Animal Remedy Program

South Dakota is one of the few states that has an animal remedy program. Please note that South Dakota does not allow hemp byproducts or components and CBD or CBD derivatives in animal remedy products until it is determined to be a safe additive for the animal class per FDA.

An Animal Remedy is defined as all drugs, combinations of drugs, proprietary medicines, biological products, and combinations of drugs and other ingredients other than for food or cosmetic purposes, which are prepared or compounded for animal use. SDCL 39-18

Any articles that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; or anything that is intended to affect the structure or function of the body of the animal (that isn’t food). Animal Remedy products contain mostly ingredients that are not approved in AAFCO, although not just any ingredients are allowed. The ingredients must be justifiable with the claims that are being made, and support of the claims will need to be provided to state officials if they are requested. With remedies/health supplements, the intended use needs to be non-nutritional, and all the approved ingredients need to play to the intended use (joint support, for example) in a non-nutritional way. Sometimes approved ingredients can have dual benefits, but the ultimate question is why is the company using the approved ingredient in the product?

Who needs to register an animal remedy product?

Before being distributed in South Dakota, each animal remedy shall be registered by the manufacturer or the person responsible for distributing the animal remedy.

Any person who is registering the animal remedy product will register the products online at https://apps.sd.gov/doa/prrs/companysearch.aspx.

All animal remedy products will need to have an accompanying label. FDA/CVM numbers that are required on the label will be cross-referenced with the FDA for approval, conditional approval, or not approved status.

The fee for animal remedies registration is $75 per product. There is no license for animal remedy products.

What needs to be on an animal remedy label?

All labels for feed or animal remedies are reviewed. The main things that are looked at are the claims that are being made along with if the product provides more nutritional value for the animal rather than the structure or function. Contents of the animal remedy label include:

  • The name and principal addresses of the manufacturer or person responsible for placing such animal remedy on the market;
  • The name, brand, or trade-mark under which the animal remedy is sold;
  • An accurate statement of the minimum net contents of the package, lot, or parcel, such contents stated by weight in the case of solids, by volume in the case of liquids, and by both count and weight or volume per dose in the case of dosage forms;
  • The common or usual name and quantity of each active ingredient;
  • Adequate directions for use;
  • Adequate warnings against use in those conditions, whether pathological or normal, where its use may be dangerous to the health of animals, or against unsafe dosage, methods, or duration of methods, administration, or application in such manner and form as are necessary for the protection of animals.

If you have further questions, please reach out to Feed and Remedy Team.