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Executive Summary

The Office of Management and Budget "stands ready" to respond to FDA proposals to change its current policy on health claims for foods, OMB Office of Information and Regulatory Affairs (OIRA) Acting Administrator James MacRae told a House subcommittee hearing Nov. 9. "It seems clear that something should be done" with regard to potentially misleading health claims, he told Rep. Weiss' (D-N.Y.) Government Operations/Intergovernmental Subcommittee. MacRae added: "I stand ready to review" what FDA proposes. "We have heard today that OMB may be interested," Weiss observed, in publishing the FDA draft final rule submitted to OMB in 1988 but never cleared by the office. He urged that consideration be given to whether the 1988 rule goes far enough in restricting misleading claims. The hearing was Rep. Weiss' second on oversight of FDA's food labeling regulation this year ("The Pink Sheet" Nov. 6, p. 9). At the earlier session on Oct. 31, Weiss criticized FDA Commissioner Young for not pushing harder to get the 1988 draft final rule through OMB. The rule would have amended a 1987 proposed rule to restrict the health claims which may be made for foods. OMB's MacRae was accompanied by Shannah Koss-McCallum, assistant branch chief of the OIRA Human Resources and Housing Branch. Koss-McCallum also indicated that OMB may be open to reconsidering the 1988 draft rule. Koss-MacCallum told the hearing that she had not been aware of the recent Exachol case, which has increased pressure on FDA to finish the regs, until recent conversations with FDA. In the Exachol case, a New York federal court denied an FDA request for summary judgment in its motion for seizure action against Exachol, a lecithin-based food supplement marketed as an aid to coronary disease prevention. Issued in July, the court's decision was based on the fact that the agency had deferred regulatory action, under the 1987 proposal, against such products as Kellogg's All Bran cereal, which made similar claims. The Exachol case has been cited by Weiss as an illustration of the misleading claims that have gone unchecked under current agency policy. "In light of" the Exachol decision, Koss-McCallum said, OMB has become "more concerned" with the acceptability of maintaining the status quo. She added that she has indicated to FDA that "maybe our concerns" with regard to the 1988 draft final rule, "are not so far apart" that they cannot be reconciled. Koss-McCallum noted that among the FDAers she had spoken to on food claims is Linda Horton, deputy chief counsel for regulations and hearings. FDA Commissioner Young said at the Oct. 31 hearing that FDA was considering a "modification" of the 1987 proposal in order to provide some immediate restraint on misleading health claims before the issuance of a comprehensive new food labeling policy sometime in the spring. In response to a statement from Weiss charging that OMB blocked promulgation of the 1988 rule, MacRae maintained that OMB does not "kill" regulations. He argued that "all OMB does is give advice and the agency is free to ignore that if it chooses to do so." The description of OMB's activities, Weiss responded, is "a load of bull." He accused the OMB representatives of being "disingenuous." MacRae stated that review of the 1988 draft rule was "suspended" pending completion of FDA's new food labeling policy, which would include a provision on health claims. The decision followed conversations with FDA at which OMB conveyed its concerns over the regulation. In his prepared statement, MacRae noted that the concerns included the fact that "truthful and nonmisleading health messages can provide significant public health benefits." The procedure of suspending review is a relatively new one at OMB, instituted early in 1989 by former OIRA Administrator Jay Plager, MacRae noted. The procedure is used for regulations that the originating agency has agreed to revise, so "they are no longer on our clock" for review, he explained. Other regulations are simply returned by OMB with an explanation of the office's objections. MacRae estimated the suspension procedure has been used "six or seven" times; Weiss said the subcommittee's information showed a total closer to 16. * During the initial part of the hearing, MacRae said he had very little input in the decision regarding the 1988 draft. The discussions with FDA Commissioner Young had been handled primarily by Plager, McRae said. Plager left OMB Oct. 31 to become a justice in the U.S. Court of Appeals for the Federal Circuit. MacRae was previously deputy administrator of the office and continues in those duties. No permanent successor to Plager has been announced. Koss-MacCallum was involved in the 1988 rule at a lower staff level. She has worked on FDA issues at OMB since 1987. In his closing statement, Weiss noted that the hearing marked the first appearance of OMB before his committee and expressed his concern that OMB understand that "it, too, is . . . accountable" to the public with regard to regulatory action. Weiss recently introduced a bill that requires OMB to keep an administrative record of all activities related to regulatory review ("The Pink Sheet" Nov. 6, T&G-2).

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