Infant Formula Evaluating the Safety of New Ingredients (2004) / Chapter Skim
Currently Skimming:
Pages 29-40
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 29... ...
In the case of infant formulas, this assumption is modified to some degree because it has been proposed that the products must be capable of sustaining physical growth for a specified period of time. Currently, however, manufacturers are not required to demonstrate the benefits of an individual ingredient in the product.
|
From page 30... ...
This chapter describes fundamental concepts of safety regulations, statistical considerations in assessing food safety, models of safety assessment (including the Novel Foods model of Health Canada) , and special considerations for ensuring the safety of infants and regulating infant formulas.
|
From page 31... ...
The process of establishing the safety of food products, especially infant formulas, is complex and requires empirical evidence from many disciplines. Each step in the process requires the application of the highest standards, whether using methods of bioassay, nutritional analysis, or basic chemistry.
|
From page 32... ...
The result of such a statistical test procedure does not establish with certainty the "true state of nature," but rather it expresses a degree of confidence that one of the two states is not likely to occur. The randomized clinical trial and associated NHST are the mainstays of certain safety and efficacy approaches, such as the FDA drug trials described later, but they have certain potential limitations in their application to the safety of ingredients new to infant formulas.
|
From page 33... ...
In assessing the safety of ingredients new to infant formulas, investigators must consider whether the NHST approach is the most appropriate method to analyze empirical data or whether an approach that more directly assesses effect sizes, clinical significance, dominance, or equivalency is preferred. Of particular importance in the selection of a proper analytical technique is the question of whether any decrease in infant growth rate can be tolerated.
|
From page 34... ...
, are the regulations and guidelines that are used to assess the safety of food ingredients and infant formulas. Regulatory oversight of the addition of new ingredients to infant formulas is governed largely by two processes: the Food Additive Petition and the Generally Recognized as Safe (GRAS)
|
From page 35... ...
.2 These guidance documents were prepared to assist in the design of protocols for animal studies conducted to test the safety of food ingredients and include detailed guidelines for testing the effects of food ingredients on mothers and their developing fetuses. However, due to the special conditions surrounding infancy described below, special considerations need to be taken into account when applying the Redbook in the case of infant formulas.
|
From page 36... ...
. SPECIAL CONSIDERATIONS FOR INFANT FORMULAS Infancy as a Vulnerable Period Dealing with infancy makes interpretation of safety guidelines particularly difficult.
|
From page 37... ...
Immune Function The infant immune system is not fully mature at birth; it has deficits in the ability to prevent invasion of pathogens and to respond to antigens. Of particular concern in the context of ingredients new to infant formulas is the increased permeability of the gut mucosal barrier in the presence of inflammation or infection or if the integrity of the epithelial cell layer is disrupted.
|
From page 38... ...
These changes are thought to have long-range implications for the human -- not all of which are expressed directly during infancy. The current safety models for infant formulas only look at relatively short-term outcomes and are narrowly limited to the maintenance of physical growth.
|
From page 39... ...
Other than this proposed requirement for sustaining physical growth, however, the manufacturer would not need to demonstrate the benefits of any proposed new ingredient to infant formulas. Given the special circumstances of the use of infant formulas and the fact that is it virtually impossible to understand the long-term outcomes of adding any given ingredient (the clinical trials are, of necessity, of relatively short duration)
|
From page 40... ...
Dev Psychol 31:723 738. OFAS (Office of Food Additive Safety)
|
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.