Pet Supplements

PET SUPPLEMENTS

CAN THIS INDUSTRY BE SAVED?

by Dr. J.C. Hofve, DVM

“A new initiative to remove animal supplements for sale is coming soon. Any supplement labeled specifically for animals and containing ingredients targeted by the FDA/AAFCO [U.S. Food & Drug Administration/Association of American Feed Control Officials] recommendations - whether it is sold by pet stores, veterinarians or health food stores - will be pulled. This effects a number of popular supplements YOU may find indispensable to your pet’s health! A final decision on the targeted ingredient will be made by AAFCO in April - after that, the supplements will start disappearing.” http://www.altvetmed.com/supplements.html

Sounds scary, doesn’t it? This comes from a website created by reputable veterinarians who are concerned about potential governmental infringement on the ability of guardians and veterinarians to provide complete treatment for our animal companions. The initiative in question can be found on the AAFCO website at the bottom of the home page, under “DRAFT AAFCO Recommended Enforcement Strategy.”

Without a doubt, there are many “unapproved” ingredients currently included in pet foods, animal feeds, and supplements. It is important to understand that manufacturers who are putting these ingredients into their products may be doing so in violation of federal and state laws. The “new initiative” being undertaken by FDA /CVM (Center for Veterinary Medicine) and AAFCO is not really new at all. The regulatory mechanisms are already in place; however, enforcement of these existing regulations has been sporadic at best. The Enforcement Strategy being proposed by FDA and AAFCO reiterate and expand on the current enforcement guidelines. Still, they are only guidelines, not mandates; adherence is strictly voluntary. Some states are already implementing the Enforcement Strategy guidelines, and others plan to do so.

The goal of the Enforcement Strategy is to remove or restrict unapproved products in general, but special priority is given to “concerns about food safety, animal health, and consumer fraud.” The primary interest is in the wide variety of ingredients on the market that are neither listed in AAFCO’s Official Publication nor recognized as GRAS (generally recognized as safe). Unapproved ingredients that can be found in dog food include medicinal herbs like ginseng and hawthorn berry, which can have toxic side effects, as well as more benign ones like glucosamine and chondroitin. Many ingredients and products are being marketed without submitting documentation to FDA concerning either safety or efficacy, and without petitioning AAFCO to define them (only defined and GRAS ingredients may be used in animal feeds and pet foods). Some pet supplements contain just about everything but the kitchen sink, and many product labels make extravagant medical claims – most of which are clearly prohibited by law. Here’s a small sampling of products currently being advertised on the Internet:

Tumor Aide™ Is a natural remedy that experience has shown to aid in reducing tumors of all types.
Pet Pectillin: Diarrhea Medicine for dogs and cats and birds.
Kidney-Stone - Treatment and prevention of kidney stones and related problems. Helps the body to break down and excrete kidney stones as well as prevent further stone formation.
Easy Pee - For Treatment of bladder infections, cystitis.
Aller'G Free - works like magic to eliminate scratching, rubbing, foot chewing, fur pulling rashes, throat, nose, ear, and eye irritation.

From my perspective as a veterinarian, such products worry me, although I use many nutraceutical products in practice. Their colorful websites, fantastic claims, glowing testimonials, and easy availability to animal guardians make a potentially dangerous combination. I have seen many animals that have been ineffectively or inappropriately treated by home remedies, until the disease is so far advanced that nothing will help. Had the caregiver sought veterinary guidance earlier – whether conventional or alternative – the animal’s comfort, health, or even its life, could have been saved.

It is FDA’s position that nutraceuticals, botanicals, herbs, and other “functional” ingredients being added to pet foods and animal feeds may actually be “unapproved new animal drugs.” Specifically, FDA is concerned about products intended for use in “the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “to affect the structure or function of the body.” If an ingredient in any feed, pet food, or animal supplement is intended to induce a “non-food” effect, FDA considers it a drug. In order for such an ingredient to become approved, a manufacturer would have to provide adequate, allowable documentation that it is safe and effective. This, of course, would require controlled testing using protocols and standards that are scientifically valid as well as satisfactory under
FDA regulations. If companies are willing to provide adequate documentation to FDA and AAFCO, and to cooperate in creating labels and promotional materials that are acceptable within the current legal framework, it is likely that their products will not be subjected to the harshest enforcement measures. However, until proper documentation is accepted by FDA and/or AAFCO, no company’s products are safe or exempt from enforcement.

Let’s take a closer look at the organization at the heart of this issue. There are many misconceptions about AAFCO, the Association of American Feed Control Officials. One is that the organization is a pawn of the pet food industry – but nothing could be further from the truth. This erroneous notion originally came from the listing in the AAFCO Official Publication of not only the state feed control officials (FCOs) who make up the voting membership, but also the many “liaison” members, now referred to as "advisors", many of whom are affiliated with the pet food industry, animal feed industry, and other related fields. Liaisons have no real power in AAFCO and cannot vote. Their position is advisory only – they are basically lobbyists. I myself was a liaison to AAFCO from the Animal Protection Institute (a non-profit animal rights organization) for two years. I attended all annual and semi-annual meetings, wrote letters, made phone calls, and spoke at committee meetings in defense of API’s interests, just as other liaisons did for their special interests. While it is true that some lobbyists have more influence than others, ultimately the individual state Feed Control Officials (FCOs) make up their own minds.

It is important to note that it is unusual for an FCO’s first action to be a stop-sale order banning a product from the marketplace. While this is one option for enforcement, there are many other avenues that may be tried first by an FCO concerned about a product. The first step may be a phone call to discuss the problem, or an informational or warning letter, followed by a meeting or hearing. The procedure chosen may be based upon the history, attitude, and cooperativeness of the company, the scope and significance of the violation, and other mitigating factors. In general, FCOs would rather work with a manufacturer to create an acceptable marketing process than to bully a product off the shelves. AAFCO’s Official Publication says of stop-sale (withdrawal from distribution) orders that they would be utilized “when other tools have failed to achieve compliance for serious administrative violations or gross labeling violations.” In the cases of stop-sale orders that I am familiar with, there were implied or actual drug claims on the product label, which is considered a serious violation.

Another misconception is that AAFCO “regulates” pet foods and animal feeds. AAFCO itself does not regulate anything, nor does it have any enforcement powers. AAFCO is a non-profit organization serving the 50 state agencies (in most states, the department of agriculture) that do regulate animal feed (that is, feed intended for food-producing animals such as cattle, hogs, or chickens), and pet food. Considering the 9 billion chickens, 100 million hogs, and 37 million cattle slaughtered for human consumption annually, in addition to 130 million companion dogs and cats, one can see that the FCOs have their hands full. AAFCO’s primary mission is to safeguard the health of animals and man. To this end, it provides a forum for discussion, “model” regulations, standards for labeling, pet food nutrient profiles and feeding protocols, template forms, and guidelines for enforcement.

The individual FCOs in each state are the real regulators, yet even they have only the power given to them under their state’s particular laws. Every state has its own laws, which vary greatly in scope and depth.

Feed laws were initially passed many years ago to regulate what is fed to food-producing animals. Pet food laws were added later as commercial dog and cat foods gained in popularity. The term “feed” generally includes products given to animals that provide major nutrients such as protein, fat, carbohydrates, vitamins, and minerals. This definition would generally include some pet supplements, such as taurine supplements or vitamins, but other supplements, such as glucosamine or an herbal mixture, may or may not fall within a particular state’s laws.

Only half the states have actually adopted the AAFCO “model” regulations within their state laws, and not all of those have adopted the most recent version – though most FCOs use the AAFCO book as a general guide. The model regulations were substantially revised in 1994, are constantly under review, and are updated when necessary to keep up with technology and the marketplace. For instance, the section on pet “treats” such as rawhide chews was recently updated to include the plethora of new products, such as pig ears and cow hooves, now on the market.

How feed laws and standards are interpreted and enforced also varies from state to state. For instance, California has great pet food laws, but essentially zero enforcement. Nevada’s feed laws do not include pet food. In my home state of Colorado, we have only one FCO and one assistant to do it all – pet food, chicken feed, hog grub, cow cuisine, everything.

Thus, while not all states specifically include supplements under their feed laws, most include pet food as well as animal feeds. Some states consider anything that is fed to an animal to be within the scope of their feed regulations. The new Enforcement Strategy merely provides a framework for regulation at the state level, if the state’s laws allow it and if the state FCO chooses to follow it. It is unclear how strong or uniform enforcement will actually be when implemented.

AAFCO has actually made several efforts toward appeasing manufacturers, through the work of its Botanicals and Herbs Committee and Novel Ingredients Regulatory Framework Task Force. These committees requested information and assistance from the feed industry, but received only limited response. They even went so far as to try to gather safety and efficacy data on a number of herbs from sources around the world – even though that should be (and legally is) the responsibility of the manufacturer. However, both committees have since been disbanded. There are more than half a dozen avenues available to manufacturers for the approval of new ingredients, one of which is through AAFCO’s Ingredient Definition Committee (IDC). However, not a single manufacturer has submitted a petition to AAFCO for any currently unapproved ingredient. After years of asking nicely for cooperation, it is not surprising that AAFCO and FDA have concluded that their only option is to carry a bigger stick – the Enforcement Strategy initiative.

For its part, the pet supplement industry must face factors that make compliance with the Enforcement Strategy problematic. Most supplements, such as nutraceuticals and herbs, are made up of common ingredients that cannot be patented; thus limiting the potential profit on newly developed products. Many products designed for animals contain ingredients that are also present in human supplements that can be purchased in health food stores, creating potentially unfavorable competition. The currently available means of obtaining approval for animal supplement ingredients are somewhat unwieldy and time-consuming, as well as expensive, perhaps even cost-prohibitive. The inconsistencies in laws and enforcement policies make it difficult to create products, labels, and marketing plans that will be acceptable in all states.

Since publication of the new Enforcement Strategy guidelines, the pet supplement industry has responded to AAFCO’s needs for assistance and cooperation. The National Animal Supplement Council (NASC) has proposed a program called “Compliance Plus” that outlines steps to be taken by member supplement manufacturers to ensure the safety and quality (but not necessarily the efficacy) of their products. Bill Bookout, president of NASC, believes that the AAFCO/FDA initiative is a real and potentially serious issue for animal supplement manufacturers, and notes that enforcement is already getting tougher. NASC does not represent all supplement manufacturers, and Bookout warns that there will always be a few “fringe” companies out there who are never going to abide by anyone’s rules. These companies are as concerning to responsible industry participants as they are to the regulatory agencies. It is unfortunate that it took a threat of imminent stringent enforcement for the manufacturers to open a serious dialogue with regulatory agencies regarding animal supplements. However, “Compliance Plus” appears to be a potentially workable compromise that will address most of AAFCO’s legitimate concerns about quality and safety (though not efficacy), yet continue to provide a wide variety of animal supplements to the consumer.

The ESMI task force met in April, but little concrete action was taken. NASC’s proposal was discussed, but no final determination was made on how to respond to it. However, a decision is expected shortly. One of ESMI’s goals is to pick a single “target” ingredient for the initial cooperative enforcement effort by the states that choose to participate. It was hoped that this ingredient would be selected at the April meeting, but again, no firm decision was made. While rumor has it that glucosamine will be the first target, this appears to be an unlikely choice. Glucosamine, while pervasive in the marketplace, has a good record of safety and a relative plethora of research supporting its use (though not in the dosages or for the purposes claimed by most dog food makers. Some states have decided to take no action against pet foods or supplements containing glucosamine as long as no drug claims are made on the label. AAFCO would prefer to pick an ingredient for which there are real health and safety concerns. However, some FCOs have raised concerns about the source of glucosamine-containing products, to ensure that they come from areas or species where “mad cow” disease is not a risk.

What does all this mean to you, the consumer? Ideally, the Enforcement Strategy will weed out those products - and hopefully those companies marketing products - solely to cash in on your concerns for your animal
companions’ health, without regard to quality control or ingredient safety. Unfortunately, FCOs may not be able to easily distinguish between products that many of us consider good and effective and those that are mostly “snake
oil.” Thus, any non-compliant product on the market could be targeted for enforcement. The Enforcement Strategy may make some products harder to get in some areas for a while, as violations are tracked and remedied. But in the long run, a cooperative working relationship between manufacturers and regulators will benefit consumers by ensuring that everyone is playing by the same rules, and by protecting you from product labels that play on your hopes and fears by making unfounded medical claims.

What can you do to help? Contact your state AAFCO feed control official and FDA’s Center for Veterinary Medicine and let them know you appreciate their efforts to work toward a viable solution with industry that does not interrupt the supply of products while still providing a reasonable certainty of safety, quality, and efficacy. To preserve effective products, you should specifically mention the NASC Compliance Plus program. The feed control official in your state can be identified on the AAFCO web site www.aafco.org, and you can contact the FDA at www.fda.gov – Center for Veterinary Medicine.

I believe that strong, consistent enforcement will create a more credible, safer, and higher quality supplement industry, and that this will ultimately be good for everyone.
--� Dr. J. C. Hofve 2002