Creature Comforts

When times are tough, people are willing to skimp on themselves-but not their pets. American shoppers spent $43.3 billion on pet-related items in 2008, including $10.3 billion on over-the-counter medicines and supplies, according to the American Pet Products Association (Washington, DC). A growing slice of the pie is the category of pet supplements, which could reach $1.7 billion in sales by 2012, notes Packaged Facts (New York City). Experts cite a number of reasons for the robustness of the category.

"People are accustomed to taking supplements themselves," says Phil Brown, DVM, senior vice president of research and development for Nutri-Vet LLC (Boise, ID), a manufacturer of pet supplements and functional treats. "It's a natural extension of their desire to stay healthy. They see what it does for them and think maybe it can help their pet."

Paul Dijkstra, CEO of InterHealth Nutraceuticals (Benicia, CA), notes that the rising awareness and acceptance of supplements among the general population has translated into a similar acceptance of nutraceuticals for pets.

"Because people consider pets as members of their family, it's only natural that they would consider supplements as a way to keep them healthy and active," Dijkstra says. He adds that like humans, pets are living longer and developing more health problems. "Older animals face many of the same chronic conditions that aging humans face, like arthritis," he says.

Brown agrees. "Pets are living longer, and as they age, they develop maladies," he says. "The number one area of pet supplements is still joint supplements." In fact, arthritis affects one in five adult dogs in the United States, according to the Arthritis Foundation (Atlanta). Brown adds that veterinarians are also becoming more knowledgeable about supplements as awareness of nutraceuticals has grown. "Years ago, veterinarians probably wouldn't recommend a supplement because they wouldn't have understood them."

One of the Family
Pet product companies that ignore the natural pet category do so at their own peril, according to Packaged Facts. An August report on the subject by the market research firm notes that natural supermarket sales of pet products surged by 22% in 2007. Similarly, a September Packaged Facts report predicts that the pet medication market, led by a boom in the senior pet population, could reach $8.6 billion by 2012.

"Pets are living longer because their owners are taking better care of them, both medically and nutritionally," says Tatjana Meerman, publisher of Packaged Facts. "Even more important, perhaps, longer lives mean ever stronger emotional bonds between pets and their owners, and thus an increased willingness among pet owners to do whatever it takes to keep their pets healthy and happy for as long as possible."

Indeed, the emotional bonds between humans and pets are a key factor behind the growth of the market.

"Pet owners tend to humanize their pets," says Garrett Lindemann, PhD, CEO and chief science officer of Gourmetceuticals LLC (Big Horn, WY). "They see them as essentially a part of the family and are putting more emphasis on the safety, quality, and health benefits of the food they feed their pets."

A large percentage of America's baby boom population are current pet owners, adds Bret Wyant, sales representative for American Laboratories Inc. (Omaha, NE). "These individuals have reached retirement age, and their children are grown," Wyant says. "The new pet companions have become an integral part of their daily life, perhaps filling a place once filled by their children. As such, they are cared for as children, with the highest-quality products."

The massive 2007 recall of pet food products contaminated with melamine as well as more recent recalls have intensified this trend, and consumer concerns appear to be shaping the way the pet supplement industry now handles its raw materials.

"The melamine scare has put more focus on the supply chain and where the raw materials are coming from," says Matt Phillips, president and COO of Cyvex Nutrition (Irvine, CA). "Additionally, more QA/QC testing is being put in place to prevent adulterated raw materials from entering the market. Knowing your suppliers, knowing their technical capabilities, and auditing the entire supply chain are critical for ingredient sourcing.

"Ingredient suppliers are more cautious than ever about the ingredients they source," agrees Dijkstra. "This has led to greater scrutiny of raw-material suppliers, and to a much greater focus on QA and QC. Material testing by reputable and carefully selected laboratories is more critical than ever, as is traceability. Many manufacturers are now demanding documentation for complete traceability of particular ingredients."

Country of origin is also becoming a significant issue. "Following the melamine contamination of pet foods in 2007, there has been an increased focus on QA/QC, including investigations into pet foods imported from China," says Lindemann, who notes that Congress tightened communication requirements for recalls and other safety issues as part of the FDA Amendment Act of 2007. "Because there is not complete confidence that all of the QA/QC issues and challenges in China have been resolved, several companies have also shifted their manufacturing of products from China to the United States."

Lindemann adds, however, that manufacturers are actively attempting to address these concerns. "Companies are focusing more on testing and establishing new safety and quality standards for their products before they enter the market," he says. "It has grown increasingly important for companies to understand the quality standards and testing of manufacturing facilities they work with." Gourmetceuticals, for instance, manufactures all of its ingredients in the United States under good manufacturing practices (GMPs), he says.

"Customers are looking to protect the quality of the materials they are sourcing, to help ensure that the materials they are supplying are of the highest quality," agrees American's Wyant. "As a manufacturer, we have taken the necessary extra steps to assure our customers that they have a high-quality product, including performing additional testing and providing detailed documentation for all of our products."

InterHealth also has a strict QC management policy in place to ensure the safety of its raw materials, says Dijkstra. "InterHealth's joint-care ingredient is sourced and man­ufactured in the United States using a patented, low-temperature GMP-standard manufacturing process," he says. Key parts of the program include lot-to-lot trace­abil­ity, batch-to-batch production records, and the use of materials that are free of BSE, GMOs, and allergens.

Similarly, Nutri-Vet manufactures its pet supplements in a GMP facility that also manufactures dietary supplements for people. "We're very fortunate in that our facility is our own," Brown says. "That makes a difference in our traceability. You need to know where every ingredient comes from."

For instance, Brown notes that the company uses liver, which is highly palatable to dogs, as a base ingredient. "Liver can be a problem because of BSE," he explains. "We only use USDA-inspected liver from Argentina, which is a BSE-free country. If you use flavor enhancers, you've got to know your supplier and its history, or all bets are off."

As the demand for quality ingredients continues to rise, quality products become more expensive to produce, adding to the difficulty. "The cost of organic ingredients has gone through the roof," Brown says.

Substantiation and Regulation
The pet supplements industry is also taking a look at another important area: efficacy. The fact that a nutraceutical works in humans doesn't necessarily mean it works in pets. Vitamin C supplements, for instance, may help people but not dogs. Other supplements that are beneficial for humans may actually hurt animals. While some studies already exist, more substantiation is needed for pet supplements. Unfortunately, good research does not come cheap.

"Most products that are helpful for humans are probably helpful for animals," Brown says. "More research is being done on side effects, but is enough being done? Not really. It comes down to economics. Most pet supplement companies are pretty small."

"I don't know of too many companies that can afford to do the research that is done at the same level as the research for human supplements," he adds, noting that even pilot studies can easily cost $200,000–$300,000.

In November 2008, the National Academy of Sciences (Washington, DC) issued a report on the safety of dietary supplements for horses, dogs, and cats by the National Research Council. The report, which only assessed the safety of lutein, evening primrose oil, and garlic, found that there was insufficient data to determine safety limits, such as a no observed adverse effect level (NOAEL) or safe upper intake levels (SUL). While some critics have said the report oversimplifies the issue, most experts agree that more research is needed.

"We believe that a shift toward more scientific validation is warranted and necessary in the pet food and pet supplement industries," says Lindemann. "We are adamant about the importance of analytical research, and both of our ingredients, GLPH-1 and PPL-240 have gone through extensive in vivo and in vitro studies to ensure efficacy and safety of the ingredients as a pet supplement." Lindemann says the company already knows what receptors the ingredients bind to and what part of the immune system they affect.

Likewise, InterHealth has conducted research on pet supplement applications for its UC-II type II collagen ingredient. "The performance and safety of UC-II is supported by randomized, double-blind, placebo-controlled studies in dogs and horses published in peer-reviewed journals," Dijkstra says. "Its efficacy is based on triggering the deactivation of the inflammatory process to stop the destructive cycle of osteoarthritis and allow the body to repair and heal joints."

"Clinical research could provide a great understanding of how a specific ingredient would work in different species," notes Dijkstra. "To fully understand the safety, benefits, and efficacious amount needed in certain animal groups, it is ideal to conduct well-designed research studies on targeted species. Manufacturers prefer to see studies conducted in targeted animal species."

However, he adds that before manufacturers can use ingredients in pet supplements, they must ensure not only that the product was tested for safety and efficacy, but also that it has been approved for use in animal products. In some respects, the pet supplement marketplace is similar to the pre-DSHEA marketplace for dietary supplements.

"Another area of concern for manufacturers intending to enter the companion animal product category is a lack of an official regulatory environment for animal supplements," says Dijkstra. "Currently, products can be marketed either as a food or a drug, with no official supplement category in place yet."

In 1996, FDA's Center for Veterinary Medicine (CVM) published a Federal Register notice outlining its views on pet supplements. The notice suggested that DSHEA does not apply to animal products, leaving just the food and drug categories. Other permissible materials for animals aside from food and approved medications include approved food additives, generally recognized as safe (GRAS) ingredients, and ingredients noted in the official publication of the Association of American Feed Control Officials.

The National Animal Supplement Council (NASC; Valley Center, CA), a trade association for the industry, has been working with FDA to develop a regulatory framework for pet supplements. NASC also administers a self-regulatory program for its members. To qualify for NASC's Quality Seal Program, the group's members must be audited to ensure that they meet several criteria. Requirements for the seal include creating a QC manual that describes standard operating procedures, participating in an adverse-event reporting (AER) system, and adhering to labeling guidelines.

NASC's AER system, which tracks more than 6000 products, reported only 0.31 adverse events per million administrations of all products sold by NASC members, and of those events, only 0.001 events per million administrations were serious adverse events, according to an NASC November 2008 newsletter. The newsletter also noted that NASC's member companies represent more than 90% of the industry.

"It isn't mandatory to join NASC, but what I hear from the major buyers is that they will only purchase a product if the company has been certified or audited by the council," says Brown. "It's a voluntary organization with teeth."

Market Expansion
Nearly 37% of American households have dogs and 32% have cats, according to the American Veterinary Medical Association (Schaumburg, IL). Moreover, 20 million households with dogs and cats are run by consumers who currently purchase supplements for themselves but not for their pets, according to Packaged Facts. This suggests ample room for growth. Pet supplement manufacturers therefore have reason to be optimistic about the future.

"Gourmetceuticals is interested in the pet supplement market because there is growing market demand for innovative products to address the consumer need for pet-related products that are as beneficial as those available for people themselves," says Lindemann. He adds that his company recently signed an agreement with Curamedics Pharmaceuticals (South Plainfield, NJ) to codevelop its ingredients for the human and veterinary markets. "As people look to take a more active role in seeking out products for their pets that contain ingredients that target specific physiological needs, we look forward to addressing pet health management."

Nutri-Vet's Brown sees growth ahead as well, despite today's challenging economic climate. "This is a recession like we haven't seen in some time," he says. "But pets are recessionproof. I know people who will take better care of their animals than their children."