March 25, 2024
(press release)
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The U.S. Department of Health and Human Services Food and Drug Administration received the following public communication dated Feb. 28, 2024: * * * To: Dr. Robert Califf Commissioner, U.S. Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 RE: [Docket No. FDA-2023-D-4095] Using Relative Supersaturation to Support "Urinary Tract Health" Claims for Adult Maintenance Cat Food; Draft Guidance for Industry Dear Commissioner Califf: For more than 90 years, Nestle Purina PetCare Company (NPPC) has manufactured dog and cat food in the United States. As the number one pet food company in the country, we offer more than 30 brands in our pet food portfolio and feed more than 100 million dogs and cats each year. We appreciate the opportunity to provide comments to docket FDA-2023-D-4095 regarding using Relative Supersaturation (RSS) to support "urinary tract health" claims in adult maintenance cat foods. We support a modernized approach to "urinary tract health" claims on wellness adult maintenance cat foods, but we do have specific feedback regarding the proposed claims language, the calculation software, and components of the utility and safety studies. Section II - Background B. Relative Supersaturation (RSS) Methodology Today there are several algorithms or software used by industry to calculate RSS values. We urge the FDA to be flexible in the software a manufacturer chooses to use, while also ensuring the same standard is met for all products utilizing this pathway. Knowing that different programs can deliver slightly different values, it is important for manufacturers to understand how the Agency will validate programs. Section III - Recommended Information to Substantiate RSS-Based UTH Claims The Agency is requesting "a complete quantitative formulation of the product." We would like verification that ingredient inclusion levels can be provided as ranges to maintain the proprietary nature of product formulations. Ranges are currently accepted by the FDA for products making Hairball and Reduced Urinary pH claims that require pre-market approval. Furthermore, we would like clarification on the process to utilize claims other than the proposed "Formulated to promote a healthy mineral content in the urinary tract." This recommended claim is not consumer friendly and is unlikely to fit, legibly, on smaller packaging types such as three ounce cans. The mechanism of action is not required for other pre-market approved cat food claims, like the currently accepted "helps minimize hairballs" on a wellness hairball diet. We hope for a more consumer-friendly claim that does not require a mechanism of action, such as "supports urinary health". Section IV - Utility A. Target RSS Values For transparency, it would be helpful for the FDA to provide additional clarification behind the rationale of the 95% confidence interval and only using the mean values no greater than the midpoint of that urolith's metastable supersaturation range. Using the approach of a midpoint is overly conservative and not supportive of the ranges shown to be efficacious. We recommend the upper level for metastable struvite uroliths be 2.5 and the upper level for metastable calcium oxalate uroliths be 12. These values are supported both by the references used in the docket and the background information provided on page three of the draft guidance. B. Study Duration and RSS Assessment Schedule The 40-day duration to support utility efficacy goes beyond what is required to provide efficacious results. Research, including the supporting references of the docket, do not support the need for a utility study of that duration. Published literature has shown successful studies within 10 to 14 days. To support responsible animal testing and resource use, we support a study duration of 10 days to show utility success. Section V - Target Animal Safety A. Safety Concerns We would appreciate the FDA to elaborate on their basis for requiring an additional safety study for a product that is either formulated to be complete and balanced using the Association of American Feed Control Officials (AAFCO) Cat Food Nutrient Profiles or shown to be complete and balanced by conducting the appropriate AAFCO maintenance feeding protocol. If a cat food product is nutritionally complete and balanced for adult maintenance by either formulating to the AAFCO Cat Food Nutrient Profile or conducting the appropriate AAFCO maintenance trial, then there should not be concerns of safety with the product. We recommend the removal of this requirement if the manufacturer can provide sufficient evidence that the product is formulated to meet the maintenance requirements in the AAFCO Cat Food Nutrient Profiles, the product has successfully completed the appropriate AAFCO maintenance feeding protocol, or the product fits under the family lead of a product that has completed the appropriate maintenance feeding protocol. B. RSS Study Design 2. Urinary pH Measurements and Mineral Balance Conducting a study of 40 days, with four data collections, with the possibility of the study lasting 26 weeks, is not in alignment with internationally accepted goals of reducing animal testing when study designs of shorter duration provide reliable results. Requiring a 40-day feeding trial for a cat food product that is already proven to be complete and balanced for adult maintenance does not seem justified nor in alignment with the FDA's goals to reduce animal testingi. 4. Other Considerations We ask that the FDA provide clarification if this section relates to the utility study, the safety study, or both. If this section refers to the safety study, we suggest that the appropriate statistical comparison be to evaluate for equivalency between baseline and end of study on safety measures only and clarify that 10% is the defined effect size considered to be a physiological difference. Furthermore, extending studies for an additional six months is not in alignment with the principles of reducing animal testing. Can the FDA please clarify why the study would need to continue if the Agency is providing the protocol that must be followed? Furthermore, we encourage the FDA to establish a 45-day review and response period following the submission of all completed study data to the Agency. NPPC is in support of the Agency taking a modernized approach to "urinary tract health" claims in adult maintenance cat foods. We appreciate the chance to provide comments and hope this feedback is considered for the final guidance. Sincerely, Justin Schmidt Senior Director, Regulatory and Scientific Affairs Nestle Purina PetCare Company * * * Original text here: https://downloads.regulations.gov/FDA-2023-D-4095-0037/attachment_1.pdf TARGETED NEWS SERVICE (founded 2004) features non-partisan 'edited journalism' news briefs and information for news organizations, public policy groups and individuals; as well as 'gathered' public policy information, including news releases, reports, speeches. For more information contact MYRON STRUCK, editor, editor@targetednews.com, Springfield, Virginia; 703/304-1897; https://targetednews.com © 2024 Targeted News Service
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