Taking the Lead

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Horse owners in large numbers customize rations for their animals by adding supplements to the forage and concentrates they feed. They assume that whether they choose to feed their animals a basic vitamin/mineral mix or garlic or glucosamine, a product will be readily available the next time they open a catalog, log onto a website, walk into a tack shop or pick up the phone to place an order with their local feed store.

But in making these assumptions, animal supplement buyers are generally unaware that, in the eyes of government regulators, they may be buying an illegal product (see sidebar).

From the consumer standpoint, the animal supplement issue may appear a bit cockamamie. If people can walk into a supermarket or drugstore and legally buy supplements for themselves, how is it that regulators consider these same supplements unsafe for their pets? The quick answer is that even human supplements fell into a somewhat gray regulatory area until the Dietary Supplement Health and Education Act of 1994 (DSHEA) established them as a new class of food for purposes of federal regulation. In 1996, a Pennsylvania court ruled that DSHEA does not apply to animal supplements, which remain in a somewhat gray area.

While the concerns of state feed officials and the Food and Drug Administration (FDA) over ingredients fed to animals in the human food chain are certainly justifiable, supplement manufacturers feel that existing regulations can be overkill when it comes to companion animals such as cats, dogs and horses. Because many of the animal supplement ingredients that the American Association of Feed Control Officials (AAFCO) and the FDA are currently concerned about are available in the human supplement market, manufacturers feel that if animal supplements are pulled from the market, people will feed the ingredients anyway.

Many of the ingredients deemed “questionable” in animal supplements are used daily by consumers, says National Animal Supplement Council (NASC) president Bill Bookout, who is also president of Genesis, a dog and cat supplement manufacturer. Animal owners perceive them as beneficial to the quality of life of their animals, particularly older animals. “If animal supplements are no longer available, they will go to Wal Mart, buy a human product and feed it to their pets,” says Susan Domizi, president of SOURCE, Inc., an NASC member which produces supplements for horses and dogs.” A big problem, Domizi points out, is that they will have no guidance on how to translate human dosages into dosages for their pets or about the potential risks for animals versus humans.

From the supplement industry’s perspective, the crux of the problem is that many animal supplements should not be pigeonholed as either “feeds” or “drugs,” the only categories that current law allows regulators to recognize and address. This categorization puts the many pails and bottles of supplements lined up in tack and feed rooms across the country in a legal limbo.

In the past, manufacturers and regulators have often patched the problem using semantics. Since FDA considers products claiming to treat or prevent disease as new animal drugs, some companies long ago scrubbed health claims from their labels and literature. When Iowa threatened to remove all animal supplements from the market in 2003, the stopgap solution was to sanitize labels so that they contained no references to nutrition, diet or feeding. The problem for manufacturers remains, however, that one state’s regulatory compromise may be cause for legal action in one of the other 49.

Neither the FDA nor AAFCO can make or change existing laws regarding foods or drugs. With 50 states separately writing and enforcing feed laws, supplement manufacturers are constantly subject to legal interpretations that make product distribution uncertain. The only long-term way to resolve the problem, the NASC board feels, is to pursue federal legislation that recognizes non-human food chain animal supplements as a category separate from either animal feeds or animal drugs.

Recognizing that some of their supplements are sold in a legal limbo and that regulators could, on a moment’s notice, decide to pull them off the shelves in a regulatory crackdown, manufacturers have formed NASC to address the problem. They have undertaken ambitious programs to standardize manufacturing procedures and, to discover any bad reactions to supplements, created an adverse event reporting system unparalleled even in the human supplement industry. They are also turning toward Washington with an eye to rewriting existing laws to gain legal recognition for non-human food chain animal supplements. “The issue will ultimately require a legislative solution so we can accomplish our objective—a fair, reasonable, and consistent national policy on non-human food chain animal supplements,” says Bookout.

RAISING THE BAR

The cornerstone of NASC’s efforts is its Compliance Plus program. Members will be allowed to use the NASC Compliance Plus seal on product labels and in their marketing literature to indicate their commitment to the highest quality standards. The program includes:

• Labeling. After December 2004, no labels, websites or marketing materials can include a health claim. “Labels can only make structure/function claims,” says Nick Hartog, NASC board member and president of Grand Meadows. For example, a label might say “supports joint function” but it cannot say “helps arthritis pain.”

Labels will also list all ingredients in terms of milligrams per serving so that consumers can easily compare products (see sidebar this page).

• Quality control. Members agree to follow specific best manufacturing processes (BMP) and to submit to audits that will ensure consistent, industry-wide quality controls. The long-term goal is a complete accounting of manufacturing practices and consistent record keeping that allows manufacturers to track ingredients and products at every stage of manufacture and distribution.

Down the road, the association would like to institute a compliance program that compares the actual ingredients in a tub or pail pulled from a retailer’s shelf with the ingredients promised on the label.

• Adverse event reporting. Members must report any complaint or adverse event such as diarrhea or vomiting, whether or not it is ultimately linked to the product, on a monthly basis. The FDA will have complete access to this reporting system, giving them a depth of information on supplement safety that is currently unavailable even for human supplements.

Additionally, supplement manufacturers must file quarterly reports on the number of doses of each ingredient sold. The combination of servings sold and adverse events reported will give the industry and FDA statistical information on supplement safety which has never before been available. According to NASC, its current members account for 65 percent of animal supplement sales, and the database already accounts for more than 300 million servings of various ingredients. Those numbers will grow as more manufacturers join.

• Ingredient compliance and risk assessment. Manufacturers agree to an assessment based on sales that will fund collective efforts to help the animal supplement industry navigate the current regulatory environment. This includes developing ingredient definitions and doing research to establish ingredient safety. “We are starting to feed horses and dogs ingredients for which there is no research on their effect in horses and pets,” Domizi. “We need species-related information.” Ingredient safety testing is a difficult and costly thing for an individual company to do, says Hartog. “But we can pool funds for research.”

“Ultimately, this is about the lack of a category,” says Hartog. “We have to pursue legislation in Congress to insure consistent, fair, national regulatory protocols.” Bookout admits that lobbying for legislative reform is not an inexpensive process and that raising dollars is not easy when there is no imminent crisis that calls consumers to action (the NASC’s initial goal is to raise $300,000 by February 2005). However, NASC does not intend to wait for the next regulatory crisis.

The Regulatory Dance

Officials in each state have regulatory authority for animal feeds sold in their respective states. In the early 1900’s, these officials and others formed the American Association of Feed Control Officials (AAFCO). Over time, AAFCO assumed the collective responsibility for defining feed ingredients, setting labeling criteria, and setting other regulatory standards. AAFCO’s annual Official Publication listing feed ingredient definitions and lists of acceptable ingredients has become the bible for those manufacturing animal feeds or supplements. AAFCO has also written a “model law” for state regulators to follow in drafting feed legislation. The model suggests ingredient definitions, labeling requirements, registration, licensing, inspections and enforcement measures.

But AAFCO has no regulatory enforcement authority. States are free to follow the AAFCO recommendations or write their own laws regulating feeds and feed ingredients. (Currently, less than half use the AAFCO model). Each state can also decide how strictly to enforce whatever regulations it has put in place. So the reality is that supplement manufacturers serve 50 different masters.

The Federal Food, Drug and Cosmetic Act of 1938 gives the Food and Drug Administration (FDA) legal authority over foods and drugs in interstate commerce. The FDA oversees the proper registration and labeling of drugs. While its primary concern is with animal food additives and drugs that become part of the human food chain, it also oversees food additives and drugs for companion animals—horses, ironically, fall into both. Through time, state officials, AAFCO and the federal Food and Drug Administration (FDA) have developed a supportive relationship that recognized that the process of defining a new ingredient or registering a new animal drug was beyond the financial resources of the small companies in the supplement business. Recently, however, some state and FDA officials have taken a harder line that puts a tighter regulatory squeeze on supplements.

While feed additives and supplements for companion animals that are not in the human food chain may be of lower regulatory priority, the FDA is clear how it feels about their legality. “Animal supplements may be considered either foods or drugs under the Act,” says Linda Grassie Director of the FDA-CVM Communications Staff. “Animal supplements that contain unknown, unproven, or unsafe ingredients or that make unsubstantiated claims may be considered adulterated and/or misbranded under the Act.”

AAFCO’s feed ingredient definitions include all sorts of things, from alfalfa meal to vitamin supplements that help a feed measure up to or exceed the nutrient levels recommended by the National Research Council (NRC). When a supplement is marketed as an animal feed, state officials take notice. They generally have no problem as long as the ingredients are on AAFCO’s lists.

However, many of the “nutraceutical” ingredients consumers choose to feed their animals, such as chondroitin sulfate, glucosamine, and MSM, do not have definitions accepted by AAFCO or FDA, are not on either agency’s approved lists of feed ingredients, and are not registered as drugs. If the supplements are sold as animal feeds, state officials can choose to regard them as adulterated feed products and have them pulled from the shelves in that state..

If these nutraceuticals are marketed with health claims, they cross the line from “feed” to “drug” and the FDA takes notice. “Because these products are not generally recognized as safe and effective (GRAS/GRAE) for their intended use, they are considered new animal drugs,” says Grassie. The FDA considers them adulterated or misbranded products and, therefore, subject to federal regulatory action.

“There’s not a lot of wiggle room,” says Ben Jones, a supervisor with the Office of the Texas State Chemist and past president of AAFCO. States see these supplements as animal feeds with unapproved ingredients.

Isn’t there some sensible way out of this dilemma? Yes—if the human experience is any guide.

Human food supplements were marketed in a similar legal limbo until Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) which established human supplements as a regulatory category separate from “foods” or “drugs.” Animal supplements, however, were not specifically included in the bill and in 1996 a Pennsylvania court ruled that DSHEA did not apply to them. So their legal status in the marketplace remains uncertain.

Over the years, several states have issued “stop orders” to individual manufacturers when regulators felt they were misleading consumers because of improper labeling or other violations. AAFCO committees on nutraceuticals and novel ingredients raised important issues but were unable to come up with solutions.

Sensing that the existing regulatory environment offered no viable long-term solution, a small number of pet and equine supplement manufacturers formed the National Animal Supplement Council in the fall of 2001. When NASC held its first official meeting in the spring of 2002, the attending companies were approximately half equine and half pet. Those that signed on as members agreed to a series of unprecedented actions that include quality control standards and procedures that ensure their products meet the health and safety intentions of the current laws; an adverse event reporting system completely accessible by FDA regulators; an agreement to work together to obtain ingredient definitions for unapproved ingredients; and pooling of funds to do research.

NASC officials currently feel that the best long-term solution to the regulatory squeeze is legislation to establish a new regulatory category for non-human food chain animal supplements. Their goal is to raise sufficient funds by February 2005 to begin that process. —BK

A Seal of Approval

It takes more than paying membership dues to earn the right to use the National Animal Supplement Council’s Compliance Plus seal on a label. Members must agree to all of the program’s requirements. Otherwise, they are not only prohibited from using the seal, they are also out of the council. “The NASC seal is a warranty, a measure of quality that consumers can be confident about for the first time,” says NASC’s and Grand Meadow’s Nick Hartog, an outspoken advocate for ethics in the animal supplement industry.

While NASC officials are quick to point out that lack of the seal does not necessarily mean that a product is below standard, when consumers see the Compliance Plus seal they are guaranteed that the company has agreed to some rigorous requirements that ensure product safety and quality. Over time, as consumers begin using the Compliance Plus seal in their supplement buying decisions, NASC leaders hope that more and more manufacturers will join them and that companies paying marginal attention to product quality will be forced out of the industry.

Supplement labels that meet Compliance Plus standards will also enable consumers to easily compare products. Currently, supplements list their ingredients in a variety of ways, such as milligrams per pound, milligrams per kilogram, parts per million, percentage or International Units. It takes a calculator and conversion tables to figure out exactly how much of an ingredient is in a single serving of a product.

Compliance Plus labels will list ingredients in terms of milligrams per serving. For the first time, consumers will be able to compare one product to another without doing complicated math. Combined with the best manufacturing practices NASC members pledge to follow, that makes the new seal a real plus for consumers. The new seal began appearing on animal supplement products at the end of 2004. —BK