Infant Formula Evaluating the Safety of New Ingredients (2004) / Chapter Skim
Currently Skimming:
Pages 186-203
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 186... ...
The committee was requested to apply the recommended tools and approaches to the specific situation of adding long-chain polyunsaturated fatty acids (LC-PUFAs) to infant formulas and to consider another example of a specific ingredient, if appropriate.
|
From page 187... ...
and DHASCO (docosahexaenoic acid-rich single-cell oil) in infant formulas.
|
From page 188... ...
(See Sidebar C) FIGURE D-1 Proposed process for evaluating the safety of ingredients new to infant formulas algorithm: Application by using the long-chain polyunsaturated fatty acid Generally Recognized as Safe (GRAS)
|
From page 189... ...
No 6 10 7 DISCONTINUE Neurological Safety Assessment DISCONTINUE PROCESS (See Figure D-3) PROCESS FIGURE D-2 Proposed preclinical assessment algorithm: Application by using the long-chain polyunsaturated fatty acid Generally Recognized as Safe (GRAS)
|
From page 190... ...
No 9 6 5 Continue to clinical Re-evaluate results before DISCONTINUE studies considering clinical trials PROCESS FIGURE D-3 Proposed levels of preclinical assessment algorithm: Application by using the longchain polyunsaturated fatty acid Generally Recognized as Safe (GRAS) Notifications 000041 and 000080 as a case study.
|
From page 191... ...
Sidebar B: Clinical Endpoints Assess symptoms and adverse laboratory indicators in the following: - Gastrointestinal tract - Kidney * - Blood - Immunological system 4 - Endocrinological system Abnormal growth or Assess absorption, distribution, adverse effect/event on Yes metabolism, and excretion of specific organ, immune, or ingredient where appropriate endocrine systems Sidebar C: No Developmental-Behavioral Assessment 6 *
|
From page 192... ...
No 4 Evidence of effect/adverse Yes event? No 9 5 Continue to DISCONTINUE neurobehavioral clinical PROCESS studies FIGURE D-5 Proposed levels of clinical assessment of major organ, immune, and endocrine systems algorithm: Application by using the long-chain polyunsaturated fatty acid LC-PUFA Generally Recognized as Safe (GRAS)
|
From page 193... ...
- Avoid over-control of mediator variables OR Yes - Use measurement aggregation Evidence of significant - Use repeated measures individual difference in susceptibility to the ingredient? Sidebar B: Level 1 Assessment No 11 Neural and behavioral screening measures administered during a routine Known or theoretical well-baby physical exam or through indirect link to other Yes parent reports.
|
From page 194... ...
Yes 8 Expert panel makes recommendations to 7 Lev el 3 Assessment: regulatory agency about 12 Initiate studies at level and type needed long-term safety status of Continue surveillance to establish safety of formula formula with new ingredient (See Sidebar B) and whether further long-term follow-up is needed FIGURE D-7 Proposed in-market surveillance algorithm: Application by using the long-chain polyunsaturated fatty acid Generally Recognized as Safe (GRAS)
|
From page 195... ...
Figure D-8 provides an overview of the proposed process. Probiotics have a history of safe use in infant formulas in other countries, and a review of the scientific literature showed no significant adverse events linked to these ingredients.
|
From page 196... ...
FIGURE D-8 Proposed process for evaluating the safety of ingredients new to infant formulas algorithm: Application by using the probiotics Generally Recognized as Safe (GRAS) Notification 000049 as a case study.
|
From page 197... ...
Organ level studies - Gastrointestinal tract - Hepatic No - Renal - Hematology - Immune - Endocrine - Neurologic 5 Any positive test for toxicity or concern for Yes safety? No 6 10 7 DISCONTINUE Neurological Safety Assessment DISCONTINUE PROCESS *
|
From page 198... ...
No 4 Any evidence of adverse effect/event or concern Yes for safety? No 9 6 5 Continue to clinical Re-evaluate results before DISCONTINUE studies considering clinical trials PROCESS FIGURE D-10 Proposed levels of preclinical assessment algorithm: Application by using the probiotics Generally Recognized as Safe (GRAS)
|
From page 199... ...
Sidebar B: Clinical Endpoints Assess symptoms and adverse laboratory indicators in the following: - Gastrointestinal tract - Kidney * - Blood - Immunological system 4 - Endocrinological system Abnormal growth or Assess absorption, distribution, adverse effect/event on Yes metabolism, and excretion of specific organ, immune, or ingredient where appropriate endocrine systems Sidebar C: No Developmental-Behavioral Assessment 6 Assess: - Sensory and motor function *
|
From page 200... ...
Lev el 1 Assessment in the following: (See Sidebar A) - Gastrointestinal tract - Liver - Kidney - Blood 8 - Immune - Endocrine Evidence of (See Tables 6-3, 6-5, 6-6, 6-8, and 6-9)
|
From page 201... ...
Neural and behavioral screening 11 measures administered during a routine Known or theoretical well-baby physical exam or through indirect link to other Yes parent reports. (See Table 6-10)
|
From page 202... ...
- The location of those infants participating in the clinical trials should be tracke d after the trials are over. No 3 11 Lev el 2 Assessment: Convene an expert panel (in consultation with Any adverse effect/event the regulatory agency)
|
From page 203... ...
Their application also shows the importance of standardized elements and frameworks when considering the safety of new ingredients added to infant formulas.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.