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 Likewise, pet owners often do not cite nutraceutical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".
Labeling
No 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".
