Pets 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 remaining compliant 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 FDA.”2 Just like with the 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 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 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). While humans deal with pesticides, most commonly thought of from a narrowed perspective as insecticides for pesky mosquitoes and biting flies, animals need protection from these often injurious pests. 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 when formulating or purchasing products for your pet. The EPA wonderfully outlines the requirements and guidelines that need to be met. Through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA’s regulated pesticides on the market are well-established and researched, allowing for an expansive choice for your product needs. It is imperative to understand that the FDA regulates certain medicated products for animals as drugs, while the EPA regulates others as pesticides. Always double-check regulations and ensure you’re registered with the right government agency.
What is TSCA? According to the EPA, The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures.4 Regarding TSCA, certain substances are generally excluded from TSCA, such as food, drugs, cosmetics, and pesticides. In the realm of personal care, we are privy to the TSCA exemption for cosmetics; therefore, we can continuously use novel and exciting ingredients. Around every six months, the TSCA inventory will get updated.5 As it stands, the TSCA Inventory contains 86,770 chemicals, but only 42,377 are active.5 You can download the TSCA inventory and search by chemical CAS number. You can also go to your raw material SDS and check section 15 for regulatory information. The green light is when your ingredients are listed on the U.S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory. If you can’t find it on TSCA, it’s considered a new chemical to U.S. commerce. The reason you want to be compliant is if you use an item not registered on TSCA, expect to follow Section 5 of TSCA, which requires anyone who plans to manufacture a new chemical substance for a non-exempt commercial purpose to provide EPA with a Premanufacture Notice (PMN) at least 90 days before initiating the activity or incur repercussions from the EPA for violation.6 If you think regulations for U.S. commerce seem daunting, keep in mind other countries’ inventory lists, along with requirements for pet products.
Of course, we know regulations are not only everchanging but also nuanced. Just within the U.S., remaining compliant is important. While easier said than done, do not forget about state regulations! Medicated products might not be as accessible given your company’s bandwidth to support and keep up with hefty regulations, but showcasing them is an option since these are popular within the pet space. Just like every cosmetic manufacturing site might not be making OTC, grooming aids alone might make the most sense, given your company’s capabilities. While R&D folks typically need a slice of regulatory knowledge to commence formulating, it is vital to utilize government resources, trusted industry sources, and regulatory consultants for utmost compliance for your unique development needs. This overview should be enough to whet the regulatory knowledge perspective so we can get down to some fun formulations.
Pet Chemistry
As we learn more about concepts like microbiome, we can understand skin pH is not necessarily ubiquitous depending on the region. This same concept applies to pets. While human skin is more so on the acidic side, dogs are more alkaline, with a recent report revealing the mean pH of 7,48 for canine skin.7 The skin pH level for a cat is around 6, which is slightly on the acidic side.8 We find bigger pets like horses to have a pH from 7.0-7.4, around the neutral arena.9 Little fuzzy pets like guinea pigs zone in at 5.5 while a rabbit will circle around 6.7, which shows variation between all types of animals.10 Of course, there is a massive list of all kinds of pets, from skunks to turtles, but not all of these types of pets necessarily need assistance from grooming aids. Having a baseline understanding of skin pH will help keep animals in balance and avoid adverse skin reactions.
There is a question: can pets share products with humans? It is complicated. In a pinch, it should be okay, but it is really best to use products intended for the subject itself. There are hybrid products on the market that say they are for humans and other types of animals. In that case, you need to follow the most stringent regulations; although, is best practice to separate church and state to avoid weighing what you need from each category to be compliant.
What a Pet Wants, What a Pet Needs
It is paramount to consider all pets have special needs, and they should be addressed per the veterinarian’s recommendations. The first product most people think of is a pet shampoo. We know pets can get into messes or have the proclivity to get dirty and smelly sometimes. Maintaining cleanliness and perhaps primping can be ideal for a pet’s appearance. We can heavily hinge on our knowledge of personal care based formulas to help build our pet grooming line. I’ll be providing the best items to add to a product line with some tips and tricks along the way.
One concept is how often pets are groomed. Typically, a domesticated animal will not bathe as often as a human would. So consider what your final sizes for finished goods will be. On the other hand, large and bulk sizes might make sense for someone with multiple pets, larger pets, or for groomers. Travel sizes can come in handy because pets can often tag along for the ride or may need to be presented for showings, like horses or dogs.
Let’s talk about why we should mirror cosmetic protocol. Safety substantiation is key. Test all of your standard specifications, conduct stability, run microbial studies, and test/substantiate all claims on your bottle. While a list of ingredients is not necessary for animal products, it is a good practice to follow cosmetic labeling guides for transparency and courtesy to the consumer. We owe it to the special members of the family to give them the best they deserve!
Let’s start with a good wash. We can keep the classic picture of a shampoo/body wash in mind, but consider the pH of the pet you want to formulate for. Pets may not be able to close their eyes or anticipate the sting that some anionic surfactants might cause. It is best to go with surfactants that have a low irritation profile based on results from reliable ocular studies. These are often gentle but still offer robust foam. Fragrance can really make a product, but if this is used around the eye area or for pets with allergenic tendencies, it might not be ideal. Be sure to advise your fragrance house that you are working on pet products, so they can help develop the best fragrance for your application. Consider adding humectants and detangling agents to nourish the animal’s skin and keep their hair from tangling post-bath… or shower… or sink! Once you have a favorable base, you can add actives, just ensure they are on TSCA and registered with the FDA or EPA.
Now that the pet is squeaky clean, adding a conditioner next will enhance their coat’s softness and shine. Something to note is animals are known to have fur; however, this is just the animal classification of hair. Regardless, fur is a special type of hair, and even animal hair varies from human hair. Pets need conditioning to maintain manageable hair. Given most pets are more alkaline, we need to reconsider our final pH with conditioning. A classic opaque base with conditioning agents will be a great start. If wanting to incorporate butters and oils, consider things like chocolate is toxic to dogs and cats. For that reason, it is probably best not to use something like cocoa butter, even though it only has trace amounts of theobromine, the compound toxic to these pets. Although we associate dogs with loving peanut butter, others might have some nut allergies, so consider this as well for nut-based butters and oils. Pets battle with issues like dry skin, excessive shedding, dander, tangles, matted hair, and malodor, to name a few. These are some elements to consider based on the solutions you want to provide the pet.
To help maintain the post-bathing conditioning, it is good to follow up with a leave-in conditioner. Consider where this product may be sprayed and if the pet will have interactions with licking around these regions. The same ideas apply to the butters and oils concept from the conditioner portion. You can choke up on the viscosity and focus on elements like detangling, moisturizing, and perhaps even deodorizing. You can have fun with the final dispensing form from a flip top to a manual spray to an aerosol. Again, actives can be administered once you have a satisfactory base. A fun project I worked on was creating a stellar leave-in conditioner for a horse, but incorporating insecticides to keep the biting flies off.
Next would be a deodorizing product or pet perfume/cologne because bathing processes for pets can be, well, a process! Maintenance between can help elongate the time between baths. For this product, we are focusing on neutralizing malodor and imparting some moisture. This formula is as simple as adding a deodorizing agent along with a pleasant fragrance. Just make sure everything is nice and soluble. Feel free to add humectants and extracts to bring the marketing story all together. You can even make a wipe version of this product for quick freshness, especially on the go. If you are using this on smaller pets or those that might self-groom, consider where they can lick or come into contact with this item.
Similar to the deodorizing spray would be a dry shampoo. Get the scent of your pet fresh from the bath without the water. This will help mattify your pet if they are prone to getting slick coats. Dry shampoos are simplistically solvent and mattifying powder. You can go the mineral route or even explore the many starches. Be sure to consider large micron sizes or wetter sprays and consider your pet’s sniffer. You can go the classic aerosolized dry shampoo route or something in a pump bottle. Be cognizant of potential clogging issues. It might make sense to employ an anticaking agent. Work closely with your packaging engineer or vendor to perfect the dispensing of this item. You can add a hint of emollient to your dry shampoo. Feel free to top it all off with a pleasant fragrance. You can even add some deodorizing benefits to this formulation.
Cold weather, rough walking surfaces, and sensitive areas make pet balm essential. This would most likely be a hot fill item or squeeze tube fill. A semi-soft balm used to protect the pads of the paws, the nose, and any other areas of the body that need some extra love. Like in the conditioner section, consider the oils and butters used if the pet might lick this item off. You want this item to be safe if consumed. Focus on moisturizing and occlusivity for this item.
Certain pets might have the proclivity to have eye discharge buildup. Having a wipe to remove the tears and staining can help keep your pet healthy and looking fresh. Consider utilizing safe ingredients for use near the ocular area. Something hybrid of a gentle surfactant mix to loosen up debris with a mild saline-like solution to do the “rinsing” would be the silver bullet for this type of formula.
Just like fingernails, hooves need special care. Horses are prone to breaks, dullness, fungal infections, dryness, and brittleness. From a salve to a spray, you can really have fun with the application for a nail protection and maintenance formula. By going with humectants, occlusives, and emollients, you’re sure to help gloss up their hooves, moisturize, and seal it all in from the elements. Of course, antifungals can be incorporated if you are pursuing the drug route for this item.
We can spend all day discussing formulation. I will pop a few other ideas into your head on this that might be more entailed, niche, or surround the needs one might have because of pets. For our fancy pups and horses out there, pet hairspray or hair coloring is popular in the realm of animal showcases. I just recall in The Wizard of Oz how the horses were different colors. Ear rinses and wound care are important within the realm of animal care; however, most of this does tread into the medicinal application. For our pals that stay inside, odors can persist from various circumstances, cage cleaners, urine/pet mess cleaners, and air fresheners come in handy. Keep in mind pet-friendly ingredients!
Here’s a little helpful list to leave off with when formulating grooming aid products for U.S. commerce. These are a few questions to send your vendor or investigate on your end:
Is this item on TSCA inventory? Is this item safe for use on (animal you are formulating for)? Does this material fall within (the pH range of the animal you are formulating for)? Does this item have any affiliation with toxicity, allergy, or other concerns (for the animal you are formulating for)? Are these ingredients affiliated with any FDA or EPA registration? Does this raw material have any glaring regulatory issues on a state level?
All in all, formulating grooming aids for pets is satisfying because you are helping pets actualize their best selves so they can have the most positive experiences with their family and loved ones. A healthy and happy pet is so wonderful! There are so many types of products that can be made to help pets or issues surrounding them. Understanding the special regulations surrounding grooming aids will help keep your formulations compliant. Having a baseline understanding of formulating all things personal care can give you an edge in formulating for pet care. Now go out there and make the most PAWpular formulas on the market!
(1)Pet Grooming Product Market Size | Industry Report, 2019-2025. www.grandviewresearch.com. https://www.grandviewresearch.com/industry-analysis/pet-grooming-products-market.
(2)Sec. 653.100 Animal Grooming Aids Compliance Policy Guide Guidance for FDA Staff. https://www.fda.gov/media/121177/download.
(3)US EPA, O. EPA’s Regulation of Flea and Tick Products. www.epa.gov. https://www.epa.gov/pets/epas-regulation-flea-and-tick-products.
(4)US EPA. Summary of the Toxic Substances Control Act | US EPA. US EPA. https://www.epa.gov/laws-regulations/summary-toxic-substances-control-act.
(5)US EPA, O. How to Access the TSCA Inventory. www.epa.gov. https://www.epa.gov/tsca-inventory/how-access-tsca-inventory.
(6)US EPA, O. About the TSCA Chemical Substance Inventory. US EPA. https://www.epa.gov/tsca-inventory/about-tsca-chemical-substance-inventory.
(7)Matousek, J. L.; Campbell, K. L.; Kakoma, I.; Solter, P. F.; Schaeffer, D. J. Evaluation of the Effect of PH on in Vitro Growth of Malassezia Pachydermatis. Canadian Journal of Veterinary Research 2003, 67 (1).
(8)Table 5 . Skin pH in different regions in cats. ResearchGate. https://www.researchgate.net/figure/Skin-pH-in-different-regions-in-cats_tbl3_49731296 (accessed 2024-09-29).
(9)Let Your Horse Shine Bright. FEI.org. https://www.fei.org/stories/lifestyle/health-fitness/let-your-horse-shine-bright-cavalor#:~:text=The%20pH%20of%20your%20horse (accessed 2024-09-29).
(10)Proksch, E. PH in Nature, Humans and Skin. The Journal of Dermatology 2018, 45 (9), 1044–1052. https://doi.org/10.1111/1346-8138.14489.
ABOUT THE AUTHOR
Amanda Rountree
IKI Manufacturing
Amanda Rountree is a Senior Manager of Product Development at IKI Manufacturing. She has been in the cosmetic industry for seven years. Her primary R&D expertise is centered around aerosol and liquid development of personal care and household products. She has made everything from laundry detergent, eyelash serum, peel-off masks, and hairspray. Amanda’s favorite aspect is innovative product development and helping craft an exciting marketing story for a successful product launch. She has always been passionate about science and knew she would be a cosmetic chemist since high school. This led her to pursue her Bachelor’s in Chemistry at North Central College. As a student, Amanda became involved with the Midwest Chapter of the Society of Cosmetic Chemists. She has served as Hospitality Chair in 2019, Secretary in 2020, Bylaws Chair in 2021, Chair-Elect in 2022, Chair in 2023, and Teamworks Chair in 2024. Amanda has championed better connections within the Midwest Chapter by branching outside of the Illinois/Chicagoland area and incorporating Wisconsin and Indiana for exciting events. She is also involved as a board member of the Southern Aerosol Technical Association (SATA) and serves as an active speaker at industry conferences. Her educational message spreads beyond the industry, as she recently spoke at an a Household & Commercial Products Association (HCPA) event to Federal legislators regarding research and development.