n January, the Association of American Feed Control Officials unveiled a plan for helping states remove unapproved dietary supplements for animals from the market. For several years, products promising therapeutic and nutritional benefits unsubstantiated by the Food and Drug Administration were being sold in pet stores, in catalogs, and on the Internet in increasing numbers.
AAFCO worried that these purported health aids might harm animals and pose a food safety risk for people eating products from livestock treated with these supplements.
Reaction among veterinarians, pet owners, and industry to the imminent crackdown was immediate, if somewhat ill informed. They feared state regulators, in accordance with AAFCO suggestions, were about to begin pulling "natural remedies" for animals from the market.
As part of its enforcement strategy, AAFCO, in cooperation with the FDA, planned on targeting an unspecified, unapproved ingredient as part of its "uniform enforcement event." Many guessed that ingredient would be possibly the most popular ingredient on the market: glucosamine.
With speculation abounding, the AVMA weighed in with a letter to AAFCO, which provides states with guidance regarding animal feed laws. In the letter, dated April 23, the AVMA stressed the importance of glucosamine products for treating osteoarthritis in companion animals, and encouraged AAFCO to defer to the discretion of state regulators in regard to this particular ingredient.
Rumors of a comprehensive crackdown and the selection of glucosamine are unfounded, according to AAFCO President John Breitsman. AAFCO had wanted to implement the enforcement event this spring. But because of a "misinformation campaign" directed at consumers, the event was postponed. "It was obvious to us that we needed to target our resources to those areas to try to clear up the confusion that was created," Breitsman explained.
He insists AAFCO is moving forward with its enforcement strategy, saying the association has been working toward it for the past five to six years. By making an example of one ingredient, AAFCO officials hope to increase consumer awareness, limit the availability of unapproved feed ingredients, establish a uniform regulatory approach among the states concerning animal feeds, assess the success of the program, and create a fair playing field in the feed industry.
"It's important for [industry] to understand that what we're requesting is compliance," Breitsman said. "The intent is not to remove products from the marketplace. The intent would be to achieve compliance so those products could be sold in the marketplace, meeting the existing laws and regulations."
Not long after the enforcement event was announced, the National Animal Supplement Council, a relatively new nonprofit coalition of 25 animal supplement companies, quickly put together a program that it hopes will assuage AAFCO and the FDA's concerns.
On April 10, NASC submitted its Compliance Plus for review by AAFCO and the FDA Center for Veterinary Medicine. It is a proposal for industry and regulators to work together to bring unapproved ingredients into compliance with federal and state laws. "What we really tried to do was put forth a proposal that would be not a finished document but essentially a starting point," said William Bookout, NASC president.
More than feed, not quite drugs
Although difficult to categorize definitively, dietary supplements can refer to a broad range of feed ingredients and so-called natural remedies, including vitamins, herbs and botanicals, nutrients, and minerals. Manufacturers promise animals will receive any number of health benefits, from a balanced diet and healthy joints to increased energy levels and stress relief.
The term "nutraceuticals" reveals the conviction among supplement proponents that these ingredients are more than feed additives but less than pharmaceuticals. At least where animals are concerned, current regulations recognize only the food additive and drug categories and make no allowance for any regulatory gray area.
On the other side of the spectrum, human dietary supplements are immensely popular and less rigorously regulated. The U.S. Pharmacopeia estimated the industry was worth $16 billion in 2000.
Pressed by public demand, Congress passed the Dietary Supplement, Health, and Education Act of 1994, creating a middle ground for human dietary supplements. With some caveats, the law allows supplements to be sold without FDA approval. Manufacturers cannot make disease treatment claims, for which the law requires that proof of safety and efficacy be presented to FDA before product approval. But they can promise that their product's nutritive value can affect the body's structure or function.
With the ready availability of human supplements, many people concluded that if ginseng or vitamin B are good for them, then it stands to reason they will make their pets feel good, too. Consumer demand paved the way for companies to offer a range of supplement products promising healthier and happier dogs, cats, horses, and other companion animals.
According to Dr. Sharon Benz, leader of the Nutrition and Labeling Team in the FDA-CVM's Animal Feeds Division, there was a perception in the animal supplement industry that DSHEA applied to them, as well. Not so, she said.
The agency took the strict position that ingredients in supplements must be approved by the FDA as food additives, generally recognized as safe for use (GRAS), or defined in the AAFCO manual. Furthermore, any product making a therapeutic or curative claim and not approved by the FDA as a drug is not in compliance with the federal Food, Drug, and Cosmetic Act.
In 1999, the U.S. Court of Appeals for the Third Circuit affirmed the agency's decision in a ruling against a manufacturer selling products he marketed as able to cure, treat, or prevent diseases in horses and cows.
While many supplement products on the market are in compliance, many others make claims with no scientific backing. "The states are trying to get a handle on the great number of products out there that are not approved to be marketed in their states," Dr. Benz said in regard to the AAFCO enforcement strategy.
Crossing the regulatory line
Some within the animal supplement industry admit there is a general lack of compliance. "Industry went over the line in some cases, blatantly violating labeling standards," Bookout acknowledged. In addition to his NASC role, Bookout is president of Genesis, Ltd., which markets natural supplements for dogs and cats.
Unregulated supplements are able to flourish because of too little policing. According to FDA officials, the agency has limited resources and will take action when alerted to a specific safety issue. The FDA, observes Dr. Dawn Boothe, secretary-treasurer of the American College of Veterinary Clinical Pharmacology, has neither the time nor the resources, in a climate of preventing the introduction of bovine spongiform encephalopathy into animal feed, for a comprehensive crackdown on unapproved supplements.
Dr. Boothe, an associate professor at Texas A&M University College of Veterinary Medicine and chair of the AVMA Council on Biologic and Therapeutic Agents, believes veterinarians have exacerbated the situation by embracing ingredients that have not been scientifically evaluated. Yet she believes some—glucosamine, chondroitin sulfate, and coenzyme Q, to name a few—are "critically important."
"I think that they play a very important role in the health and well-being of animals," Dr. Boothe said, but added that for every legitimate ingredient she mentioned "there's probably 20 out there that are popular for no valid reason."
Dr. Susan Wynn believes dietary supplements complement traditional treatment programs. "They do things that nothing else does," she explained. "They help animals that are on all the drugs they should be on and still aren't well, or are eating complete and balanced food and still aren't well. They add another [treatment] dimension."
"I can say for sure that I have patients that would be harmed if these supplements were removed from sale," she added.
Dr. Wynn is executive director of the Veterinary Botanical Medicine Association and secretary-treasurer of the American Academy of Veterinary Nutrition, and serves as a scientific adviser to NASC. (The AAVN has no official policy on the AAFCO enforcement strategy, Dr. Wynn noted.)
Drs. Wynn and Boothe acknowledge that little empirical evidence exists proving the health benefits of dietary supplements, and that they can pose a risk to patient health. However, they said, veterinarians use them, especially herbs and botanicals, in their treatment programs because of anecdotal evidence of success and what Dr. Wynn calls a tradition of efficacy.
Weighing the options
So little data exist because companies have no financial incentive to invest time or money for research. Unlike pharmaceutical companies that can spend years and millions of dollars investigating new drugs, and then patent their formulations to recoup their costs, no such protection exists for dietary supplements. Once a food additive is approved, anybody can manufacture and market it according to regulations, said the FDA's Dr. Benz. Food additive manufacturers can, nonetheless, apply for patent protection, the FDA points out.
Industry recognizes that the cost of research would mean more expensive products in a highly competitive market. This would likely drive pet owners to purchase cheaper, unregulated products or human dietary supplements and use those instead.
Supplement manufacturers must also navigate a complex web of state feed laws. Based on a survey compiled last October by the American Pet Products Manufacturers Association, no regulatory uniformity exists among the states. AAFCO recommends feed laws, which the states may accept, modify, or reject.
"There can literally be many, many different sets of rules and guidelines," Bookout said.
"What that creates is, in some states, calling a product 'joint support' would be OK, and in other states that verbiage is not OK." It isn't cost effective for companies to create different product labels for each state, he added.
A little more than a year ago, NASC was formed to help member companies respond to the regulatory complexities and increasing consumer demand, according to Bookout. Council membership started to increase after AAFCO's announcement in January. Industry was gripped by a sense of alarm, he said.
Dr. Wynn faults industry for not being more proactive about funding research and working toward safety and quality assurance programs. "I do blame the industry for not even starting to do anything about it until the last moment. On the other hand, the financial pressures are real," she said.
Searching for compromise
At a meeting in early April, NASC fashioned its alternative to the AAFCO plan in hopes of averting aggressive regulation. "When the enforcement strategy was announced, it was very apparent that industry needed to do something or our destiny was going to be shaped for us," Bookout said.
Compliance Plus is a nonregulatory program that applies to non-food-producing animals only and addresses several key areas. It would establish an adverse event reporting system and require NASC members to implement labeling, manufacturing, and quality control standards. Members would contribute a percentage of product sales to subsidize research initiatives for five ingredients: glucosamine, chondroitin, methylsulfonylmethane, garlic, and rehmania.
NASC hopes that by demonstrating it can voluntarily bring its members into compliance, regulators would consider NASC member products a low regulatory priority.
One challenge is bringing product labels into line with regulations while also informing consumers about the product or ingredients. Considerable consumer awareness exists for the purported benefits of some ingredients, such as glucosamine or MSM. "Industry needs to be given a reasonable ability to effectively communicate the purpose of the product to the customer," Bookout explained.
AAFCO president Breitsman called Compliance Plus a "good first step," whereas FDA-CVM had yet to comment as of the latter half of July. Compliance Plus can be viewed at www.nasc.cc. AAFCO's comments are available on its Web site, www.aafco.org.