ISAPP clarifies definition of probiotics

The International Scientific Association for Probiotics and Prebiotics (ISAPP) has released a statement that clarified the definition of ''probiotic'' to help consumers, manufacturers, researchers and regulators.

 

The FAO/WHO in 2001 defined probiotics as live microorganisms, which when administered in adequate amounts could benefit the health of the host.

 

But the term ''probiotic'' is commonly misused when it is featured on products with no substantiation of human health benefits, and when the term is used to describe bacterial components, dead bacteria or bacteria with uncharacterised health effects in humans.

 

Therefore, the key aspects of the definition of ''probiotic'' include:

 

- A probiotic must be alive when administered

- A probiotic must have undergone controlled evaluation to document health benefits in the target host

- A probiotic must be a taxonomically defined microbe or combination of microbes

- A probiotic must be safe for its intended use

 

Although regulations differ internationally, in general, foods and nutritional supplements are targeted for the generally healthy population and can carry substantiated claims for both disease risk reduction and claims which relate them to general health or the normal structure and function of the human body.

 

Substantiation is required for all claims.

 

The FAO/WHO effort was specifically focused on food uses of probiotics; however, the definition advanced by this group is sufficiently broad to encompass a range of probiotic preparations and intentions of use. In addition to being a food or a dietary supplement, a probiotic microorganism(s), including genetically modified strains, may be used in drug applications, microbial feed, and live vaccines if administered orally.

 

A probiotic used as a drug must not only fulfill the general FAO conditions, but also conform to existing national regulations and guidelines on good clinical practices.