Infant Formula Evaluating the Safety of New Ingredients (2004) / Chapter Skim
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Pages 17-28
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From page 17... ...
and Health Canada to review methods currently used to assess new ingredients to be added to infant formulas, including preclinical and clinical studies and in-market monitoring, and to identify gaps in current safety regulations and guidelines. The committee 17
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Two sections of the FD&C Act, 409 and 412, are the primary laws that relate to infant formulas. Section 409 gives authority to HHS to ensure the safety of new food ingredients (e.g., food additives and Generally Recognized as Safe [GRAS]
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include specific requirements for infant formulas, novel foods,1 and other ingredients. Division 25 of the Regulations provides for the addition to infant formulas of nutritive substances, in addition to specified vitamins and mineral nutrients, found in human milk, provided the nutritive substance is added to the formulas to the level found in human milk (section B.25.056)
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CHARGE TO THE COMMITTEE FDA and Health Canada asked the committee to review methods currently used to assess new ingredients to be added to infant formulas, including preclinical and clinical studies and in-market monitoring, and to identify gaps in current safety regulations and guidelines. As part of its task, the committee was requested to provide recommendations to strengthen the scientific approaches used in assessing the safety of ingredients added to infant formulas.
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2. Appropriate clinical studies of nutritional and safety assessment should be performed par ticularly for components, and combinations of components, which have not been previously included in infant formulas and other dietary products for infants.
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The committee was also asked to consider how the process of estimating intakes and safety of substances intended for infant formulas has evolved over time and to discuss whether and how this process is changing in light of the current state of clinical science to safeguard the health and well-being of infants enrolled in clinical studies. In addition, the committee was requested to apply its recommended approaches to the specific situation of adding long-chain polyunsaturated fatty acids (LC-PUFAs)
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A recent article reported that breastfed infants had lower total cholesterol and low-density lipoprotein cholesterol in adulthood and suggested that infant formulas should have added cholesterol to more closely match that of human milk (Owen et al., 2002)
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Details about the concept of safety and surrounding issues are provided in Chapter 2. Use of a Hierarchical Approach to Safety Assessment The committee recognized that its charge was to provide comprehensive guidelines for evaluating the safety of the addition of ingredients new to infant formulas -- not to produce a "how to" document.
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Finally, the algorithmic format allows the regulatory agency and the manufacturer to follow a linear approach to critical information needed at the major decision points. The algorithms in this report are provided as generic guides and as tools for stepwise approaches to be used in assessing the safety of ingredients new to infant formulas.
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26 INFANT FORMULA: EVALUATING THE SAFETY OF NEW INGREDIENTS 1 2 Yes No 4 3 No 5 6 7 ACTION and ENDPOINT FIGURE 1-2 An example of an algorithm. Using this flexible, stepwise approach, each potential new ingredient is considered using evidence-based approaches and high-quality scientific data to assess potential adverse effects on: · growth and development (including temperament)
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The remainder of the report reviews the current regulatory processes involved in evaluating the safety of ingredients new to infant formulas and provides recommendations for the overall process (Chapter 4) , preclinical studies (Chapter 5)
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1998. Assessment of Nutrient Requirements for Infant Formulas.
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