Food and Drug Administration Policy

The U.S. Food and Drug Administration policy is based on the conclusions of the Joint FAO/ WHO Expert Committee on Food Additives (JECFA). In its Thirty-Second Report (1988), it concluded, on the basis of its safety assessment of residues of estradiol-17/3, progesterone, and testosterone, and in view of the difficulty of determining the levels of residues attributable to the use of these hormones as growth promoters in cattle, that it was unnecessary to establish an acceptable residue level. As to trenbolone acetate (TBA), a synthetic steroid with anabolic properties, JECFA concluded that its safety assessment could be based on establishing the no-hormonal-effect level. It therefore recommended a maximum residue level of 2 /zg/kg for /3-tren-bolone in meat and of 10 /xg/kg for a-trenbolone in liver on the basis of a daily intake by a 70-kg person of 500 g of meat. /3-Trenbolone is the major metabolite in muscle. For zeranol, an acceptable residue level of 10 /xg/kg for bovine liver and 2 /zg/kg for bovine muscle was established. 

Food and Drug Administration Policy Statement for the Development of New Stereoisomeric Drugs. Chirality 1992, 4, 338. 

Merkatz RB, Temple R, Sobel S, Feiden K, Kessler DA. Women in clinical trials of new drugs. A change in Food and Drug Administration policy. The Working Group on Women in Clinical Trials. N Engl J Med 1993 329 292-6. 

United States Food and Drug Administration (U.S. FDA), Food and Drug Administration Policy Statement for the Development of New Stereoisomeric Drugs (May 1, 1992 last updated July 6, 2005). Available online. URL www.fda.gov/cder/guidance/stereo.htm. Accessed February 12, 2006. Provides guidelines for testing and separation of chiral drugs. 

Statement of FDA recall policy, by A. M. Schmidt (Commissioner, Food and Drug Administration), Sept. 21, 1973. 

FDA. 1992a. Lead in ceramic foodware revised compliance policy guide availability. Department of Health and Human Services, Food and Drug Administration, Washington, DC. Federal Register... 

United States Food and Drug Administration.(1992). FDA s policy statement for the development of new stereoisomeric drugs. Chirality 4, 338-340. 

In 1977, The Food and Drug Administration initiated a warning label policy in light of inconclnsive evidence that the sweetener might cause cancer in high doses. Their increased application in food and drink products has given a new impetus to develop fast and accmate methods for their determination. 

Kessler DA, Wilkenfeld JP, Thompson LJ (1997). The Food and Drug Administration s rule on tobacco blending science and Law. Pediatrics 99(6) 884-887 Koop EC (2004) Tobacco the public health disaster of the twentieth century. In Boyle P, Gray N, Henningfield JE, Seffrin J, Zatonski W (eds) Tobacco and public health science and policy. Oxford University Press, Oxford, UK, pp v-xvii... 

The interest of the Food and Drug Administration (FDA) in compounding by and for veterinarians dates back to the early 1990s. The avowed purpose of the symposium in 1993 was to provide a forum for a eomprehensive, public debate in response to the Ameriean Veterinary Medieal Assoeiation (AVMA) position on eompormding prior to the issuanee of the FDA Compliance Policy Guide on veterinary eompotmd-... 

The views expressed above are the personal views of the authors. The content of this article does not necessarily reflect the views or policies of the Food and Drug Administration, nor does the mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. 

Food and Drug Administration (FDA). Guidance for Industry - Computerised Systems Used in Clinical Trials. RockviUe, MD Division of Compliance Policy, 1999. 

Office of Medical Policy, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Silver Spring, Maryland, U.S.A. 

Quality assurance personnel must have the appropriate training, experience, familiarization with the manufacturing facility and products, enforced independence from the production chain of command, and the ability to review adherence to procedures, policies, and agreed-upon approaches to manufacturing quality pharmaceuticals. This helps to provide both an environment and a manufactured product that can withstand Food and Drug Administration (FDA) inspection and support a firm s reputation for quality products. 

The many worst-case assumptions built into cancer risk assessments are there because of policy decisions, not because of scientific ones, and they confuse attempts to allocate money effectively for public health. For example, EPA estimates of synthetic pesticide residues in the diet have used the theoretical maximum human residue that is anticipated under the most severe field application conditions, which is often a large overestimate compared to the measured residues in food. Despite the EPA s estimated high risks from exposures to several pesticides, the U.S. Food and Drug Administration detected no residues of those pesticides in the food samples in its Total Diet Study.59... 

Food and Drug Administration, in Extra-Label Lise of New Animal Drugs in Food-Producing Animals, Compliance Policy Guide 7126.06, Food and Drug Administration, Rockville, M.D. (1986). 

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