Page 68 - COVER__October2020.indd

VETERINARY VIEWS
EQUINE HEALTH SUPPLEMENTS by Nancy S. Loving, DVM
It is commonplace for horse owners and train- ers to look to supplementation of their horse’s diet to maximize health and performance.
Called “nutraceuticals,” such oral products are available in abundance and without prescrip- tion in feed stores and through on-line animal health outlets. The economics of this industry is substantial: The worldwide nutraceutical market for humans and animals has topped $250 billion USD.
A “nutraceutical,” as defined by the Dietary Supplement Health and Education Act of 1994, is a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement
the diet. Depending on its ingredients and its marketing claim, a product is considered either as a drug (affecting form and function), a food, a food ingredient, or a dietary supplement.
WHAT ABOUT REGULATION?
Supplements can claim to support normal health, structure and function and should
be from an FDA-approved list of additives. However, under the Federal Food, Drug
and Cosmetic Act (FFDCA), expressed or implied claims of a product being able to cure, treat, prevent or mitigate disease or affect the structure/function of the body
in a manner other than food may identify
an intent to offer the product as a new animal drug. Statements such as ‘good for joint health’ are found as claims for human nutraceuticals and are commonly printed on horse joint supplements. If a statement says the product is intended for ‘management
of osteoarthritis,’ then the product is considered a drug.
None of the label claims on animal nutraceuticals are approved by the Food
and Drug Administration (FDA). Lack of regulation is a concern and therefore safety and effectiveness may be compromised.
The FDA can regulate animal foods,
additives and supplements; however, the ultimate responsibility for safe and truthful production lies with the manufacturers and distributors. Standards used are formulated
by the Association of American Feed Control Officials (AAFCO) in regard to manufacture, distribution and sale of animal feeds. The FDA is supposed to regulate that the product is safe, but in most cases, this is not enforced due to limited resources to enforce its authority.
While nutraceutical products for horses remain essentially unregulated, there is some oversight by the National Animal Supplements Council (NASC), which audits and certifies manufacturing and packaging sites and tracks adverse events of nutraceutical ingredients. The NASC process is voluntary and does not require pre-market research data in support of the product; instead, the certification process is connected to the manufacturing process with safety data collected post-market. The FDA’s Center for Veterinary Medicine (CVM) has initiated a GRAS (generally recognized as safe) notification process for animal feed ingredients to identify and authenticate the safety and functionality of animal feed ingredients. The limitation to this process is that it is ingredient-
based and therefore cannot predict interactions between ingredients in a complex product. And this process only captures a small portion of ingredients potentially available.
Human nutraceutical products rely
on current good manufacturing practices (cGMP) per regulations implemented by the FDA in 2007. These practices imply that a pharmaceutical company is in compliance with a certain standard of principles and general guidelines that must be followed during the manufacturing process to ensure quality. However, this does not apply to veterinary products because the FDA does
not recognize nutraceuticals for veterinary use. Manufacturers of equine products can make any claims they want. There is limited enforcement action against ‘low risk’ products for non-food animals.
In most cases, claims of efficacy are not supported by efficacy or safety research specific to the product in the intended animal species. This is a serious problem in the industry, and
it puts the consumer in a vulnerable ‘buyer beware’ situation.
CLINICAL TRIALS
Evidence-based medicine relies on repeatable results obtained through research that implements a rigorous scientific method to analyze results. Reliable data is achieved through adequate numbers of live (in vivo) cases conducted in well-controlled studies. In vitro (outside the living animal) studies are the lowest form of substantiation for
None of the label claims on animal nutraceuticals
are approved by
the Food and Drug Administration (FDA).
Be careful not to blindly follow the latest vogue, or only believe what you hear at the latest event, read on a blog or advertisement, or glean from the label about nutraceutical claims that extend beyond nutritional benefits.
66 SPEEDHORSE October 2020