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Letters to the Editor

Comments on LSRO Report's Recommendations on Infant Formula Nutrient Requirements¹

^a President, International Formula Council, Atlanta, GA 30342, ^b Executive Director, International Formula Council, Atlanta, GA 30342

Dear Dr. Suttie:

The International Formula Council, an association of manufacturers and marketers of formulated nutrition products including infant formulas and medical foods, has reviewed carefully the Life Sciences Research Office (LSRO) of the American Society for Nutritional Science's report Assessment of Nutrient Requirements for Infant Formulas (the LSRO report) published in the November 1998 supplement issue of The Journal of Nutrition. The report's recommendations will be considered by the Food and Drug Administration (FDA) to determine whether existing regulations for infant formula nutrient requirements should be revised, and thus could have a major impact upon consumers, the medical profession, and the infant formula industry. While the industry appreciates the obvious effort, deliberation, and academic expertise that went into this report, it also recognizes the dangers and limitations inherent in translating the available scientific database into workable regulations for the applied science of manufacturing infant formula. In particular, many new maximum nutrient levels were recommended in the LSRO report despite the absence of any toxicological evidence that would justify the major application problems they will involve. In addition, the report did not take into consideration Good Manufacturing Practice issues, such as processing overages and nutrient stability that have a direct impact on ensuring the availability of essential nutrients throughout the product's shelf-life.

The recommendations appear to ignore the cautionary advice regarding unnecessary regulation expressed during the 1989 symposium on Upper Limits in Infant Formulas (Miller 1989 ), as well as the infant formula industry's extraordinary safety record, especially since the passage of the Infant Formula Act. Dr. Sanford Miller, the former Director of FDA's Center for Food Safety and Applied Nutrition, reminded those attending the Upper Limits conference that government should regulate only as a last resort when private initiations, inspired by enough responsibility and with the assistance and balance of government, has finally failed. Assessing the need for upper limits of nutrients in infant formula in 1989, Dr. Samuel Fomon (of this LSRO committee) summarized for the symposium editors, "we agree with the infant formula manufacturers in opposing regulations that would increase the cost of formula production without contributing substantially to infant safety." A strong rationale exists for establishing in infant formulas the upper limits for those nutrients that have adverse effects when consumed in excessive quantities. It is also appropriate to review and revise those upper limits and to establish new limits where there is adequate scientific evidence to suggest that limitation is warranted. However, in our assessment, neither the current scientific literature nor the actual experience of US infant formula manufacturers warrant the establishment of any additional upper limits for required nutrients other than those already identified in the current Infant Formula Act.

Formulas for term infants will, in fact, be fed to infants of differing ages and sizes, and with very different nutrient requirements. These formulas represent the sole source of nutrition for many infants during the early months of life and are complementary to solid food during later infancy. Thus, regulations for minima and maxima must be broad enough to account for the nutrient needs of the entire infant population. Narrow limits are also incompatible with Good Manufacturing Practices, particularly for labile nutrients whose presence in the formula must be relied upon through the product's expiration date to meet label claims. This narrow approach leads to unnecessary complexities and risks in the manufacturing process, which can increase costs without gaining a public health benefit, an outcome in conflict with the views of the leaders of the 1989 conference.

We earlier submitted to LSRO extensive comments (Infant Formula Council 1996 ) stating our assessment that the current scientific literature, as well as US infant formula manufacturers' experience, did not justify the establishment of additional upper limits for currently required nutrients. Similarly, the United States' written comments on the Proposed Draft Revised Standard for Infant Formula, (which were submitted by Food and Drug Administration delegates in September 1998 to the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses), objected to "arbitrary regulatory maximum limits," noting: "Standards for nutrient maxima should be scientifically based and incorporate risk assessment." (U.S. FDA, 1998 ) The LSRO report's recommendations regarding maxima are not consistent with these positions.

We are strongly encouraging the FDA to carefully evaluate the LSRO report's recommendations in conjunction with current scientific literature, and to solicit input from additional scientists with expertise in infant nutrition, toxicology, and infant formula manufacturing.

Before making any proposal to revise the current regulations for infant formula nutrient requirements, FDA must be assured its decisions are feasible and based on science that is both sound and relevant to the regulatory and manufacturing purposes to which it will be put. US infant formula manufacturers² endorse this position.

We encourage you to publish this letter to inform your readers of the potential impact of the LSRO report, Assessment of Nutrient Requirements for Infant Formulas.

FOOTNOTES

¹ Editorial Note: The LSRO has declined an invitation to respond to this letter on the basis that the issues raised are largely policy matters, not scientific issues, and they would be most properly addressed by the FDA. A member of the expert panel, Dr. Sam Fomon has been given the opportunity to respond, and his response follows.

² Mead Johnson and Company, Mead Johnson Nutritionals; Néstle USA, Nutrition Division; Ross Products Division, Abbott Laboratories; and Wyeth Nutritionals International.

Manuscript received February 3, 1999. Revision accepted March 8, 1999.

REFERENCES

1. Miller S. A. Problems associated with the establishment of maximum nutrient limits in infant formula. J. Nutr. 1989;119(suppl. 12S):1764-1767

2. Infant Formula Council. (1996) Submission to the Federation of American Societies for Experimental Biology on the Review of Infant Formula Nutrient Requirements. May 31.

3. United States Food and Drug Administration. (1998) United States Comments on the Proposed Draft Standard for Infant Formula, Codex Stan 72-1981, CX/NFSDU 98/7, CRD-16. Submitted at the 21st Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses: Berlin, Germany. September 21–25, 1998.

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