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Nutrition Nuggets is the newest offshoot of petMD's Dog Nutrition Center. Each week Dr. Coates will use her expertise and wisdom to blog about the intricacies of dog nutrition.

Is Tighter Enforcement on the Horizon for OTC Therapeutic Diets?

October 05, 2012 / (4) comments

On September 10, 2012 the Food and Drug Administration (FDA) published a Draft Compliance Policy Guide (CPG) on the "Labeling and Marketing of Nutritional Products Intended for Use To Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats." CPGs are not new laws or regulations; they simply serve to communicate what the Agency’s current strategy is with regards to a particular area of concern.

To quote from the CPG:

Since 1988, the Center for Veterinary Medicine (CVM) has observed an increase in the number of dog and cat food products making [labeling or marketing claims to diagnose, cure, mitigate, treat, or prevent disease] that are sold with, or without, the direction of a licensed veterinarian. Because of this increase, and to help ensure animal safety, CVM is issuing this draft CPG to set out its current thinking with respect to factors it will consider before determining whether to take regulatory action against dog and cat food products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

FDA does not generally intend to recommend or initiate regulatory actions against dog and cat food products that are labeled and/or marketed as intended for use to diagnose, cure, mitigate, treat, or prevent diseases and to provide nutrients in support of meeting the animal's total daily nutrient requirements when all the following factors are present. Specifically:

(1) Manufacturers make the products available to the public only through licensed veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian;

(2) manufacturers do not market such products as alternatives to approved new animal drugs;

(3) the manufacturer is registered under section 415 of the FD Act (21 U.S.C. 350(d));

(4) manufacturers comply with all food labeling requirements for such products (see 21 CFR part 501);

5) manufacturers do not include indications for a disease claim (e.g., obesity, renal failure) on the label of such products;

(6) manufacturers limit distribution of material with any disease claims for such products only to veterinary professionals;

(7) manufacturers secure electronic resources for the dissemination of labeling information and promotional materials such that they are available only to veterinary professionals;

(8) manufacturers include only ingredients that are general regarded as safe (GRAS) ingredients, approved food additives, or feed ingredients defined in the 2012 Official Publication of the Association of American Feed Control Officials (AAFCO) for the intended uses in such products;and

(9) the label and labeling for such products are not false and misleading in other respects.

I’m reading this to mean that if a pet food manufacturer sells a diet directly to consumers making a claim along the lines of "this food will help your dog with his 'insert disease name here,'" they are opening themselves up to litigation. I’m sure the devil is in the details. A label or ad that says “this food will cure your dog’s obesity” is obviously more deceptive than one that states "10% fewer calories than our regular diet to help with weight management."

I’m interested in hearing what you all think. Increased enforcement of potentially misleading claims with regards to over-the-counter therapeutic diets could help pets get more timely and appropriate veterinary care. On the other hand, I’d be willing to bet that most owners like the option of trying an OTC food for non-critical, dietary-responsive conditions before moving on to one that is available by prescription only.

If you feel strongly about this CPG, consider submitting a formal comment at regulations.gov. I was surprised to see that no one had done so as of 9/20/12.

Dr. Jennifer Coates

Image: Yuri Arcurs / via Shutterstock

Comments  4

Leave Comment
  • Thoughts on Pet Food
    10/05/2012 11:06am

    While I'd love to be able to pick up any kind of critter food at the local PetSmart, I'm not sure a lot of pet owners read the labels. They just see "weight loss" or "urinary tract" on the label and substitute that food for the prescription food prescribed by the veterinarian (if the critter has, in fact, been to the veterinarian).

    Feeding pets is such a hot topic on these blogs. I wish that all pet owners were as passionate about feeding their critters the right things.

  • 10/06/2012 01:10pm

    The major problem with some of these so-called prescription diet foods is that they really are the "same old -- same old" junk food with a supplement or two added.

    For example, Hill's h/d kibble, supposedly "the" answer to heart issues, consists mainly of corn and pork fat, with some soy protein and "chicken by-product meal", and some added vitamins and supplements. There is NO MEAT in this junk food, and it is a horrible solution to deal with heart problems like mitral valve disease (MVD). Dogs with MVD need a lot of easily digestible protein from fresh meat. Corn and soy and chicken by-product are the only sources of protein in this junk food; hence, it is the "same old - same old".

    Most vets sadly ARE NOT knowledgeable enough about canine and feline nutrition to realize that this is crap food for pets with heart problems. Instead, they think Hill's has the answer, every time. So, they are not a reliable source of information about which health-problem foods to prescribe.

  • Regulation of pet food
    10/06/2012 03:21pm

    Let me find my soap box. This is a grossly misleading industry. I have 5 small dogs and a cat. One dog has had pancreatitis in the past (a Yorkie) and the cat currently has become diabetic (which we are trying to manage with food). My father was an animal scientist (swine) so I have at least been exposed to discussions on nutrition. The Yorkie is on a strict diet in which I measure on a gram scale her food and the other 4 also. It is very difficult to obtain caloric values for determining how much to feed them, and honestly 99% of veternarians are poorly trained in nutrition. Most questions I ask receive sketchy answers at best and sometime a shrug. They do not know about the compostion of the dog foods they sell nor the commercial varieties. They depend entirely on research done by the manufacturers - do you think the companies have vested interest in this research? I was give the formula for determining caloric needs to lose or manitain weight. I need more information than that!!
    I would welcome more restrictions/guidelines imposed on pet food/treat manufacturers - honest, independent research to which the average pet owner has access. I do not like by-products unless they are specified, and all ingredients need to be fully identified by more than some chemical nomenclature. Ingredients along with ratings on cleanliness and sanitary conditions under which they are handled need to be included.
    I would really like for someone to say, "You need to cook x pounds of meat, add x vegetables, x grains and give them x number of grams at each feeding. See that they have this nutritional supplement. A recent article I read claimed that dogs fed table scraps (no, no) lived longer than those fed commercial foods. Where are pet lovers/owners to turn for information.
    I have even called tthe manufacture and you can not get very far with them other than the sweet little voices that utter scripted answers. Perhaps more regulations would help.

  • I don't care what they do
    10/07/2012 04:06pm

    I know way to much about dog and cat food to ever want to feed it to my pets. To me it's a simple case of understanding that "dog and cat food" that is pushed on us by companies that only care about how much money they can make selling us waste products disguised as food, is NOT biologically appropriate for carnivores. It is not rocket science to figure out what the best diet is for your dog or cat. Over processed non living food is not conductive to the health of any animal. It's no wonder our pets are are unhealthy and are dying from cancer, heart problems, and organ failure! It's no wonder they suffer from allergies, skin infections and have bad teeth. They are living creatures designed by nature to consume a specific diet, and that stuff they call food in the bag falls very far short. How healthy would you be if you ate nothing but a meal replacement bar every meal for your whole life? You might survive, but you would not thrive. Don't expect your dog or cat to thrive if you are not going feed them what nature intended.