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NATIONAL NUTRITIONAL FOODS ASSN. v. WEINBERGER

September 25, 1973

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


Frankel, District Judge.


The opinion of the court was delivered by: FRANKEL

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 ...


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