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This article was originally published in The Tan Sheet

Executive Summary

FDA'S FOLIC ACID SUBCOMMITTEE SLATED TO MEET in a joint session with the agency's Food Advisory Committee "during October or the first week of November," according to a July 29 memorandum from Center for Food Safety and Applied Nutrition Director Fred Shank, PhD. The memo was sent to members of the Food Advisory Committee, its Folic Acid Subcommittee and speakers who made presentations during the first Folic Acid Subcommittee meeting in October 1992. The agency is considering Oct. 25-26 as a tentative date for the joint meeting. The Folic Acid Subcommittee last convened in April, when it voted 6-4 in favor of FDA authorizing health claims that daily consumption of 400 micrograms of folic acid in either dietary supplements or fortified foods can reduce the risk of conceiving a child with neural tube defects ("The Tan Sheet" April 19, p. 3). The Food Advisory Committee was last briefed on folic acid at an April 16 session, but deferred voting on the issue. Shank said that the purpose of the meeting is to discuss and make recommendations on three proposals that FDA is developing on folic acid. The agency expects that the proposals will be released simultaneously as a set of documents prior to the joint meeting. One proposal deals specifically with authorizing a health claim for folic acid and neural tube defects, a document FDA had originally envisioned would be released in July ("The Tan Sheet" June 21, p. 5). The other two proposals are essentially amendments to the standards of identity for enriched grain products and to the food additive regulations to allow for the fortification of foods with folic acid. The Folic Acid Subcommittee endorsed the idea of folic acid fortification at its April meeting. In the memo, Shank asked speakers from the October 1992 session to provide written comments on the three proposals prior to the meeting. The comments will then be given to the advisory committee members for review and discussion at the fall meeting. "We envision that some very specific questions will be incorporated into the proposals," the CFSAN director said. The agency anticipates that the meeting will coincide with the mid- point of the comment period for the proposals. Accompanying the July 29 memo was the June 18 set of three proposed regulations implementing the Nutrition Labeling & Education Act for dietary supplements as well as the advanced notice of proposed rulemaking on the regulation of supplements ("The Tan Sheet" June 21, pp. 1-11). Shank invited the advisory committee members to comment on the proposals by Aug. 17, the end of the comment period for the documents. Although not on the official agenda for the upcoming meeting, the issue of a surveillance system to monitor adverse effects associated with folic acid fortification and health claims is expected to be mentioned by the committee. The Centers for Disease Control and Prevention held a meeting on Aug. 12 to discuss options for instituting a folic acid surveillance mechanism. CDC called the Aug. 12 meeting to gather data and opinions from an invited group of "qualified experts" on folic acid adverse effects. Based on the discussion, CDC's Chronic Disease Control Division Director Marjorie Spears, PhD, concluded that it is "not clear exactly what we ought to do." She emphasized, however, that "CDC feels a responsibility to look into the surveillance issues around increased folate consumption . . . we are committed to doing something." Division of Chronic Disease Control Director for Science John Livengood, MD, added that a surveillance system monitoring a "1 mg upper limit [of] folate consumption" would be a possible option to pursue, since there "seemed to be very little concern" by the invited experts about "lower levels of [folic acid] consumption and the possible adverse effects of folic acid complicating the diagnosis of pernicious anemia." At the Folic Acid Subcommittee's April meeting, the group unanimously endorsed the implementation of a surveillance program that would both gauge the positive impact and monitor the potential adverse effects of folic acid consumption ("The Tan Sheet" April 19, p. 4). At that meeting, CDC officials volunteered to research and design such a program.

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