Look What the Cat Dragged In: FDA’s Draft Guidance on Urinary Tract Health Claims for Cat Food

On November 30, FDA’s Center for Veterinary Medicine (CVM) released a draft guidance, “Using Relative Supersaturation to Support ‘Urinary Tract Health’ Claims for Adult Maintenance Cat Food,” to provide recommendations for how pet food companies manufacturers can use relative supersaturation (RSS) methodology to support urinary tract health (UTH) claims for certain adult maintenance cat food.

RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats.  In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis.  We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?”  (Apologies to our readers—word play is FDA Law Blog’s catnip.)

Acknowledging concerns about urolithiasis, pet food manufacturers use a range of formulation strategies to make UTH cat food, which have included limiting the magnesium content or formulating it to produce slightly acidic urine.  However, creating UTH cat food has been quite the cat-and-mouse game: apparently, the historical strategies of limiting the cat food’s magnesium content or formulating it to produce slightly acidic urine are effective in creating a urinary environment that is unfavorable to certain types of urolith growth, yet favorable to others.  Formulating cat food based on RSS methodology is a more recent dietary strategy whose principles apply to all urolith types.

The recommendations in the draft guidance address:

1. The wording of UTH claims based on RSS for use on adult maintenance cat food labeling;
2. The RSS criteria to substantiate those UTH claims; and
3. The study data that CVM recommends to demonstrate the utility and target animal safety of the cat food.

For pet companies that use RSS methodology to substantiate general structure or function claims that an adult maintenance cat food supports UTH, CVM recommends that prior to marketing the product, the company submit the following:

1. Empirical data demonstrating the utility and safety of the product’s mechanism(s) for maintaining UTH (discussed in greater detail below);
2. A complete quantitative ingredient formulation and nutrient composition of the product; and
3. A complete product label, which includes the following FDA recommended claim regarding : “Formulated to promote a healthy mineral content in the urinary tract.”

To demonstrate a UTH cat food’s utility based on RSS methodology, CVM recommends that pet manufacturers submit the results of at least one feeding study demonstrating that cats that consume the food achieve RSS values below the formation products for the two most common types of uroliths found in cats (struvite and CaOx).  CVM explicitly states in the draft guidance that preventing one urolith type while potentially promoting formation of the other is not supportive of a general UTH claim.

To allow for some spread in individual RSS values while still providing an acceptable margin of safety against urolith formation, CVM’s recommended mean RSS and 95% CI limits are:

• Struvite: Mean RSS ≤ 1.8; Upper bound of 95% CI ≤ 2.5
• CaOx: Mean RSS ≤ 6.0; Upper bound of 95% CI ≤ 12

In addition, CVM advises the study to be based on at least four separate RSS measurements on urine collected over at least 24 hours.  To be clear, this minimum measurement requirement is intended to provide evidence that cats consistently produce urine that meets the RSS targets, as demonstrated by at least four consecutive measurements.  Apart from these recommendations, the length of a study and how many RSS measurements are performed are left to the pet food company.

In terms of target animal safety, CVM highlighted potential safety concerns that vary with the method(s) used to formulate the cat food (e.g., the degree to which the cat food acidifies the urine, which could increase the risk of metabolic acidosis, or the nutritional adequacy of the cat food).  CVM recommends that UTH cat food based on RSS methodology meet at least one, and preferably both, of these Association of American Feed Control Officials (AAFCO) methods for substantiation of nutritional adequacy:

1. Formulate the cat food to meet the AAFCO Cat Food Nutrient Profile for Adult Maintenance, and/or
2. Successfully complete and pass an appropriate AAFCO Protocol Feeding Study that demonstrates the cat food to be adequate for maintaining the nutritional status of adult cats.

The draft guidance provides a number of other specific recommendations on study data used to demonstrate target animal safety of the cat food.  Although not all of them are covered in this blog post, do not fur-get:

1. Because CVM recommends conducting both target animal safety and utility studies for a minimum of 40 days, pet food companies may choose to combine safety and utility in one feeding trial to maximize efficiency;
2. Regardless of duration, the study should include:
   • Veterinary physical exams, serum chemistries, hematologies, and urinalyses performed at the beginning and end of the study;
   • Weekly body weight measurements;
   • Daily food consumption measurements;
   • Morbidity and mortality observations;
   • A record of any medical treatment provided and why; and
   • All data generated from individual animals as well as summary statistics for each day of measurement.

You can submit comments on the draft guidance here until February 28, 2024—unless, of course, the cat’s got your tongue.