The Center for Veterinary Medicine, abbreviated as CVM, is a department within the FDA.
The FDA is charged with the endorsement of the Federal Food, Drug and Cosmetic Act. It is the FDA's responsibility that all human and animal foods are safe and adhere to labeling standards set. All pet food production plants are subject to FDA inspection.
The CVM is responsible for the regulation of animal drugs, medicated feeds, food additives, feed ingredients including pet food.
We make a clear distinction between drugs and foods. “Well, of course!”, you'd think… but let's look at the definitions in more detail.
Food is defined as any substance that provides nutrition, taste or aroma. It only affects the body because of these properties (by definition).
Foods must be safe and nutritious, contain no harmful substances and be properly labeled.
GRAS ingredients are Generally Recognized As Safe substances.
When all ingredients in the dog food recipe are GRAS substances, then no pre-market approval is required.
For food additives a pre-clearance mechanism was developed by the FDA / CVM in the form of a Food Additive Petition. A manufacturer that wants to use a food additive that is not (yet) published in the Federal Register, has to apply and describe its chemical identity, manufacturing process and controls, analytical methods, utility data, food safety data and product labeling. Should the FDA/ CVM agree then the substance is added to the list of "Food Additives Permitted in the Feed and Drinking Water of Animals".
A drug is defined as a substance that is intended to diagnose, cure, mitigate, treat or prevent disease. A food ingredient that affects the structure or function of the body, apart from its nutritive value, is considered a drug.
Medical high fashion food additives (nutraceuticals) therefore must adhere to rules set for drugs, when these are used for the treatment or prevention of disease or "non-food" structure/function effect. Safety and efficacy must be demonstrated in a controlled clinical trial as described in the "New Animal Drug Application". Before the new substance is used in dog food it must first be approved.
A substance is considered GRAS (Generally Recognized As Safe) only for a specific purpose. Food ingredients cannot be GRAS for prevention, treatment or mitigation of a disease since then it is considered a drug.
The word 'Generally' is somewhat misleading as it is not the public's opinion that is referred to. Only the opinions of qualified experts are taken into account when evaluating the safety of a substance.
These experts must reach a consensus that the compound is safe for use as a food ingredient and their opinion must be based on one of the following:
Dog food labeling in the US is regulated at two levels.
The FDA (via its division CVM) maintains the Federal regulations that apply to all animal feed. The dog food bag or can must list the following information according to FDA rules:
The second level is regulated by the State and most States adopt the AAFCO model for pet food labeling.
Low Acid Canned Foods (LACF) are defined as canned foods that are packaged in a hermetically sealed container and have a pH value higher than 4.6.
For canned dog food the same rules apply as for canned foods for human use and these are strict! Since 1973 specific rules for low acid canned foods exist to ensure safety from harmful bacteria and their toxins. Specifically Clostridium botulinum is the reason for this rule and defined GMP's (Good Manufacturing Processes). Rules apply to equipment designs and processing as well as trained supervisory personnel.
In July of 2007, the US faced a recall of 'Natural Balance' canned dog food because of botulism fear. Four people had been taken to hospital because of botulism poisoning after eating Castleberry's Hot Dog Chili Sauce. For over three decades the US has not experienced an outbreak of botulism due to commercially canned foods; this is extremely rare.
The risks are high as botulism is a paralytic illness that can be fatal.
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