Why rolling over or standing on the side-lines is no longer an option
The last couple of months has seen an unprecedented clamp-down by national regulators on natural health products. They are acting on a raft of EU laws that have been incrementally implemented since 2002, when the EU’s Food Supplements Directive was passed.
This would be all very well and good if the products that were being jumped on from great height were bogus, posed a significant risk to human health and were not of any benefit to anyone. But none of these apply. The vast majority of products being targeted and impacted are demonstrably safe and demonstrably effective.
And because the world of the EU is topsy-turvy, if the product is ineffective, that’s just fine – it’s the really effective ones that most often get into trouble with law enforcers.
The main culprit is the extraordinarily broad reach of the EU’s definition of a medicine, which effectively makes any product a medicine ‘by function’.
National and EU regulators: armed with a loaded gun
We’re not in the habit of running challenges that involve cash pay-outs for successful challengers, but here is one we considered recently: We’ll give €1,000 to anyone who can provide us with details of a food or food supplement product that DOES NOT breach the second limb of the EU definition of a medicine (as per Article 1.2(b), of amending Directive 2004/27/EC):
Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis
But we won’t waste either your time or ours, let alone risk hard-earned campaign funds pursuing this challenge, lest you find one of Big Food’s latest offerings to be completely inert. To-date, we haven’t found a single food or food supplement that can escape this clause, mainly because they all have some sort of metabolic action at the least.
Yet it’s this very clause that is used over and over again by national medicines regulators to classify food supplements as drugs, arbitrarily, either at their will or at someone’s request. That ‘someone else’ is invariably a representative from a company that sells drugs or foods, who views the targeted product as competition.
Most of the products being pulled off the market have no safety concerns – EU regulators end up using EU medicines law as a protectionist tool under the guise of protecting public health. This mechanism is used to protect the biggest European players in the drug and food business, almost always at the expense of the smallest players who are often responsible for making the highest quality, most effective products.
The rot at the heart of the EU
Making things even worse; the machine that generates all these EU laws is rotten to its core. Here is a non-exhaustive account of evidence of the rot:
Pharma vitamin price-fixing. Back in 2001, the EU fined eight companies a total of €855 million for operating a vitamin price-fixing cartel. The guilty companies weren’t recognised innovators in the natural products sector, however: without exception, they were pharmaceutical companies like Hoffman–LaRoche and Takeda. These and their ilk are the very companies who will benefit the most from the ongoing EU natural health crackdown, and who were involved in lobbying for these misbegotten laws from the start
Corruption in EU finances. Until 2005, Marta Andreasen was the EU’s chief accountant. That is, until she went public over a €130 million discrepancy between accounts, describing EU book-keeping as rife with, “Slush funds and fraud”. In true autocratic style, Andreasen was sacked by her boss, former UK Labour leader Neil Kinnock, and hung out to dry by an EU tribunal. 2012 marked the 18th consecutive year that the Court of Auditors found “significant error” in payments in the EU budget
Conflicts of interest. Further corruption abounds at the European Food Safety Authority (EFSA), the EU body responsible for the ‘science’ supporting the EU’s anti-natural healthcare legislation – and of approvals for pesticides, genetically modified (GM) foods and food additives. Despite repeated and documented reports of conflicts of interest on its expert panels, EFSA maintains an extremely industry-friendly approach, most recently illustrated by its stances on Monsanto’s NK603 GM maize and aspartame. In its defense, EFSA is fond of pointing to recently revamped procedures and an externally commissioned report – neither of which are convincing
‘Dalligate’. Until recently, John Dalli was a European Commissioner, head of the Directorate General for Health & Consumer Policy (DG SANCO). That is, until he was abruptly ‘asked to resign’ by Commission President José Manuel Barroso in 2012. Dalli faced the axe, “Following an OLAF [the EU’s anti-corruption watchdog] report which claimed that a Maltese lobbyist had approached the tobacco producer Swedish Match and proposed to make use of his contacts with Dalli to fix the EU export ban on chewing tobacco (snus).” This would have been bad enough – but now, it appears that Dalli may have been badly served by both OLAF and Barroso. A full-blown scandal appears to be brewing, which has been dubbed ‘Dalligate’
Cyprus. Of course, we couldn’t fail to mention the EU’s recent and ongoing financial blackmail of Cyprus and its citizens. The EU has effectively said to Cyprus, “Unless you hand over nearly 40% of savers’ deposits over €100,000 to pay off bank debts, you won’t get any EU bailout money” – a negotiating position that would do the Mafia proud.
With that kind of a track record, how respectful can you really be for either the people who create the laws, or those who blindly and increasingly feverishly attempt to enforce them?
What’s more, rolling over and taking a product off the market just because a regulator says its fallen foul of the second limb of the EU definition of a medicine should not be an option. This is time for natural health companies to stand by the great products they make and ensure they are available to consumers not just today, but also in the future.
Call to Action
Companies: Don’t just roll over! Challenge decisions by regulators whenever possible
Consumers: Demand and expect the best, most effective products, and make sure the companies who make or sell the products you are reliant on are doing everything they can to beat back any hostile assaults on their products by local, national or EU regulators.
Speak out. If you’ve lost products, either as manufacturer, supplier or consumer, you should get the word out on social media, via website commentaries, in writing – or just verbally. Please let us know via [email protected] whenever you’ve discovered a product has been removed from the shelves because of the action of over-zealous regulators.