Cholesterolimbroglio: Inside an EU claims mess
It’s a case that highlights absurdities that exist in the category and the health claims process, says EU food law expert and author, Bert Schwitters, in this guest piece.
FoodWatch contends that margarine containing cholesterol-lowering sterols must be classified as a medicinal product although the case itself rests on a more technical matter.
On the Dutch version of its website, the FoodWatchers state that Unilever's Becel pro.activ is a "cholesterol-lowering medicinal product" that has "the form of a food-product to which a highly concentrated active ingredient has been added."
FoodWatch also states the health benefits of the product "have not been proved." Readers are invited to sign a petition entitled: "Do you agree that Becel pro.activ does not belong in the supermarket ?"
Claims possession
For one thing, FoodWatch is barking up the wrong tree because the claims are EU-approved and usable by the plant sterol and stanol sector. They are not specific to Unilever or Becel pro.activ.
The European Food Safety Authority (EFSA) NDA Panel approved the submissions, then they were backed by the European Commission.
NDA panellists are meticulously screened to prevent someone being tainted by the slightest shadow of a connection with ‘industry’.
When it comes to the use of health claims in commercial communication, food business operators are far, cosmically far, removed from the evaluation and authorisation process. The cholesterol lowering health claims used by Unilever are Union-authorised claims for sterols and stanol-esters.
In its zeal to brandish an important food business operator, FoodWatch conveniently overlooks the regulatory reality that Unilever must respect when it communicates about pro.activ. Undeterred, FoodWatch invites consumers to support its petititon that Unilever should apply for a marketing authorisation to place Becel pro.activ on the market as a medicinal product.
Commercially speaking, this might not be such a bad idea. Unilever should think about this suggestion. After all, cholesterol lowering ‘statins’ are among the most profitable drugs of all time. And they achieve precisely what pro.activ seems to accomplish.
Claims wonderland
It is here that FoodWatch touches a nerve.
In 2013 the European Commission added a disclaimer to the claim, stating manufacturers had to warn that products like pro.activ were not intended for people who don't need them.
Who are these bionic consumers who do not need to control their blood cholesterol level? You? Me? How does anyone know whether he/she belongs to this mysterious and undefined group? Who must protect him-/herself against the risk of potentially purchasing a product he/she doesn't need? How do you figure out that all the stanols and sterols you have been dutifully consuming all those years have not been in vain because you didn't need them?
When these products, according to one Union-authorised health claim also "contribute to the maintenance of normal blood cholesterol levels," who then belongs to the group of people who don't need to control blood cholesterol?
Unimportant as this cholesterolimbroglio may seem in the broader context of public health and the "hectics" of daily life, it sheds light on the fact that when government bureaucrats take control of things, we inevitably get a mushrooming complexity that might well fit the Wonderland where Alice could have said: "Come and see, my little consumers. I have something wonderful for you. It tastes just as good as eggs in the morning. You should eat it every day and, I promise you, it brings you healthy hearts and kisses. It will also save your life. But beware, little consumers, I haste to say, it's not for those of you who don't need it. And what's so very funny, although I assure you that all of you need it, I'm not going to tell you which ones of you don't need it!"
This is an abbreviated version of Schwitters' blog that can be found here.
