The Pet Food Prescription Pad Has Been Challenged – Truth about Pet Food

On September 29, 2023 a several years established lawsuit against Hill’s Prescription Pet Food was granted “Class Certification; the lawsuit becomes a class action allowing many more pet owners to join.

This lawsuit revolves around the ‘prescription’ illusion of Hill’s Prescription Diets. Quoting the ruling allowing the class:

At the heart of Plaintiffs claims is the undisputed fact that Defendant Hill’s restricts the sale of Prescription Diet (“PD”) pet food to those with a prescription from a veterinarian… Plaintiffs assert deceptive practices claims, which allege that PD is not legally required to be sold by prescription, and so Defendants’ representations that PD is required to be sold by prescription are literally false. Plaintiffs further allege that Defendants engaged in deception in the manufacturing, distributing, marketing, advertising, labeling, and/or selling of PD at above-market prices to diagnose, cure, mitigate, treat, or prevent diseases or other conditions, even though PD: (a) does not contain a drug, medicine or other ingredient that is not also common in non-prescription pet food; (b) does not contain a substance medically necessary to the health of the pet for which it was prescribed; and/or (c) is not materially different than non-prescription pet food.”

Plaintiffs also assert unfair practices claims, alleging that Defendants manufactured, marketed, labeled, and/or sold PD at above-market prices to diagnose, cure, mitigate, treat, or prevent diseases in animals without approval as a “new animal drug” pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. (“FD&C Act”), and without being registered and listed as a “drug” with the Food and Drug Administration (“FDA”). (2d Am. Compl. ¶¶ 38-45.) As a result, PD is allegedly adulterated and misbranded under the FD&C Act and its introduction into interstate commerce is a prohibited act.”

The lawsuit claims are true. Hill’s and other brands of pet foods intended to cure, mitigate, treat or prevent diseases – currently sold ONLY through a veterinarian prescription – are NOT legally required to be sold only through a veterinarian. This is a choice that the veterinary diet industry made, and now it is coming back to bite them.

Federal regulations are very clear, any product (drug, supplement, food) that claims to diagnose, cure, mitigate, treat, or prevent diseases is considered a drug. The FDA states – specific to veterinary pet foods: “By virtue of their intended use to treat or prevent disease, such products meet the statutory definition of a drug in section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)(1)(B)].

Further the FDA states that unless these products have been approved as an Animal Drug – having completed a New Animal Drug Application and being approved, the products would be “adulterated” – exactly as claimed in the lawsuit.

The FDA also makes it very clear that veterinary diets do not meet the requirements of a drug stating: “most dog and cat food products that claim on their labels or in their labeling or other manufacturer communications to treat or prevent disease are not approved new animal drugs, and do not comply with drug registration and listing requirements, or with current good manufacturing practices applicable to drugs even though the products are drugs under the FD&C Act.”

BUT, the FDA also states the agency will ‘look the other way’ (enforcement discretion) and allow these products to violate law “when 1) those products provided all or most of the nutrients in support of the animal’s total required daily nutrient needs, 2) product labels and labeling and other manufacturer communications that were available to the general public (i.e., non-veterinary professionals) did not contain claims to treat or prevent disease, and 3) those products were distributed only through licensed veterinarians.

The catch…

…FDA ‘enforcement discretion’ is not legally binding. The FDA decision of enforcement discretion regarding veterinary diets is ONLY a Compliance Policyit is not a law.

The FDA could have made a regulation that allowed veterinary diets to be sold strictly through veterinarians, but they did not do that. The FDA took a hands-off approach and wrote a Compliance Policy instead of a regulation. FDA’s Compliance Policy Guide on this veterinary diet issue states (at the top of the first page): “This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”

But Hill’s and others that sell veterinary diets did NOT ‘use an alternative approach’. Instead, these pet food manufacturers decided to sell pet foods marketed as a drug that do not meet any legal requirement of a drug based on a nonbinding (not legal) FDA opinion. And further they decided to sell these illegal pet foods at a significantly higher price than other pet foods – taking advantage of consumers.

Personal opinion: Kudos to these pet owner Plaintiffs and lawyers battling this issue out. You are right, they are wrong. Your continued fight has great potential to force some significant change in pet food (regarding other FDA enforcement discretions).

Wishing you and your pet(s) the best,

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

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