Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Look up keyword
Like this
2Activity
0 of .
Results for:
No results containing your search query
P. 1
Safety of Dietary Supplements for Horses, Dogs, and Cats, Report in Brief

Safety of Dietary Supplements for Horses, Dogs, and Cats, Report in Brief

Ratings: (0)|Views: 180|Likes:
Published by earthandlife
Growing numbers of pet owners are giving their pets dietary supplements in hopes of supporting their health. This increased use of animal dietary supplements has raised concerns regarding the safety of specific supplements and the guidelines for determining safety of dietary supplements for horses, dogs, and cats. At the request of the Food and Drug Administration (FDA), the Natural Research Council convened a committee of experts to assess the safety of supplements in general and to review three specific supplements (lutein, evening primrose oil, and garlic) offered for horses, dogs, and cats. This report concluded that because of inadequate data, an upper limit of safe use of lutein, evening primrose oil, and garlic could not be determined but could cite historical safe intakes (HIS) and estimate presumed safe intakes (PSI) based on available research findings. The report also stresses that clear and precise regulations need to be established.
Growing numbers of pet owners are giving their pets dietary supplements in hopes of supporting their health. This increased use of animal dietary supplements has raised concerns regarding the safety of specific supplements and the guidelines for determining safety of dietary supplements for horses, dogs, and cats. At the request of the Food and Drug Administration (FDA), the Natural Research Council convened a committee of experts to assess the safety of supplements in general and to review three specific supplements (lutein, evening primrose oil, and garlic) offered for horses, dogs, and cats. This report concluded that because of inadequate data, an upper limit of safe use of lutein, evening primrose oil, and garlic could not be determined but could cite historical safe intakes (HIS) and estimate presumed safe intakes (PSI) based on available research findings. The report also stresses that clear and precise regulations need to be established.

More info:

Categories:Types, Research, Science
Published by: earthandlife on Apr 08, 2011
Copyright:Attribution Non-commercial No-derivs

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

12/07/2013

pdf

text

original

 
Safety of Dietary Supplements forHorses, Dogs, and Cats
Growing numbers of pet owners are giving their pets dietary supplements in hopesof supporting their health. This increased use of animal dietary supplements has raised
concerns regarding the safety of specic supplements and the guidelines for determining
safety of dietary supplements for horses, dogs, and cats. This report examines issuesin determining safety of animal dietary supplements in general, and the safety of threeanimal dietary supplements; lutein, evening primrose oil, and garlic, in particular.
L
ike many people who takemultivitamins and other supplementsto support a healthy lifestyle,growing numbers of pet owners are also givingsupplements to their pets for similar reasons. Itis estimated that between 10 to 33 percent of dogs and cats in the United States are fed ananimal dietary supplement, with some of thesame supplements being fed to horses. But arethese supplements safe for pets?The increased use of animal dietarysupplements has raised several concerns. Amongthe issues involved are the safety
of specic dietary supplements,
the general approaches taken todetermine the safety of animaldietary supplements, the monitoringof adverse effects, and the state of the regulation of animal dietarysupplements.To assist in making decisionsabout the safety of dietarysupplements for horses, dogs, and cats, theFood and Drug Administration (FDA) askedthe Natural Research Council to produce areport on the safety of supplements in general
and to review three specic supplements
(lutein, evening primrose oil, and garlic)offered for horses, dogs, and cats. A committeeof experts, consisting of animal nutritionist,veterinarians, clinical pharmacologists, andtoxicologists, was established for this purpose.The committee addressed safety only; utility
or efcacy of animal dietary supplements was
not part of its task.The committee found that there was alack of quality safety data available for thesupplements lutein, evening primrose oil, andgarlic, that would be required to determinesafety in drugs and animal food additives.Therefore, the committee could only report
BOX 1:
Denition: Animal Dietary Supplement
Animal dietary supplements are dened as any substance for oral
consumption by horses, dogs, or cats, whether in/on feed or offered
separately, intended for specic benet to the animal by means
other than provision of nutrients recognized as essential or for  provision of essential nutrients for intended effect on the animal
 beyond normal nutritional needs, but not including legally dened
drugs.
 
on historical safe intakes (HSI) and estimate a presumed safe intake (PSI) for the three animaldietary supplements (see opposite page). The presumed safe intake (PSI) was estimated byreviewing evidence to determine a level at which
the animal health or production efciency were
not impaired. While the historical safe intake(HSI) was based on the known levels consumed by wild or domestic animals over long periods of time with no apparent ill effects.Despite these limitations, the committee took this opportunity to review the general issues of 
animal dietary supplement safety. They identied
a number of data elements for consideration whenconstructing any framework for assessing animaldietary supplement safety that may be differentfrom those routinely considered for prescriptiondrugs.
REGULATION OF DIETARYSUPPLEMENTS IN THE UNITED STATES
Dietary supplements for both humans andanimals are subject to regulation under the FederalFood, Drug, and Cosmetic Act (FFDCA). The wayin which human dietary supplements are regulatedwas amended by the passage of the DietarySupplement Health and Education Act (DSHEA)in 1994, but the Food and Drug Administrationconcluded that the Act does not apply todietary supplements for animals. Thus, dietarysupplements for humans and dietary supplements,despite often being the same substance, givenin the same manner, and for the same purpose.Currently the FDA and other regulatory bodiesare under pressure to resolve the public’s desire to provide some of the same supplements availableto humans to their animals.
ASSESSING SAFETY OF ANIMAL DIETARYSUPPLEMENTS
The safety of a supplement, additive, or drugis generally assessed in two ways. Controlledstudies, such as a study looking at the toxicityof a compound, usually done prior to the compound hitting the market,with the intent of identifying potentialadverse events (box 2) associated withthe administration of the compound.And surveillance studies, generally postmarket, done to monitor anticipated or unanticipated adverse events associatedwith general use of the compound.The committee found that in additionto there being limited safety studiesthere are many other factors that further challenge the assessment of animalsupplements safety, including the lack of standardization among active ingredientsin the animal supplement market and thelack of a comprehensive adverse eventreporting system. Because of thesechallenges, other types of evidence, found
BOX 2:
Denition: Adverse Events
As dened by the International Harmonization Conference
(IHC), an adverse event is any untoward medical occurrencethat may present during treatment with a (pharmaceutical) product, but which does not necessarily have a causalrelationship with this treatment.
Expert opinionIn vitro and ex vivo researchPathophysiologic rationaleResearch in other speciesHistorical use/exposureCase series/signalsModels of diseaseEpidemiologic studies
Randomized controlled studies in target species
Meta- analysis
Figure 1 Evidence pyramid
The strength of evidence increases in progression from bottom to top.The guidelines for ranking strength of evidence should be consideredwhen evaluating supplement safety.
 
in the evidence pyramid (gure 1), were reviewed
and should be reviewed when determining safetyof animal supplements such as lutein, evening primrose oil, and garlic.
FINDINGS AND RECOMMENDATIONS
I
n assessing animal dietary supplementsafety, elements such as the relevance of thestudy to safety, dosage, contaminants in thesupplements, and size of the study, all need tobe considered when designing and assessinganimal dietary supplements.
Although theuse of animal dietary supplements is potentiallygreater than the use of drugs or food additives,minimal safety data were available. Ideally, thecommittee would have liked to have adequatedata to determine a no observed adverse effectlevel (NOAEL) for or a safe upper limit (SUL) for each of the three supplements. With the limiteddata currently available, the committee could onlyreport historical safe intakes (HIS) and estimate presumed safe intake (PSI) for garlic (except for cats), evening primrose oil, and lutein.
The use of other species (i.e. non-targetspecies) is important in assessing safety of supplements but is limited.
Because of limitedamounts of data about supplements in the animalsof intended use (i.e. target species), research usingother species can provide important safety signals.Although non-target species provide importantevidence about safety they do not guaranteesafety in the target animals. An example is garlic,although considered safe in humans when taken asa supplement, there is a concern that excess garlicsupplement can cause hemolytic anemia in horses,
dogs, and cats. The committee has identied
several factors that should be considered whenselecting appropriate substitute animals. Factorsto be considered include the metabolic and naturaldietary pattern similarities between surrogate andtarget animals and whether the supplement isnaturally occurring in both animals’ diet.
LUTEIN
Lutein is abundant in green and yellow fruits
and vegetables. The purported benets of 
lutein supplements in humans include:Treatment or prevention of age-related macular degenerationAnti-oxidant and anti-cancer effectProtection against UV radiationAnti-aging effect
ANIMAL
PSI
(mg/kg BW)
HSI
(mg/kg BW)
Note
Horses8.3*8.3*
*When eaten as forage or naturalsources; no data exist for supplements
Dogs1.80.45Cats7.20.85
EVENING PRIMROSE OIL
Evening primrose oil (EPO) is an oil found inthe evening primrose plant. EPO is made up of fatty acids. Two of the fatty acids found in EPOare recognized for their contributions to the maintenance of normal health and metabolism.
ANIMAL
PSI
(mg/kg BW)
HSI
(mg/kg BW)
Note
Horses400*25-80
*Assumes that total fat will not exceed23 percent of diet
Dogs424*
42-424
*Which is the upper limit used in trials
Cats391*
20-391
*It is likely that cats could toleratehigher levels
GARLIC
Garlic has been used in the diet of humans for centuries. Ancient medical text from Egypt,Greece, Rome, China, and India includeprescribed medical applications of garlic. Today garlic is
thought to have numerous health benets including reducing
the risk of cardiovascular disease and cancer, stimulatingimmune function, and restoring physical strength
ANIMAL
PSI
(mg/kg BW)
HSI
(mg/kg BW)
Note
Horses9015Dogs5622*
*There is a long history of safe use.
Catsn/a*17
*The committee was unable to esti-mate a PSI for garlic.
DIETARY SUPPLEMENTS FOR HORSES,DOGS, AND CATS
Presumed safe intake (PSI) and historical safe intake (HSI) aregiven in milligrams per kilogram of body weight (mg/kg BW)

Activity (2)

You've already reviewed this. Edit your review.
1 thousand reads
1 hundred reads

You're Reading a Free Preview

Download
scribd
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->