Teat dips are classified as drugs by the Food and Drug Administration (FDA) and are regulated by the Code of Federal Regulations (CFR). To market a teat dip in compliance with the regulations, a manufacturer must: 1) register with FDA all plants where teat dips are manufactured; 2) provide FDA with a list of manufactured teat dip products along with respective product labels; 3) label teat dip products according to CFR provisions; and 4) comply with Good Manufacturing Practices found in the CFR. Currently, FDA does not require data on product effectiveness prior to marketing.

Over 20 years ago, the National Mastitis Council (NMC) developed protocols for teat dip manufacturers to use for determining product effectiveness. The original protocols were designated A, B, and C. In 1990, the protocols were revised to reflect new technologies and further ensure standardization of testing procedures. The protocols are no longer referred to as A, B, and C; instead the names have been changed to identify the investigative method used. In addition, protocol A is no longer recommended, nor recognized by the NMC. The revisions do not invalidate or change the meaning of studies conducted using the original protocols, or require that they be redone.

Remember, the NMC does not test teat dip products, nor does NMC approve or endorse specific products. NMC recommends the use of teat dips that comply with FDA regulations and have been shown to be effective under controlled, scientific studies. Before using or recommending a product, request written information from the manufacturer or distributor on compliance with FDA regulations and results of effectivenesss studies.

Source: National Mastitis Council Newsletter "Udder Topics", Vol. 18, No. 3, June 1995