By Rob Verkerk PhD, founder, executive and scientific director

The European Court of Justice handed down a ruling on 14 July that makes illegal, EU-wide, the ability of natural products companies to communicate life-saving and disease preventing information about their products.

The case (C-19/15) was referred to the ECJ by a German regional court. It was based on a challenge by the bounty-hunting, anti-natural health, German skeptics group, Verband Sozialer Wettbewerb eV who challenged Innova Vital GmbH, a vitamin D producer. The company communicated important and scientifically validated information about the benefits of vitamin D exclusively to doctors and other health professionals, who in turn were shown how they could obtain the company’s liquid vitamin D3 formula.

Bogus complaint or bogus complainant?

At the heart of VSW’s complaint was Innova Vital’s statement that “87% of children in Germany have blood vitamin D levels below 30 ng/ml….[and] According to the DGE [(Deutsche Gesellschaft für Ernährung, German Food Association)], that level should be approximately 50 to 75 ng/ml". The company added that it had “already been demonstrated in numerous studies [that] vitamin D plays an important role in the prevention of several illnesses, such as atopic dermatitis, osteoporosis, diabetes mellitus and MS (multiple sclerosis). According to those studies, vitamin D deficiency in childhood is partly responsible for the subsequent development of those illnesses.”

The problem? These health claims are not authorised by the European Commission under the EU Nutrition and Health Claims Regulation, following assessment by the European Food Safety Authority, another EU institution that has itself been exposed on numerous occasions for conflicts of interest.

Reducing consumer access to facts about natural healthcare. Commercial communications by the trade to consumers (1) has been limited to authorised health claims. Now the European Court restricts commercial communications to authorised nutrition and health claims (2), even if there is no evidence that the same information will be communicated to the public (3).

Far-reaching precedent

The ruling now sets a precedent that effectively bans any commercial communication to a health professional that isn’t specifically authorised by the EU. There are only 256 authorised health claims out of many tens of thousands that could be related to foods or their constituents, including over 40,000 originally submitted for consideration when the EU Nutrition and Health Claims Regulation was in its early implementation.

The ruling drives a sledge-hammer through a very important educational communication channel for companies, for health professionals, and particularly for the main beneficiary, the public. Out of the many tens of thousands of foods and constituents in foods, the EU has seen fit to grant only 14 authorised disease risk reduction claims for adults. Half of these relate to cholesterol lowering and its alleged and now largely disproven relationship with reduction of coronary heart disease risk; two relate to vitamin D (risk of falling and osteoporotic bone fractures among) and two to xylitol-containing chewing gums for reduced risk of tooth decay. Only one children’s health claim for vitamin D is authorised, namely “for normal growth and development of bone in children.” One relates to folic acid, the synthetic forms of folate, and its role in reducing neural tube defects among pregnant women, yet the bioactive natural form (5-methyltetrahydrofolate) that is available and approved for use in the EU in supplemental form. Go figure…

EFSA opinions do not reflect emerging science

The reality is that EFSA is ‘out to lunch’ on the science, looking largely only at published research that is put in front of its expert panels and having no remit to deal with therapeutic use of nutrients.

Despite the valiant efforts of Dr. Thomas Büttner in trying to defend the case, the Court has ruled that any commercial communication involving nutrition or health claims, even if not “addressed to the final consumer, but exclusively to health professionals, falls within the scope of that regulation.”

The bottom line, is that the European Court has dramatically overstepped the mark in terms of its legal capacity, and this complaint is far from the first to made. Criticism of its heavy-handed approach in The Economist magazine over 20 years ago is especially poignant a little over a month after its decision to leave the EU.

How can the European Court rule on commercial communications between traders and health professionals when health professionals have the requisite skills and training to translate information for the benefit of consumers and therefore will communicate differently to consumers?

Defective, unsubstantiated concerns

The Court justifies its extraordinary ruling on a number of premises:

1. Health professionals cannot be expected to be up-to-date with the latest science and so are not in a position to evaluate the authenticity of commercial information (surely that applies to drug reps to doctors too?) [see paragraph 43 of ruling];
2. Health professionals are as liable to being “misled by nutrition or health claims which are false, deceptive, or even mendacious” as consumers [see paragraph 44 of ruling];
3. Health professionals are likely to “exercise significant influence over ….[their] patients” because they are trusted (doesn’t that arise from their expertise?) [see paragraph 45 of the ruling], and;
4. The Court wants to close what it sees as a loophole [see paragraph 46 of the ruling]

Let’s take stock

Imagine if the same logic was applied to drug companies peddling their wares to doctors? They of course have a whole different regulatory framework – one specifically for drugs – about which they can make claims that are very rarely supported by ‘genneraly accepted scientific evidence”, the ridiculous threshold – itself open to even more ridiculous interpretation by EU authorities such as the European Commission and EFSA.

Here is a way out though for traders and health professionals: erect a ‘Chinese wall’ between educational content and commercial communications about products. It’s an approach that’s already in use and it needs to be used to its full as some of the companies in the natural health space have necessarily become the primary educators in this field given that pharma has almost entirely ‘stolen’ the educational environment for healthcare products in medical schools. That’s another project in which ANH-Intl is involved.

Frankly, it is laws like the EU Nutrition and Health Claims Regulation and its subsequent interpretation by the European Court that contributed to the decision by millions of Britons to leave the EU last month.

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