The opinion of the court was delivered by: GURFEIN
The defendants move to dismiss the complaint pursuant to Fed. R. Civ. P. 12(b) (1) and 12(b) (6) on the grounds that the Court lacks subject matter jurisdiction and that the complaint fails to state a claim upon which relief can be granted. Alternatively, the defendants seek a protective order vacating the notice of deposition which the plaintiffs have issued to the defendant Alexander M. Schmidt, Commissioner of Food and Drugs and for a direction that such discovery not be had.
The plaintiff National Nutritional Foods Association ("National") is composed of business concerns located in New York State and throughout the United States and includes manufacturers, wholesalers, and retailers of vitamins and dietary supplements. Plaintiff Solgar Co. Inc. ("Solgar"), a member of National, is a New York corporation with its principal place of business in Manhattan and engages in the manufacture, distribution and sale in interstate commerce of vitamins and dietary supplements.
The defendant Caspar W. Weinberger is Secretary of Health, Education and Welfare ("Secretary") and is authorized to issue regulations pursuant to 21 U.S.C. § 371 under the Federal Food, Drug and Cosmetic Act. The defendant Alexander M. Schmidt is Commissioner of Food and Drugs ("Commissioner"), to whom the Secretary has delegated his authority to promulgate such regulations.
National and Solgar have filed a complaint, 73 Civ. 3739, seeking (a) preliminary and permanent injunctions enjoining and restraining the defendants from enforcing certain regulations relating to the labeling and content of dietary supplements and (b) a mandatory injunction directing the Commissioner "to properly consider, review and evaluate the record before him" in connection with the regulations described and "to publish his findings of fact and conclusions of law."
Federal jurisdiction is found under 28 U.S.C. §§ 1331(a) and 1337. The matter in controversy arises under the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 301 et seq. and also the Administrative Procedure Act, 5 U.S.C. § 551 et seq. The complaint alleges that this action is authorized by 5 U.S.C. §§ 702-706. Venue purportedly lies here by virtue of 28 U.S.C. § 1391(e) 4.
The complaint attacks the promulgation by the Commissioner of certain portions of the Dietary Supplement Regulations which were published in 38 Fed. Reg. 20708-20718, 20730-20740 (1973). The plaintiffs allege that the promulgation was not in accordance with the requisite procedural requirements.
FACTS: Procedural History of the Challenged Regulations
The parties agree about most of the essential facts. The regulatory scheme here attacked finds its inception with a notice of proposed rule-making published in 27 Fed. Reg. 5815 (1962). Numerous comments were received in response to this notice. In June 1966, orders were subsequently promulgated establishing definitions and standards of identity for dietary supplements of vitamins and minerals and revising the regulations for labeling of food for special dietary uses. 31 Fed. Reg. 8521 et seq. (1966). Objections to these orders and requests for a public hearing were filed. After issuing a stay of the effective date of the June 1966 order (31 Fed. Reg. 15730 (1966)) public hearings commenced on June 20, 1968 and concluded nearly two years later on May 14, 1970. The transcript of the hearings comprises over 32,000 pages of testimony plus additional thousands of pages of documentary exhibits.
The hearing examiner who presided over the two years of hearings submitted his report to the Commissioner on January 25, 1971.
On January 19, 1973 the Commissioner -- who was then Charles C. Edwards -- published proposed findings of fact, proposed conclusions of law and tentative orders. 38 Fed. Reg. 2143-2150 and 38 Fed. Reg. 2152-2162. These orders permitted those who appeared at the hearing to file written exceptions within 60 days, which was subsequently extended to April 20, 1973. (38 Fed. Reg. 6396 (1973)). Exceptions to the orders and findings were filed by 35 persons who had appeared at the hearing, consisting of over 1,000 pages, and approximately 20,000 additional letters.
Shortly before the expiration date for exceptions to be filed, Commissioner Edwards resigned his position on April 6, 1973.
On July 12, 1973 the defendant Schmidt was sworn in as Commissioner of Food and Drugs. On August 2, 1973 the final findings of fact, conclusions of law and orders were published in the Federal Register, 38 Fed. Reg. 20768-20718, 20730-20740 (1973). Included in the August 2 promulgation was the Commissioner's statement:
"Having considered the evidence received at the hearing, the hearing examiner's report, and all the exceptions and written arguments which were filed, the Commissioner, pursuant to the Federal Food, Drug, and Cosmetic Act (secs. 201(n), 401, 403(a) and (j), 701(a) and (e), 52 Stat. 1046, 1048, 1055, 1056, as amended by 70 Stat. 919; 21 U.S.C. 321(n), 341, 343(a) and (j), 371(a) and (e)) and under authority delegated to him (21 CFR ...