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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