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Administrative Law Keyed to Breyer
National Nutritional Foods Association v. Food and Drug Administration
Citation:
491 F.2d 1141 (1974)Facts
In July 1973, FDA Commissioner Alexander Schmidt signed two final orders establishing regulations for dietary supplements, which were published in the Federal Register on August 2, 1973. These regulations were the culmination of a decade-long process that included extensive hearings producing over 32,000 pages of testimony and thousands of pages of exhibits. The formal exceptions to the proposed regulations spanned over 1,000 pages, with an additional 20,000 letters submitted. Commissioner Schmidt had only taken office on July 12, 1973, just 13 days before signing the final regulations. During this brief period, he also signed and published 14 final regulations, 13 proposed regulations, and 6 notices on various matters. Petitioners sought to depose the Commissioner to determine whether he had personally reviewed and considered the objections prior to signing the orders, as required by statute and as stated in the regulations’ preamble.
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