Deciphering Nutraceutical Labels
Did you ever go to the tack store and try to figure out the exact amounts per serving of each ingredient contained in some of the nutraceutical products? It can be an important issue if your horse's joint supplement, vitamin supplement, and food product contain duplicate vitamins and minerals, some of which can be harmful if given in excess doses. But when ingredients are labeled as X parts per million (ppm), and you don't know how many ppm are in a one-pound container, let alone a one-ounce serving, how the heck do you know what ingredient amounts your horse is getting? And that's just one of the problems with nutraceutical labeling! It makes you want to go home and reach for the aspirin (from a clearly and accurately marked bottle with an easy-to-understand ingredient list).
The trouble with labeling begins with a somewhat vague definition as to what nutraceuticals actually are, coupled with regulations that strictly limit manufacturer claims, and complicated by some products that don't always contain exactly what they say they contain.
Nutraceuticals are often described as a combination of nutrition and pharmaceuticals. Nick Hartog, president and co-owner of Grand Meadows Nutritional Products, Inc., and president and founding member of the National Association of Equine Supplement Manufacturers, has been an advocate of raising ethical and manufacturing standards in the equine supplement industry. Hartog defines nutraceuticals as a "step beyond vitamins, in that they are sold with the intent of having an effect in some way on the body's ability to heal itself, to help support the horse's ability to fight diseases, utilizing a non-allopathic, or non-drug approach. They are not pharmaceuticals because they haven't gone through a drug application process through the FDA (Food and Drug Administration), but they are more than vitamin supplements."
Steve Traylor, PhD, feed coordinator at the University of Kentucky's Division of Regulatory Services and state feed control official for Kentucky, simply sees "most nutraceuticals as new animal drugs."
Both agree that most nutraceuticals in today's market are geared toward addressing arthritis and joint disease. "The most popular are chondroitin and glucosamine sources, along with MSM and other derivatives," says Traylor. "Herbal products have gained in popularity and use for the benefit of various marketing claims (increased strength, increased blood flow, improved oxygen supply, prevention of tying-up, etc.)."
Although nutraceuticals for animal use do not undergo the same approval process as foods, drugs, or nutraceuticals destined for human use, they still are reviewed and regulated by the FDA for safety and efficacy. Labels are supposed to list in descending order the amounts of all ingredients contained in the product. Product labels should not make the claim of doses per bottle or effective dose like a drug would, warns Traylor.
"Few, if any, of the firms can provide scientific evidence to substantiate the claims," says Traylor. "In addition, the analytical testing methodology and quality control is lacking to provide consumer protection." Making claims as to how the nutraceutical can heal or fight disease, therefore, would then cause said product to "most likely be considered a drug additive, which is subject to stringent FDA review."
In addition, the Association of American Feed Control Officials (AAFCO) works closely with the FDA regarding nutraceutical regulations. "Although AAFCO as an organization has no enforcement powers, its role in feed regulation is to develop model laws and regulations and to act as a clearinghouse for ingredient definitions," explains Traylor. "AAFCO's membership is comprised of state, federal, and international feed regulatory officials who have enforcement powers in their respective states or countries. The majority of state feed control officials will review labels for compliance with federal and state labeling regulations, and they also look for product labeling that is either adulterated or misbranded. States do consult with the FDA concerning laws and regulations regarding feed ingredient definitions and labeling requirements. States have labeling regulations and usually reference the ingredient definitions adopted by AAFCO. The FDA has some labeling guidelines for some products (i.e., drugs, devices, etc.); however, the states are considered to be an enforcement arm for the FDA. The FDA's prime role is to review commercial feed and drug submissions for efficacy and safety."
What muddies the water is that rules and requirements vary from state to state. Explains Hartog, "There are criteria for labeling if you want your product registered for sale in a state. But there is no uniformity amongst the states in regards to labeling. In one state, you don't have to submit any data, you just pay them a fee. In another state, they go berserk if you don't have every single, tiny little permutation of the label characterized the exact way. In New Mexico, the Department of Agriculture approved glucosamine for sale without any ingredient definition process, but in Texas joint ingredients--including glucosamine and chondroitin--are not allowed to be sold."
Making things even more interesting, by many accounts nutraceuticals fall under the "low regulatory priority" umbrella. Traylor says that although the FDA and the states have the responsibility for regulating the use of animal feed products, the ultimate responsibility for the production of safe and effective animal feed products lies with the manufacturers and distributors of the products.
"For example, nutraceuticals that are labeled with unapproved drug claims are routinely relabeled without the claims," he says. "If there are no known food safety concerns, this is accomplished with the support of the companies manufacturing the products without removing the product from sale within the distribution channels. However, if there is a food safety concern, immediate action is taken to remove the products from distribution. For example, when the labeling lacks the required bovine spongiform encephalopathy (mad cow disease) caution statements of 'do not feed to cattle or other ruminants' or other required caution statements, the products are immediately placed under stop sale using the regulatory authority of the states."
Still, a recent article in The Horse, Supplement Loss? by Kimberly S. Brown, noted that state officials "haven't chosen" to regulate nutraceutical manufacturers, leading to a situation whereby many nutraceutical manufacturers ignore regulations, forego the process to make their products legal, and make illegal claims on the labels.
Charges Hartog, "A number of manufacturers are making direct claims, in one notable instance that their product works better than a drug. There are products out there that contain active ingredients that are not listed on the label."
Obviously, the differences in labeling requirements, restrictions against making product claims, regulations against providing dosage amounts, and inaccurate labeling make it tough for the consumer to ascertain what and how much to give a horse. Even with accurate labeling, it's still difficult. "It's like the Wild West," Hartog says. "One company has values expressed one way, another company has values expressed another way. Unless the consumers have a calculator with them in the store, they will be unable to know on a per-serving basis what they should be feeding their horse when comparing various products."
Label Deciphering 101
What's a consumer to do? Despite the vagaries, one still needs to check the label at some point to get some sort of product indications.
Examine product claims--Some labels will discreetly describe what their products can do. "Clearly the FDA is very much against any claim of any kind relative to trying to treat, diagnose, prevent, and cure in any form any disease because that's what drugs (not nutraceuticals) do," says Hartog. "In regards to labeling, it's a very delicate balancing act, so often there's an implied understanding between the consumer and the manufacturers about why they are feeding the product. Technically, we can't actually say what the product does; we can only allude to it."
That said, despite regulations, some labels are more bold in product claims than others. For similar types of glucosamine/ joint supplement products, there are subtle, carefully worded labels varying from "appear[s] to promote healthy joint, cartilage, and other connective tissue," "a complete nutritional program," and "nutritional joint support formula with a unique combination of synergistic ingredients." Others are more forward, proclaiming that a product "addresses all areas of possible nutrient depletion in the joints, tendons, and ligaments," and "rebuilds cartilage with dramatic pain relief."
Quite a range!
Still, subtle or bold proclamations on the label in and of themselves don't mean a product is more or less effective. Just be a little wary, Hartog warns, of products claims that are drug-related--i.e., a direct statement that makes curative claims--or that offer a time frame on how long it takes the product to work.
"What we're selling are supplements, not drugs," he says. "Supplements are designed to supplement the body's ability to repair itself, not to independently come and take charge and cure the problem."
Hartog points to the market explosion a few years back of liquid joint supplements: "A number of those products, when they first came to the market, were sold with claims of results within four or five days. When you think about it and consider the arthritis foundations around the world that are spending billions and billions of dollars to find a cure for arthritis, it's a little bit of a stretch to think the horse industry was able to come along and do it."
Underscores Traylor: "Product claims can be found for just about everything in the marketplace. Buyers should use their common sense and the old adage of 'buyer beware.' If it sounds too good to be true, then it probably is."
Best bet: Before you arrive at the tack store, try to find out through veterinary advice, articles, or the experience of knowledgeable horse professionals (trainers, farriers, etc.) and other trusted horse owners about what kinds of nutraceuticals--and which kinds of active ingredients--are useful for particular conditions.
Look for red flags--Because nutraceutical labels might not contain all the listed ingredients, the consumer is stuck not really knowing for sure what's in the product. "There is a tremendous amount of naiveté amongst consumers," Hartog says. "They make the assumption that every manufacturer is acting in good faith. That's clearly not the case."
Applying the "if there's smoke, there's fire" approach, look for red flags in other areas, such as:
- Undecipherable per serving amounts of each ingredient. "You have to wonder why the manufacturer would not be prepared to provide the servings on their packaging so that consumers can, in the store, know what the amount per day of that particular ingredient is going to be fed to that horse," Hartog says.
- Products without lot numbers and expiration dates. Lot numbers are important to identify the batch samples in case a problem arises with the product, Hartog says. Expiration dates are necessary to assure product ingredients are still viable. Notes Hartog, "Vitamins are quite volatile, particularly when blended with minerals. Their potency can diminish quite dramatically. If there is no expiration date visible on the product or no lot number, why? That would be a very significant red flag."
- A considerably cheaper product listing the same ingredient profile as other products. "We all pay more or less the same for the raw materials," Hartog says. "Although bigger manufacturers get some incentives for their raw material supplies, it's nothing really dramatic. So if one product is selling for $60 and another is selling for $40, ostensibly with the same kind of ingredient profile, I'd wonder why."
Get out your calculator--If per-serving amounts of particular ingredients are an issue, Hartog suggests that you take your calculator to the store and use the following formula to accurately read the levels of active ingredients in the product on a per-serving basis:
1. For parts per million, multiply by 0.0001 to get a percentage.
2. Multiply that percentage by 453,592 (number of milligrams in a pound) to get the number of milligrams of active ingredient per pound serving.
3. To determine the amount of active ingredient in a serving, adjust the number from step 2 to reflect the serving amount recommended on the label. For example, for a one-ounce serving, divide the step 2 number by 16 (the number of ounces in a pound). You then have the number of milligrams for each one-ounce serving. As another example, if you are feeding a vitamin/mineral-enhanced feed product, you would multiply the step 2 number by however many pounds are in one serving.
Changes on the Horizon
Although these suggestions don't offer complete resolution in solving label riddles, change might be on the way.
Notes Traylor, "The FDA has proposed Labeling and Manufacturing Standards For All Human Dietary Supplements. I am fully aware that they are not considered animal feed products; however, it does offer some insight into the quality and manufacturing standards that firms (which manufacture animal supplements) would be required to follow. Products that fail to meet the minimum guarantees would be considered to be adulterated under state and federal laws." Details about the proposal can be found at www.fda.gov/bbs/topics/NEWS/2003/NEW00876.html and could provide clues as to the kind of regulations the FDA would like to see applied to the animal nutraceutical industry.
Nutraceutical manufacturers of animal supplements are also pressing for uniformity and standards from within. The National Animal Supplement Council (NASC), a voluntary association of pet and equine nutraceutical manufacturers, is trying to work with the FDA and AAFCO toward producing equitable legislation and regulations concerning the safe manufacture and accurate labeling of high-quality animal health care supplements (see Supplement Regulation News). Among other requirements, NASC members would adopt certain quality manufacturing processes, maintain an adverse event reporting system, place an NASC logo on their products to signify the product meets NASC standards, and define consistent, uniform, and user-friendly label protocols. Read more about NASC at www.nasc.cc.
But until these changes are implemented, deciphering most nutraceutical labels is still somewhat a matter of interpretation.
About the Author
Marcia King is an award-winning freelance writer based in Ohio who specializes in equine, canine, and feline veterinary topics. She's schooled in hunt seat, dressage, and Western pleasure.
POLL: Colic Surgery