Probiotics and Infant Feeding with B Probiotics and Infant Feeding with B. lactis Common mistakes and misconceptions Including quotes form recent talks and publications October 2007

1) Probiotics: Concept and Efficacy Misconceptions “Probiotics are not uniformly efficacious” “Efficacy an safety of probiotics is not well demonstrated or studied sufficiently” “Probiotics are not ready for prime-time” “The probiotic strain did not show an effect in this study” “There is no benefit shown with probiotics in healthy infants”

Probiotic Concept Facts Probiotics are number of different organisms, not a single substance Only a specific microorganism which has shown an specific benefit(s) in the population intended can be called a probiotic. If a benefit wasn’t shown in a study- it should not be called a “probiotic” bacteria Efficacy and safety can only be defined for a specific organism(s) – and not for “probiotics” in general

Probiotic Concept Facts It’s INCORRECT to say “probiotics are safe” or “we need more studies to show probiotics are safe or efficacious”. IE: It’s CORRECT to say this bacteria (genus, species, strain) is a probiotic, with this (these) benefit(s), for this population It’s CORRECT to say this bacteria has a well (or not well) documented safety record Efficacy and safety are species - specific STOP saying “PROBIOTICS “ If you are discussing safety or a specific effect

2) B. lactis: Efficacy Misconceptions and Disinformation “Efficacy with B. lactis has not been shown” “For healthy infants and children, there is no research that probiotics provide any health benefits.” “Putting probiotics [B.lactis] in the GI tract is like a putting them into a black box”… “we don’t know they work…There are no mechanisms known” “… one doesn’t know how many servings or how much to take for what period of time or for a lifetime,… “

B lactis Efficacy Facts B. lactis is a specific bacteria: Bifidobacterium animalis, sub-species lactis* B. lactis has been studied in clinical trials and shown to have specific benefits in various populations including , and mostly, in healthy children [See references] as well as in adults [See references] Clinical benefits have been shown during the time of consumption, at the amounts currently found in infant formula in the US. --> B. lactis is a probiotic * Also referred to as B. bifidum and/ or strain Bb12 in certain studies. See attached bibliography

B lactis Efficacy Facts In vitro studies [See references] and animal trials [See references], provide support and the mechanistic rationale for the findings documented in human clinical trials with B. lactis. The human, animal, and basic science literature [See references] on use of B. lactis specifically supports their beneficial effects on gut barrier function and immune development and modulation during consumption This supports the use of B. lactis an ideal probiotic for the incorporation into routine infant feeding See attached bibliography

3) B. lactis Safety Misconceptions “Probiotics [including B. lactis] are not uniformly safe- we need to be cautious using it in healthy infants” “Safety of B. lactis is not adequately documented because trials are powered for efficacy” “Any bacteria can be pathogenic” ”Sooner or later there will be a case of bifidobacteremia” “It is only approved for infants above four months of age”

B. Lactis safety Facts The safety of B. lactis is documented based on multiple sources of evidence Thorough understanding of the organism itself, its bacterial properties, including its full genome: No invasive or identifiable pathogenic potential. No undesirable metabolic characteristics (no D- lactate , no toxin production, etc.). Bifidobacteria are the species most commonly found in the GI tract of breast fed infants Bifidobacteria are regularly found in human breast milk in significant amounts

B. Lactis safety Facts B) Not a single documented bacteremia or infection associated with ingestion of bifidobacteria in general or B. lactis specifically, despite extensive history of use C) History of safe use Hundreds of thousands of metric tons of B. lactis containing products are consumed globally each year Infant formula with B. lactis has been commercialized for more than 15 years, in more than 30 countries No adverse effects documented with free use in the food supply nor in infant formula

B. Lactis safety Facts D) Safety in clinical trials Not a single adverse effect reported in more than 60 controlled human clinical trials with B. animalis and specifically B. animalis sub-species lactis in humans, including premature infants B. lactis is currently the only bacteria with GRAS status for routine use in infants from birth After through evaluation and assessment , B. lactis has been approved by the FDA, for use in routine infant formula from birth.

4) Probiotic Quality Misconceptions “Probiotics are not well regulated” “Probiotic products don’t always have the bacteria or the amounts they claim” “Once a can of powder formula is opened, moisture gets in and probiotic bacteria begin to die, so efficacy can not be guaranteed” “Heat treatment or freeze drying (lyophilizing) decreases viability”

Probiotic Quality Facts Quality assurance criteria are different for supplements, foods, and drugs Foods are strictly regulated, and infant formula much more so. They contain the species stated in the label in the amounts stated by the manufacturer In the US, a drug is a product specifically commercialized to prevent or treat disease. A supplement is a dietary component that does not replace part of a normal diet

Probiotic Quality Facts In the US, a product commercialized to prevent or treat disease is a drug; and can be commercialized even if it produces side effects (as long as the side effects outweigh the benefits) In the US a product commercialized as a food must have NO side effects Thus, in practice, the “safety” bar is in fact higher for a food than for a drug

Summary Although much remains to be learned, the safety and efficacy documentation to date support the statement that B. lactis, incorporated into the diet, and at the levels found in infant formula in the US, “helps support a healthy immune system” Use of certain probiotic bacteria, including B. lactis, have been shown to have specific prophylactic and therapeutic effects. However, in the US they are not commercialized as drugs (for treatment or prevention of disease )