What you need to know about claims substantiation to keep you out of hot water!
Any claim made on a label requires substantiation. Some examples of acceptable substantiation include: affidavits, certifications and peer-reviewed literature. Any claim related to the structure of function of any part of the body can only refer to supporting the normal, healthy state of pets. One example is: Supports Healthy Skin & Coat. Claims that include terms like enhancing, boosting or improving, such as “boosts the immune system” are considered drug claims. Below, we will do a deep dive into some of the more common claims that appear on pet foods. Today we will cover Digestibility, Dental, Skin & Coat, Immune, Urinary Tract, and Hairball claims.
Digestibility claims
Digestibility refers to the extent to which an ingested nutrient is digested by an animal. Substantiation for overall digestibility should be obtained by conducting digestibility and stool quality feeding studies. The standard for dry matter digestibility is 80%, that is 80% of the nutrients in the food are absorbed by the animal. Digestibility above this would be considered "easily digestible". The threshold for "highly digestible" claims are significantly higher at greater than 86% digestibility for dog foods and greater than 84% for cat foods with less than 10% total dietary fiber. The alternate claim to digestible food is easily or highly digestible ingredients. These claims can be substantiated through peer-reviewed studies supporting the particular ingredients you are making the claim about.
Dental claims
Dental-related claims such as claims that the food can cleanse or whiten teeth or freshen breath through abrasive or mechanical action are permitted. Plaque and tartar reduction or prevention claims and control of bad breath odor can be made only with respect to the product’s abrasive action or masking flavor. Examples include, “with ridges to help scrape teeth”, “coated with a unique ingredient to help prevent tartar buildup” or “with peppermint to help freshen breath”.
Implied drug claims to prevent or treat dental disease are not permitted unless they are the subject of approved New Animal Drug Applications. Ingredients that are not GRAS for the intended purpose of affecting the teeth or gums may be unapproved food additives or drugs. Currently, the only approved ingredient for reducing the accumulation of dental tartar in dogs and cats is sodium hexametaphosphate. Dental claim substantiation using any means other than mechanical action or masking flavor must have an approved New Animal Drug Application or letter of favorable review from the FDA prior to being marketed.
Skin & Coat claims
Skin and Coat claims can be substantiated by guaranteeing nutrients such as Omega-3 and Omega-6 Fatty Acids or more specific fatty acids such as Linoleic Acid, and Eicosapentaenoic Acid (EPA). Minerals known to have an impact on skin or coat health, such as zinc, can also be used to substantiate these claims. If you do not have a study pertaining to your product, you can gather peer-reviewed studies that investigate the impact of these nutrients on skin and coat health. Make sure that your product contains nutrient levels similar to those studied and that the study was done in the same species. Mouse studies don’t work to substantiate a claim on a dog or cat product.
Immune claims
Immune claims can be substantiated by guaranteeing antioxidant vitamins, minerals and other nutrients. These can include Vitamin C, Vitamin E, Omega-3 Fatty Acids, Zinc, Manganese, and Selenium, to name a few. Similar to the skin & coat substantiation, you will want to have your own feeding studies/clinical trials or peer-reviewed studies to support your claim. Be particularly cautious not to claim that your product enhances immunity in any way, as only claims about supporting immune health are allowed. In addition, make sure not to make claims about ingredients that are not approved for this function, such as turmeric. While turmeric is commonly found in human supplements with claims about its anti-inflammatory effects, turmeric is allowed only as a source of flavor or color in pet products.
Urinary Tract
The claim, “maintains urinary tract health by reducing urine pH or by relative supersaturation methodology” is a structure function claim. However, there is no reason to claim this except to indicate prevention of struvite urolithiasis which is a disease. Urinary tract claims need to be submitted to the FDA-CVM for pre-market approval. Generally, these are tied to the reduction of urinary pH. Requirements include diets that are nutritionally complete and balanced for adult maintenance, product utility, data sufficient to demonstrate product safety, and at least a 6-month study.
The ability of the diet to produce an appropriately acidic urine can be substantiated through a concurrent control group of cats fed a non-acidifying diet to demonstrate meaningful comparisons. Cats should be housed individually, and the control diet may be a commercially available product or an experimental formulation. Adequate numbers of animals in control and test groups should be used to detect significantly significant differences between the groups.
Product safety data should include veterinary observations on cat health, measurements of body weight, food consumption, urinalysis (including sediment examination), serum chemistries, blood gasses, and mineral balances (Ca, P, Mg, K). Statistical comparisons should be conducted, using suitable methodology and numbers of animals to confidently (95 %) detect statistically significant (10%) differences. Particular attention should be paid to parameters that assess renal and bone function. A necropsy should be performed on any animal that dies during the study, and the findings recorded. The reason for any medical treatment or removal of any animal from the study should be noted.
At minimum, a 6-month study, consistent with the length of time to conduct an AAFCO maintenance feeding trial, is needed. Food consumption and body weight determinations should be measured routinely and collected on at least four occasions throughout the course of the study.
The submission to FDA-CVM should include all data generated and include data on individual animals and group summaries. Full discussion of product formulation, experimental methodology, statistical methods, and interpretation of findings should be included.
Data on additional parameters and/or longer studies may be required depending on the study findings. Keep animals in the study and continue data collections while the data is under review. Serum and urine samples should be frozen for possible additional testing. Submission of protocols for review can be submitted before beginning the study.
In general, any urinary support claim on a product will be denied registration without FDA approval, even if it is not specifically about urine pH or relative supersaturation.
Hairball
FDA-CVM considers ‘hairball control’ claims to be drug claims but has permitted their presence on complete cat food products regulated as animal food under certain conditions. Hairball control claims must be submitted to FDA-CVM for pre-market approval. The requirements include a complete quantitative ingredient formulation of the product, quantitative nutrient composition of the product (including all essential nutrients according to the AAFCO Cat Food Nutrient Profiles), a rationale for why the product formulation is expected to control hairballs, and a complete product label. The rationale may be based on the information published in the scientific literature or on scientific studies that have been completed with the specific product.
Claims about specifically eliminating or reducing hairballs are considered drug claims and are not allowed. The FDA-CVM does not evaluate or accept hairball control claims on treats or products intended for intermittent or supplemental feeding only. Pet treat products with high fiber levels, designed to be fed along with a complete and balanced hairball control diet may be acceptable.
In Summary
It is up to you as the brand owner to maintain proper substantiation for any claim being made on your packaging or in your collateral marketing materials. If you need help with your claims substantiation, contact us today!