OTC and Rx Food: Demystifying the Definitions, Ingredients, and Regulations

In regard to prescription diets, pet food ingredients, ingredient labels, laws, and regulations, there is an endless amount of misunderstanding and false misinformation currently littering the internet. Many websites claim this or that, but almost always have some type of underlying bias, utilize unreliable sources, or do not have the necessary medical knowledge to fully round out their evaluations. With this in mind, here is a breakdown of terms and topics — complete with all the acronyms you’ll ever need!

To begin, pet food in the U.S. is regulated at two levels: federally by the FDA, then also at the state level, where most states follow the guidelines set forth by the Association of American Feed Control Officials (AAFCO):

“AAFCO is a voluntary membership association of local, state and federal agencies charged by law to regulate the sale and distribution of animal feeds and animal drug remedies.” [1]

AAFCO’s function is to develop and implement laws, regulations, standards, definitions, etc. for the animal feed industry — which covers not only the food itself, but the accompanying manufacturing, labeling, and sale.

Ingredients in pet food are constantly reviewed and evaluated by the FDA’s Center for Veterinary Medicine (CVM). CVM applies the mandates set forth by the Federal Food, Drug, and Cosmetic Act (FFDCA):

“FFDCA requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.” [2]

When it comes to pet diets, ingredients are almost always Battleground Zero for most people, regardless of where they may stand. This is where CVM comes in. Ingredients fall into one of two categories: “GRAS” (Generally Recognized As Safe) for their intended use, or approved food additive. Both categories are regulated and explained in various sections of the Title 21 Code of Federal Regulations. For an ingredient to be considered GRAS, qualified experts must determine that it is safe when added to food for that specific use. The FDA explains more on that definition, by stating that this determination can only be obtained by:

• “Experience based on common use in food. There must be information to prove that the substance has been commonly used in food for animals since before 1958, with a lengthy and known history of a significant number of animals consuming the food.”

OR

• “Scientific procedures. These procedures require the same quality and quantity of scientific data needed for FDA to approve a food additive petition. Also, the data must be published in scientific literature or a similarly trusted source such as a textbook. Data in a company’s annual report do not meet this standard.” [3]

Companies are allowed to determine on their own if an ingredient is considered GRAS, then must submit information about that ingredient and its intended use to the FDA, who will then evaluate it using a scientific basis and ensure there are no questions or disagreement.

If the safety of an ingredient is ever questioned or outright found to be harmful to animals via factual evidence and scientific study/research, then it is either suspended from use and/or completely banned. One aspect that many do not take into account is the safety of one particular ingredient for one species vs. another. Propylene Glycol is a perfect example. In humans, dogs, and other mammals, propylene glycol is a safe, harmless food additive. However, it is banned from use in foods and drugs designed for cats, as studies have linked it to Heinz body anemia. [4]

One of the biggest arguments made by pet food critics is in regard to meat by-products, which are contained in most formulations. However, by-products are not inherently bad. The problem is that most people do not understand the true definitions used in pet food labeling.

Per AAFCO, the definition of meat is:

“The clean flesh derived from slaughtered mammals and is limited to that part of the striate muscle which is skeletal or that part which is found in the tongue, in the diaphragm, in the heart or in the esophagus; with or without the accompanying and overlying fat and portions of the skin, sinew, nerve, and blood vessels which normally accompany the flesh. It shall be suitable for animal food. If it bears a name descriptive of its kind, it must correspond thereto.” [5]

Thus meat is uncooked muscle tissue only — skeletal, heart, diaphragm, tongue, etc. These tend to be the most commonly accepted and consumed meats by humans.

AAFCO’s definition of meat by-products is:

“The non-rendered, clean parts, other than meat, derived from slaughtered mammals. It includes, but is not limited to, lungs, spleen, kidneys, brain, livers, blood, bone, partially defatted low temperature fatty tissue, and stomachs and intestines freed of their contents. It does not include hair, horns, teeth and hoofs. It shall be suitable for use in animal food. If it bears name descriptive of its kind, it must correspond thereto.” [6]

Thus by-products are the uncooked organs as listed above, plus necks, skulls, other bone, and fat. For poultry, it also includes heads and feet. The visceral organs cannot contain any undigested food or feces/urine, and are cleaned out and sanitized first.

Then we have AAFCO’s definition of meal:

“The rendered product from mammal tissues, exclusive of any added blood, hair, hoof, horn, hide trimmings, manure, stomach and rumen contents except in such amounts as may occur unavoidably in good processing practices. It shall not contain extraneous materials not provided for by this definition. …. {the definition goes on to include the required mineral specifications and required nutrient guarantees}….. If the product bears a name descriptive of its kind, composition or origin it must correspond thereto.” [7]

This also applies to poultry (which can include undeveloped eggs, heads, and feet) in addition to mammals. So meal simply means that the meat or by-products have been rendered (cooked) so that fat and moisture have been reduced and evaporated. For example, “chicken meal” or “chicken by-product meal” is a dry, condensed, concentrated form of only chicken protein, vitamins, and minerals. If the species isn’t listed and the general term “meat meal” is used, then it can be cattle, pigs, sheep or goats, or any combination of those.

The FDA also adopts these same definitions and labeling requirements.

In regard to by-products, the CVM states:

“Some people prefer to pass up animal by-products, which are proteins that have not been heat processed (unrendered) and may contain heads, feet, viscera [organs] and other animal parts not particularly appetizing. But protein quality of by-products sometimes is better than that from muscle meat.”

— William Burkholder, D.V.M., Ph.D.

People as a whole tend to anthropomorphize animals, which means to unnecessarily attribute human qualities and thought processes to them that they are not actually capable of having or understanding. Thus when owners think of feeding their pet a food that is made from bones, brain, lung, stomach, intestine, kidneys, liver, blood, etc, they shudder and think of this as a lower quality diet than one made with cuts of beef, pork, or chicken just like they would buy at the store — when in reality an animal is not picky or grossed out, and these are the exact sources of nutrition they would choose and consume if still able to hunt for themselves (in addition to the muscle meat).

When reading an ingredient label, a pet owner needs to be educated and cautious. Labels are strictly regulated down to the exact wording, but if you don’t know what those words mean, you can’t truly make an informed decision.

Per AAFCO definitions and upheld by the FDA:

“All ingredients are required to be listed in order of predominance by weight. The weights of ingredients are determined as they are added in the formulation, including their inherent water content. This latter fact is important when evaluating relative quantity claims, especially when ingredients of different moisture contents are compared.” [8]

They then give a fantastic example of why these definitions and regulations are so critically important when comparing and evaluating foods:

“One pet food may list “meat” as its first ingredient, and “corn” as the second ingredient. The manufacturer doesn’t hesitate to point out that its competitor lists “corn” first (“meat meal” is second), suggesting the competitor’s product has less animal-source protein than its own [implying lower quality].

However, meat is very high in moisture (approximately 75% water). On the other hand, water and fat are removed from meat meal, so it is only 10% moisture (what’s left is mostly protein and minerals). If we could compare both products on a dry matter basis (mathematically “remove” the water from both ingredients), one could see that the second product had more animal-source protein from meat meal than the first product had from meat, even though the ingredient list suggests otherwise.”

There are more definitions on the cited FDA page above, which I highly suggest reading for extremely detailed information on labeling and what specific terms like “dinner” and “chow” mean, and how they fit into the evaluation picture.

Clients always ask me for recommendations on what food to feed their pet or if they should change. For healthy animals with no issues or sensitivities, I always tell them to look for higher protein foods when possible (little to no corn/fillers, meat products clearly identified as to what species and listed first, etc) — but ultimately what it boils down to is this:

1. Will your pet eat it?

2. Are they staying healthy on it?

If the answer to both of those is yes, then whatever food you choose is probably just fine and there is no need to change. The most expensive, high quality food in the world does no good if an animal will not eat it.

(As an aside, the vast majority of allergies in cats and dogs are environmentally caused — dust, pollen, grass, mites, human dander, etc. — not by food ingredients. Yes, food allergies do exist, but they are less common and generally manifest as GI issues, not skin issues.)

Another point of contention that often comes up in the food debate is the validity of prescription diets. While Rx diets do not contain medications, the FDA does indeed define and regulate them as drugs. This is due to the fact that the specific formulation of ingredients and/or nutrients in the food is designed to alter the body’s function or affect a disease process:

When is a food a drug?

“Some food products may affect the structure or function of the body. For example, a food containing calcium may affect bone structure in puppies, or a food containing the amino acid taurine may help with heart health in cats. FDA considers these products to be food, not drugs, because they exert their effect by providing nutrition, taste, or aroma.

If a food affects the structure or function of the body apart from its nutritive value, such as by making a cat’s urine more acidic or improving joint function in an arthritic dog, FDA may consider it a drug. Similarly, a food marketed with a claim that it improves or increases production and performance may be a drug. Another example of when a food may be a drug is if it’s intended to treat or prevent a disease.” [9]

This specific definition is why Rx diets require a valid prescription from a licensed DVM in order to obtain them, whether it be from the veterinary clinic itself or from a pet store or online supplier. Only a DVM is qualified to determine whether an Rx diet is appropriate for a specific patient, given knowledge of that patient’s health and current physiological function.

The laws governing veterinary medical practice in each state (backed by AVMA regulations) require that in order to have a prescription, a patient must have a valid Veterinarian-Client-Patient Relationship (VCPR). The AVMA regulations stipulate that in order for a VCPR to be valid:

  • The veterinarian assumes all responsibility for medical decisions, and the client agrees to follow all instructions.
  • The veterinarian has personally examined the patient within a reasonable timeframe, has sufficient knowledge of the patient’s care and health to determine a diagnosis (or preliminary one), and maintains capability for follow-up examination and continued care.
  • The veterinarian oversees all treatment, compliance, and outcome for the patient, and maintains accurate medical records. [10]

Many states have laws that clarify the examination timeframe, and most clinics also set their own policies to state that a patient must have been examined within the past 6 to 12 months in order for the VCPR to be valid (and thus write a prescription and/or dispense medication/Rx foods).

Inevitably the ingredient critics usually make their way to a discussion regarding the “quality” of prescription food vs. the benefit it offers to the animal with the disease. The #1 thing I always tell clients and anyone who asks is this:

The ingredients in Rx food are not the priority.

When you get to the point of having an ill pet, the carefully researched and scientifically balanced levels of vitamins, minerals, proteins, fats, pH, etc. designed for the specific health issue they are prescribed to treat (i.e. renal disease, urinary crystals, metabolic issues) are the primary focus and the reason Rx diets are successful. When you get down to the basics, a little bit of corn gluten pales in comparison to what an imbalance of phosphates and protein does to malfunctioning diseased kidneys.

Now I need to address the proverbial elephant in the room.

“Kickbacks.”

NO, veterinary professionals do NOT get “kickbacks” for selling prescription diets. There is no such thing. It has been a persistent myth for decades with zero foundation or proof. Most veterinary practices hardly make any profit from Rx food whatsoever, so it isn’t a “moneymaker” and we don’t push Rx diets to rack up the bill. In fact, most distributors set a firm cap on how much the products can be marked up for retail sale in practices, in order to avoid competition and price gouging. Some companies can buy in such bulk quantities that the discount they receive allows them to price lower than others, but the cap is still in place. The difference between that cap and what most practices pay wholesale to buy the products is minuscule. We’re lucky if we make $5-$10 on that $40 bag of Rx food. Usually we break even.

The entire purpose of a practice keeping Rx food in stock and prescribing/recommending it is owner convenience and effectiveness. The vast majority of pet owners want a quick solution. They have no interest in spending hours upon hours researching how to read labels to find a commercial food that could work, nor spending hours upon hours formulating their own diets to manage chronic illnesses, nor spending the money or time to create said diets. They want to leave their appointment with a trusted solution in hand, and want it to be something proven effective that they can start immediately.

Many people believe veterinary professionals have no knowledge or education when it comes to nutrition, and while that was perhaps the case in years past, recent decades have seen drastic shifts in the goals of education and modernization. When I was in school as a technician, we had a semester-long course specifically on nutrition and nursing, taught by a DVM who specialized as a nutritionist. I’m sure clients wish we had even more than that, but in the grand scheme of things, learning extensive info on nutrition/food is less vital than focusing on pharmacology, anatomy, physiology, anesthesia, surgery, parasitology, hematology, radiology, microbiology, pathology, etc.

Clients also need to understand that our education doesn’t simply end when we graduate, and that we don’t only work with what we learned in those 2-4 years. We have to complete a set amount of continuing education hours every year to maintain our licenses. An LVT has to complete 12-15 hours, a DVM has to complete 28-32. Each state has different exact amounts but they’re all in that range, and most professionals exceed those basic requirements each year. Most of us attend conferences such as VMX, CVC, the ACVS Summit, etc, where we have dozens if not hundreds of lectures to choose from that are presented by the best of the best in our profession. Nutrition-related lectures are almost always an available section in the course schedule at these conferences, and they tend to be very popular as most veterinary professionals want to keep updated on the changing knowledge, and stay in line with current client concern trends.

The bottom line is that the internet is full of misinformation. Please be selective, check your sources for reputable organizations/authors and citations, look for empirical evidence and peer-reviewed studies, and in the end, trust your veterinary team. We’re the devoted animal lovers who went to school for 4-8+ years and became licensed veterinary doctors/nurses (and who continue to add endless more hours of education every single year). We don’t do what we do just for the adorable kittens and the cool medical toys — although those are definitely a bonus…🤓

[featured image source]

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