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Pages 160-174

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From page 160... ... Although formal regulatory guidelines for in-market surveillance do not exist in the United States or Canada, infant formula manufacturers routinely conduct passive surveillance via toll-free calls, contact with health care professionals, and reports from their field sales force. Satisfactory completion of the appropriate preclinical and clinical studies diminishes the likelihood of systematic adverse reactions; however the risks for adverse reactions cannot be ignored because adverse effects may not be detected in preclinical studies if the wrong animal model was chosen, if the assessment instrument chosen measured a function other than the one adversely affected by the new ingredient, or if a subpopulation of individuals who are highly sensitive to the new ingredient added to infant formula was not sufficiently represented in clinical studies. Read the entire page →
From page 161... ... , if a subpopulation of individuals who are highly sensitive to the new ingredient added to an infant formula are not sufficiently represented in the clinical studies, adverse effects may not be detected until the formula is marketed to a wider population. These reasons support the need for a systematic plan to include both types of in-market surveillance into every submission to the regulatory agency for the addition of an ingredient new to infant formulas. Read the entire page →
From page 162... ... Follow-up The second component of in-market surveillance, the follow-up component, is one that is less often considered during clinical trials to assess the safety of new ingredients added to infant formulas. In contrast to in-market monitoring, which focuses on adverse effects occurring during the period of maximum formula usage, in-market follow-up concentrates on possible long-term adverse effects after the period of maximum formula usage. Read the entire page →
From page 163... ... that have been determined as GRAS for addition to infant formulas. These LC-PUFAs are derived from genetically selected algae that produce triglycerides with a high content of either arachidonic acid or docosahexaenoic acid onto two or three of the fatty acid chains of the triacylglycerol molecule. Read the entire page →
From page 164... ... Finally, as outlined in Chapter 2, sample sizes must be large enough to ensure sufficient statistical power in follow-up studies. As noted in Chapter 6, analysis indicated that the majority of studies investigating the cognitive effects of the addition of LC-PUFAs to infant formulas had insufficient statistical power. Read the entire page →
From page 165... ... Since infants are unable to verbally communicate, any adverse effects must be observed and reported through the parents or caregiver, thus special attention must be paid to detect adverse or unusual reactions when feeding infant formulas containing new ingredients. Similarly, in Canada there are no explicit guidelines or requirements for in-market surveillance of infant formulas specified under Canada's Food and Drug Regulations in Divisions 16 (Food Additives) Read the entire page →
From page 166... ... is sufficient for monitoring all ingredients that might be added to infant formulas, a hierarchy of the options was developed. Level 1, 2, and 3A assessments would seem most appropriate for in-market monitoring studies, whereas level 2 and 3 assessments would be appropriate for in-market follow-up studies. Read the entire page →
From page 167... ... ? Sidebar B: Level 3 Assessment The following issues should be considered in level 3 No assessment: - The domains to be inv estigated and the 9 instruments to be used will var y depending on Lev el 1 Assessment: the organ or functional systems that are most PASSIVE SURVEILLANCE likel y to be affected b y the ingredient and 1-800 line or Internet web site results from in-market, preclinical, or clinical studies. Read the entire page →
From page 168... ... . In-Market Follow-up Assessments Potential long-term adverse consequences associated with the addition of ingredients new to infant formulas may not be detected in clinical studies. Read the entire page →
From page 169... ... � The action of the new ingredient may have an effect only when individuals are exposed to excess calories or other specific situations. In the submission to the regulatory agency, the following criteria should be referred to when justifying the strategy proposed for in-market follow-up of new ingredients added to infant formulas. Read the entire page →
From page 170... ... This means that even if potentially plausible alternative explanations are offered to explain adverse findings, level 2 in-market monitoring is not warranted since adverse effects were reported. � A review of the relevant scientific literature by an expert panel (level 2 assessment) Read the entire page →
From page 171... ... Other research models also exist. An efficacy and safety study of an infant formula with added LC-PUFAs was carried out for 18 months (Lucas et al., 1999) Read the entire page →
From page 172... ... . The committee recommends a systematic plan for both continued in-market monitoring and long-term surveillance as an essential part of each safety evaluation seeking to add new ingredients to infant formulas. Read the entire page →
From page 173... ... 1998. Prenatal cocaine exposure: Long-term deficits in learning and motor performance. Read the entire page →
From page 174... ... Increased sensitivity to stressors and other environmental experiences after prenatal cocaine exposure. Read the entire page →

From page 160...

... Although formal regulatory guidelines for in-market surveillance do not exist in the United States or Canada, infant formula manufacturers routinely conduct passive surveillance via toll-free calls, contact with health care professionals, and reports from their field sales force. Satisfactory completion of the appropriate preclinical and clinical studies diminishes the likelihood of systematic adverse reactions; however the risks for adverse reactions cannot be ignored because adverse effects may not be detected in preclinical studies if the wrong animal model was chosen, if the assessment instrument chosen measured a function other than the one adversely affected by the new ingredient, or if a subpopulation of individuals who are highly sensitive to the new ingredient added to infant formula was not sufficiently represented in clinical studies.