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A Acronyms and Glossary AAP American Academy of Pediatrics ADME Absorption, distribution, metabolism, and excretion ALAT Alanine amino transferase Algorithm “A step-by-step procedure for solving a problem that contains con- ditional logic (if/then) statements” (SMDMC, 1992) ARA Arachidonic acid ASAT Aspartate amino transferase CDC U.S. Centers for Disease Control and Prevention CFSAN U.S. Center for Food Safety and Applied Nutrition CNS Central nervous system DEXA Dual X-ray absorptiometry DHA Docosahexaenoic acid DNA Deoxyribonucleic acid DRI Dietary Reference Intakes Efficacy The capacity to produce an intended effect under the realistic situ- ation of product use FDA U.S. Food and Drug Administration FDA Redbook Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Redbook II-Draft (OFAS, 2001) and Redbook 2000. Toxicological Principles for the Safety of Food Ingredients (OFAS, 2003) FD&C Act Federal Food, Drug and Cosmetic Act 175

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176 INFANT FORMULA: EVALUATING THE SAFETY OF NEW INGREDIENTS Food additive “Any substance the intended use of which results or may reason- ably be expected to result, directly or indirectly, in its becom- ing a component or otherwise affecting the characteristics of any food . . . , if such substance is not generally recognized, among experts qualified by the scientific training and experience to evalu- ate its safety, as having been adequately shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use” (FD&C Act, Section 201(s)) GFR Glomerular filtration rate GMP Good Manufacturing Practices GRAS Generally Recognized as Safe Harm The nature of the undesired outcome (usually a health outcome) associated with a hazard; often expressed in terms such as “cost” Hazard Some substance or combination of substances (organic or inor- ganic, or in some cases psychological) that may, under some cir- cumstances and/or for some individuals, produce undesired health- related outcomes. HDL High-density lipoprotein HHS U.S. Department of Health and Human Services HIV Human immunodeficiency virus HPLC High-performance liquid chromatography IgA, IgE, IgG, IgM Immunoglobulin A, E, G, M Infant formula A food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk (FD&C Act, Section 201(z)) IOM Institute of Medicine IVH Intraventricular hemorrhage LC-MS Liquid chromatography-mass spectrometry LC-PUFAs Long-chain polyunsaturated fatty acids LD50 Lethal dose for 50 percent of the animals used in a study LDH Lactate dehydrogenase LDL Low-density lipoprotein LSRO Life Sciences Research Office MRI Magnetic resonance imaging NHST Null hypothesis significance test Novel food “(a) a substance, including a microorganism, that does not have a history of safe use as a food; (b) a food that has been manufac- tured, prepared, preserved or packaged by a process that (i) has not been previously applied to that food, and (ii) causes the food to

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177 APPENDIX A undergo a major change; and (c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that (i) the plant, animal or microorganism exhibits character- istics that were not previously observed in that plant, animal or microorganism, (ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or (iii) one or more characteristics of the plant, animal or microorganism no longer fall within the antici- pated range for that plant, animal or microorganism” (Canada, 2001) Prebiotic “a non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, and thus improves host health” (Gibson and Roberfroid, 1995) Probiotic “a live microbial feed supplement which beneficially affects the host animal by improving its intestinal microbial balance” (Fuller, 1989) Quality factors Factors necessary to demonstrate that the infant formula, as pre- pared for market, provides nutrients in a form that is bioavailable and safe as shown by evidence that demonstrates that the formula supports the healthy growth when fed as the sole source of nutri- tion (FDA, 1996) Risk Likelihood that an adverse event will occur given exposure to a hazard Safety A reasonable certainty of no harm or, in some systems, a reason- able balance between costs (harm) and benefits Term infants Infants delivered between gestational age of 37 to 42 weeks with birth weights of 2.5 kg or more; safety parameters and commit- tee reviews were limited to healthy term infants with no chronic disease TLC Thin layer chromatography Type I error The probability of falsely rejecting the null hypothesis (i.e., the chance of concluding that a systematic relationship exists in the population when it does not) Type II error Failure to detect a real effect; occurs when one fails to reject a false null hypothesis UL Tolerable Upper Intake Level VLDL Very low-density lipoprotein WHO World Health Organization

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178 INFANT FORMULA: EVALUATING THE SAFETY OF NEW INGREDIENTS REFERENCES Canada. 2001. Departmental Consolidation of the Food and Drugs Act and the Food and Drug Regulations. (Food and Drugs Act). Ottawa: Minister of Public Works and Government Services Canada. FDA (Food and Drug Administration). 1996. Current good manufacturing practice, quality control procedures, quality factors, notification requirements, and records and reports, for the production of infant formula. Proposed rule. Fed Regist 61:36153–36219. Fuller R. 1989. Probiotics in man and animals. J Appl Bacteriol 66:365–378. Gibson GR, Roberfroid MB. 1995. Dietary modulation of the human colonic microbiota. Introducing the concept of prebiotics. J Nutr 125:1401–1412. OFAS (Office of Food Additive Safety). 2001. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Redbook II-Draft. Washington, DC: OFAS, Center for Food Safety and Applied Nutrition, Food and Drug Administration. OFAS. 2003. Redbook 2000. Toxicological Principles for the Safety of Food Ingredients. Online. Center for Food Safety and Applied Nutrition, Food and Drug Administration. Available at http://www.cfsan.fda.gov/ ~redbook/red-toca.html. Accessed November 19, 2003. SMDMC (Society for Medical Decision Making Committee). 1992. Proposal for clinical algorithm standards. Society for Medical Decision Making Committee on Standardization of Clinical Algorithms. Med Decis Making 12:149–154.