Bovine somatotropin (bST) is an animal drug approved by FDA to increase milk production in dairy cows. This drug is based on the growth hormone naturally produced in cattle. Growth hormone is a protein hormone produced in the pituitary gland of animals, including humans, and is essential for normal growth, development, and health maintenance. In the 1980s it became technically possible and economically feasible to produce large quantities of bST by a process using biotechnology.
FDA approved a bST product in 1993 after determining that its use would be safe and effective. Part of FDA’s safety evaluation was to ensure that milk from treated cows was safe for human food.
For more information about bST, see the following references.
- October 30, 2013
Report on U.S. Dairy Industry Demographics, Mastitis Incidence, and Antibiotic Residues in Milk Since the FDA Approval of Recombinant Bovine Somatotropin in 1993(PDF - 191KB)
- February 10, 1999
Report on the Food and Drug Administration's Review of the Safety of Recombinant Bovine Somatotropin
Freedom of Information Summary
NADA 140-872 - original approval(PDF - 660KB)
- NADA 140-872 Posilac 1 Step® - 2001 supplemental approval (PDF - 231KB)
- NADA 140-872 Posilac 1 Step® - 2003 supplemental approval (PDF - 496KB)
NADA 140-872 - FONSI - Posilac® Sterile Injectable for Cattle(PDF - 535KB) NADA 140-872 - EA - Posilac® Sterile Injectable for Cattle(PDF - 4.1MB)