When does a new probiotic strain need regulatory pre-approval to be used in food?

In recent years, consumer awareness and desire for bacterial cultures that provide gastrointestinal health benefits (and perhaps other benefits beyond the gut) has driven the food industry to isolate new strains of probiotic bacteria. This consumer demand has also driven food innovation in how probiotic cultures can be delivered which in turn has expanded the categories of food products which can now market their probiotic content. This article will explore how new probiotic strains will be classified under food regulation and in what circumstances a company may be required to obtain regulatory pre-approval before adding a new probiotic to food products.

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