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 conditional 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 situation 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

Food additive

“Any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming 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 evaluate 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 inorganic, or in some cases psychological) that may, under some circumstances 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 manufactured, prepared, preserved or packaged by a process that (i) has not been previously applied to that food, and (ii) causes the food to

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 characteristics 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 anticipated 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 prepared 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 nutrition (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 reasonable 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 committee 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

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.