The FDA and the Life Sciences Research Office (LSRO) of the Federation of American Societies for Experimental Biology (FASEB) are holding an open meeting on the review of infant formula nutrient requirements for preterm infants on March 26, 1997. (Docket No. 96N-0391) This meeting is open to the public and is intended to allow public comment regarding the subject on the docket. For further information contact: Daniel J. Raiten, Life Sciences Research Office, FASEB. 301-530-7030 or Linda H. Tonucci, Center for Food Safety and Applied Nutrition (HFS-456), Food and Drug Administration 202-205-5372
The FASEB can provide copies of the Federal Register (Vol 62, No. 22, Feb. 3, 1997 and Vol. 61, No. 222, Nov. 15, 1996) that detail the mission of the FASEB review of infant formula guidelines.
Specifically, note items 6-8 which address LCPUFA's (long-chain poly-unsaturated fatty acids):
"6) Does available evidence establish the essentiality of addition of subcomponents of the macronutrients (specifically, taurine, carnitine, and LCPUFA's to formulas for preterm infants, and if so, does the evidence establish what the amount and ratios of these compounds should be in the formula? For example, the Canadian Guidelines for the Composition and Clinical Testing for Formulas for Preterm Infants (p.17) finds that term infant formulas that contain adequate and balanced 18:2n-6 and 18:3-3 fatty acids do not require addition of the 20 and 22 carbon n-6 and n-3 fatty acids.
7) Is there available evidence to suggest that this result also applies to preterm infant formulas? If so, is there an optimum level and ratio of 18:2n-6 and 18:3n-3 fatty acids in formulas for preterm infants?
8) Does the available evidence address the issue of safety of various sources of these LCPUFA's for use in preterm infant formulas? If so, is there a safe source of LCPUFA's?"
"Under its contract with the FDA, FASEB will provide the agency with its scientific report on or about September 30, 1997."
How about that?
Onward...
Mark |
