales channel, and it seems that authorities are targeting this area first.

At least one case within a&r’s purview has occurred recently where a product was deemed unmarketable due to some formal labeling problems and unsubstantiated health claims made on the label. Those claims weren’t even particularly outrageous, and the labeling problems weren’t particularly crucial; and the product was still called out, which seems to indicate that watchdogs aren’t going after the more outlandish product claims first, but are targeting everything that is not in line with the regulations equally. However, this product, too, is being marketed on television, which seems to support the observation that this sales channel is currently being scrutinized more closely than others.

This does not mean, however, that products sold exclusively on shelves are safe. Sports nutrition products, for example, were already in the watchdogs’ gaze last year, and with the Health Claims Regulation finalized there is no reason to suppose this scrutiny will lessen now.

All in all, developments are in flux, and it will be interesting to see how the food category, and specifically the dietary supplements category, will develop in Europe in the future. With products becoming unmarketable due to illegal label claims, manufacturers will have to resort to using the generic health claims allowed for generic ingredients; and it seems that watchdog authorities are not going to be very lenient.