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OCR for page 175
Infant Formula: Evaluating the Safety of New Ingredients
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 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
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Infant Formula: Evaluating the Safety of New Ingredients
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
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Infant Formula: Evaluating the Safety of New Ingredients
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
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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.