Herbal bladder-control capsules for dogs. All-natural anti-anxiety chews for cats. Joint-relief supplements for horses. Take a walk through any pet store, natural foods store or veterinarian's lobby and you'll discover that the complementary medicine revolution is slowly making its way to the animal world, in large part through the sale of dietary supplements for dogs, cats, horses and other animals. You'll also see that many of the companies long dedicated to creating dietary supplements for humans now make products for animals as well and are doing a pretty good job of penetrating the pet supplement market.

Animal supplements represent “a relatively cluttered category with very few strong leaders and the potential to grow as fast as or even faster than human nutrition did. That, to me, means opportunity,” said Tom O'Leary, a dietary supplement industry veteran and the brain behind Rainbow Light Nutritional Systems' new GreenDog Naturals line of canine supplements.

Twenty-five-year-old Rainbow Light is one of the latest human supplement companies to venture into the animal category, joining such industry leaders as Thorne Research, Standard Process, 21st Century HealthCare and FoodScience Corp. in a young, promising market that many say looks a lot like the natural foods market did 15 years ago. But, as more human companies consider moving into the pet world, veterinarians and pet product pioneers warn that the transition is more complex than some might assume. Facing an uncertain and convoluted regulatory environment, a veterinary field that is cautious at best when it comes to understanding and recommending animal supplements, and a patient population that is vastly different from humans, companies wishing to extend their brand to pets have their work cut out for them. “It's definitely a good time to get into the business,” said Dale Metz, CEO of FoodScience Corp. and a founding member of the National Animal Supplement Council (NASC). “But if you are a human supplement company and you think you can just take your existing product and put it in a capsule for an animal, that is not the case. It's complicated.”

A Promising Market

Despite a sluggish economy that has sent many industries grinding to a halt, all things pet continue to be on a roll — including supplement products. As many as one-third of dogs and cats are already taking some form of supplement, with the average dog owner spending $77 per year on vitamins, and the average cat owner spending $31, according to the American Pet Products Association's 2007/2008 National Pet Owners Survey. Nutrition Business Journal estimates show that sales of animal supplements increased 7.4% to $1.4 billion in 2008. Joint-care and other condition-specific supplement products designed for the aging pet population fared particularly well last year.

Such numbers have lured dozens of human supplement companies to the animal segment in recent years. “Capitalism, pure and simple, is driving human supplement companies to move into the animal supplement category,” said NASC President Bill Bookout. “It's an opportunity to expand and leverage their capabilities laterally across other industry segments to meet other market demands.”

Essex Junction, Vermont-based FoodScience Corp. — which started in 1971 with an immune-support product (Dimethylglycine or DMG) for people — now has three pet divisions: U.S. Animal Nutritionals caters to the equine and companion-animal markets with a wide range of supplement products sold online; Vetri-Science Laboratories sells joint-support supplements through veterinarian offices; and Pet Naturals, launched in 2002, sells everything from bladder-support products to anti-anxiety capsules at retailers. In all, Metz estimated that pet health products constitute roughly one-third of the company's 640 SKUs, and half of its sales.

In 2002, food-based supplement maker Standard Process unveiled its own condition-specific animal supplement portfolio, sold exclusively through veterinarians. The line now features 10 canine products, six feline products and two equine products. Pet-specific supplement sales constitute 2% of the company's overall revenue and are growing at an estimated 15% annual clip, outpacing combined sales of its two human lines, which saw an increase of 11.5 % in 2008. (Standard Process sells whole food supplements for humans and is also the exclusive U.S. distributor for MediHerb's herbal supplements).

The need for effective integrative alternatives is driving the company's pet supplement sales, said Tom Cameron, DVM, veterinary technical support for Standard Process. “We are running into a real logjam of animals that are chronically ill and are becoming less and less responsive to drugs, and there is a frustration among both practitioners and owners,” Cameron said.

In 2004, Nordic Naturals unveiled a line of omega-3 fish oil supplements for dogs and cats. The company now has four SKUs and reports “consistent double-digit growth” for its animal products, said National Sales Manager Monique Wellise. RZN Nutraceuticals — maker of the Arthri-Zen brand pain relief botanical capsules and creams for arthritis and the Migra-Zen brand products for migraines — entered the market in 2006 by launching a veterinary line for dogs and horses. Rainbow Light joined the fray in February of this year with the introduction of its food-based, organic GreenDog Naturals line, which features Whole Dog Daily, a multivitamin; Healthy Motion, for better mobility; and Omega Glo-Coat 3-6-9, for heart health and healthy coat. Other major players in the pet supplement market include Nutramax Laboratories, a pioneer in the use of glucosamine/chondroitin in both animals and humans, and DVM Pharmaceuticals, a subsidiary of Teva Pharmaceuticals of North America.

Yet experts say that, unlike with human supplements, there is still plenty of room for more players in the animal supplement market. “Fifteen years ago, if you wanted to buy [supplement] products for humans, you would have had to go to a boutique health store. Now you can walk into Costco and find them,” said Metz. “That is not the case with the pet side. The market is not nearly as developed.”

Market Advantage

Industry veterans add that once a company has earned loyalty and name recognition for its human supplements, it has a big head start when it comes to distribution and branding of a pet line. For instance, Rainbow Light, with a quarter-century of history behind it, has already been able to place its new GreenDog Naturals line within hundreds of independent natural food stores and Whole Foods Markets — virtually everywhere its human products are sold — just months after rolling out the brand. Fern Weiss, the grocery purchasing manager at Wedge Co-op in Minneapolis, told NBJ that her store plans to add the Rainbow Light line to its pet supplement selection this fall. “At that point we will probably discontinue a combination of the slower sellers in the Dancing Paws and Halo Purely for Pets supplement lines,” she said. In addition, when it comes to marketing a new animal supplement brand, the machine is already in place for human supplement companies. “We have an extensive plan that involves public relations, education and advertising in many of the same vehicles where we already advertise Rainbow Light's other products,” said O'Leary.

He and others stressed, however, that although the transition from human to pet products may seem a simple one in terms of marketing and branding, you can't fake true knowledge about pet health. This is why Rainbow Light, Nordic Naturals and Standard Process all brought seasoned veterinarians on board to help them safely formulate their products and help communicate their worth to pet owners and fellow veterinarians who might not yet be convinced that they are needed.

“Companies can ride on their brand loyalty to a large extent if they want to migrate from the human aisle to the pet aisle, but a lot of research needs to be conducted before they launch,” said Wellise, of Nordic Naturals. “They should consult with a veterinarian, ensure that pet health is the key consideration, and stay committed to high standards for the sake of the industry as a whole.”

Animal Expertise Crucial

NASC's Bookout — who is the founder of Genesis Ltd., a Valley Center, California-based maker of dog and cat supplements — said the involvement of veterinarians and other animal experts in an animal supplement company is so important that he advises consumers to make this a factor when deciding which products to buy. “It is important for consumers to deal with companies that have expertise in dealing with animals because animals are not just little people,” Bookout said. “So I always suggest that when a consumer evaluates a company that there is no substitute for calling the company directly and asking questions. Who formulates their products? Do they have veterinarians on staff? Do they have people who are knowledgeable about animals?”

As Mike Uckele, founder and CEO of the animal supplement company Uckele Health & Nutrition, noted, having animal expertise when formulating species-specific supplement products can be a matter of life or death for an animal. “The different nutritional requirements among species that are safe for people may not be safe in other animals,” he said. In addition, companies transitioning from human to animal supplements “may not have experience or expertise with extrapolation dosages,” Uckele cautioned. “They also may struggle with palatability, a fundamental issue with animals.”

Another challenge is educating consumers that animals are not just smaller versions of humans. “Many people still assume that it is OK to give their pets human products, but dogs and cats are of a different species and the wrong ingredient or the wrong dose can be very dangerous,” Wellise explained. In formulating its pet line, Nordic Naturals removed the rosemary oil antioxidant found in its human products, because rosemary oil can be harmful to small animals. It also reformulated its products to take into account species, life stage and weight, and designed new AAFCO-compliant labels to instruct pet owners on dosage.

Despite such efforts, Todd Henderson, DVM, founder and CEO of Nutramax Labs, which makes the Cosequin line of animal joint supplements and has developed a strong relationship with the veterinary community because of the depth and quality of its animal-specific products and research, said he is still sometimes shocked by the pet supplement products that make their way to the market. “I have seen supplements out there that contain an ingredient that is safe for people such as garlic and then is marketed for use in cats,” he said. “Garlic can cause anemia in cats, but these formulators don't know that. That's a serious problem.”

Nature's Way Holding Co. (NWHC), which owns the Nature's Way and Enzymatic Therapy brands, said that, although it has evaluated the pet supplement market, it hasn't raced in due to the many complexities of this business. “This is a potentially large market for the future, but one that also has many considerations before a company enters the market,” said Matt Schueller, senior vice president of marketing for NWHC. “Each type of animal has different nutritional needs, safety considerations and dosage considerations. The market is probably not best developed by transferring directly over supplement products that have been developed for humans, and then giving them in their current forms, blends and dosages to animals.”

Regulatory Challenges

Perhaps the biggest hurdle facing human supplement companies working to penetrate the pet supplement market is the current rocky regulatory road animal supplement companies must navigate.

Scott McCunn, vice president of regulatory affairs at 21st Century HealthCare, said a lack of regulatory understanding can pose problems for human supplement companies attempting to break into the animal supplement market. “The problem is, many of these human vitamin companies do not understand the significant regulations that AAFCO [the American Association of Feed Control Officials] and the FDA [U.S. Food and Drug Administration] enforce to ensure consumers are informed regarding label claims,” he said. “The landscape of pet supplementation is better regulated and more tightly enforced in most instances than human vitamins and most human supplement companies that do not manufacture their own products are not prepared for such regulatory oversight.”

Nordic Naturals' Wellise agreed that the current regulatory environment for animal supplements can create roadblocks for companies. “One of the biggest challenges is the amount of time it takes to get all the regulatory issues in place,” she said. “It is a very heavy administrative burden.”

The Future

O'Leary, the self-proclaimed “K9 health advocate” for Rainbow Light's GreenDog Naturals product line, has no doubt that the market for pet dietary supplements is about to break open — and he sees human supplement companies, armed with years of experience in marketing and regulatory issues, playing a big role.

“In many ways there is a very strong analogy between a core natural foods consumer and a pet owner trying to put together a supplement program for their dog,” O'Leary said. “In both instances, you have a consumer with a very high willingness to spend who feels completely unqualified to shop the category. The key is to educate that consumer, and we are using a lot of the same tactics that we use to educate the natural food consumer.”

As the GreenDog Naturals product line rolls out its seven SKUs at hundreds of natural food retailers, pet specialty stores and 450 Petco stores across the country, Rainbow Light is embarking on a broad computer-based education campaign for store employees, and working on a five-minute video piece for its company Website. O'Leary is also trying to convince natural food stores to place such products not in the pet food aisle, but rather in the vitamin aisle, alongside human products. “The idea that you can sell a premium supplement which requires a special education sale next to a bag of dog food is completely unsupported,” said O'Leary. “It would be like selling a vitamin C supplement and putting it in the aisle next to the oranges.”

Ultimately, experts predict that the regulatory issues surrounding animal supplements will be sorted out and the body of research behind these products will grow (several clinical trials on animals are currently underway), and this will ease the minds of consumers and veterinarians and open the flood gates for more human supplement companies to make the leap into animal supplements. Said O'Leary: “[Rainbow Light] certainly won't be the last.”

The NBJ Bottom Line

In general, now appears to be an excellent time for human supplement companies to move into the pet supplement market, which is not nearly as saturated or competitive as the human market. Also, pet products seem to be somewhat recession-proof and still have room for growth in the natural retail market, which many human supplement companies have successfully penetrated. In speaking with most of the major supplement companies that have extended their brands into the pet market, we didn't find one company that wished it hadn't made the leap or that failed in its efforts to penetrate the animal market.

That said, the uncertain regulatory environment does bring with it heavy administrative burdens, which can and are being eased through membership in the National Animal Supplement Council (NASC)In addition, companies must take seriously the important differences that exist between humans and animals and bring in the veterinary and other resources necessary to formulate and market products that will be safe and maximally beneficial to dogs, cats, horses and other animals.

Narda Robinson, DO, DVM, director of the Colorado State University Center for Comparative and Integrative Medicine, has watched the pet supplement industry mature significantly over the past decade — and this, she told Nutrition Business Journal, is a very good thing for both the industry and the animals who ingest these products. “Instead of just using products that were designed for humans and having people make unfounded extrapolations relating them to animals, we now have companies with well thought out and dedicated product lines,” she said, pointing to Nutramax Laboratories (which makes lines for dogs, cats and horses) and RZN Nutraceuticals as companies that have prioritized animal-specific research as they've developed their lines.

Such noble efforts aside, Robinson said she and other veterinarians still have their worries about animal supplements. One issue for veterinarians is that many dietary supplement ingredients commonly used in humans can be dangerous for animals with smaller livers and a different metabolism, Robinson said. For instance, comfrey, often recommended as a holistic treatment for animals with cancer, can be toxic to the liver. Garlic for immune boosting can, in excess, cause anemia in dogs and cats. St. John's Wort, sometimes present in “calming” pet products, can interact with cancer treatments.

Robinson also has fears about animal supplement products not containing what they say they do — a concern that was amplified by a June 2009 analysis of animal joint supplement products by Consumerlab.com. According to the independent, for-profit testing company, only two of six glucosamine/chondroitin products analyzed contained what their labels said they did, with the remaining four containing only 5% to 17% of the chondroitin and/or glucosamine claimed on the label. In other tests, pet dietary supplements have been found to contain pharmaceuticals or even toxins, Robinson said. And in other situations, after Robinson or other veterinarians have inquired about pet supplements when animals have become ill after taking them, some manufacturers have declined to say what exactly is in their products, she said. “Things like this give vets pause when it comes to embracing dietary supplements, and there is no independent agency overseeing things,” Robinson added, noting that she is not content with “self-regulation” alone and would prefer to see more strict federal regulations for the industry. The dearth of science proving the functionality of specific nutrients for pets also makes it hard to convince pet practitioners of their value, said Jeremy Moore, director of marketing for Novus Nutrition Brands, a provider of specialty additives for companion pet and equine foods. “For these products to have any sort of merit with veterinarians they need more science,” he said.

Many vets are still resistant when it comes to animal supplementation, but things are moving in the right direction, said L. Phillips Brown, DVM, vice president of research and development for Nutri-Vet Animal Health Care Products. “Vet endorsement is getting better because they are talking about nutrition in vet school. It's not so weird anymore.” Carvel G. Tiekert, DVM, executive director of the American Holistic Veterinary Medical Association (AHVMA), said that, with 90% of vets using some aspect of supplementation in their practices, he “has never felt or seen a particular reluctance on the part of vets to use or recommend supplements for animals.” In fact, at the AHVMA's upcoming annual meeting, which will be held in September in Massachusetts, at least half of the 70 vendors scheduled to exhibit are dietary supplement companies, Tiekert said. Given that the majority of animal supplements are sold via the practitioner channel, what vets think of animal supplements is crucial to future sales. “People trust their vets without hesitation,” Moore added.

 

Fido has it pretty good these days. If he's lucky, his Baby Boomer master gives him gourmet, preservative-free, organic dog food with a little natural glucosamine to keep his joints working; some probiotics for healthy digestion; omega-3s for his brain and coat; and maybe even a lutein supplement to keep his eyes healthy. As humans adopt healthier eating habits and use supplements to prevent disease and stay healthy longer, many want to offer the same health benefits to their pets. Pet owners are also becoming increasingly savvy about bioactive ingredients — especially those for specific conditions, such as joint health, obesity, digestion, inflammation and vision dysfunction — and their benefits for pets, causing a spike in demand for new animal products with these nutrients.

But this growing interest in animal supplements and functional pet food is putting pressure on an already inadequate regulatory structure for pet nutrition products, as well as prompting growing scrutiny on the ingredients used in these products and their sources. So, although moving into the pet supplement business may seem like a no brainer for raw material & ingredient supply companies — especially for those firms that already sell nutritional products and bioactives for human products — suppliers should proceed with caution.

The opportunity is there, but companies soon learn it is not easy to break into the pet segment, said Jeff Alix, business development manager-pet industry for DSM Nutritionals, one of the primary suppliers of vitamins and vitamin premixes for pet food and ingredients for pet supplements in North America.

The key to succeeding, Alix added, is to focus on quality and science. L. Phillips Brown, DVM, vice president of research and development for Nutri-Vet Animal Health Care Products and a consultant to Newman's Own Organics, said he sees a need for new suppliers that can provide high-quality ingredients and good traceability. “I like to know where my products come from,” he said. “The companies that will thrive will offer products with valid ingredients and GMP [good manufacturing practice] capabilities.”

A Fragmented Supply Chain

The vast majority of pet foods, approximately 50%, is produced by human food companies, such as Mars, Nestlé, Colgate, Procter & Gamble (P&G) and Del Monte Foods. Vitamins are among the top-selling nutritional ingredients currently being added to foods for horses and companion animals because consumers have the greatest understanding of their value. The dominant suppliers of vitamins and premixes for pet foods in North America include DSM, ADM and Nutreco. The latter focuses only on pet food ingredients, but more typical are suppliers such as ADM and DSM, which supply ingredients for both human and pet products. Companies that play a significant role in the space include Kemin Industries, Novus International, TSI Health Sciences and DSM.

“Ninety-eight percent of the ingredients that are utilized in animal supplement products are identical to the ingredients that are used in human products,” said Bill Bookout, founder of the animal supplement company Genesis Ltd. and president of the National Animal Supplement Council (NASC). “The only general exception to that would be flavorings, which are put in to address palatability.”

Like it is for the human supplement and functional food market, the supply market for animal nutrition products is fairly fragmented because there are so many different types of ingredients, ranging from by-products used in foods to specialty ingredients such as natural antioxidants added to both foods and supplements. That said, the pet industry is fertile soil for suppliers delivering new and innovative functional ingredients, particularly naturally sourced ingredients for use in foods, Alix noted. Specialty ingredients offer the greatest opportunities in the pet industry because of the commoditization of the general vitamin supply market, Alix said. “With the major share of vitamins being produced in China, there is little profit remaining to entice companies to enter into basic vitamin manufacturing.”

Regulatory Quagmire

If an ingredient company wants to supply the pet industry, it must understand the current regulatory structure for animal nutrition products. Ingredients that are used in nutritional pet products fall into two main regulatory categories: ingredients used in pet foods (including edible chews and treats), which are regulated by the Center for Veterinary Medicine branch of the U.S. Food and Drug Administration (FDA CVM) with regulations recommended by the Association of American Feed Control Officials (AAFCO); and bioactive ingredients, such as glucosamine, chondroitin and MSM, which are commonly used in human dietary supplements and sold as pet supplements in a non-nutritive tablet or capsule form.

Because the Dietary Supplement Health and Education Act (DSHEA), which created a separate regulatory structure for human dietary supplements in 1994, did not specifically address the animal category, pet supplements currently fall between a regulatory rock and a commercial hard place. As we discuss in more depth starting on page 19, NASC was founded in 2002 to help protect the $1.4 billion dollar animal supplement industry from this erratic and complicated regulatory environment. “NASC was formed with the specific objective of establishing fair, reasonable, consistent, responsible regulatory framework that in the near term would allow responsible companies to continue to market products while we establish a foundation for a long-term solution,” Bookout said.

By working cooperatively with FDA CVM, AAFCO and state regulatory agencies, NASC has been able to gain the trust of these regulatory bodies, which essentially allow animal supplement products from responsible companies to exist in a state of enforcement discretion — just as many drugs commonly used by veterinarians do, Bookout explained.

According to NASC surveys, its 100 members market more than 400 ingredients that currently are unapproved for use in animal feed products but are able to exist under the government's policy of enforcement discretion. The most popular of these ingredients include glucosamine and chondroitin, which have a good degree of supporting scientific data. “NASC has built up their trust with the CVM to allow them to police pet supplements,” Alix noted. “You only needed to go to the last Pet Food Forum and Expo to see that the organization is making progress.” The program featured more pet supplements on display and NASC and suppliers including Kemin Industries offered educational sessions, he added.

Part of NASC's ongoing effort is to provide an industry-driven framework for bioactive ingredients by developing standardization and quality-control measures, label guidelines, warning and caution statements, and a system for adverse event reporting. NASC members, which represent about 90% of the animal supplement industry based on sales volume, must adhere to these quality requirements and submit to an independent audit to ensure conformance.

Food Ingredients

On the food side, it is difficult to work outside the constraints of the AAFCO-approved ingredients, which include various protein sources, and fat- and water-soluble vitamins and minerals, such as arginine, lycine, linoleic acid, potassium, and vitamins A, D, and E. “For the most part, the major players in pet food, Nestlé and P&G, stick only with AAFCO-approved ingredients,” explained Jeremy Moore, director of marketing for Novus Nutrition Brands, a division of Novus International and a provider of specialty additives for companion-pet and equine foods. These companies might also use a chicken meal or by-product with naturally occurring chondroitin to add nutritional value to their food. “Nestlé's Purina has a patent for the additives used in its pet foods,” Moore added.

“AAFCO has all the definitions in place for what is not allowed,” explained Ben Bowen, director of new business development for Nutrisurance, the pet nutrition division of Kemin Industries. When AAFCO developed these guidelines, the agency decided that the rules would be the same for equine and companion animals as they are for livestock. This, Bowen said, has made it “very restrictive” in terms of what is allowed to be put into pet food. “When you are dealing with functional products to improve pet health, you immediately run into the issue of what is not approved,” Bowen added.

Large pet food manufacturers can get around the system by using natural sources of an ingredient, DSM's Alix explained. For example, glucosamine is not AAFCO-approved, but hydrolyzed chicken cartilage, beef gullet and algae can provide a natural source of the substance, and these additives are on the AAFCO-approved list. Products that contain these natural sources of glucosamine also can carry joint-health claims for the nutrient. “There is a lot of pressure on the FDA CVM to allow this because the data on glucosamine is so strong, and there is no safety issue,” noted Alix. “The CVM made a loop hole, so companies can do it that way.”

If they can demonstrate that a particular ingredient is safe, manufacturers and suppliers can also apply for a letter of non-objection from the FDA CVM for an unapproved ingredient, Alix said. He added that the industry will see GRAS (generally recognized as safe) status granted for certain nutraceutical products in pet food in the near future. Although no formal GRAS notifications have been issued, Alix said DSM is cautiously optimistic that this will occur soon. “For us it will depend on how GRAS status is defined for pet food, but we will potentially look at this for a number of our carotenoid ingredients, such as lutein, lycopene, green tea extract and resveratrol,” he said. “There is still a great opportunity out there and many companies that want a clear-cut regulatory path for their products. So far nothing with functionality has been allowed to go through outside the drug process, which is just too costly for the pet segment.”

Industry's Wake Up Call

Not long after its inception, the NASC set up its adverse event reporting (AER)system to help the industry manage safety risks and boost industry credibility in the eyes of regulators and consumers. Having event data and procedures in place were a big help to members after the pet food recall in 2007, when wheat gluten and rice protein used in an estimated 5,000 pet food products was adulterated with the plastic chemical melamine, and reportedly killed more than 4,000 cats and dogs. As consumer and manufacturer concerns escalated and underscored the lack of ingredient traceability, NASC was able to identify all member products containing wheat gluten and trace where it was coming from, according to Novus' Moore. “Since that time, companies have had to be much more cautious about the source of their ingredients,” he said. Although the pet nutrition industry had been moving in the right direction by developing new and better technologies to investigate ingredients, Nutri-Vet's Brown said the “the melamine scare was a slap on the head for companies to move faster.”

The incident was a giant wake up call for the pet nutrition industry on both the food and supplement side. However, the scare also created an important opportunity for suppliers that have focused on ingredients for humans and offer high-quality ingredients produced under good manufacturing practices (GMPs).

“Because we were the only supplier with carotenoids and vitamins not coming from China, the melamine scare put us in a good light,” recalled DSM's Alix. But, he added, this incident did prompt every quality program in the industry to be revamped because everyone's reputation was at stake. “A lot of industry resources were shifted to quality control and away from innovation. But that is slowly coming back now that the quality methods are in place.”

Quality Concerns Continue

Things can't move fast enough for Larry Kolb, president of U.S. operations for TSI Health Sciences, a supplier of chondroitin for use in both human and pet products. According to Kolb, glucosamine and chondroitin together are responsible for more than 50% of the pet ingredient market, and it is frightening how much adulterated ingredient is out there. “Companies have come to me with horror stories about the quality of ingredients they are getting,” Kolb said. None of the experts interviewed for this story said they have seen animal supplement companies skimp on ingredient quality because their products are being made for animals rather than humans, but many did acknowledge that animal supplements suffer the same ingredient quality issues that plague the human dietary supplement market. “Many pet supplements are manufactured at the same facilities as human supplements because a lot of companies do both — so the quality is on par with human supplements,” explained Paul Burns, an account manager Eurofins Scientific Inc., which does third-party analytical testing of dietary supplements. “Pet supplements also have the same issues on the supply-chain side as human supplements, and we are seeing pet supplements made with adulterated raw materials, particularly chondroitin sulfate.”

Though not alone, chondroitin is the poster child for problem ingredients in both the human and animal supplement categories. “[Chondroitin] is hard to test, and there is no historical consensus on methodologies to test assay, but there also is a lot of misrepresentation and adulteration out there, where people are profiting handsomely from a difficult regulatory market,” Kolb said.

According to a recent Consumerlab analysis, four of six joint supplements for animals analyzed by the independent tesing firm lacked the amounts of glucosamine or chondroitin indicated on their labels. Consumerlab also recently released the results from its most recent test of human joint supplements, which found that five out of the 21 brands tested did not contain the promised amount of chondroitin or failed other quality measures.

Stepping Up Supply Quality

Rather than sitting back and allowing supply quality problems to damage the reputation of the animal supplement industry, the NASC is addressing supply-chain issues head on by creating a program that will help separate quality suppliers from those more focused on making money by selling adulterated or mislabeled ingredients. “We are focusing to a much greater extent on validating and qualifying raw material suppliers,” Bookout said. “How we are doing that is by requiring suppliers to have independent testing on samples that they do not control.” This testing will be followed up by a supplier facility audit by NASC or a reliable third party. Those suppliers who pass will be added to NASC's list of quality suppliers that it recommends its members do business with, Bookout said.

TSI was the first supply company to be added to NASC's list of approved chondroitin vendors. “We asked Larry Kolb to come to our annual board meeting because of his quality programs,” Bookout explained. “We said to Larry, ‘Here is what we know: Quality starts at the beginning with raw materials. Help us with this. You say you are a quality supplier but prove it to us and tell us why you are a quality supplier.’ Larry and his company were pretty heavily scrutinized, and now TSI is an NASC-approved supplier.”

To truly improve the supply landscape for animal nutrition products, such quality-control efforts need to be coupled with work to help prove ingredient efficacy. “A true verification of functionality has not been a top focus for a lot of suppliers out there,” said Nutrisurance's Bowen. For Nutrisurance, which focuses on antioxidants for pet food and supplements and generates about one quarter of Kemin's overall business, safety is paramount, Bowen said. But, he added, “We also put in a lot of time and effort to make sure our ingredients deliver a functional health advantage for a pet.”

Ultimately, Bowen said, companies need to be interested in the health of the animal. “That is how we will maintain and grow the industry.”

 

When the Dietary Supplement Health and Education Act (DSHEA) was signed into law in 1994, the legislation amended the Federal Food, Drug and Cosmetic Act to create a specific regulatory category for dietary supplements. Although the law has opened up a world of opportunities for human supplement companies, it left out discussion of what is currently a fast-growing supplement category: animal products. This omission plunged animal supplements into a complex state of regulatory limbo that continues to this day — but has been greatly eased by the existence of the National Animal Supplement Council (NASC), which represents more than 100 animal supplement companies, or about 90% of the industry today based on sales volume.

Nutrition Business Journal recently sat down with NASC Founder and President Bill Bookout — who is also the founder and president of the animal supplement company Genesis Ltd. — to discuss the current regulatory landscape for pet supplements and what human supplement companies could learn from the NASC's cooperative approach to industry self-regulation. Below is an edited transcript of our conversation.

NBJ: What are the most important things companies must know about the current regulatory status of animal supplements?

Bill Bookout: The most important thing that companies need to know — and the thing that is most often missed — is that the regulatory requirements for human dietary supplements do not necessarily apply to animal supplements. That is because the Dietary Supplement Health and Education Act (DSHEA) has been determined to not apply to animals.

Another misconception is that the animal industry is an unregulated industry. That is simply not true. The regulatory authority that is responsible for regulating animal products is the FDA Center for Veterinary Medicine (FDA CVM). However, CVM also works very closely with — and people in industry have to deal with — state regulatory agencies, and that is most typically in the Department of Agriculture, although it could be the regulatory agency at the state level that is connected with a university. When you get into the state regulations, companies also must be familiar with the Association of American Feed Control Officials (AAFCO), which is not a regulatory body but does recommend regulatory policy to the states. Despite these efforts, state regulatory enforcement varies. Some states are highly vigilant and others are not.

NBJ: What is the NASC doing to help ease regulatory confusion for its animal supplement company members?

BB: The NASC was formed in 2002 with the specific objective of establishing a fair, reasonable, consistent, responsible regulatory framework for animal supplements that, in the near term, would allow responsible companies to continue to market products while we establish a foundation for a long-term solution.

We have always believed that cooperation is better than confrontation. That is why, rather than try to amend DSHEA to include animals or mount a legal challenge against the FDA CVM, we approached the regulatory agencies at both the state and federal levels with a proposition. We said, ‘The things that you want are really very similar to the things that responsible industry participants want: We want products that are beneficial to animals and that make claims and statements that are truthful and not misleading to the consumer. We want to have a reasonable expectation that our industry's products are not going to cause harm and that companies will engage in responsible conduct through consistent process control, GMPs and a monitoring system for adverse events. We feel NASC can represent a majority of the industry and define and establish a system of responsible conduct as a precursor to a long-term solution.’ Basically, we said to the regulatory agencies, ‘If you work with us, we would be willing to work with you, and we think the outcome would be much better, because, if you simply have a regulatory directive to remove all products from the marketplace that contain ingredients that have not been approved for use in animal feed, you are going to create a black market industry, and that is going to ultimately result in harm rather than benefit to animals because the consumer does have the opportunity to buy human products and give them to their pets.’

We thought there were a number of good and compelling reasons that the regulatory agency should be willing to work with us, and we were very pleased — and I think the regulatory agencies were also very pleased — that the industry could come together and put forth a cooperative effort to address this issue in a responsible way in meeting these objectives, which are ultimately in the best interests of all stakeholders.

NBJ: What would this long-term solution look like in an ideal world?

BB: Right now, the FDA allows products from responsible companies to be marketed under enforcement discretion because of existing precedence. Why do I say existing precedence? Because people don't realize that the majority of drugs that veterinarians use or have in their pharmacies are not specifically approved for animals. So there are a number of products out there that are used for animals but are not specifically approved for animals, and FDA allows those products to be marketed under enforcement discretion.

Certainly existing in the current environment of regulatory discretion is not ideal. The industry knows that, and FDA knows that. We have had legal counsel explore any other existing opportunity under Food, Drug and Cosmetic Act law to have a permanent solution to this issue under existing law, but it doesn't appear that this is viable. So I think it will ultimately take a legislatively driven solution to address this issue in the long term. We think that if we work cooperatively with the regulatory agencies at the state and federal levels to establish, develop and implement a system that works and that we will refine over time, we can provide a strong platform for potentially introducing a legislative solution down the road.

NBJ: How long will this take?

BB: When we get to the point where we think that all of the systems are working well, we will be ready to potentially introduce a legislative solution. Right now, the adverse event reporting is working well and everyone is completely comfortable with that. We have labeling and claims guidance that is defined very well now. The last piece is the implementation by the majority of the industry of our GMPs, which, incidentally, are very similar to human dietary supplement GMPs. How long will this take? Maybe two or three years, but that is a guess.

NBJ: It is interesting that your organization came up with GMPs and an AER system even before we had them for human supplements.

BB: We looked at the creation of NASC as an opportunity to engage in a system of continuous improvement, and our No. 1 objective was to establish a system for responsible risk management. What are the two things that FDA wants to see from products? The agency wants to see safety and efficacy. But the reality is that it is impossible for the human dietary supplement industry or the animal industry to establish safety and efficacy to the degree that is required for submission and approval of new animal drug applications. Because of existing patent laws and legal precedence, there simply isn't a way for companies to recoup their investment. That said, we didn't approach these issues from the perspective of, ‘Well, we can't do this, so we are not going to do anything.’ We have approached all issues — every single one, in every single case — with, ‘Well, if we can't do that, what can we do?’ Our answer was, ‘We can effectively manage risk through an adverse event reporting system.’ We implemented this system in 2004 and have since made a number of improvements since.

NBJ: How effective has this system been at managing risk?

BB: With our adverse event reporting system, we cast a broad net because FDA suggested that we do. So we have a consistent system that requires our members to capture both serious and non-serious adverse events, including transient events such as vomiting and diarrhea that may or may not be connected to the use of a product. Companies can then use this information to help decide whether they should take corrective action.

Data is power, and we have data. In this system, we track more than 4,000 products, and more than 2,000 ingredients, with literally more than 100 billion bytes of data, in terms of individual administrations of products across our industry for various species of animals. So when FDA says, ‘We don't know if glucosamine is safe,’ we can punch into our adverse event reporting database and pull up the number of products on the market containing glucosamine. We can statistically analyze the milligrams per kilogram of body weight of the animal for glucosamine administered in mean, min and max by dogs, cats and horses. We can compare that to adverse events both serious and non-serious in nature, and we have data that can help substantiate, not safety per se, but minimal or manageable risk of use of both ingredients and products. We can track through a relational database both ingredients across the broad industry, or we can track adverse events to individual products and individual companies.

NBJ: How often does FDA come to you for that type of data?

BB: FDA has open access to our adverse event database. Agency employees can log in and look at adverse events across an ingredient, across the entire industry, and throughout our membership, or they can look at specific adverse events by an individual company. How often does FDA do that? The fact is, the agency can log in any time it wants.

NBJ: What is one lesson the human dietary supplement industry could learn from NASC?

BB: Quite honestly, when NASC was formed, we tried to learn from the history of the human dietary supplement industry. When DSHEA was passed and the statutory category was established for dietary supplements, I think the human industry should have looked at that bill as a foundation to engage in a process of continuous improvement. Rather, I think the human industry looked at DSHEA as a utopia and as good as it could get. We, on the other hand, looked at the issue and said, ‘No matter how rigorously defined any regulatory system is, it can always be improved.’

I am extremely proud of our members and of how they have responded collectively as an organization to responsibly address this issue. I also certainly acknowledge that, without the cooperation of FDA CVM and of organizations like AFFCO and leading states that contribute to this process, we would not be where we are today.

NBJ: For FDA CVM, where is the agency's main area of concern and focus in terms of enforcement?

BB: FDA CVM is mainly concerned about companies that act irresponsibly in terms of the claims that they make or where safety issues exist. That is evident by the warning letters and other actions that have been taken recently. I think it is important for companies to realize that FDA has new funding, mandate, personnel and objectives. This is a new FDA that has stepped up its actions. Incidentally, we have encouraged FDA to step up and take action on claims that are outside of the allowable guidelines involving diagnosing, preventing, treating, curing or mitigating disease.

NBJ: NASC represents about 90% of total animal supplement sales. Do you anticipate you will get the companies representing the last 10% into your membership?

BB: Broadly categorized, there are three participants in this industry — and I think the people in the human dietary supplement business would agree with this analysis: The first and largest group is made up of responsible participants in the animal segment that are NASC members. We are trying to do the right things right. We are trying to establish solutions that will ultimately apply to everyone. We are trying to contribute to a cause that is greater than any one company individually. The second group is made up of responsible companies that are not NASC members. There are some but not many companies in this group. The final category is made up of companies that I would label as opportunistic participants. They are not careful about the claims that they make. They are unscrupulous or questionable providers that give us all a bad name. These are the companies that the regulatory agencies and responsible industry members are most concerned about.

Do I think that we will ever get 100% of the industry? We don't want 100% of the industry! To join NASC, there is an interview process companies have to go through. You either must have a conversation with me or you have to be recommended by the NASC's board of directors. Why is that? Because we have established credibility with the regulatory agencies and that could be damaged. We don't want people in that third category who might simply look to NASC as a safe umbrella to huddle under while they continue to act however they want. There are specific requirements and mandates that we have put forth in our member accountability contract that spells out exactly what the requirements are to be an NASC member, and they are not optional.

NBJ: NASC is now asking its members to register with FDA. Why?

BB: Because there is no category for dietary supplements for animals, many products are considered unapproved animal drugs. Companies must drug list their facilities and register their products to exist under enforcement discretion because this helps demonstrate that they are operating in control and acting responsibly. But our members were extremely apprehensive when we initially made them aware of this requirement three years ago, and most companies flatly refused to register due to misperception rather than direct action on the part of FDA CVM.

The truth is, registering products and facilities does have ramifications. For one, it will trigger an FDA inspection. However, if a company is operating responsibly, isn't it better to have FDA view what you can do rather than guess at how the industry should be regulated if and when the agency is tasked with writing regulations? Isn't it better to have FDA know you are out there so if something unforeseen happens, like the melamine issue in pet food, the agency can notify the company and the company can take action? What if the company wants to export a product and needs a certificate of free sale? Isn't it easier to request this from FDA CVM if the agency has seen your operation? Isn't it better to act responsibly and easier to differentiate your company from irresponsible industry participants if you have registered with FDA CVM and the agency knows who you are and what you do?

The bottom line is, people shouldn't over react. If they stop and consider what the benefits of registration are, I think they will have a pretty clear answer. If someone is reading this and saying, ‘That's easy for you to say, pal, you don't have to register,’ my reply would be, ‘I have registered [Genesis Ltd.'s] products and our facility. We have had multiple FDA inspections, and we are still in business.’ In fact, I am fully confident that if companies took a more cooperative approach with FDA, they would be very surprised at the response from the agency — and I speak from direct experience.

NBJ: How many companies have now registered with FDA?

BB: Several. We have set a goal for all NASC members to complete the process by June 30, 2010, and we are helping companies with the effort.

NBJ: Why do you think NASC has been successful?

BB: It is because of the backgrounds of our board of directors and the commitment of our members. We not only have regulatory expertise within NASC, but we are also business people. I think we have, and will continue to focus on, objectives that are in the best interests of all stakeholders. While it is a privilege to serve as president of NASC, the credit belongs to our members, the regulators and downstream business partners who have all contributed to our collective efforts and will continue to be instrumental in our success going forward.

Antioxidants, omega-3 fatty acids, omega-7 fatty acids -- sea buckthorn has it all. And the uber-berry from the east is popping up all over the beauty care category. Traditionally, sea buckthorn, which derives from a shrub native to Europe and Asia, has been used in anti-aging applications, as well as to heal burns. Some science suggests that sea buckthorn may, indeed, offer skin-healing and anti-inflammatory properties. I admit that when I first started using sea buckthorn-based skin care, it was because it smelled so good. Here are some of my favorite natural sea buckthorn-based products...

Weleda Sea Buckthorn Body Lotion

I use this incredible body moisturizer daily. It's thin, fragrant and filled with fatty acids that nourish dry skin.

Aubrey Organics Skin Care Bar with Sandlewood

Smooth, soft and effective. A good option for customers with sensitive skin.

Sibu

This sea-buckthorn skin care company offers a whole line of supplements, body care and beverages. The Rosacea Skin Support System offers up the berry's anti-inflammatory action to soothe red and irritated skin.

Begun in Italy as a countermovement to “fast food,” the Slow Food movement (slowfood.com) believes in rekindling interest in fresh foods, farmers, community, and food culture—and raises awareness about how what we eat affects us and our world. Become a slow foodie by developing personal food-based traditions, savoring the meals you prepare, eating locally grown and produced foods, and participating in your local food community. To get in touch with Slow Food in your area, go to slowfoodusa.org/index.php/local_chapters/.

Did you know that, according to the Union for Concerned Scientists, about 70 percent of the antibiotics in U.S. are fed to pigs, cattle, sheep, chickens and other animals raised for food? It's been a long time in coming, but it seems that Americans are finally paying attention to what happens to animals behind closed shed doors. Concentrated animal feeding operations (CAFOs), those mega-animal-farms famous for stuffing animals full of questionable feed and antibiotics and confining them to cramped, unsanitary quarters, never to see the light of day—are ripe (pardon the pun) for re-evaluation and stringent regulation. Now with possible links to swine flu and MRSA outbreaks, the U.S. government is considering greater regulation of antibiotics fed to animals, particularly those given to promote growth rather than to combat disease.

Says Rep. Louise Slaughter (D-NY), who introduced the bill (H.R. 1549) known as the Preservation of Antibiotics for Medical Treatment Act (PAMTA): "The practice of over-using antibiotics in animal feed is certainly contributing to the rise of antibiotic-resistant bacteria. This legislation will play a critical role in protecting the integrity of our antibiotics and the health of all Americans." And at last week's House debate on the issue, Deputy FDA Commissioner Josh Sharfstein expressed support for the proposed legislation.

Go here to express YOUR support for H.R. 1549.

Learn more about the issue: Read this insightful Ethicurean.com interview with journalist–expert Maryn McKenna for the lowdown on pigs and MRSA in people. Tom Philpott of Grist explains the issue and why legislation is only one small step in the right direction. And see this interesting sidenote: According to Environmental Health News, when used as fertilizer, antibiotics can be absorbed by crops.

Publix GreenWise Markets publix.com/greenwise

Locations: Palm Beach Gardens, Boca Raton and Tampa, Fla.

Average square footage: 39,000

Publix GreenWise global products include: 100 percent organic oats, oatmeal, honey Organic apple sauce, bagged salads, canned vegetables All-natural beef and chicken Earth-friendly paper products and chlorine-free bleach

As supermarket chains go, Publix is a big one. With 1,005 stores in five states and 140,000 “associates,” it’s no longer just the place where you pick up your weekly groceries. It’s an institution. So when Publix decides to invest in natural, organic and earth-friendly private label products, then expands its brood to include stores catered specifically to those products, you can bet there’s something to this whole natural foods thing.

Born in the midst of the Great Depression, the first Publix Food Store opened in Winter Haven, Fla. under the stewardship of businessman George Jenkins—known to his associates as Mr. George—who started the still-intact employee ownership and profit-sharing programs at a time when annual sales hovered around $100,000.

By 1945, there were 19 stores. In 1956, Publix had its first million-dollar-profit year. At the end of the 1980s, total revenues from the chain’s 367 locations reached $5.4 billion, and the 1990s brought expansion to Georgia, South Carolina and Alabama. Tennessee followed, and Publix passed the $16 billion sales mark in 2004. The growth has barely skipped a beat since: Retail sales in 2008 topped $23.9 billion.

Through it all, the backbone of the company philosophy has been simple and consistent: Be nice. Treat customers well and give them what they want. So when Publix customers wanted less-processed foods and cleaner household products, the store listened. The Publix private label line of natural, organic and earth-friendly products was introduced in the late 1990s to an overwhelming response.

The first Publix GreenWise Market opened in Palm Beach Gardens, Fla., in September 2007, followed by a second store in Boca Raton and a third in Tampa. Born out of customer demand, Publix GreenWise Markets are a testament to the mainstream acceptance of items that were once considered fringe.

“It really took off,” says Maria Brouse, director of media and community relations for the chain. “We noticed that each passing year our customers were becoming more savvy. They wanted to know more about health, natural and organic products. They wanted to purchase these products more often, but they still wanted to enjoy those everyday indulgences.” Publix GreenWise Markets responded to this desire by flipping the traditional model and offering a majority of natural items alongside a smaller selection of conventional products. “Some customers, while they’re living a healthy, natural and organic lifestyle, may still occasionally enjoy a carbonated beverage or an item from the bakery—whether it’s a doughnut or a cake, or something for a social gathering,” Brouse says. For others, she says, it may be beauty products or household items.

“We want to be that one-stop shop,” she says. “Say our customers are used to purchasing Bounty paper towels or Tide detergent. We don’t want them to have to go to another store to purchase something they would normally get in a routine shopping trip.”

Although response has been positive for the GreenWise model, Brouse says there are no current plans for expansion. Instead, the chain is looking at opening a non-GreenWise-branded hybrid store in Naples, Fla., that would carry an equal number of conventional and natural brands.

“We’ve learned from each location so far. We continue to tweak the selection of suppliers and the labels we carry,” Brouse says. “It’s about tailoring the product mix to meet the customers’ expectations. What’s interesting is that even in our traditional stores, we’re having people ask for more of a selection of the products we carry at our GreenWise stores.” One thing is clear, Brouse says: Naturals are here to stay. “People have been trying to figure out if health, natural and organic was a fad,” she says. “Obviously, it’s not.”