What Europe Thinks About Limicol

The European Commission is about to take a step that’s bigger than it might at first sound: according to a draft regulation released in early October, they’re thinking about approving for the first time a health claim about the combined effect of more than one substance. The claim regards a product called Limicol.

What is it?

First hitting shelves in 2008, it’s a dietary supplement that’s meant to lower blood cholesterol, which itself is a major risk factor for heart disease and associated problems. Limicol, however, isn’t built on a single trick. Instead, it’s supposed to function through the combined efforts of several different plant compounds, whose actions in concert with one another have the combined effect of lowering blood cholesterol.

The makers of Limicol, a French company called Laboratoire Lescuyer, went before the European Commission’s regulatory arm to ask that their drug’s health effects be evaluated so that they could sell it in the European Union. Usually, health claims approved by the European Commission are focused on the effects of a single substance.

With Limicol, however, there are several different substances at play; different compounds from different plants (or not from plants at all), with different mechanisms of action, supposedly working in conjunction with one another. From the draft document published by the European Commission: “artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers (OPC) from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate.”

Altogether, it’s a mouthful, but the combined action of these different chemical bits and bobs is easy to understand: it lowers blood cholesterol, which in turn lowers the risk of developing coronary heart disease. The European Union tested the claim and found that there was indeed a cause and effect relationship between the different compounds together and the level of cholesterol in the blood.

One Small Regulatory Step

That was just the first regulatory step, however. Before the medical claim could be approved for use in the EU, the Commission requires that a certain number of medical trials are carried out. Although the cause and effect relationship was found in 2013, the unhurried gears of science grind deliberately, so it’s taken some time for those follow-up studies to come through and prove that the product was indeed safe to use as dietary supplement.

This is a single decision. It could be a one-off, or it could presage something larger — a shifting attitude in the EU towards medicines that similarly claim health effects from the action of combined substances. If more health claims of this nature are approved, we might see a real diversification of what’s available in Europe.

What About Food Safety?

More drugs doesn’t mean better food safety in the narrow sense. A more diverse drug market, however, could open up more avenues for protecting against or responding to different pathogenic threats. Take a slightly broader understanding of food safety, considering not just pathogens but the long-term health outcomes of different diets, and you find that Limicol is solidly within your wheelhouse: one of the major predictive factors for blood cholesterol is diet, although that’s a link that we’re still in the early days of understanding.

And, if you’re thinking to yourself that cholesterol has nothing to do with food safety, think again: you very well can examine the safety of your food in the long term by looking at, for example, what it does to your blood cholesterol; once you’ve started, in fact, you might find shorter-term framings of what “food safety” is to be a bit myopic.

What is Happening in the US with Limicol?

In the United States, dietary supplements like Limicol are handled differently than cholesterol-lowering medicine you might pick up from a pharmacist. The American Cancer Society’s website puts the distinction succinctly: drugs are considered unsafe until they’ve been proven to be safe. This means a whole battery of tests, on different animals as well as live human subjects, in order to disprove that the drug might have negative side effects which would make it unfit for use.

Dietary supplements, on the other hand, are considered safe until they’ve been proven to be unsafe. They’re regulated according to the Dietary Supplement Health and Education Act, a piece of legislation that was passed in 1994. According to that law, dietary supplements are considered “new” if they contain an ingredient that wasn’t in common use before 1994. The FDA needs evidence that the new ingredient isn’t harmful, but medical trials aren’t required, and supplements containing things that were in use before ‘94 are not so constrained.

What Can the FDA Do or Say About Limicol?

The FDA can pull supplements from the market if they find that they pose a significant health risk. By definition, however, this kind of retroactive action can only come after the harm. If the supplement has some previously unknown side effect or interaction with another drug that comes to light after people who are taking it get sick, well, the toothpaste is already out of the tube. The barn door is open and the horses have fled.

That’s a bit depressing, really. The food safety infrastructure of the United States would be much stronger if the FDA evaluated the health claims that supplements make on their labels before they went to market, examined them for safety before people were harmed, and required trials as part of those examinations that went beyond the rather loose requirements that dietary supplements are presently subject to. Fix that first, and then we’ll worry about getting on the level of Europeans, who aren’t just evaluating the health claims of supplements; they’re evaluation health claims about combined effects, which is some real next-level stuff.

By: Sean McNulty, Contributing Writer (Non-Lawyer)