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Select Committee on GRAS Substances (SCOGS) Opinion: Iron - Report on Clinical Research Protocols to Elucidate The Possible Hazards of Increased Iron Enrichment of Cereal Products

The GRAS Substances (SCOGS) Database allows access to opinions and conclusions from 115 SCOGS reports published between 1972-1980 on the safety of over 370 Generally Recognized As Safe (GRAS) food substances. The GRAS ingredient reviews were conducted by the Select Committee in response to a 1969 White House directive by President Richard M. Nixon.

Iron -Report on Clinical Research Protocols to Elucidate The Possible Hazards of Increased Iron Enrichment of Cereal Products

  • SCOGS-Report Number: none assigned by NTIS*
  • Type Of Conclusion: There is no conclusion type.
  • ID Code: 7439-89-6
  • Year: 1972
  • 21 CFR Section: There is no CFR citation.

SCOGS Opinion:

LSRO STAFF CONCLUSIONS:

The primary objective of this study was to determine the feasibility of developing protocols of clinical reearch which might answer the question: Will the proposed change in iron enrichment increase the prevalence or enhance the severity of iron storage disorders? We may now ask if the two experiments outlined in Protocols A and B are likely to answer that question. We conclude that neither will give a direct answer.

The experiment outlined in Protocol A is designed to permit the measuremetn of any difference in iron absorption, over a 10-day period, from two diets, identical except for the two breads with different levels of iron enrichment. The subjects will be mainly individuals with diagnosed diseases which are known, or believed,k to have some derangement of iron metabolism. However, there is no factual information that iron per se is the basic cause of the diseases listed in Protocol A. It is only when body stores of iron become excessive that they influence the clinical managemetn of patients with these diseases. Under present dietary conditions, clinicians manage this disorder by phlebotomy. We see no way of interpreting any increase in the absorptino of iron over a 10-day period in terms of ultimate accumulation of iron stores.

The objective of the experiment outlined in Protocol B is to acquire information on the response of healthy, adult males over a long period of time to different levels of dietary iron provided in bread or other four-containing items. The effects of this extra dietary iron on the accumulation of body stores will be of particular intererst. The possibility that an iron storage disease, such as hemochromatosis, might be precipitated by any of the levels of iron intake is considered extremely remote. Finally, if it is possible to conduct the clinical studies outlined in Protocol B it is highly unlikely that the basic question will be answered.

However, these two proposed experiments have scientific merit. They will supply information that is a prerequisite to a further understanding of the mechanisms regulating iron absorption and storage.

*Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions and are available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.