Safety, Efficacy Still Key To Supplement Sales

Vets are often hesitant to recommend supplements without evidence to support label claims.

Pet supplement sales are expected to yield $1.66 billion this year, slightly slower growth than was projected before the economic downturn, according to market research company Packaged Facts. Although supplements have a niche in the pet industry, a lack of evidence of safety and efficacy for many products limits full veterinary acceptance and adoption.
Many animal supplement manufacturers seek veterinary acceptance, but some practitioners are reluctant to recommend products without evidence to support label claims. The need versus financial feasibility to perform trials on all supplements continues to be debated.

“As a supplement manufacturer, [I believe] safety tests at a minimum should be performed,” says Todd Henderson, DVM, president of Nutramax Laboratories in Lancaster, S.C. “But proven efficacy is necessary if veterinary recommendations are expected. Most companies say they have performed product tests that are available in their files, but just didn’t publish them. This is not acceptable. There’s no way to determine if it’s all smoke and mirrors or if it’s a genuine, effective product.”

Setting Standards

The National Animal Supplement Council (NASC), a self-policing nonprofit group comprising industry players, is dedicated to enforcing standards within the animal supplement industry. However, the organization’s closed system for collecting and reporting adverse events from supplements is a major deficit, according to some.

“I’m very pleased that NASC exists,” says Dawn Merton Boothe, DVM, MS, PhD, professor and director of clinical pharmacology at Auburn University in Alabama. “I think they’re thinking about what’s needed, but veterinarians need an accessible way to report and view adverse effects from supplements—which would include therapeutic failure—and that doesn’t exist.”

The NASC website says that members are required to report monthly on any adverse events. Such events are tracked by ingredient or product. While confidential for all NASC members, the system and information are reportedly available to the FDA.

“Also, the fact that NASC is self-regulated as opposed to being regulated by a non-biased third party gives its seal less legitimacy,” Boothe says. “An organization like is needed to really start making progress in convincing veterinarians that products sold by NASC members are a benefit to their patients.”

Bill Bookout, president of Valley Center, Calif.-based NASC and founder of Genesis Ltd., a supplement manufacturer, says the veterinary office is the best place for pet owners to learn about supplements. And if veterinarians research supplements and purchase them through reputable companies, he says, a lack of clinical trials is superfluous.

“If you’re concerned about a label claim or have unanswered questions about a product, call the company,” Bookout says. “If the company can’t answer your questions, don’t use it. Veterinarians use drugs off label all the time without clinical trials and don’t voice as much concern about efficacy as what’s expressed with supplements.”

Bookout says some supplement companies are hesitant to conduct clinical trials of their products because of the expense involved and because the published work on their unprotected and unpatented products could then be used by a competitor to sell and support claims for their unaffiliated supplements.

Supplements and nutritional counseling should be tools that all veterinarians use in their practice, says Shawn Madere, CEO of GLC Direct in Paris, Ky.

“Many disease processes lead to nutritional deficiencies that can be aided by supplementing the diet,” Madere says. “Unfortunately, many veterinarians do not take a proactive approach by offering quality supplements or specific nutritional advice in their practice. Others recognize the problem yet will direct their clients to seek out products from the local Walmart rather than supplying them directly.

“This leads to a few problems. The over-the-counter marketplace does not always provide the quality or the specificity for the condition. Sending clients OTC represents a significant financial loss to the practice,” Madere says, adding that a study published last year by Nancy Loving, DVM, and presented at the 2010 American Association of Equine Practitioners conference showed that this type of diversion cost the average veterinarian an additional $40,000 in lost income.

Need for Trials

But Dr. Henderson of Nutramax says concern over a lack of a patent or simply saying trials are cost prohibitive creates suspicion about safety and efficacy. He adds that even when veterinarians use drugs off label, trials have typically been conducted, but the drug just isn’t yet FDA approved or isn’t approved for the specific species in which the practitioner is using it.

“In zoo animal situations, veterinarians can make assumptions on efficacy and safety based on previous trials,” Henderson says. “If a drug has undergone clinical trials in dogs and cats and has been effective and safe, we might be willing to use it in the treatment of a lemur. Once it has been used in an unapproved species, the animal is monitored and information is gathered for future decision making. This can be done on a case by case basis with tested supplements, too.”

Henderson says in 1993, when he started using glucosamine in canine patients, he was considered a “witch doctor” by some colleagues. Now, glucosamine is used in mainstream treatments of arthritis and other inflammatory conditions.

Viewed as ‘Kook’

“I was viewed as a kook, but we kept doing studies and publishing our findings and finally gained acceptance,” Henderson says. “Just like any other industry, reputable supplement and nutraceutical manufacturers don’t want to be tarred with the same brush as companies that are not invested and dedicated to the products they produce.”

Stephanie Morris, global marketing and product development specialist for Arenus, a pet and equine supplement manufacturer in St. Charles, Mo., says overcoming veterinarians’ concerns for product efficacy is a hurdle manufacturers will continue to navigate in coming years. Arenus acknowledges that veterinary acceptance will require trials in animals or humans.

“Veterinarians don’t want to recommend any products without numbers behind it,” Morris says. “As NASC members we are audited—which is a necessary process to maintain membership. We also believe supplement trials are important, and we published equine clinical trials of Assure [an equine gastroinstestinal health supplement], which showed results reported by 60 veterinarians and about 200 equine patients. Moving forward, we will be conducting and reporting on trials on other products.”

Raw Materials

Product safety as it relates to the quality of raw materials will also be an ongoing concern that needs to be monitored. The quality of materials used to make the product is the first step in ensuring efficacy and safety.

“Raw material quality and strict compounding controls are the two most important factors in most all supplement manufacturing,” Madere says. “All of our materials are sourced through approved suppliers and thoroughly tested and inspected before compounding. We also conduct finished product testing to further ensure quality. We are proud to be one of the only companies that has consistently passed independent testing for quality and content.”

Boothe says she has no doubt that supplements can prevent disease or otherwise benefit animals, but she notes that a veterinarian’s job is to uphold the oath to first do no harm, which means not using an unproved product to treat patients over one that has been proved.

“It’s hard to convince me to trust a product that has no supportive evidence,” Boothe says.

“What drives me crazy is when assumptions are made that all supplements are safe because they are made from natural products,” she added. “Plants aren’t all safe and they’re not natural to the body. In fact, plants often develop mechanisms to deter animals from eating them. Veterinarians do have to be careful about what they’re giving or recommending to clients for their pets.”

Equine vs. Companion

Compared with the equine supplement market, growth in the companion animal supplement sector is more substantial. While the companion animal market enjoyed 7-8 percent growth in 2010, equine saw only 1-2 percent increases. Those in the market attribute the dip in equine sales to the cost of providing adequate doses to a large animal versus a companion species.

“Over the next four years, the spread between small animal and equine supplement sales is expected to widen,” says David Lummis, a New Orleans-based senior pet market analyst for Packaged Facts. “We estimate sales at $911 million for small animal and $669 million for equine by 2015.”

Currently, the top three supplements sought for companion animal use are joint/senior care with glucosamine and chondroitin accounting for 32 percent of the market, followed by multi-vitamins at 23 percent and skin/coat supplements with 22 percent, Lummis says.

“One of the disturbing trends plaguing the industry is supplement companies selling on hype, following unproven and unscientific consumer trends simply to sell product,” Madere says. “Two examples are the use of electrolyte supplements and dry powdered hyaluronan supplements in the horse. Both have been well marketed and many consumers believe that they are a necessity for their animals. This, in turn, compels companies to produce products to help capture market share, regardless of the efficacy.

“The over use of paste electrolytes has been directly linked to ulcer formation in the horse, and while there is some good data on the use of well hydrated forms of HA [as found in paste and syrup products], the dry forms are simply too hydrophilic to be absorbed intact through normal digestive processes,” Madere continues. "This has not stopped even some of the most reputable companies from jumping on the band wagon and including questionable and perhaps dangerous ingredients simply to appeal to a broader consumer base. The issue here is one of perpetuating misinformation from a position of authority. If consumers cannot trust the information they are given by the supplement industry to be accurate, we are doing them a great disservice.”

“We’ve increasingly improved our relationship and acceptance of pets as family,” Boothe notes. “It’s an emotional thing for an owner to reach for a supplement instead of a drug. Owners want to do their best to prevent and maintain their pets’ health—but without guidance, choosing appropriate supplements can be overwhelming and unsafe.”

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