Regulatory Guidelines for Preclinical Studies

There are no explicit requirements for preclinical testing of infant formulas specified under Section 409 of the FD C Act. The section stipnlates that a petition to estabUsh safety of a food additive shall contain all relevant data bearing on the physical or other technical effect such additive is intended to produce.. . (21 U.S.C. 301), but it does not dictate a specific type of preclinical study. 

Under Section 412, which applies to infant formnlas, a formnla shall be deemed to be adulterated if it does not meet the quality factor requirements prescribed by the Secretary of Flealth under Subsection (b)(1). Subsection (b)(1) then states, The secretary shall by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by subsection (i). Currently, only protein quaUty is named as a quality factor in FDA regulations but there are no specific requirements to be met regarding quality factors. Subsection (i) specifies levels of certain nutrients (e.g., protein, fat, and specific vitamins) that are required to be met. There is no other requirement for any specific preclinical studies. 

The FDA Redbook 11 and Redbook 2000 (OFAS, 2001, 2003) provide comprehensive guidelines for conducting preclinical studies to test the safety of food and color additives. Chapters IV and V in the Redbook II and 2000 describe  

These guidelines, however, do not consider the unique characteristics of having infants as consumers. 

There are no explicit requirements for preclinical testing of infant formulas specified under Canada s Food and Drug Regulations in Division 16 (Food Additives), Division 25 (Infant Formulas), or Division 28 (Novel Foods) (Canada, 2001). Divisions 16 and 28 require that a notification be submitted to Health Canada that includes information used to establish the safety of a food additive or a novel food. Health Canada refers manufacturers to internationally accepted guidelines for preclinical testing or asks to be consulted because decisions are made on a case-by-case basis. 

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Preclinical studies are a vital first step to assess the safety and quality of ingredients new to infant formulas. Regulatory guidelines for preclinical studies must be based on considerations of the diversity of the potential new ingredients and the ingredients source and matrix. In the United States, the FDA Redbook provides comprehensive guidelines for conducting preclinical studies to test the safety of food and color additives, but it often does not take the many special needs and vulnerabilities of infants into consideration. 

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