Prescription Pet Foods are “Adulterated”, “Misbranded” and NOT Legal

…and the FDA designed it to be that way. Prescription pet food is another example of the FDA’s method of ‘we do what we want, not what we’re supposed to do’ regulation of pet food.

Federal law (Federal Food Drug and Cosmetic Act – laws which FDA is charged with enforcing) defines a drug as (in part): “The term “drug” means: articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

With pet foods that are ONLY sold by veterinarians, these products are prescribed by veterinarians specifically to ‘cure, treat or mitigate’ disease in dogs and cats and the very same products make label claims to ‘cure, treat, or mitigate’ disease in dogs and cats. In other words, these pet foods are used as a drug by veterinarians and they are marketed to consumers and veterinarians as a drug. As example:

Petco’s sales page for this Royal Canin Veterinary Diet clearly states a “prescription” is required.

The Royal Canin website explains to pet owners this cat food is “formulated to help manage blood glucose” – a drug claim.

And the Hill’s website explains to pet owners this dog food is “specially formulated” to “reduce the risk of struvite stones“.

Animal drugs – no matter if they are in pill form or in pet food form – are required by federal law to apply to federal authorities for approval, and required to provide “Safety and effectiveness data and information” that is approved for the specific species of animal.

But…FDA makes an special exception to federal law with animal drug pet food. None of that is required for prescription pet food.

The FDA manipulates this special exception to federal law through a nonbinding (not legal) policy – FDA policy 690.150 titled “Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.” Clearly marked on the document as “nonbinding“, FDA gives legal precedence to this policy over federal law. The FDA policy states:

“This document provides guidance to Food and Drug Administration (FDA) staff on how to address dog and cat food diets that are labeled and/or marketed as intended for use to diagnose, cure, mitigate, treat, or prevent diseases and are also labeled and/or marketed to provide all or most of the nutrients in support of meeting the animal’s total daily nutrient requirements by serving as the pet’s sole diet. Section IV below lists the factors FDA intends to consider in determining whether to exercise enforcement discretion with regard to animal drug approval requirements for dog and cat food diets that claim to treat or prevent disease.”

Note the FDA’s language “determining whether to exercise enforcement discretion“. This means (in non-FDA language) FDA determining whether to ignore federal law or not. Those enforcement discretion determining factors (factors for FDA to ignore law) are explained by the Agency as:

Under section 201(g)(1)(B) of the FD&C Act, dog and cat food products that are intended to treat or prevent disease are drugs, even if they also provide nutrients in support of the animal’s total required daily nutrient needs.

Unless these products are approved as new animal drugs, these products are adulterated under section 501(a)(5) and misbranded under 502(f)(1) of the FD&C Act. In addition, in the absence of compliance with current good manufacturing practice requirements, these products are adulterated under section 501(a)(2)(B) of the FD&C Act. Unless these products are manufactured in and listed by a facility that is registered under section 510 of the FD&C Act, they are misbranded under section 502(o) of the FD&C Act. However, FDA is less likely to initiate enforcement action against dog and cat food products intended to be fed as the pet’s sole diet that claim to treat or prevent disease when all of the following factors are present:

1.The product is made 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.The product does not present a known safety risk when used as labeled (e.g., when a product labeled for use in dogs or cats with a particular disease would be unsafe in such animals).

3.The product label does not include representations that it can be used to treat or prevent disease (e.g., obesity, renal failure).

4.Distribution of labeling and other manufacturer communications that contain representations that the product is intended for treatment or prevention of disease is limited so that it is provided only to veterinary professionals.

5.Electronic resources for the dissemination of labeling information and other manufacturer communications related to the intended use of the product are secured so that they are available only to veterinary professionals.

6.The label and labeling of the product is not false or misleading in other respects (e.g., dog food labeled and promoted for the treatment of cancer with no basis for the claim).

7.The product is not marketed as an alternative to approved new animal drugs.

8.The manufacturer is registered under section 415 of the FD&C Act.

9.The product is manufactured in accordance with CGMPs applicable to animal food (see 21 CFR part 507 subpart B)3 and other regulations applicable to animal food manufacturing.

10.The product’s labeling complies with all food labeling requirements for such products (see 21 CFR part 501).

11.The product contains only ingredients that are GRAS ingredients, approved food additives, or ingredients defined in the 2015 Official Publication of the Association of American Feed Control Officials.

In the first two paragraphs of the above, FDA admits prescription pet foods are a drug. And then FDA admits that because the pet foods are not manufactured by the legal requirements of a drug, and not validated to the effectiveness as drugs are required to be – the products are officially “adulterated” and “misbranded” per federal law. With items #1 thru 11, the FDA explains illegal drug pet foods are allowed (law ignored) as long as veterinarians are solely responsible for writing an illegal prescription for the products and no pet owner is provided access to detailed information about the illegal drug (item 1, 3, 4, 5, and 6), the illegal pet food drug doesn’t compete with legal drugs (item 7), and the illegal drug pet foods meets the pet food/pet feed regulations of any other pet food/pet feed (remaining items).

As reminder, this is not the only FDA action allowing a non-binding/non-legal policy to take precedence over law. FDA also ignores federal law allowing pet food to contain diseased animal material and material from animals that have died otherwise than by slaughter with no warning or disclosure to pet owners on the pet food label. And that same illegal diseased/non-slaughtered animal material can be used in prescription pet food too.

And then the problem gets worse.

FDA is using veterinarians to help industry sell illegal drugs. FDA puts veterinarians in a VERY bad situation; with huge potential for a massive lawsuit and potentially losing their medical license. Many state Veterinary Medical Associations require – by state law – that all prescriptions be filled ONLY by a licensed pharmacy. As example in the state of New York.

Online retailers that sell prescription pet foods that veterinarians wrote a prescription for – such as Chewy.com or Petco.com – are not licensed pharmacists.

Consider veterinarians in the state of New York that prescribed the Hill’s pet food that was recalled for excess Vitamin D earlier this year. The prescription was not legal, the product itself was not legal, and perhaps that recalled product killed someone’s pet. Will the veterinarian who wrote an illegal prescription for an illegal drug be drawn into a lawsuit? Will the online retailer that sold a prescribed illegal drug be drawn into a lawsuit?

This haphazard pick and choose which laws FDA enforces regulation of pet food is not only putting pets at risk, it is putting veterinarians at legal risk as well. Law should be enforced. If it’s a drug, then prescription pet foods should be held to every legal requirement of all other drugs. If it’s not a drug, then all scientific information about these products should be public information, industry should be stopped using veterinarians as illegal drug salesmen/women, and industry should be stopped charging ridiculous prices for these illegal drugs.

To read the full FDA policy allowing illegal drug pet foods to be sold to pet owners, Click Here.

Opinion: the definition of drug lord fits FDA perfectly in this situation.

Wikipedia defines a drug lord as: “A drug lord, drug baron, kingpin, or narcotrafficker is a high ranking crime boss who controls a sizable network of people involved in the illegal drug trade. Such figures are often difficult to bring to justice, as they are normally not directly in possession of something illegal, but are insulated from the actual trade in drugs by several layers of underlings.”

Pet owners can provide FDA comment on the policy allowing the sale of illegal drug pet foods on the government website Regulations.gov. Our consumer association will be posting a comment soon. Or pet owners can email FDA directly at AskCVM@fda.hhs.gov (cite CPG 690.150). Pet owners can also send an email to your elected officials in Washington DC asking them to intervene in FDA’s allowance of illegal drugs to be sold to pet owners (cite CPG 690.150).

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
Association for Truth in Pet Food

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