Health claims about microorganisms and use of the term "probiotic"

Probiotic that naturally forms part of the gut flora^{Footnote 4};
Provides live microorganisms that naturally form part of the gut flora;^{Footnote 3}
Probiotic that contributes to healthy gut flora;^{Footnote 3}
Provides live microorganisms that contribute to healthy gut flora.^{Footnote 3}

(1)
Foods containing, at least one of the following eligible live microorganisms:^{Footnote 5Footnote 6Footnote 7}

Bifidobacterium adolescentis
Bifidobacterium animalis subsp. animalis
Bifidobacterium animalis subsp. lactis
Bifidobacterium bifidum
Bifidobacterium breve
Bifidobacterium longum subsp. infantis
Bifidobacterium longum subsp. longum
Lactobacillus acidophilus
Lacticaseibacillus casei (Formerly Lactobacillus casei)^{Footnote 8}
Limosilactobacillus fermentum (Formerly Lactobacillus fermentum)^{Footnote 7}
Lactobacillus gasseri
Lactobacillus johnsonii
Lacticaseibacillus paracasei (Formerly Lactobacillus paracasei)^{Footnote 7}
Lactiplantibacillus plantarum (Formerly Lactobacillus plantarum)^{Footnote 7}
Lacticaseibacillus rhamnosus (Formerly Lactobacillus rhamnosus)^{Footnote 7}
Ligilactobacillus salivarius (Formerly Lactobacillus salivarius)^{Footnote 7}
Bacillus coagulans GBI-30, 6086 [GanedenBC30]^{Footnote 9}
Bacillus subtilis DE111^{Footnote 9}

(1)
1.0 x 10⁹

• maintained throughout the shelf life of the product^{Footnote 10} (Gill and Prasad 2008; Hawrelak 2006; Lenoir-Wijnkoop et al. 2007; Picard et al. 2005; Reid et al. 2003)

(1)
(a) The identity of the microorganism strain(s) should be declared on food using scientific nomenclature (genus and species)^{Footnote 11}, along with strain identity^{Footnote 12}

• as part of the health claim statement(s); or
• in close proximity to the health claim(s); or
• in the list of ingredients when the collective name, "bacterial culture" is not used; or
• adjacent to the Nutrition Facts table or Supplemented Food Facts table; or
• in close proximity to the list of ingredients.

(b) The amount of microorganism strain(s) contained in the food at the end of its shelf life must be declared in CFU per serving of stated size of the food.^{Footnote 13}

• together with the identity declaration, as part of the health claim statement(s); or
• in close proximity to the health claim(s); or
• together with the identity declaration adjacent to the Nutrition Facts table or the Supplemented Food Facts table; or
• in close proximity to the list of ingredients.

(1)
(a) The food is not unsafe and complies with all applicable Acts and Regulations including:

• Section 4 of the FDA;
• Division 28 of Part B of the FDR, for example, novel process (e.g. microencapsulation) and antimicrobial activity (Guidelines for the Safety Assessment of Novel Foods);
• Division 16 of FDR, Food additives

(2)
Foods containing at least one live microorganism strain that meets the following:

(a) The food and/or microorganism strain(s) are not novel^{Footnote 14}. Examples of novel food include microorganism strain(s) that do not have a history of safe use as food, and the use of novel technology (e.g. microencapsulation) to help deliver the live microorganism strain(s) in food; and

(b) Meets the acceptable evidence criteria (Part A, Column 5, 2(b)).

(2)
1.0 x 10⁹

• maintained throughout the shelf life of the product^{Footnote 10} (Gill and Prasad 2008; Hawrelak 2006; Lenoir-Wijnkoop et al. 2007; Picard et al. 2005; Reid et al. 2003)

(2)
(a) The identity of the microorganism strain(s) should be declared on food using scientific nomenclature (genus and species)^{Footnote 11}, along with strain identity^{Footnote 12}

• as part of the health claim statement(s); or
• in close proximity to the health claim(s); or
• in the list of ingredients, when the collective name, "bacterial culture" is not used; or
• adjacent to the Nutrition Facts table or the Supplemented Food Facts table; or
• in close proximity to the list of ingredients.

(b) The amount of microorganism strain(s) contained in the food at the end of its shelf life must be declared in CFU per serving of stated size of the food^{Footnote 13}

• together with the identity declaration, as part of the health claim statement(s); or
• in close proximity to the health claim(s); or
• together with the identity declaration adjacent to the Nutrition Facts table or Supplemented Food Facts table; or
• in close proximity to the list of ingredients.

(a) The food is not unsafe and complies with all applicable Acts and Regulations including:

• Section 4 of the FDA;
• Division 28 of Part B of the FDR, for example, novel process (e.g. microencapsulation) and antimicrobial activity (Guidelines for the Safety Assessment of Novel Foods);
• Division 16 of FDR, Food additives

(b) The acceptable evidence criteria^{Footnote 15Footnote 16} is as follows:
Minimum of two, independent, well-designed, good quality, human intervention studies on the specific strain of the live microorganism supporting a consistent, beneficial health effect related to the digestive tract. The evidence should show that the specific strain of the live microorganism was derived from human intestinal microflora or that the specific strain of the microorganism can establish itself, survive and grow temporarily within the human digestive tract (validated in vitro models of digestion may be used as supportive evidence but not as the sole basis of evidence).

Strain-specific health claims are the specific, beneficial health effect(s) conferred by the strain of live microorganism(s).^{Footnote 17}.

Foods containing at least one live microorganism strain that is the subject of the strain-specific health claim and meets the following:

(a) The food and/or microorganism strain(s) is not novel^{Footnote 14}. Examples of novel food include microorganism strain(s) that do not have a history of safe use as food, and the use of novel technology (e.g. microencapsulation) to help deliver the live microorganism strain(s) in food; and

(b) Meets the acceptable evidence criteria (Part B, Column 5, (b)).

The minimum amount required to result in the strain-specific beneficial health effect

• maintained throughout the shelf life of the product.^{Footnote 10}

(a) The identity of the microorganism strain(s) should be declared on food using scientific nomenclature (genus and species)^{Footnote 11}, along with strain identity^{Footnote 12}

• as part of the health claim statement(s); or
• in close proximity to the health claim(s); or
• in the list of ingredients, when the collective name, "bacterial culture" is not used; or
• adjacent to the Nutrition Facts table or Supplemented Food Facts table; or
• in close proximity to the list of ingredients.

(b) The amount of microorganism strain(s) contained in the food at the end of its shelf life must be declared in CFU per serving of stated size of the food.^{Footnote 13}

• together with the identity declaration, as part of the health claim statement(s); or
• in close proximity to the health claim(s); or
• together with the identity declaration adjacent to the Nutrition Facts table or Supplemented Food Facts table; or
• in close proximity to the list of ingredients.

(a) The food is not unsafe and complies with all applicable Acts and Regulations including:

• Section 4 of the FDA;
• Division 28 of Part B of the FDR, for example, novel process (e.g. microencapsulation) and antimicrobial activity (Guidelines for the Safety Assessment of Novel Foods);
• Division 16 of FDR, Food additives

(b) Substantiation of the strain-specific health claim should use the Guidance Documents for Preparing Health Claim Submissions^{Footnote 18}.