books. For example, FDA’s letter of no objection summarizing the basis for the GRAS Notification is made available on FDA’s website (OFAS, 2003b), and the full notification should be available through the Freedom of Information Act. The responsibility for the safety determination rests with the company filing the notification, and it is the company’s continuing responsibility to ensure that the food ingredients they market are safe and in compliance with all applicable legal and regulatory requirements.
The safety assessment of infant formulas is complex and not fully standardized. While the current processes that regulate the addition of new ingredients to infant formulas are both flexible and scientifically rigorous, they do not adequately address the uniqueness of infants and infant nutrition. Also, they do not provide either enough guidelines on the selection of an appropriate expert panel that may be used to show consensus or guidelines for in-market surveillance. There is an opportunity to address these limitations and standardize the elements of the safety assessment of ingredients new to infant formulas without being overly prescriptive. The recommendations described here are meant to address the specific needs of infants in improving the regulatory process for this potentially vulnerable population group.
FDA (Food and Drug Administration). 1996. Current good manufacturing practice, quality control procedures, quality factors, notification requirements, and records and reports, for the production of infant formula. Proposed rule. Fed Regist 61:36153–36219.
FDA. 1997. Substances Generally Recognized as Safe. Proposed rule. Fed Regist 62:18937–18964.
MacLean WC Jr, Benson JD. 1989. Theory into practice: The incorporation of new knowledge into infant formula. Semin Perinatol 13:104–111.
OFAS (Office of Food Additive Safety). 2001. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. Redbook II-Draft. Washington, DC: OFAS, Center for Food Safety and Applied Nutrition, Food and Drug Administration.
OFAS. 2003a. Redbook 2000. Toxicological Principles for the Safety of Food Ingredients. Online. Center for Food Safety and Applied Nutrition, Food and Drug Administration. Available at http://www.cfsan.fda.gov/~redbook/red-toca.html. Accessed November 19, 2003.
OFAS. 2003b. Summary of all GRAS Notices. Online. Center for Food Safety and Applied Nutrition, Food and Drug Administration. Available at http://www.cfsan.fda.gov/~rdb/opa-gras.html. Accessed November 19, 2003.