Will EFSA's new stance on probiotics influence FDA?

Will EFSA's new stance on probiotics influence FDA?

Starting in September of this year manufacturers wishing to distribute their products in Europe will no longer be able to put “contains probiotics” on the label.

The European Commission (EC) has determined that due to the tacit understanding prevalent with consumers associating the word “probiotic” with a health benefit—digestive health and immune health primarily—the phrase constitutes a health claim. And because “probiotic” encompasses so many different strains, none of which have yet produced the quality or quantity of research necessary to win an approved health claim from the EC, no manufacturer, as of yet, can legally make a health claim about probiotics on their product.


Bummer because for someone like me, deeply steeped in the industry and having, on many occasions, personally experienced the health benefits of quality probiotics, I want the brands I believe in to be able to market their products according to the good they do, regardless of whether or not they have the clinical trials to prove it beyond the shadow of a doubt. The anecdotal evidence provided to me by my digestive tract is all I need to claim a health benefit.

But I suppose Michel Sirgent, senior vice president of Bio-K Plus International, made a pretty indisputable point in our interview on the subject yesterday. “Until you do the research, especially with respect to probiotics, you don’t know if you’re delivering the benefit that you’re purporting.”

So far not one submission for a probiotic health claim has been approved by the European Food Safety Authority.

According to Sirgent, “one of the issues EFSA has with a lot of submissions is that a lot of submissions only claim to be able to increase the number of friendly bacteria in the colon. That’s as far as their research has gone. But that’s not a health benefit. No more than saying, ‘Well, my supplement can add two extra fingers on your left hand.’ How is that a benefit? Can I type faster? Can I wash my hair quicker? Maybe there’s a benefit but I have to prove it. Just having more beneficial bacteria in the body isn’t necessarily a benefit.”

Probiotics' catch-22

The crux of the issue comes from the nature of probiotics themselves. The health benefits are difficult to prove, the studies are costly, and because the bacteria are, for the most part universal, unpatented strains, it would be very difficult for manufacturers to make back the money they might invest in clinical trials from product sales alone.

In the world of pharmaceuticals this isn’t the case. Drug developers will have a patent on their creation. The formula is proprietary and protected and if it works they’ll make all of their investment back and then some. But when you’re talking about naturally occurring microorganisms that anyone can cultivate and use, that incentive disappears.

This is the most difficult contention we have to deal with as an industry as regulatory bodies like EFSA abroad and the FDA here at home begin to treat supplements and functional ingredients more and more like pharmaceuticals.

The catch-22 is that for those of us who believe in the products, we know that some of these ingredients are better than pharmaceuticals and we want to tell people all the amazing things they can do for your health. The industry has been struggling with these growing pains for years now, but I think we’re seeing more and more optimism from suppliers and manufacturers about our ability to rise up and meet the research challenge laid down, not just by EFSA and FDA, but by consumers themselves.

And if you ask me, Sirgent has the right attitude when he said, “If you’re going to make a claim you should be able to back it up. If you can’t back it up, as far as the consumer is concerned you shouldn’t be making those promises or creating those expectations. And if the government or regulators have a problem with that, then I think they’re probably justified.”

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