Washington Law Review


Within 13 days of being named Commissioner of the Food and Drug Administration (FDA), Commissioner Schmidt issued "14 final regulations, 13 proposed regulations and six notices stretching over many pages of the Federal Register. Schmidt was authorized to make the requisite final review of the National Nutritional Foods Association's objections prior to issuing final FDA regulations. The final regulations, which govern the public sale of dietary supplements, were preceded by a recital that the Commissioner had considered the evidence from public hearings, the hearing examiner's report and all the later exceptions and written arguments filed against the regulations. Petitioners argued that the severely limited time available for personal consideration, even of staff-prepared synopses, suggested that Commissioner Schmidt in fact had not considered objections to the regulations and thus had not complied with the authorizing statute in issuing the challenged regulations. In view of the allegedly "more than ordinary basis of doubt as to the extent of his personal reading and consideration," petitioners moved for discovery of the Commissioner's actual consideration. The motion was denied. Held: Agency head may not be examined on statutorily required personal consideration of objections to promulgated regulations despite circumstances raising doubts concerning the existence of appropriate consideration. National Nutritional Foods Association v. Food & Drug Administration, 491 F.2d 1141 (2d Cir. 1974).

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