pet supplements primer - venable llp...2006/05/16 · that vitamin e serves as an antioxidant in...
TRANSCRIPT
Dietary supplements for animals,which are considered a subset of ani-mal feeds under FDA regulations, areregulated by FDA’s Center for Veteri-nary Medicine (CVM) in cooperationwith state and local authorities. CVMpartners particularly closely with theAssociation of American Feed ControlOfficials (AAFCO). The use of animalfeeds, like human food, is governed bythe federal Food, Drug, and CosmeticAct (FDCA).
IngredientsIn 1994, Congress passed the Dietary
Supplement Health and Education Act(DSHEA), which defines a dietary sup-plement as a product intended to sup-plement the diet and that contains atleast one or more of the followingingredients: a vitamin; a mineral; anherb or other botanical; an amino acid;a dietary substance for use to supple-ment the diet by increasing totaldietary intake; or a concentrate, met-abolite, constituent, extract or combi-nation of any of the previously men-tioned ingredients. The main effect ofDSHEA was to remove certain dietaryingredients from regulation as foodadditives, which requires premarketapproval. However, in 1996, CVMannounced that DSHEA does notapply to animal products. Thus, manysubstances that are permitted inhuman dietary supplements may notbe legally sold in animal supplements.
In announcing that DSHEA does notapply to animal products, CVM rea-soned that many substances that qual-ify as dietary supplements for humanconsumption, such as botanicals, havea history of use in humans that can beused to establish reasonably safe lev-els. However, the same is not true for
many of the same ingredients in ani-mals. Animals may react very differ-ently to substances than humans, andeven small doses can cause adverseeffects. Moreover, each animal speciesrequires different nutrients, absorbsand metabolizes nutrients differently,and can exhibit different toxic reactionsto food and its components.
In general, the FDCA requires thatanimal feeds be pure and wholesome,contain no harmful or deleterious sub-stances, and be truthfully labeled.Specifically, only those substances thatare (1) listed as generally recognized assafe (GRAS) in FDA regulations at 21C.F.R. Part 582; (2) listed as anapproved food additive in FDA regula-tions at 21 C.F.R. Part 573; or (3) listedas a defined ingredient in the OfficialPublication of the Association of AmericanFeed Control Officials (the AAFCO book)are permitted in animal feeds, includ-ing animal/pet supplements.
Many unapproved ingredients arecurrently marketed for use in animalsupplements. Some of these includeburdock, comfrey, echinacea, ginseng,horsetail and nettles. Currently, noneof these ingredients is permitted foruse in pet supplements.
ClaimsBecause CVM has determined that
DSHEA does not apply to animal sup-plements, many claims that are per-mitted for human dietary supple-ments are not permitted for animalsupplements. The courts have inter-preted “food” as a substance that pro-vides nutrition, taste or aroma. Thus,claims on animal feed products(including animal supplements) thatestablish the intended use of the prod-uct to affect the structure or function ofthe body of animals in a manner otherthan via nutrition, aroma, or tastecauses the product to be a drug. Ac-cordingly, CVM categorizes ingredi-ents in animal supplements as one oftwo types: (1) a nutritional ingredient(intended to provide nutrition); or (2)a non-nutritive ingredient (does notprovide nutrition). The AAFCO bookcontains nutrient profiles for cats and
30 • www.nutraceuticalsworld.com Nutraceuticals World • June 2006
CAPITOL COMMENTS
Understandingthe rules in thepet supplement market.
By Todd Harrison& Michelle Gayeski
Pet SupplementsPrimer
Todd Harrison is partner with Venable,which is located in Washington, D.C. Headvises food and drug companies on avariety of FDA and FTC matters, with anemphasis on dietary supplement, func-tional food, biotech, legislative, adulter-ation, labeling and advertising issues. Hecan be reached at 575 7th St. NW, Wash-ington, D.C. 20004; 202-344-4724; E-mail: [email protected].
capitol comments pg. 30-31 5/16/06 2:09 PM Page 30
dogs that list the ingredients consid-ered to be essential nutritive ingredi-ents. According to CVM, a claim thatan animal supplement affects the struc-ture or function of the body based onits nutritive value (a nutritional ingre-dient) is considered a food claim, andthe product will be categorized as afood. For example, calcium is listed asan essential nutritive ingredient in theAAFCO book for both dogs and cats.Thus, a claim that a supplement thatcontains dried milk provides calciumto support proper bone structurewould be a permitted food claim, andthe supplement would be categorizedas a food.
Conversely, a claim that an animalsupplement affects the structure orfunction of the body apart from itsnutritive value (a non-nutritive ingre-dient) is considered a drug claim, and
the product will be categorized as adrug. For example, glucosamine is notlisted as an essential nutritive ingredi-ent in the AAFCO book for either dogsor cats. Thus, a claim that a pet supple-ment helps to improve joint functionbased on glucosamine in the productwould be a drug claim, and the sup-plement would be considered a drug.Moreover, claims for (1) improved orincreased production and perform-ance, (2) alteration or improvement infunction, or (3) treatment or preventionof disease are also considered drugclaims, regardless of whether theingredient is nutritive or non-nutritive.
On a case-by-case basis, CVM haspermitted some exceptions and agreedto exercise regulatory discretion for certain references to “nutritional sup-port” for specific organs or body func-tions. For instance, CVM has explain-
ed that it would not object to a claimthat vitamin E serves as an antioxidantin the body of animals.
Legally Marketing a Pet SupplementIn order to ensure that you are mar-
keting your pet supplement legally,you should be certain that each of theingredients in your pet supplement islisted in one of the following:• FDA regulations at 21 C.F.R. Part 573as an approved food additive;• FDA regulations at 21 C.F.R. Part 582as a GRAS substance; or • The ingredient definitions in theAAFCO book.
You should also make certain thatany claims that your product affects thestructure or function of the body of ani-mals is based on an essential nutritiveingredient, according to the AAFCOnutrient profiles for cats and dogs. NW
Nutraceuticals World • June 2006 www.nutraceuticalsworld.com • 31
CAPITOL COMMENTS
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