National Nutritional Foods Ass'n v. Weinberger, No. 73 Civ. 3448.
| Court | United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York |
| Writing for the Court | FRANKEL |
| Citation | 366 F. Supp. 1341 |
| Docket Number | No. 73 Civ. 3448. |
| Decision Date | 25 September 1973 |
| Parties | The NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Co., Inc., Plaintiffs, v. Caspar W. WEINBERGER, Secretary of Health, Education and Welfare, and Alexander M. Schmidt, Commissioner of Food and Drugs, Defendants. |
366 F. Supp. 1341
The NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Co., Inc., Plaintiffs,
v.
Caspar W. WEINBERGER, Secretary of Health, Education and Welfare, and Alexander M. Schmidt, Commissioner of Food and Drugs, Defendants.
No. 73 Civ. 3448.
United States District Court, S. D. New York.
September 25, 1973.
Bass & Ullman, New York City, for plaintiffs.
Paul J. Curran, U. S. Atty., for the S. D. of N. Y., Naomi L. Reice, Asst. U. S. Atty., Joanne S. Sisk, Chief App. and Sp. Proceedings, Dept. of Health, Education and Welfare, for defendants; Stephen H. McNamara, Atty., Office of Gen. Counsel, Dept. of Health, Education and Welfare, of counsel.
MEMORANDUM
FRANKEL, District Judge.
On October 1, 1973, regulations of the Food and Drug Administration will become effective requiring that preparations of Vitamin A and Vitamin D in excess of 10,000 I.U. (international units) per dosage unit and 400 I.U. per dosage unit, respectively, shall be restricted to prescription sale and that such vitamins shall be labelled accordingly. The regulations read as follows:
21 C.F.R. § 3.94
"(a) Vitamin A is an essential nutrient for humans. It is widely recognized that large amounts of vitamin A can cause adverse effects, some of
which are serious. The U.S. Recommended Daily Allowance (U.S. RDA) for vitamin A is 1500 International Units, (IU) for infants, 2500 IU for children under 4 years of age, 5000 IU for adults and children 4 or more years of age, and 8000 IU for pregnant or lactating women.
"(b) In view of the toxicity of excessive consumption of vitamin A, the Food and Drug Administration finds that, in order to protect the public health, oral preparations containing vitamin A in excess of 10,000 IU per dosage unit or recommended daily intake are drugs subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act and shall be restricted to prescription sale. Such products will be regarded as misbranded if at any time prior to dispensing the following conditions are not met:
"(1) The label bears the legend, `Caution: Federal law prohibits dispensing without a prescription'; and
"(2) The labeling bears full disclosure information as required by § 1.106(b)(3)(i) of this chapter, and especially appropriate warnings regarding vitamin A toxicity.
"(c) Preparations containing 10,000 or less IU of vitamin A per dosage unit will be regarded as misbranded if their recommended daily intake exceeds 10,000 IU."
21 C.F.R. § 3.95
"(a) Vitamin D is an essential nutrient for humans. It is widely recognized that vitamin D, when ingested daily in large amounts, is toxic. The U.S. Recommended Daily Allowance (U.S. RDA) for vitamin D is 400 International Units (IU).
"(b) In view of the toxicity of the excessive consumption of vitamin D, the Food and Drug Administration finds that, in order to protect the public health, oral preparations containing vitamin D in excess of 400 IU per dosage unit or recommended daily intake are drugs subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act and shall be restricted to prescription sale. Such products will be regarded as misbranded if at any time prior to dispensing the following conditions are not met:
"(1) The label bears the legend, `Caution: Federal law prohibits dispensing without a prescription'; and
"(2) The labeling bears full disclosure information as required by § 1.106(b)(3)(i) of this chapter, and especially appropriate warnings regarding vitamin D toxicity.
"(c) Preparations containing 400 or less IU of vitamin D per dosage unit will be regarded as misbranded if their recommended daily intake exceeds 400 IU.
"(d) Foods which are represented for use solely under medical supervision to meet nutritional requirements of persons with poor vitamin D absorption may contain vitamin D not in excess of 1000 IU per dosage unit or recommended daily intake."
This is an action charging that the quoted regulations are invalid and seeking to enjoin their enforcement. The plaintiffs have moved for a preliminary injunction. The extraordinary relief thus sought must be denied upon the findings of fact and conclusions of law outlined below.
The plaintiffs are the National Nutritional Foods Association, a trade association composed of manufacturers, wholesalers, and retailers of vitamins and dietary supplements, and Solgar Co., Inc., a New York corporation which manufactures, distributes, and sells vitamin supplements.
The immediate background of the regulations in question begins with their promulgation by the Commissioner of Food and Drugs as proposed regulations in the Federal Register dated December 19, 1972 (37 Fed.Reg. 26618). These regulations were corrected in minor detail in the Federal Register dated January 4, 1973 (38 Fed.Reg. 799). The
Explaining what were then his tentative views, the Commissioner said:
"The acute and chronic toxicity of these vitamins is documented extensively in the medical literature. Vitamin A is available over the counter in dosage levels up to 10 times the recommended daily dietary allowance (RDA) of the Food and Nutrition Board, National Academy of Sciences-National Research Council (NAS-NRC) and vitamin D is available up to 60 times the RDA. The availability without prescription of these vitamins in high dosage levels contributes significantly to their misuse and the occurrence of serious adverse effects." (37 Fed.Reg. 26618 (1972)).
Adverse effects which the Commissioner found from excessive intake of Vitamin A include among others anorexia, growth retardation in children, migratory arthralgia and intracranial pressure. Adverse effects resulting from an excess of Vitamin D include anorexia, weight loss, polyuria, certain forms of calcification, hypertension, anemia, irreversible renal failure and death. In respect of Vitamin D the Commissioner noted that some of these severe effects are...
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National Nutritional Foods Ass'n v. Food and Drug Administration, Nos. 1189-1203
...drugs' under 503(b)(1)(B), 21 U.S.C. 353(b) (1)(B), and labeled accordingly. See National Nutritional Foods Ass'n v. Weinberger, 366 F.Supp. 1341, 1343-1344 (S.D.N.Y.) (denial of temporary injunction), aff'd, 491 F.2d 845 (2 Cir. 1973), 376 F.Supp. 142 (S.D.N.Y.1974) (dismissal of complaint......
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National Nutritional Foods Association v. Weinberger, No. 73 Civ. 3448.
...Their motion for a preliminary injunction was denied on September 25, 1973. National Nutritional Foods Ass'n v. Weinberger, D.C., 366 F.Supp. 1341, aff'd 491 F.2d 845 (2d Cir., Defendants have now moved for summary judgment dismissing the complaint. Counsel have made extensive submissions, ......
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National Nutritional Foods Ass'n v. Weinberger, No. 228
...of the proposed regulations. In September 1973 Judge Frankel denied a motion for preliminary injunctive relief in an opinion at 366 F.Supp. 1341, (S.D.N.Y.1973), which we affirmed, 491 F.2d 845 (2d Cir. 1973). On October 1, 1973, the regulations Page 694 went into effect. In a further opini......
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National Nutritional Foods Ass'n v. Mathews, No. 561
...denial of preliminary injunctive relief in National Nutritional Foods Association v. Weinberger, 491 F.2d 845 (2d Cir. 1973), aff'g 366 F.Supp. 1341 (S.D.N.Y.1973). The regulations sought to be declared invalid, therefore, have been in effect since October 1, 1973. On the second appeal, the......
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National Nutritional Foods Ass'n v. Food and Drug Administration, Nos. 1189-1203
...drugs' under 503(b)(1)(B), 21 U.S.C. 353(b) (1)(B), and labeled accordingly. See National Nutritional Foods Ass'n v. Weinberger, 366 F.Supp. 1341, 1343-1344 (S.D.N.Y.) (denial of temporary injunction), aff'd, 491 F.2d 845 (2 Cir. 1973), 376 F.Supp. 142 (S.D.N.Y.1974) (dismissal of complaint......
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National Nutritional Foods Ass'n v. Weinberger, No. 228
...of the proposed regulations. In September 1973 Judge Frankel denied a motion for preliminary injunctive relief in an opinion at 366 F.Supp. 1341, (S.D.N.Y.1973), which we affirmed, 491 F.2d 845 (2d Cir. 1973). On October 1, 1973, the regulations Page 694 went into effect. In a further opini......
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National Nutritional Foods Association v. Weinberger, No. 73 Civ. 3448.
...Their motion for a preliminary injunction was denied on September 25, 1973. National Nutritional Foods Ass'n v. Weinberger, D.C., 366 F.Supp. 1341, aff'd 491 F.2d 845 (2d Cir., Defendants have now moved for summary judgment dismissing the complaint. Counsel have made extensive submissions, ......
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Pharmadyne Laboratories, Inc. v. Kennedy, Cir. A. No. 78-2792.
...Penn Galvanizing Company v. Lukens Steel Co., 468 F.2d 1021, 1023 (3d Cir. 1972); National Nutritional Foods Ass'n v. Weinberger, 366 F.Supp. 1341, 1347 (S.D.N.Y.), aff'd per curiam, 491 F.2d 845 (2d Cir. 1973). In litigation involving the administration of regulatory statutes designed to p......