November 2024 • Vol. 30 • Issue 9
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Mastering U.S. Pet Care Formulation: Understanding Regulations and Animal Needs …Amanda Rountree
ets play a significant role in many of our lives, and the pet care market reflects this, with an estimated value of 13.88 billion USD according to a 2023 global market analysis of the pet grooming product market.1 From our loyal companions like dogs and cats to our majestic equine friends, pets come in all shapes and sizes, each with their unique grooming needs. Understanding how to formulate for pets is crucial from a regulatory perspective. Allow me to walk you through some compliant issues and various formulations essential to animal care.
FDA Cosmetic Counterpart for Animals: Grooming Aids
Understanding how pet care is categorized from a legislative perspective will greatly help your formulation journey. Pet care falls within its own realm, similar to personal care, and requires compliance with specific regulations. We will still need the FDA’s help on this one. Sec. 653.100 Animal Grooming Aids from the U.S. Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs and Center for Veterinary Medicine will guide everything we need from a United States-based formulation perspective. Very similar to cosmetics, “products intended solely to cleanse or beautify animals—commonly referred to as ‘grooming aids’—are not subject to the FD&C Act and are not regulated by the FDA.”2 Similar to the case of cosmetic vs. drug debate, “if a product purporting to be a grooming aid is intended to cure, mitigate, treat, or prevent disease in animals or to affect the structure or function of the body of animals, the product is a drug Painting of Elsa by Bego Blázquez. Copyright 2024. under section 201(g) of the FD&C Act.”2 Another similarity is to demonstrate a product’s safety and effectiveness; likewise, anything unapproved or adulterated is subject to FDA enforcement. Of course, there could be hybrids, just like cosmetics; however, these lean more toward the drug side of things. Medicated shampoos for pests like fleas and ticks would be considered a drug over a shampoo that just cleanses. If you’re wondering if your product would be considered a drug, you can always reference the monthly updated FDA Green Book for all the information you need on approved animal drugs. Even though grooming aids have their own special category, the Federal Trade Commission (FTC) labeling regulations still play a role in pet products. As you can see, cosmetics and grooming aids have some similarities, but then again, there are stark contrasts.
EPA Defined Ingredients
From a cosmetic lens, we look to the Environmental Protection Agency (EPA) for regulations concerning issues such as volatile organic compounds (VOCs). The EPA comes into play for pet care for two major purposes, and that would be for registered pesticides and the Toxic Controlled Substances Act (TSCA). Pesticides are often used in animal care to protect from injurious pests such as pesky mosquitos and biting flies. The EPA ensures the safety of pesticides, even when used on animals, in accordance with label directions.3 A vital callout is not all pesticides are universal. What might be okay for a dog, can be toxic to a cat. This is critical to keep in mind (continued on Page 5) when formulating or purchasing products for your pet. The EPA wonderfully outlines the requirements and
PET CARE AND GROOMING • NOVEMBER 5th ...see page 10 for more information.