National Nutritional Foods Association v. Schmidt

• Decision Date: 15 November 1973
• Docket Number: No. 73 Civ. 3739 (MIG).,73 Civ. 3739 (MIG).
• Citation: 367 F. Supp. 889
• Parties: The NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Co., Inc., Plaintiffs, v. Alexander M. SCHMIDT, Commissioner of Food and Drugs, and Caspar W. Weinberger, Secretary of Health, Education and Welfare, Defendants.
• Court: U.S. District Court — Southern District of New York

367 F. Supp. 889

The NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Co., Inc., Plaintiffs, v. Alexander M. SCHMIDT, Commissioner of Food and Drugs, and Caspar W. Weinberger, Secretary of Health, Education and Welfare, Defendants.

No. 73 Civ. 3739 (MIG).

United States District Court, S. D. New York.

November 15, 1973.

Bass & Ullman, New York City, for plaintiffs.

Paul J. Curran, U. S. Atty., S. D. N. Y., for defendants; Samuel J. Wilson, Asst. U. S. Atty., Joanne S. Sisk, Chief App. and Sp. Proceedings, Dept. of Health, Educ. & Welfare, Stephen H. McNamara, Howard M. Holstein, Attys., Office of Gen. Counsel, Dept. of Health, Education and Welfare, of counsel.

GURFEIN, District Judge:

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 Casper 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. XXXXX-XXXXX, 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 2.120), issues the following Findings of Fact, Conclusions, and Final Order. . . ." (38 Fed.Reg. 20712, 20734)

The regulations at issue are complex, technical and interrelated but for purposes of this motion it is only necessary to summarize their purpose and effect.^*

The two groups of regulations involved here, Part 80 and Part 125 of 21 CFR, provide for labeling which will identify the nature of the product being purchased and its nutritional value. These regulations are part of a coordinated package of 19 regulations, proposals, and policy directives designed to govern the definition, identity, formulation and promotion of vitamin and mineral products.

Pursuant to 21 U.S.C. § 341, the regulations of Part 80 establish definitions and standards of identity for dietary supplements of vitamins and minerals and for vitamin and mineral foods. These regulations, under statutory authority to issue such regulations as will promote honesty and fair dealing in the interest of consumers, are designed to facilitate consumer understanding as to the composition of vitamin and mineral products which are represented to be of special dietary use to supplement the diet by increasing the dietary intake of vitamins or minerals or both.

The new provisions of Part 125, pursuant to authority granted in 21 U.S.C. § 343(j), revised the regulations governing the labeling of food for special dietary uses. Section 343(j) deems a food to be misbranded if it purports to be or is represented for special dietary uses, unless its label supplies information necessary to inform purchasers as to its value for such uses. Due to the complexity of conventional food supply the regulation requires the labeling of a food for special dietary use to indicate clearly to the consumer the ingredients of significant value and need in human nutrition and the proportion of such ingredients. This indication is to be achieved through the use of a simplified unit of measurement—the Recommended Daily Allowance (RDA).

Briefly summarized, the purpose and effect of these two regulations is to require full and honest labeling and the fair promotion of vitamin and mineral products as the basis for a more informed consumer choice, while leaving the basic responsibility for deciding personal nutritional practices to the consumer himself. The regulations define the term "special dietary use." They establish the U.S. Recommended Daily Allowance (U.S. RDA) to replace the former Minimum Daily Requirement (M.D.R.) as the official measurement of nutritional intake. They specify the U. S. RDA for various vitamins and minerals for infants, children under four years of age, adults and children over four years of age, and pregnant or lactating women. The regulations draw a distinction between ordinary food, special dietary foods intended for diet supplementation, and drugs intended for the treatment of disease.

The plaintiffs contend that it was physically impossible for the Commissioner to have reviewed and considered the record prior to signing the Dietary Supplement Regulations into effect, and that the Commissioner did not act and could not have acted in the exercise of considered independent judgment when he promulgated these regulations. The plaintiffs point to the fact that the Commissioner signed the Dietary Supplement Regulations only thirteen (13) days after his appointment, although the matter had been under agency consideration for eleven years and the record consisted of 32,000 pages of transcript plus thousands of pages of documentary exhibits. Moreover, during that same period the Commissioner signed and caused to be published at least 33 items comprising 14 final regulations, 13 proposed regulations and six notices (including the two final orders at issue here).

MOTION TO DISMISS

The defendants move to dismiss pursuant to Fed.R. Civ.P. 12(b)(6) and 12(b) (1) on the grounds that the complaint does not state a claim upon which relief can be granted and because this court lacks jurisdiction.

The defendants argue that the plaintiff's sole recourse for review of the orders promulgating the Dietary Regulations is on review by a Circuit Court of Appeals. Before we can consider the merits, we must first determine whether the...