Nutraceuticals: myth or must? (Proceedings)
Close to 30% of pet owners have used or considered the use of novel ingredients (eg, nutraceuticals and herbs/botanicals) in their animals. In the USA, approximately 90% of veterinarians sell some type of novel ingredient and the current market of veterinary novel ingredients is between $20 and $50 million per year. The American Veterinary Medical Association recognizes the importance of these medicaments through its guidelines regarding complementary or alternative medicine, which includes veterinary nutraceutical therapy. In Europe and other nations, the use of herbs/botanicals in particular enjoys a long historical use of general acceptance. However, despite the economic and medical impact of novel ingredients, their use is and should be controversial. Much more than drugs, the use of novel ingredients is complicated by issues regarding their safety, efficacy and manufacturing. The term nutraceutical is not a legal term, but was coined in the 1980's by a physician referring to oral compounds were neither nutrients nor pharmaceuticals. The North American Veterinary Nutraceutical Council (now defunct) was formed in 1996 by interested persons in industry, practice and academia. It defined a veterinary nutraceutical as "a [non-drug] substance which is produce in a purified or extracted form and administered orally to a patient to provide agents required for normal body structure and function and administered with the intent of improving the health and well-being of animals." The commonality among novel ingredients products is that legally they are neither food, food additives nor drugs (as recognized by the Food and Drug Administration (FDA) of the USA). As such, they undergo no premarket approval process and neither safety, efficacy nor manufacturing is assured. At least two groups in the USA have formed in North America with an interest in veterinary nutraceuticals: the Nutraceutical Alliance ( http://www.nutraceuticalalliance.com/) based in Canada, and the National Animal Supplement Council (NASC; www.nasc.cc), based in the USA. The latter group has taken an aggressive approach in trying to implement voluntary actions among nutraceutical manufacturers that will cause regulators to respond to their products in a positive fashion.
Novel ingredients often are used without doctor supervision. Up to 70% of humans do not report herbal use to physicians, in part because of their failure to recognized the products as drugs. Likewise, pet owners often do not cite nutraceutical or herbal use when queried regarding drug therapy for their pet. The availability through medically recognized and trusted sources often leads the consumer to assume both their accuracy in labeling, efficacy and safety. Yet, the lack of regulations and guidelines should lead to the "buyer beware".
LabelingNo mechanism (other than voluntary) exits to hold a manufacturer accountable for the labeling of a novel ingredient. Yet, the novel ingredient that is inappropriately labeled negatively impacts both safety and efficacy. Strong consideration should be given to purchasing those products for which assurance in manufacturing can be obtained. Manufacturers should be queried about the accuracy of their label and all aspects of their manufacturing program, with an emphasis on which "Good Manufacturing Program" they follow. The manufacturer also should be queried regarding its participation in any of the programs that offer evidence of quality assurance, such as exists in the USA: ConsumerLab's ( http://www.consumerlab.com/) certification seal; the Institute for Nutraceutical Advancement, or trade associations (eg, NASC when available). Several sources of scientific information indicate the need to focus on those products whose quality assurance can be verified. Chondroitin sulfates (CDS), an expensive ingredient of many "joint" targeted products, offers an example of consistent mislabeling. A study, funded in part by Nutramax Laboratories, found deviations from label claims for CDS in 84% (9 of 11) of the products studied; the amount by which products were mislabeling ranged from 0 to 115%.3 Further, the study found products costing less than or equal to $1 per 1200 mg CDS were seriously deficient (than 10% of the label claim), suggesting that cheaper products should be avoided. However, expense did not guarantee accuracy. Several of the most expensive products also were found in this study to be mislabled. Consumer Lab has found similar results: at least 50% of products containing CDS are mislabled. Two of three veterinary products contained no chondroitin despite labels that noted otherwise. In contrast to CDS, glucosamine is much more likely to be accurately labled in regard to content. Consumer Laboratory ( http://www.Consumerlabs.com/) is a for-profit laboratory that offers a seal of "validation" for dietary supplements sold in the USA that are appropriately labeled. Products that pass analysis are allowed to place the ConsumerLab seal on the product label. The public can access selected information from the Consumer Lab web site for a fee ($20 annual at the time of this printing) for ingredients that have been tested. Criteria for passing and failing and reasons for failure for specific ingredients can be accessed, as can a list of proprietary products that have passed. Ten of the ingredients studied by Consumer Lab and listed at their web site have been used in veterinary medicine (although none of the products are veterinary). Yet, products of only four ingredients (glucosamine, co-enzyme Q, iron and methosulfone [MSM]) were accurately labeled at least 80% of the time. Reasons for failure ranged from unacceptable inaccuracy in labeling of product content to contamination (with heavy metals or pesticides). Among the pass products was Cosamine®, the human version of Cosequin® DS for dogs, manufactured by Nutramax Laboratories. The presence of a "seal of verification", unless from a recognized, reputable source, does not necessarily indicate sufficient quality in manufacturing. The presence of a lot number and expiration date offers some evidence of accuracy in labeling. Labels should contain a list of ingredients and the intended use of the product. Ingredients should be listed by their common name in decreasing order of magnitude based on weight. Note that for selected herbs, the total constituents may not be known. Additionally, the number of constituents in herbs can be overwhelming: garlic alone contains over 200 active ingredients. Because the ingredient content can vary with the portion of the plant, the source of the plant (leaf, flower, root, stem) should be included. Labeling techniques may contribute to the advent of adverse effects. Manufacturers may improperly identify plants. Even if properly identified, the consumer may have difficulty identifying a product as potentially dangerous because an herbal agent may be referred to by many different names or an herbal name may be used in lieu of the more easily recognized chemical name (eg, guarana for ephedrine or mahuang for caffieine). The FDA has become more proactive in directing manufacturers to list generic drug names in lieu of or in addition to herbal names; however, consumers may have to look closely.
Adequate directions for use also should be provided. Absence of any of this information should cause the user of the product to look for alternative products. Products whose labeling is accompanied by scare tactics, exaggerated claims and testimonials should be avoided as should products whose label includes medical claims, such as " for use in the prevention or treatment of", or intended to changes in body structure or function".