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Guidance Issuing OfficeCenter for Veterinary MedicineOffice of Regulatory Affairs
Teat dips are drugs that are applied to the teats of lactating animals immediately following milking and removal of the milking machine to control the spread of mastitis. Since the control of mastitis is inherent in the purpose for using teat dips, the control of mastitis constitutes their intended use whether or not specifically labeled for this purpose. In the FEDERAL REGISTER of August 9, 1977 (42 FR 40217), the agency published a proposed regulation which would designate teat dips as new animal drugs and require them to be subject to approved NADAs. The proposed regulation has not been finalized. The comments submitted in response to the proposal and other factors have resulted in a reevaluation of the intended regulation. This Guide establishes agency policy pending final disposition of the proposed regulation.
There are many products being marketed which are intended and labeled for cleansing the udders of lactating cows and goats prior to milking. Use of these products is consistent with the Grade "A" Pasteurized Milk Ordinance (1965 Recommendation of the United States Public Health Service) which includes the following statements:
The udders and teats of all milking cows shall be cleaned and treated with a sanitizing solution just prior to the time of milking, and shall be relatively dry before milking. Udder washes may be classified as animal drugs if formulated to contain one or more antimicrobial chemicals as active ingredients, and labeling includes claims for controlling mastitis or the spread of mastitis, or labeling includes other claims for controlling microorganisms in or on the animal.
Teat dips and udder washes classified as drugs, may currently be marketed without NADA approval. At some future time, these drug products may be required to comply with the NADA approval requirements of Section 512 of the Act.
Udder wash products promoted as cleansing agents and not classified as drugs could be required to be the subject of food additive regulations unless they are considered GRAS. This decision will be made on individual products based on directions for use and potential to contaminate milk and dairy products.
We do not expect to take regulatory action against teat dip and udder wash drug products on a 501(a)(5) charge unless we have specific information that a particular product may be harmful, or ineffective. The *Center for* Veterinary Medicine will continue to review the labeling of all teat dip and udder wash products and provide comment on their regulatory status and appropriateness of the labeling.
Manufacturers of teat dips and udder washes falling within the drug definition are subject to the registration and drug listing requirements of Section 510 of the Act. Part 211 of the GMP regulations is applicable to the manufacture of teat dips and drug udder washes.
*Material between asterisks is new or revised*
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0632.