The stop-and-go, uncoordinated approach of EU-level and national regulators to bans on nutritional supplements including DMAA, dexaprine and synephrine, should be a cause for concern among policy makers and industry alike, warns Luca Bucchini, PhD.
Lack of a uniform European approach is no news. Given the stuttering, uncoordinated approach to DMAA (1,3-dimethylamylamine/methylhexanamine) of European national regulators, coupled with the localised ban of dexaprine, the isolated Finnish ban on synephrine, the uncertain outcome of the European Food Safety Authority (EFSA) assessment of yohimbe, and the lack of obvious action in the EU on Oxyelite Pro (despite a formal US Food and Drug Administration (FDA) warning) - it is hard not to conclude that EU-level and national regulators in Europe have a tough time in dealing coherently and proactively with the marketplace, even if food supplements at fault are a microfraction of those available to European consumers.
This should worry policymakers and industry alike.
Companies, with good reason, complain that, despite the principle of mutual recognition it is easier to export to India or the Middle East than across the European Union.
National rules are still omnipresent; they, and EU law, are more or less keenly enforced; some EU member states require notifications which are essentially pre-market authorisations under other names.
While all this makes the single market a partly theoretical proposition, e-commerce is still mostly lawless, with US and extra-European products available everywhere in Europe via a click. This trade, which is vital for a forward-looking industry, happens with little or no regard of EU rules and with no oversight comparable to that of the FDA; unless they hear illegal trade of aspirin, and drugs agencies get involved, it is difficult to see much action.
Will the American internet giants, which have established a firm foothold in Europe with local storage sites, respect EU regulations including labels in national languages, novel food regulations, additives laws, restrictions on botanicals in supplements versus herbal medicines, national rules on ingredients? I doubt it.
One would expect EU regulators, most of whom are very qualified and able, to be coordinating plans to respond to such sea changes. Yet, recent history is not encouraging.
In the case of DMAA European regulators knew that the substance was unsafe, and there was little doubt it was illegal in the EU. Some countries took action without much information to consumers, others pondered the drugs/supplement borderline, till an adverse event occurred in Sweden: but the US FDA had acted two months earlier.
In the case of dexaprine, most countries are silent. Now Finland bans synephrine – while it remains safe in much of the rest of the EU.
US consumers were warned not to consume Oxyelite Pro, but manufacturer USP Labs continues to sell it internationally. It is still sold across Europe and European authorities don’t seem in a hurry to communicate anything.
Fragmented and unreliable?
Does all this matter? Of course it does. If the European market is fragmented, and rules unpredictable or unreliable, European companies suffer.
As people buy more and more online, competition from around the world that does not abide by EU law – will take advantage of the fragmented nature of the key markets for European companies.
European companies which have so far opposed greater EU harmonisation should take note. Bad apples may spoil the name of the entire orchard if not rapidly removed, and food supplements have fewer friends in the EU than in America. Quality is an empty buzzword if there is no sheriff to apply the law.
Step up EFSA
Obviously some matters need to be resolved at the EU level, and not at the national level. The data for each substance are the same for all European regulators. If Europeans can agree on how to regulate food additives, or Salmonella, or even health claims - they surely can agree on whether DMAA is too risky for consumers or not. In fact, we Europeans have EFSA, which is assessing risks in a competent and authoritative way.
While EFSA has done a great job in many areas, including vitamins and minerals in supplements, and provides routinely good advice on emerging risks, it’s not yet as relevant as it should be for the odd hazardous food supplement ingredient.
Perhaps the noble idea of assessing botanicals as a self task was in part a distraction, and, judging from the yohimbe assessment, the methodologies are not yet fit for purpose. It’s great to report uncertainty back to risk managers, but someone should say when the uncertainty is too much to be on the safe side.
Risk managers – the regulators who make policy, and enforce it – should be clearer with EFSA, which has all the capabilities to do this job well as long as the methods and focus are right.
In fact, it should all be quite easy. There is a warning signal from consumers, the medical community or industry; the warning signal is assessed by EFSA with a reliable methodology for acute risks and sparse data; authorities take EU-wide decisions, which are rapidly enforced.
Yes, it does take some coordination and communication, but it can’t be more difficult than forging a banking union - a task which the EU is partially achieving.
Surely risk assessment and management of potentially unsafe substances in food supplements can be pooled by EU regulators that have written regulations on fruit size. And the EU food supplement industry should be all for it.
Luca Bucchini PhD, MPH, is the managing director of Italian-based Hylobates Consulting.