“Unhelpful”: EU regulatory framework fuels nutrition industry dissatisfaction 

16 Feb 2018 --- A survey reveals that one-third of all nutrition industry professionals believe that the current EU framework for achieving a health claim on new products is stunting innovation because it’s complicated, expensive, long-winded and has several “gray areas.” And “regulation frustration” is a strong feeling running through the industry with many more professionals now believing the current EU regulatory environment is “unhelpful” – a 25 percent hike compared with statistics from the beginning of 2017. Experts are attributing this sharp rise in dissatisfaction to the EU’s tough stance on health claims and the current regulatory deadlock on botanicals.

The data was gathered by the organizers of Vitafoods Europe, and although 34 percent find the framework helpful, this figure has dropped from 37 percent. 

Speaking with NutritionInsight, the consulting team of Analyze & Realize - a German-based company tailor-making solutions for natural health products, from product development to regulatory affairs and market entry – explains how the current EU framework contains a lot of gray areas.

And how the regulatory challenges for the industry have remained or even increased, over the past year, making it very hard for companies to develop innovative products that comply.

“Without the possibility to make (legal) health claims, it is often difficult to educate consumers about the benefits of a product. The EU framework leaves a lot of gray areas, the pending botanical claims are one of them,” says Dr. Iris Hardewig, head of Consulting.

“Another area is maximum levels of vitamins and minerals. While it has not been possible to establish harmonized maximum levels in the EU, we have now the situation that different values are established on the national level. This makes pan European product launches more difficult.”

The framework is considered unnecessarily complicated. However, the Analyze & Realize team points out that this has a lot to do with the history of national laws and practices on traditional herbal medicines and botanical food supplements. 

“The interest to find a compromise that helps the European supplement industry as a whole is different among the various players, first of all, the member states with their own paradigms and national legislations, and the supplement industry and manufacturers of traditional herbal medicines, just to mention a few.”

“On the other side, EFSA needs to take into account that they are looking at food products and at clinical evidence obtained in healthy people. This combination leads to very small effect sizes. Therefore, the evaluation criteria used by EFSA lead to the disapproval of most applications, not only for botanicals.”

Botanical bottleneck 
A particular area of concern is the current deadlock on the regulation of botanicals. Thousands of botanical health claims have been on hold for several years while European Food Safety Authority (EFSA) considers how to evaluate them.

The pending botanical claims is a factor of uncertainty for the industry and while some companies are willing to take the risk and use the claims although not finally approved by EFSA, other companies, want to go the safe way and stay away from the unapproved pending claims. The latter is mainly the bigger players who invest heavily in marketing.

Over a quarter (28 percent) of respondents to the Vitafoods Europe survey said the EU policy change that would most help their business was an overhaul of health claims regulations.

How can it be improved?
“The industry would like to have the opportunity to obtain authorizations for health claims on botanicals either based on tradition or based on newly developed clinical evidence,” Dr. Hardewig continues. 

“This approach would resolve the contradictions between herbal drugs and supplements and would allow for innovation. With clarity for the botanicals, further harmonization of the food supplement regulations would become possible.”

The low number of approvals is a disincentive to research and development and frustration within the industry is high because clinical trials are a major investment for food companies. Firms are put off from investing heavily if they think R&D doesn’t lead to any competitive advantage – and it’s industry and consumers who lose out. 

NutritionInsight asked the Analyze & Realize team for an idea of the costs involved for a company to successfully get a health claim approved.

“By far the biggest chunk of the price is caused by the clinical studies, but their prices depend on the indication, the design of the studies, the number of subjects, duration, the type of analysis and their costs, and so forth.”

“As a rule of thumb, at least one smaller pilot trial and one confirmatory trial are necessary. This will lead to costs of €300,000 (US$375,912) – €500,000 (US$626,580), just for the clinical trials. There may be exceptions to that, for specific indications.”

And in terms of progressing to a situation when realistic and actual improvements can be made to the EU framework, the team say they simply “don’t have the answers.”

“And neither do the regulators seem to have one. The EU regulators have not given any hint on the roadmap and timeframe for a resolution,” Dr. Iris Hardewig added.

Because of the challenges in the EU market, some manufacturers are trying to expand into the US or Asia, but this is largely reserved for the few big players and specific products, according to the team. 

“We also observe that foreign manufacturers, e.g., from Asia, prefer to access the US market rather than the EU due to less strict US regulation of the supplement market.”

“On the other hand, we see that there is now a lot of innovation with respect to new delivery formats on the EU market. This development is certainly due to the limits of innovation in terms of health claims. We also observe riskier business models, out of the oversight of the monitoring bodies.”

By Gaynor Selby