Changes

==== Complete and Balanced - Nutritional Adequacy Statement ====

==== Complete and Balanced - Nutritional Adequacy Statement ====

In the USA, all pet food labels, with the exception of products clearly labelled as treats and snacks, or supplements must contain a statement of nutritional adequacy and manufacturers must indicate the method and life stage that was used to substantiate this claim (validation of nutritional adequacy). AAFCO regulations allow three methods to substantiate such claims 1) based on product formulation 2) based on feeding trials, and 3) based on "product family" criteria . In 1990 and 1991, AAFCO convened the Canine Nutrition Expert (CNE) and Feline

In the USA, all pet food labels, with the exception of products clearly labelled as treats and snacks, or supplements must contain a statement of nutritional adequacy and manufacturers must indicate the method and life stage that was used to substantiate this claim (validation of nutritional adequacy). AAFCO regulations allow three methods to substantiate such claims:

#Based on product formulation  

#Based on feeding trials, and  

#Based on "product family" criteria .  

Nutrition Expert (FNE) subcommittees to establish practical nutrient profiles (minimums and maximums) for cat and dog foods based on commonly used ingredients. The profiles were last updated in 2016. The reports of the CNE and FNE subcommittees (and subsequent revisions) form the basis for the nutrient profiles that are published in the annual edition of the AAFCO Official Publication. The formulation method allows a manufacturer to claim ‘complete and balanced’ for a given life stage or life stages when the product is formulated to meet the AAFCO Dog or Cat Food Nutrient Profiles for that life stage(s). These nutrient profiles cover two categories: 1) growth and reproduction and 2) adult maintenance (AAFCO 2015). For example, a pet food meeting the AAFCO nutritional profile of adult dogs can bear the following statement: ‘(Name of product) is ‘formulated to meet the nutritional levels established by the AAFCO Dog Food Nutrient Profiles for maintenance of adult dogs.’ The most recent revision of the AAFCO Dog Food Nutrient Profiles include a lower maximum calcium level in foods that MAY be fed to large-breed puppies. All products indicated "for growth" or "for all life stages" and that contain no more than 1.8% Ca on a dry matter basis must include the clause "including growth of large size dogs (70 lbs or more as an adult)." Dog foods exceeding that amount (but still in conformance with the maximum calcium allowance for all dog foods) must state "except for growth of...).

In 1990 and 1991, AAFCO convened the '''Canine Nutrition Expert''' (CNE) and '''Feline Nutrition Expert''' (FNE) subcommittees to establish practical nutrient profiles (minimums and maximums) for cat and dog foods based on commonly used ingredients. The profiles were last updated in 2016. The reports of the CNE and FNE subcommittees (and subsequent revisions) form the basis for the nutrient profiles that are published in the annual edition of the AAFCO Official Publication. The formulation method allows a manufacturer to claim ‘complete and balanced’ for a given life stage or life stages when the product is formulated to meet the AAFCO Dog or Cat Food Nutrient Profiles for that life stage(s). These nutrient profiles cover two categories:  

#Growth and reproduction and  

#Adult maintenance (AAFCO 2015).  

The second method requires that the manufacturer performs an AAFCO-protocol feeding trial using the food as the sole source of nutrition. The feeding trial method can result in a nutritional adequacy claim for one or more of the following categories: 1) gestation and lactation, 2) growth, 3) adult maintenance and 4) complete for all life stages. AAFCO has published minimum testing protocols for adult maintenance, growth and gestation/lactation. A food that successfully completes a gestation/lactation trial, followed by a growth trial using the puppies/kittens from the gestation/lactation trial, can also make a claim for all life stages. The required terminology for labels of pet foods that have passed these tests is: ‘Animal feeding tests using AAFCO procedures show that (brand YY) provides complete and balanced nutrition for (lifestage xx)’. The adult maintenance protocol uses a minimum of eight animals that are fed the food as the sole source of nutrition for six months, during which the animals are evaluated for any change in body weight and other clinical signs of nutritional deficiency or excess and blood analyses are performed. Growth protocols include feeding the food for a minimum of 10 weeks during the most critical growth phase to maximize the ability to detect nutritional problems with the food. Evaluation of feeding trials to support nutritional adequacy for pregnant or nursing dogs and cats also looks at additional parameters, such as litter size and puppy/kitten weight at the end of the trial.

 

The second method requires that the manufacturer performs an AAFCO-protocol feeding trial using the food as the sole source of nutrition. The feeding trial method can result in a nutritional adequacy claim for one or more of the following categories:  

#Gestation and lactation,  

#Growth,  

#Adult maintenance and  

#Complete for all life stages.  

 

AAFCO has published minimum testing protocols for adult maintenance, growth and gestation/lactation. A food that successfully completes a gestation/lactation trial, followed by a growth trial using the puppies/kittens from the gestation/lactation trial, can also make a claim for all life stages. The required terminology for labels of pet foods that have passed these tests is: ‘Animal feeding tests using AAFCO procedures show that (brand YY) provides complete and balanced nutrition for (lifestage xx)’. The adult maintenance protocol uses a minimum of eight animals that are fed the food as the sole source of nutrition for six months, during which the animals are evaluated for any change in body weight and other clinical signs of nutritional deficiency or excess and blood analyses are performed. Growth protocols include feeding the food for a minimum of 10 weeks during the most critical growth phase to maximize the ability to detect nutritional problems with the food. Evaluation of feeding trials to support nutritional adequacy for pregnant or nursing dogs and cats also looks at additional parameters, such as litter size and puppy/kitten weight at the end of the trial.

The third method (product family criteria) requires the testing of a representative lead member through the appropriate feeding trials. To be designated a member of the product family, foods must be the same processing type and in the same moisture category, be intended for the same or more restrictive life stages, be similar in energy density (±7.5% kcal/kg on a dry matter basis), and meet other nutritional criteria compared to the lead product. Provided that the calorie content of both products are determined by digestibility trials, product family members are allowed to bear the same "animal feed tests..." statement as found on the tested product.

The third method (product family criteria) requires the testing of a representative lead member through the appropriate feeding trials. To be designated a member of the product family, foods must be the same processing type and in the same moisture category, be intended for the same or more restrictive life stages, be similar in energy density (±7.5% kcal/kg on a dry matter basis), and meet other nutritional criteria compared to the lead product. Provided that the calorie content of both products are determined by digestibility trials, product family members are allowed to bear the same "animal feed tests..." statement as found on the tested product.

Products substantiated by the latter two methods may be subject to re-substantiation upon any changes to the formulation or after 5 years on the market. The label for pet foods that fail to meet AAFCO requirements by any of the three standard methods (feeding trial, product family or formulation) and is not prominently identified as a snack, treat, or supplement must bear the statement: This product is intended for intermittent or supplemental feeding only.

Products substantiated by the latter two methods may be subject to re-substantiation upon any changes to the formulation or after 5 years on the market. The label for pet foods that fail to meet AAFCO requirements by any of the three standard methods (feeding trial, product family or formulation) and is not prominently identified as a snack, treat, or supplement must bear the statement: This product is intended for intermittent or supplemental feeding only.

Veterinary therapeutic foods, which are intended for use by or under the supervision or direction of a veterinarian, must be substantiated for nutritional adequacy by one of the above

Veterinary therapeutic foods, which are intended for use by or under the supervision or direction of a veterinarian, must be substantiated for nutritional adequacy by one of the above methods or its label must bear the "intermittent or supplemental" statement as required for all dog and cat foods. However, labels for these foods may bear the statement ‘use only as directed by your veterinarian’ in lieu of feeding directions. Technically, veterinary therapeutic foods are drugs as defined by FFDCA, and have not undergone the approval process as required by the law for drugs. However, FDA exercises enforcement discretion in not taking action against these products provided they meet [http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM318761.pdf FDA's guidelines].

 

methods or its label must bear the "intermittent or supplemental" statement as required for all dog and cat foods. However, labels for these foods may bear the statement ‘use only as directed by your veterinarian’ in lieu of feeding directions. Technically, veterinary therapeutic foods are drugs as defined by FFDCA, and have not undergone the approval process as required by the law for drugs. However, FDA exercises enforcement discretion in not taking action against these products provided they meet FDA's guidelines (http://www.fda.gov/downloads/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/UCM318761.pdf).

 

==== Batch information ====

==== Batch information ====