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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