pet supplements primer - venable llp...2006/05/16  · that vitamin e serves as an antioxidant in...

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Dietary supplements for animals, which are considered a subset of ani- mal feeds under FDA regulations, are regulated by FDA’s Center for Veteri- nary Medicine (CVM) in cooperation with state and local authorities. CVM partners particularly closely with the Association of American Feed Control Officials (AAFCO). The use of animal feeds, like human food, is governed by the federal Food, Drug, and Cosmetic Act (FDCA). Ingredients In 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 at least one or more of the following ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use to supple- ment the diet by increasing total dietary intake; or a concentrate, met- abolite, constituent, extract or combi- nation of any of the previously men- tioned ingredients. The main effect of DSHEA was to remove certain dietary ingredients from regulation as food additives, which requires premarket approval. However, in 1996, CVM announced that DSHEA does not apply to animal products. Thus, many substances that are permitted in human dietary supplements may not be legally sold in animal supplements. In announcing that DSHEA does not apply to animal products, CVM rea- soned that many substances that qual- ify as dietary supplements for human consumption, such as botanicals, have a history of use in humans that can be used 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, and even small doses can cause adverse effects. Moreover, each animal species requires different nutrients, absorbs and metabolizes nutrients differently, and can exhibit different toxic reactions to food and its components. In general, the FDCA requires that animal feeds be pure and wholesome, contain no harmful or deleterious sub- stances, and be truthfully labeled. Specifically, only those substances that are (1) listed as generally recognized as safe (GRAS) in FDA regulations at 21 C.F.R. Part 582; (2) listed as an approved food additive in FDA regula- tions at 21 C.F.R. Part 573; or (3) listed as a defined ingredient in the Official Publication of the Association of American Feed Control Officials (the AAFCO book) are permitted in animal feeds, includ- ing animal/pet supplements. Many unapproved ingredients are currently marketed for use in animal supplements. Some of these include burdock, comfrey, echinacea, ginseng, horsetail and nettles. Currently, none of these ingredients is permitted for use in pet supplements. Claims Because 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 animal supplements. 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) that establish the intended use of the prod- uct to affect the structure or function of the body of animals in a manner other than via nutrition, aroma, or taste causes the product to be a drug. Ac- cordingly, CVM categorizes ingredi- ents in animal supplements as one of two types: (1) a nutritional ingredient (intended to provide nutrition); or (2) a non-nutritive ingredient (does not provide nutrition). The AAFCO book contains nutrient profiles for cats and 30 • www.nutraceuticalsworld.com Nutraceuticals World • June 2006 C APITOL C OMMENTS Understanding the rules in the pet supplement market. By Todd Harrison & Michelle Gayeski Pet Supplements Primer Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, func- tional food, biotech, legislative, adulter- ation, labeling and advertising issues. He can 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

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Page 1: Pet Supplements Primer - Venable LLP...2006/05/16  · that vitamin E serves as an antioxidant in the body of animals. Legally Marketing a Pet Supplement In order to ensure that you

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

Page 2: Pet Supplements Primer - Venable LLP...2006/05/16  · that vitamin E serves as an antioxidant in the body of animals. Legally Marketing a Pet Supplement In order to ensure that you

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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