From People to Pets: Which "Human" Ingredients are Making Their Way into Pet Supplements?

April 12, 2012

Yes, we want to give our pets supplements. But can a pet benefit from a dietary supplement the same way we can?

What separates man from animal? Not a whole lot, when it comes to bodily ailments. Both humans and (most) animals can suffer the ache of a joint, or the irritant of a skin allergy. And as owners of companion animals increasingly humanize their furry-or non-furry-friends, many believe pets can benefit from dietary supplements just as much as humans do.

Through two decades, the pet supplements market has evolved alongside the human supplements market, now exceeding $1.5 billion in annual U.S. sales, according to Nutrition Business Journal. Yes, we want to give our pets supplements. But can a pet benefit from a dietary supplement the same way we can? It turns out that concerning dogs and cats in particular, pets and their owners do start to look alike.
 

Pets vs. Humans

“When you’re talking about dogs and cats, they’re a lot more like us than we think,” says Chelsea Tomat. Tomat is the new-products developer for the animal division of FoodScience Corp., a nutrition company whose animal range includes the Pet Naturals of Vermont retail brand and the Vetri-Science Laboratories veterinary line. (By the way, this article focuses mostly on dogs and cats, which according to latest statistics from the American Pet Products Association make up the lion’s share of U.S. household pets.)

The digestive tract of a dog or cat is more similar to a human’s than a human’s versus a horse (a hindgut fermenter), a cow (a ruminant), or a bird, says Tomat. These similar bodily mechanisms mean that you’ll find many of the same supplement ingredients for humans also used for pets. In fact, before the pet supplements market grew, many pet owners simply gave pets their own human supplements. “The raw materials and ingredients used in pet products are essentially the same as those in human products,” says Bill Bookout, president of the National Animal Supplement Council (NASC; Valley Center, CA). “There’s no animal-grade glucosamine out there.”

Given the wide selection of ingredients for human supplements, there’s no shortage of ingredients for pets, says Dale Metz, CEO of FoodScience Corp. and an NASC board member. “A lot of the ingredients we deal with are human-grade ingredients, so getting the ingredients isn’t really a problem.”

Condition-specific pet categories largely mirror those in the human market: joint health, skin (and coat), and calming/relaxation are a few of the big ones. “The animal world tends to follow the human world in trends by anywhere from three to five years,” says Scott Garmon, NASC board member and president and CEO of The Garmon Corp. The Garmon Corp. owns, among others, the NaturVet retail brand. It is also one of the few companies to do its own manufacturing as well as private-label manufacturing for other pet brands.

“The need and the benefit [of supplements] are not much different than for humans,” Garmon adds.

But not all ingredients that are good for you are good for Fido or Whiskers. “Most things extrapolate over to the animal world fairly well from the human world-but not everything,” Garmon says.

Also, what’s good for one species might not be good for another. “For instance,” says Garmon, “you can give white willow bark to a human and to a dog, but you can’t feed it to a cat.”

Tomat provides other examples. Acai, a popular superfruit among humans, contains theobromine, the same chemical in chocolate poisonous to dogs. “The other ingredient we keep a red flag out for is alpha-lipoic acid,” she says. “It’s a great ingredient for dogs; it’s bad for cats. A lot of our formulas are not that different between cats and dogs-usually it’s just a flavor difference-but if we include alpha-lipoic acid in a dog formula, we have to be very careful to let our customers know not to use the product on their cats.”

Between breeds, there are fewer exceptions. Some breeds may be more sensitive to certain ingredients. For instance, Tomat says, some Dalmatians can be sensitive to Perna canaliculus, or green-lipped mussel. Shar Peis may be more sensitive to hyaluronic acid.

With such exceptions, how do you determine which ingredients tested for humans are likewise safe and efficacious for pets?

While more human nutrition research is always needed, at this point in time, human research has a leg up on pet research. Whereas clinical studies (e.g., toxicity) for human ingredients are often done on pets (e.g., rodents), there is a great need for more ingredient research for pets. Cost prohibits more pet research, as it does in the human world. Nutraceuticals manufacturers in general aren’t able to patent natural products and recoup any research investment that way.

“I wish I could just do species-specific research all day,” says Tomat. “We get a lot of questions like, ‘Exactly what dose should I give of X ingredient for my dog every day?’ The problem is that in order to have all of that research data on all of these ingredients, it costs a lot of money. With nutraceuticals, if we had that much research and the specific mg/kg dosage that we knew was the magic number, then we would be a drug.”
 

Research Crossover

Instead, pet-supplement companies often rely on historical and field-trial data-and yes, human clinical trial data as well-to extrapolate information on the safety, efficacy, and appropriate dosage for pets. “You look for what the literature says is a common pathway with the species you’re working with, and if the evidence stacks up, then you’re heading in the right direction,” says Andrew Yersin, PhD, president of the animal nutrition and health/vet division for ingredients firm Kemin Industries (Des Moines, IA).

Dosage is often adjusted to the animal’s size or breed (e.g., a small dog versus a large one); or it might be adjusted for the animal’s age (e.g., an elder cat may not need as many calories, or may need more joint support, than a growing kitty).

NASC has in fact created an impressively comprehensive adverse-events reporting (AER) system, NAERS, specifically for the animal supplement market. In lieu of a legal supplements category (read sidebar 1, below) or a government-run AER system for animals, this system gives pet companies a broad body of historical data with which to connect the dots for something such as safe dosage.

“The NASC database tracks, by product, any adverse events that are reported,” Garmon says. “It tracks by ingredient, by how much of the ingredient was given to the animal-both the maximum dose and the mean dose-and then the total number of doses that were provided over the years. The system goes back more than 10 years on most products.”

“We track almost every single ingredient that’s used out there, so we have a pretty good idea,” adds Metz. “When we’re going to use an ingredient, we can go into the NASC database and find out what is the average dosing per kg of body weight for that specific species, whether it be a cat or a dog or a horse.”

For newer-to-the-market ingredients for pets, says Yersin, “we’re building that history now.” This robust AER database could tie into a national database should FDA’s Center for Veterinary Medicine eventually adopt one-something the industry is working toward.

Part of the reason the animal world needs its own AER system is precisely because ingredients may not behave the same way in pets as in humans, Garmon adds.

“Just because something works in humans in an effective way may or may not translate to animals, and that’s why there really needs to be clinical testing for efficacy,” says Lisa Alley-Zarkades, vice president of animal wellness for ingredients distributor Horn (La Mirada, CA). Thankfully, she says, more are starting to look into pet research. Horn encourages its ingredient suppliers to do pet-specific research on their ingredients and even helps guide them through the process. “We do encourage our suppliers that if they don’t have that kind of information available-if they strictly have human data only-they do need to do their homework on the animal side. Although pets and humans do have a lot of similar systems, you can’t assume that if it’s good for people, it’s good for pets, or that it will work in the same way.”

While there are too many pet ingredients to name in one story, if an ingredient is used in human health, it’s probably been considered for pets. Let’s take a look at just a few.
 

Joint Health

The joint-health category helped found the pet-supplements market. Green-lipped mussel is now one of the ingredients gaining mobility.

FoodScience’s Tomat says green-lipped mussel is a star of the Vetri-Science veterinary line. “It’s a whole-food approach because it contains glucosamine, chondroitin, and hyaluronic acid.”

However, in the retail market, she says, “the average consumer doesn’t seem to know yet what Perna canaliculus is. But the average vet knows what it is.”

Nichole Deblock, marketing director for Nutraceuticals International Group (Paramus, NJ), says green-lipped mussel extract is one of the ingredient supplier’s strongest performers for pets, as well as chondroitin.

Tart cherry is another joint-health ingredient doing very well for one company in particular. Garmon’s Overby Farm brand specializes in tart cherry joint products for pets under the names Hip Bones and Hip Flex. The brand uses a patented tart cherry licensed from Michigan State University that is supported by both human and animal research-with more research in the works, says Scott Garmon. Its recognition with consumers is “starting to evolve,” he says.

According to NASC’s Bookout, another ingredient seen more is NEM Natural Eggshell Membrane, developed by ESM Technologies (Carthage, MO) and distributed by Stratum Nutrition (St. Louis).

In general, anti-inflammatory ingredients such as omega-3s, curcumin, ginger, Echinacea, boswellia, and pterostilbene-the list goes on-are all gaining traction in the pet market, for various benefits.

Ingredients supplier Ecuadorian Rainforest (Belleville, NJ) says its best seller for domestic animals is yucca (Yucca schidigera), a known anti-inflammatory and antioxidant that has been used for some time in the equine market and is now making its way into canine retail.

And, of course, the heavy hitters in the human world-glucosamine, chondroitin, methylsulfonylmethane (MSM), and hyaluronic acid-can likewise be found on the pet shelf, as well as calcium, vitamin D, vitamin K, vitamin C, vitamin B6, and magnesium.

Bergstrom Nutrition (Vancouver, WA) says that an MSM ingredient like its PurforMSM (“Pure Form MSM”) is a staple ingredient for companion animals and horses. “The same MSM that provides fluid, functional joint support to humans is also shown to promote respiratory health, along with healthier cartilage, nails, and coats in animals,” it says.

Another company turning its attention to pet joint health is the marketer of the Jusuru Life Blend liquid supplement. The company launched Jusuru Pet Blend this year. Like its human version, it stars BioCell Technologies’ (Newport Beach, CA) BioCell Collagen-a naturally occurring matrix of hydrolyzed collagen type II, chondroitin sulfate, and hyaluronic acid. The company says it “wanted to provide a pet-safe alternative for consumption by dogs and cats….The articular joints (which are associated with movement) of mammals tend to be very similar across different species, which is why Jusuru Life Blend and Jusuru Pet Blend have similar benefits for humans and pets, respectively.” Also, BioCell Collagen’s hyaluronic acid and collagen can help pets achieve a shinier, healthy coat, just as it offers skin benefits to humans.

Performance

Pets also need to be kept in tip-top shape for sports-think Frisbee, fetch, hiking, agility courses, or even just a long walk.

Tomat says for dogs and cats, one of Pet Naturals’ premier researched ingredients is dimethylglycine (DMG), a derivative of the amino acid glycine. “It’s an intermediary metabolite,” Tomat explains. “It does so many different things for your body. It helps break down lactic acid in your muscles so that when you work out, you’re not sore afterwards. And it helps you maintain top performance for longer, giving you more endurance and stamina.” It can also help with joint health and mental acuity. Pet Naturals features DMG in its Agility DMG product targeting “an active canine competing in performance events or for a dog that’s just having fun and needs a little energy.” Tomat adds that because DMG is water soluble, it should be replenished throughout the day. Thus, Agility DMG comes in small chews as tiny treats owners can give their pets as they’re training them.

Mental acuity is also key to performance. Pets can suffer the same symptoms of cognitive decline that humans can-behavioral changes, memory loss, disorientation, anxiety.

Chase Hagerman, business development and marketing manager for ingredients supplier Chemi Nutra (White Bear Lake, MN), says that while cognitive decline in pets should be a concern, “for pet owners, the warning signs are much more difficult to see, especially since we have a limited understanding of our pets’ mannerisms. Most of the other health categories are noted with a physical improvement-weight management products help your chubby tabby shed excess fat, and joint- and bone-health products help your Labrador run more freely. But since the improvements of cognitive aids are not physically altering, it is hard to judge the success a product has on a pet.”

Still, Hagerman says, although the cognitive-health category is lagging for pets, with the amount of condition-specific interest consumers are showing in pet health, don’t be surprised if the category grows.

One ingredient with researched benefits is phosphatidylserine (PS), such as Chemi Nutra’s SerinAid PS. It is a proven ingredient for humans that Hagerman says is turning out to be very promising for the young-pet industry. A key player in neurotransmitter synthesis, PS has studies exploring effects on animal cognition. A 2008 review (Osella et al., Journal of Veterinary Behavior) evaluated past clinical trials in canines and found PS to be well-tolerated, safe, bioavailable, and effective for cognitive decline. The growing population of older pets stands to benefit from such a nutrient.

But don’t forget about young pups and kittens. They, too, can benefit from a brain-development nutrient such as omega-3 fatty acid DHA, a staple in human infant nutrition.

“In baby animals, DHA omega-3 influences brain-, eye-, and immune-function development,” says Jeff Alix, pet business development manager for DSM Nutritional Products (Parsippany, NJ). Horn’s Alley-Zarkades even mentions that the Association of American Feed Control Officials (AAFCO) is considering formally adding DHA as a recommended ingredient for puppy products in its nutrient guidelines.

DSM offers DHAgold (which Horn also distributes), an earth-friendly source of DHA omega-3 derived from algae. The company says that puppies nourished with high levels of DHA were found to be more trainable than puppies given low levels.

DHA is good for older pets, too. “In the senior animal, DHA contributes to healthy mobility, brain function, and skin and coat quality,” Alix says. Other benefits of omega-3 fatty acids in general include digestion and gut health, heart health, and immune health.

And don’t forget other ingredients crucial to cognitive health, says DSM, including choline, B vitamins, and antioxidants like vitamins E and C.

Also, animals can stress out just like humans can. A pet going to a kennel or the vet’s office, or just plain in a situation it’s not accustomed to, will likely feel more stress, says Kemin’s Yersin. Thus, the “calming” category is growing.

Many of the same ingredients in the human industry can be found here: L-theanine, valerian, to name a few. Tomat says that Pet Naturals has had a lot of success with a Colostrum Calming Complex. The brand combines this complex with Suntheanine-brand L-theanine to help a pet relax and focus. “The L-theanine works by balancing the neurotransmitters in the brain, while the colostrum complex helps with the receptors. When you use the two of them together, they help each other work better,” she says.
 

Digestive Health

Think about what animals eat in the wild. Now think about what your Chihuahua or Persian cat eats in your kitchen. It’s staggering to think how domestication has changed animal diets.

Scott Ravech, CEO of enzymes supplier Deerland Enzymes (Kennesaw, GA), says that as pet companies get savvier and consumers start shopping for higher-quality food, food options are expanding. Tomat also agrees that quality is improving beyond a pet food that might comprise mostly byproduct and filler, with very little real meat in between.

Still, thanks to commercial processing, many of the nutrients animals would get from food in its raw form can often be destroyed. Take the enzymes in a raw food, for instance. Pet foods are often extruded, and extrusion adds heat and moisture, which in turn can cause the enzymes in a food to denature. It’s the same way in the human food market as well-and it’s the same reason enzyme supplementation can help. “Pet cellular levels are pretty similar to humans’-more so dogs than cats,” says Brandon Prenger, central northeast business development manager for Deerland. “Their pancreas, which provides their enzymes, should produce sufficient amounts, but they can also suffer depletions the same as a human.” Reasons may include genetics, related health conditions, stress, or, as mentioned, food processing.

Also, keep in mind that as we’re adding specialty nutraceuticals or even just ingredients that we think will appeal to the pet palate, we’re introducing things that animals’ digestive tracts are not accustomed to. “Any time you make changes to a domesticated animal’s diet, you have the possibility of allergic reactions,” says Prenger. “They’re adding so many different things to these foods. Venison? Who would have thought 10 years ago that someone was going to add deer to a dog’s diet?” The addition of new animal proteins can be addressed through proteases in an overall enzyme blend. Enzyme needs may also differ by a species’ diet. Cats, for instance, require more protein.

Horn’s Alley-Zarkades says that plant proteins like Roquette’s (Lestrem, France) pea protein are increasingly being combined with animal protein. “By having other sources of proteins from plants, it’s more economical-as long as you have the right amino acid profile. They also make it possible to do a lot more with some of these feed formulas.”

Also, she believes that ingredients like soy or corn have been “unfairly demonized” in the pet space due to allergy misconceptions-something that Horn is working to educate people on. “Those are still good ingredients,” she says. “Humans eat them, and our pets probably get them in other things that we don’t realize.” Like in humans, pet allergies aren’t the same across the board. Certain pets are allergic to some ingredients, while others aren’t.

Prebiotics (such as a fructooligosaccharide) and probiotics are also gaining traction in pet digestion. Ganeden Biotech (Cleveland) supplies its direct-fed microbial GanPro BC to the livestock industry, where it is often used to maintain healthy bacteria balance due to the widespread use of antibiotics (bacteria killing) in livestock. For companion animals, the company’s Ganeden BC30 probiotic strain (also used in the human market) is seeing growth.

Ganeden most recently partnered with retail pet company Healthy GOO to include Ganeden BC30 in Doggy GOO peanut butter products marketed for dog allergies. Another innovative probiotic product was showcased at Natural Products Expo West this year. A company called The Bear & The Rat promoted its line of frozen probiotic yogurts for dogs, containing live and active cultures. Company cofounder Matt Meyer calls the product a “cool” treat that may fool Fido into thinking he’s getting “people” food.

And where there’s digestive health, there’s immune health-a pet category that Alley-Zarkades says has grown. Horn offers ingredients such as Biothera’s (Eagan, MN) APG 3-6 gluco polysaccharide yeast beta-glucan and specialty mushroom mycelium powders from M2 Ingredients (Oceanside, CA). (Other ingredients in Horn’s animal line include maltodextrins and food starches from Grain Processing Corp. in Muscatine, IA.)
 

Skin and Coat

Skin and coat health are also important. Tear-stain products are becoming more popular here, says Scott Garmon.

Also, sometimes what a cat laps up is its own fur. Enter the hairball. Tomat says that Pet Naturals’ Hairball product contains fatty acids omega-3 and -6, as well as biotin and zinc. “The idea is that the biotin and zinc help the cat to shed less so it’s consuming less hair, but then we also have the oils in there to help move the hairball through the system, along with psyllium fiber.”

Food or environmental allergens can cause skin conditions, says Tomat. An anti-inflammatory ingredient like an omega-3 can help manage skin flare-ups, she says. DSM says that dietary omega-3 supplementation has been used to treat feline skin disorders, including miliary dermatitis.

An ingredient that Horn offers, Garli-Eze from Nutra Products (Fairfield, CA), helps repel flies, mosquitoes, and gnats, whose bites can cause allergic skin reactions. Although some vets believe garlic may have some toxicity in dogs, Alley-Zarkades says scientific literature on this is still “not really clear” and that this buffered-form of garlic supplement has shown good results in canine safety tests.

Odor, Etc.

Not everything we give to pets is for their benefit alone; sometimes, it’s to protect the owner-or, more specifically, the owner’s carpet or lawn.

The newest products in this category are designed to help a dog stop “scooting.” Anyone who’s seen a dog drag his behind across a carpet knows the problem, which stems from a buildup in the anal glands. Anal glands are part of what’s used to mark an animal’s territory in the wild-not so great for a Persian rug.

Both NaturVet and Pet Naturals debuted new scoot products this year: No Scoot powder and Scoot Bars, respectively. Tomat says pets may need a little anal gland help these days, considering some of the foods they eat. Pet Naturals’ Scoot Bars contain three sources of fiber: a prebiotic larch tree extract, digestion-resistant maltodextrin, and pumpkin powder. “The fibers help firm up the poop,” Tomat explains. “The idea is that every time the dog poops, the anal glands are expressed and keep being flushed at a healthy amount.”

Speaking of, well, poop (as well as urine), a new technology that Horn’s Alley-Zarkades says has worked very well is Odor-No-More, a blend of micronutrient salts and SAP developed by BioLargo Inc. based on its CupriDyne technology. An iodine-based oxidative system, Odor-No-More, when sprinkled in a litter box or on horse bedding, can help control odor and moisture.

Animals also get urinary tract infections (UTIs). For bladder health, Tomat says marshmallow root powder is popular because it has antimicrobial properties that can dissolve and prevent crystals and decrease inflammation. The human world’s major UTI ingredient, cranberry, is also much in demand on the pet side, adds Nutraceuticals International Group’s Deblock.

And back again to the other end, controlling smelly breath is also desirable. Tomat says Pet Naturals likes an ingredient called Champex, an odor-neutralizing ingredient from mushroom extract (Agaricus bisporus) that addresses breath and body odor. Yucca is also a natural ingredient that helps with odor, and parsley and chlorophyll are good for freshening breath.

Probiotics are also emerging in the pet dental market. Last year, Oragenics Inc. (Tampa, FL) patented ProBiora3-a blend of three strains: Streptococcus oralis KJ3, Streptococcus uberis KJ2, and Streptococcus rattus JH145-that is already used in pet dental products to stop bad breath and improve overall dental health.
 

Still Emerging

While human trends may inspire the pet market, some major human categories haven’t yet quite crossed over to the retail pet world. Cardio is one, says Tomat. For a cardio product, many pet owners turn to their vets first.

Weight management is still lower profile, although the need is great, says Scott Garmon. “Something like 52% of dogs are considered overweight, yet people don’t recognize it.” Like in humans, overweight can result in conditions like metabolic syndrome, poor cardio health, and diabetes. In fact, Garmon says, there is a much higher incidence of diabetes in dogs these days.

The weight category could emerge, however. Some companies, says Kemin’s Yersin, are selling non-caloric filler products mainly for satiety-much like a rice cake for humans.

And there are some innovative weight-management products for pets. NaturVet offers Slim-N-Fit weight-control tablets for pets featuring Pharmachem Laboratories’ (Kearny, NJ) Phase 2 Carb Controller white kidney bean extract.

“It acts in much the same way [as it does in humans], by temporarily inhibiting the enzyme that digests starch,” says Mitch Skop, Pharmachem’s senior director of new product development. “One postulated reason for this weight gain in pets is the increased use of starch carbohydrate additives to commercial dog and feed products. Since the canine digestive tract is designed to digest and assimilate mostly protein, the addition of a significant percentage of starch carbohydrates into the diet will be stored as fat, often in the abdominal area.” Phase 2 was tested in a product called VetSlim in 17 overweight canines, showing weight-loss benefits in a majority of subjects. The study (S Rosenblatt et. al) was published in the Journal of the American Holistic Veterinary Medical Association.
 

Taste and Form

Finally, no matter what you put in a supplement, a pet simply won’t eat something that tastes bad, even if it’s supposed to be good for him. Thus, palatability in the pet nutraceutical market is arguably even more important than it is in the human market, says FoodScience’s Metz.

“We spend a lot of time trying to develop palatable products that may contain some pretty nasty-tasting ingredients,” he says.

Prinova USA (Carol Stream, IL) provides a full range of natural, artificial, and organic flavoring agents for the animal feed and pet food markets. Donnie Moran, sales and marketing manager, feed flavors and ingredients, says that while common flavors for our carnivorous friends are meat-based, other popular flavors may be less expected. “We know that cranberry is a popular flavor for cats,” he says. “Dogs like sweetener-based flavors that can be included in a range from minty to fruity.”

“In many instances,” he adds, “it is not what the animal likes, but what we like.” A flavor that sounds appealing to the owner will likely be purchased, he says, “as we humanize our pets.” As trends on the human side increasingly influence what’s included in pet products-such as vegetables, rice, and unique grains-it could affect taste and palatability for the pet, so formulas should be scrutinized.

Delivery system is also crucial for pets. FoodScience has had a lot of success with chews in particular. “We used to be very happy with tablets if we could get 60% palatability acceptance with cats. And with these chews, we’re now getting 80 to 90% for cats,” Metz says. Something that a dog or cat thinks is a treat is usually a winner, he says. Tasty liquids or something sprinkled over food also work.

Tablets-including controlled-release technologies-are still a delivery system of choice for Garmon’s firm, which also offers liquids, powders, and nutrition gels. When flavored the right way, pets will eat a tablet right out of your hand like a treat. “For dogs, my number one delivery system is still tablets. We do a fair amount of soft chews and some gels as well, but tablets are still number one,” he says. “In cats, it’s really becoming soft chews first, and gels second.”

Why tablets? “It’s simple to dose,” he says. “Owners don’t have to worry about whether they’ve scooped out the right amount. Also, with soft chews, sometimes you have problems during shipping-they might crumble or fall apart on you. Because of variations in temperature and humidity, soft chews are not necessarily a perfect choice.”

 

Sidebar 1: Pet Regulations: Gray Area

The biggest obstacle to pet supplements in the United States is the lack of a clear-cut regulatory space. While human supplements have their own legal category, no similar category exists for animal supplements. Bill Bookout is president and founder of the National Animal Supplement Council. He explains how this “gray area” happened.

As most know, in 1994, the Dietary Supplement Health and Education Act (DSHEA) created a separate regulatory category for human dietary supplements, as a subset of food. This legal category allows human-supplement marketers to sell non-drug products and make structure-function claims. However, DSHEA failed to include language that would also create a supplements category for animals. “In fact,” says Bookout, “congressional record shows that they never even considered animals. So they neither included nor excluded animals from the language of DSHEA.” As a result, pet supplements today can be classified in only one of two legal categories: food or drug. (This is the same situation human supplements faced pre-DSHEA.)

What does this mean for pet supplements? A product classified as food may only contain ingredients approved for use in animal food or feed. A drug product can make a health claim but would first have to obtain a New Animal Drug Application (NADA). Consider the implications. While an ingredient like glucosamine or chondroitin might have a long history of use in human supplements, those ingredients, if not approved for use in animal food, are prohibited from being marketed in an animal product, unless the company has obtained a drug application for it. (There are many obstacles to going the drug route for nutraceuticals, whether for humans or animals.) Depending on circumstances, firms may or may not be able to make structure-function claims implying a health effect, such as maintenance of joint health, claims that are meanwhile widespread in human supplements.

According to NASC, there are more than 400 ingredients currently being marketed in animal supplements that are unapproved for use in animal feed. Thus, as demand for pet supplements has increased, pet supplement marketers are operating in a murky space. Unapproved supplement ingredients-even something as commonly used as glucosamine or chondroitin-are now on the market at their own peril.

Firms are more than aware they face the threat that such products could be pulled from market. In fact, Bookout says, FDA’s Center for Veterinary Medicine (FDA-CVM), which oversees animal food and drugs under the Food, Drug, and Cosmetic Act, at one point talked about removing animal supplements from the market. “All they would do is create a black-market industry,” he says. “The consumer demand isn’t going to go away. Or people are just going to go buy human products and give them to animals.”

Understandably, this legal ambiguity has many marketers nervous-and may also inhibit innovation. “Because there is no DSHEA for pets, regulations for the animal market are even more stringent than for human supplementation-to the point where you can’t really say much of anything about what your product can do, even for something as benign as digestive health. A lot of marketers struggle with that,” says Scott Ravech, CEO of supplier Deerland Enzymes. (Bookout adds, “People think animal products are not regulated. That’s not true. Actually, they’re regulated more strictly than human products because they’re regulated at two levels: they’re regulated at the federal level by the FDA-CVM, and they’re also in many cases regulated at the state level through the Department of Agriculture or other state regulatory agency.”)

Ravech says future innovation will depend heavily on whether the regulatory environment changes. “I think the big question mark for me as far as enzyme use, pet supplements, and what growth is going to look like is going to weigh heavily on the clarity of the regulations. More-conservative companies will stay away from the category, and those willing to take some risks will push forward with structure-function claims, reasoning that if an ingredient is good enough for humans, how could it not be good for pets?”

NASC was founded in 2002 in the midst of this legal confusion as a nonprofit industry advocate for a category Bookout says had already started to grow significantly. Ultimately, the mission is to establish “a regulatory framework-working with FDA, state regulatory agencies, and also associations that recommend regulatory policy for these types of products-that is fair, reasonable, responsible, and nationally consistent,” he says. NASC also committed itself to helping the animal supplements industry-non-food-chain animals such as companion animals and horses-and its members self-regulate and commit to industry-wide GMPs. For instance, NASC members are audited and must operate by a quality-control manual, have an adverse-event reporting (AER) system in place, follow proper label guidelines, and have product labels that include, for particular ingredients, any specific warning or caution statements recommended by FDA-CVM and NASC’s own Scientific Advisory Committee. The NASC Quality Seal can be found on many of its members’ products on the market.

NASC also maintains an impressive AER database. (Read more in the main story above.) Says Bookout, “FDA-CVM said they were concerned about products being unsafe. We said, ‘Well, no one can afford to do safety studies, but we’ll monitor products through an adverse-event reporting system, and we’ll give you access to it. If something turns out to be problematic, we’ll help you remove it from the marketplace.’ I believe NAERS is the most thorough and comprehensive system of its kind, human or animal.”

He continues, “We thought that if we could gain the majority of the industry [NASC currently represents about 90% of the industry], and we could define a system that was fair, reasonable, and responsible, and the regulatory people would know about it and give us input-even if it was unofficial input-then we would drive the program rather than letting the government dictate it to us. So our first objective was to engage the government, state and federal, and cooperatively if we could, to define how the industry should be regulated. And if we could get more members in NASC, we would demonstrate that our industry is doing the right and responsible things. But we did all this with the intention of creating a responsible platform in the industry that we could use as a foundation to drive a long-term solution at the appropriate time.”

What is the long-term hope? Bookout says as NASC continues working with regulators as well as the Association of American Feed Control Officials (AAFCO), the hope is to establish a clearer regulatory pathway for pet and equine supplements. The bottom line is that “we need to formalize through something greater than just discretionary enforcement,” he says. “Whether that means finding a solution that works for both industry and FDA within existing laws, or if it means enacting new legislation for the category as DSHEA did for humans, remains to be seen.”

 

Sidebar 2: Pet Ingredients: Is It Safe?

Scares over melamine and other hazards in pet products are headline news. As with any other industry, the pet-supplements industry is plagued by its share of bad actors. However, the majority of companies are responsible, says NASC’s Bill Bookout. “I’d say that the majority of companies in this industry truly try to operate responsibly. But I would say that 5% of the people out there are questionable; they shouldn’t be in the industry.”

What should consumers look for in a safe, quality pet supplement? Just as in the human industry, Bookout says, here’s the red flag: “If a company makes claims that sound too good to be true, they probably are. Also, cheap products are cheap for a reason. If you compare two labels and one of the products costs half as much as the other, you should stop and ask why.”

Consumers should also be mindful of any adverse news regarding ingredients for humans. Because those are often the same ingredients in pet supplements, “any trends, positive or negative, that affect the human dietary supplement industry could possibly impact the animal industry,” says Bookout.

 

Sidebar 3: Pet Nutrition Research: In the Lab

What does the subject group in a clinical pet trial look like? Often, a test group will comprise one type of breed-say, Beagles-in order to maintain a uniform test group.

Ensuring that the results of a test population can translate to those who would use a supplement outside of a clinical setting is also important. “I can do a feeding trial for pet food on a group of Beagles that has been in this type of clinical lab setting forever, and their responses could vary compared to, say, the German Shepherd, Great Dane, or Golden Retriever that you or I might own,” says Andrew Yersin, PhD, president of the animal nutrition and health/vet division for ingredients firm Kemin Industries. “A set population that has been in numerous safe-feeding trials may have become some standardized so that then taking their response to the real world may not always create an apples-to-apples comparison. It’s sometimes difficult to get the data you need because you don’t always have the study groups that always translate to a real-world situation. That’s just hard in research, period, whether it’s for pets or humans.”

To eliminate biases, says Yersin, often animals are rotated in and out of studies, and new dogs that haven’t yet been clinically tested will be brought into trial. “You may also have to test in other diverse models [other species or breeds] to make sure that your data set is robust enough,” he says.