The lack of a legal definition for the term 'probiotic' makes it crucial for US food and beverage manufacturers to meet certain criteria that would ensure the efficacy of their products, industry members heard yesterday.
The criteria, which are based on FAO/WHO guidelines, are nothing new to industry, but they are not being adhered to by many manufacturers, said Dr Mary Ellen Sanders, who has in the past worked with the two organizations in establishing guidelines for probiotics and prebiotics.
"The biggest issue in the US is that there is no legalized definition of a 'probiotic'. That means that the term is used on products that don't meet minimum criteria," said Sanders, who was addressing attendees at the Probiotech 2008 conference in Nantes, France, yesterday.
Criteria - as set out in a 2002 FAO/WHO working group report - include a definition of genus, species and strain, as well as a safety assessment and efficacy research in humans.
The views were expressed on the same day as NutraIngredients.com covered similar statements from Gregor Reid from the Canadian R&D Centre for Probiotics at the Lawson Health Research Institute, and The University of Western Ontario.
To view the FAO/WHO guidelines, click here .
There are a number of labeling recommendations that should be adhered to in order to provide consumers with adequate information about the efficacy of the probiotic product. These are again based on the FAO/WHO guidelines.
- Labels should list all microbes, with the genus, species and strain designation. Significantly, the strain designation should not mislead consumers about the functionality of the strain.
- The number of each microbial component should also be given, although this must reflect the count at the end of the product's shelf-life, and not at the time of manufacture.
- Proper storage information should be provided.
- Efficacy claims must also be listed, and these must be truthful and not misleading. They must be based on human studies documenting efficacy of the specific strain in the product, and they must also take into account the impact of the delivery vehicle or additional active ingredients or strains of bacteria.
- Use information must be listed, and this should include recommended consumption level based on levels found efficacious in human studies. The target consumer should also be listed in the case of probiotic supplements, although in the case of probiotic foods and beverages the target consumer is considered to be the general population.
- A product must carry a contact number to report any adverse effects.
These label recommendations are, in fact, similar to those set out by the International Probiotics Association (IPA), which represents probiotics suppliers and product manufacturers, including Nestle, Danisco, Fonterra, DSM, Chr Hansen, Morinaga and Proctor & Gamble.
The 41-member IPA - founded in part to establish probiotic standards - in March this year announced its labeling criteria as part of a scheme that will ultimately allow probiotic products to carry a quality seal.
Probiotics companies can apply to the IPA to have batches of their products analyzed by third party independent agencies and if they meet the IPA criteria, will be eligible to bear the seal.
At the time of announcement, IPA executive director, Ioannis Misopoulos, told NutraIngredients-USA.com that he expected the seal would be available on products in 6-8 months.
In her presentation, Sanders also summarized the different types of claims allowed on probiotic foods and supplements in the US. These include structure/function claims, qualified health claims or significant scientific agreement claims.
The two latter types of claims, which are the least frequently used on probiotic products, require approval by the US Food and Drug Administration (FDA).
Structure/function claims, which describe how a product may impact the structure or functioning of the normal human body, are the claims most typically used on probiotic products.
However, because these do not require FDA approval - and because they are not well enforced by the agency - many US probiotic products carry structure/function claims that may be properly worded but that do not have adequate substantiation, said Sanders.
She stressed that research to substantiate health claims or structure/function claims should be done in healthy subjects. This is, unfortunately, not often the case, she said, as much of the research conducted worldwide on probiotics is on non-healthy people.
"Strictly speaking, this type of research should not be the primary support you use for structure/function claims as it is conducted on diseased populations," said Sanders.
Sanders was the founding president of the International Scientific Association for Probiotics and Prebiotics, and is its current executive director. She is also director of Dairy Food & Culture Technologies.
Probiotech 2008, which ran today and yesterday in Nantes, France, is in its second year and has established itself as one of the primary events on probiotics in Europe. It gathers representatives from three industries: food, pharmaceutical, and cosmetics, and focuses on scientific and technological issues impacting pre- and probiotics.