adverse-effect level, safety factor, and estimated daily intake need to be determined, taking into account the differences in risk posed by the ingredient and possible contaminants. This will need to be determined for each new ingredient by each new expert panel.

Element 11: Expert Panel Findings

The findings of the expert panel are the heart of the safety evaluation submission. A properly constituted panel must be objective and consist of the appropriate types of scientific experts. In other words, the panel should have the appropriate experts to ask the right questions and form an opinion that is robust and of the highest scientific integrity. The manufacturer, in consultation with the regulatory agency, should determine an appropriate expert panel early in the process (see Figure 4-1, Box 6) to:

  • guard against the theoretical possibility of bias,

  • ensure an efficient process, and

  • minimize the chance of rejection after submission.

The experts serving on the panel need to be free of any conflicts of interest (e.g., former employees or current stockholders of the manufacturer). Although there is no evidence of biased panels in the past, the potential for bias is a theoretical concern that needs to be addressed when selecting panel members.

The committee strongly recommends that in selecting appropriate experts to analyze ingredients new to infant formulas, the expert panel should include a physician with experience in clinical assessment, preferably a pediatrician. The composition of the rest of the panel should be determined in consultation with the regulatory agency and will depend on the nature of the ingredient (e.g., if dealing with probiotics, a microbiologist and immunologist should be included on the panel). A subpanel of specific experts may be needed in certain instances (e.g., when certain levels of in-market surveillance are needed; see Chapter 7). The panel members must be recognized experts in their field of expertise and highly regarded by their peers and the regulatory agency. They must conduct an independent critical evaluation of the information that is publicly available and conclude that they, as well as other experts in the field, would generally recognize that the ingredient is safe for its intended use.

The regulatory agency would review the panel’s safety assessment and other data in the submission and if satisfied, would issue a letter of no objection. If the regulatory agency has questions and the manufacturer does not answer them satisfactorily, the agency can reject the submission, ask the company to withdraw it, or suggest consultation with additional experts qualified to opine on the specific safety concerns.

RECOMMENDATION: In seeking to add new ingredients to infant formulas, manufacturers should establish balanced, qualified expert panels in consultation with the regulatory agency. The panel members should review existing data and may identify a need for additional studies.

Element 12: General Availability of the Data

The requirement for all the pivotal data to be generally available for scrutiny by the scientific community at large makes the process transparent and robust. The data on which the safety determination is based must be published in peer-reviewed scientific journals and could be supplemented by secondary scientific literature, such as review articles and text-



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