National Nutritional Foods Ass'n v. Weinberger, 228

CourtUnited States Courts of Appeals. United States Court of Appeals (2nd Circuit)
Citation512 F.2d 688
Docket NumberD,No. 228,228
PartiesThe NATIONAL NUTRITIONAL FOODS ASSOCIATION and Solgar Co., Inc., Plaintiffs-Appellants, v. Casper W. WEINBERGER, Secretary of Health, Education and Welfare and Alexander M. Schmidt, Commissioner of Food and Drugs, Defendants-Appellees. ocket 74-1738.
Decision Date03 February 1975

Milton A. Bass, New York City (Bass & Ullman, New York City, of counsel), for plaintiffs-appellants.

Naomi Reice Buchwald, Asst. U.S. Atty. (Paul J. Curran, U.S. Atty., for the Southern District of New York, Gerald A. Rosenberg, Asst. U.S. Atty., New York City, of counsel), for defendants-appellees.

Kirkpatrick W. Dilling, and Dennis M. Gronek, Chicago, Ill. (Diana J. Dilling, Chicago, Ill., of counsel), for amicus curiae National Health Federation.

Before LUMBARD, WATERMAN and MANSFIELD, Circuit Judges.

MANSFIELD, Circuit Judge:

This appeal by producers and vendors of vitamin preparations arises out of their unsuccessful attempt in the Southern District of New York to challenge regulations promulgated by the United States Food and Drug Administration ("FDA" herein) pursuant to § 701(a) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (the "Act" herein), which classify as "prescription drugs" all preparations of Vitamin A containing more than 10,000 IU (international units) per dosage form and of Vitamin D containing more than 400 IU per dosage form. 1 In the district court appellants sought declaratory and injunctive relief against the regulations, claiming that the FDA has no power to issue binding regulations under § 701(a), that the vitamin preparations at issue are foods and were improperly classified as prescription drugs under the Act, that plaintiffs were entitled to a de novo trial in the district court of factual issues going to the basis of the regulations and the FDA's action in promulgating them was unsupported by substantial evidence. Appellants further contended that the "whole record" of the agency's action was not before the district court, and sought to depose the Commissioner of Food and Drugs ("Commissioner" herein). The district court, Marvin E. Frankel, Judge, vacated the notice of deposition and granted summary judgment dismissing the complaint.

Purporting to act under the general rule-making power vested in the Secretary of Health, Education and Welfare ("HEW" herein) by § 701(a) of the Act, 21 U.S.C. § 371(a), which authorizes him "to promulgate regulations for the efficient enforcement of this Act," the Commissioner, to whom this rule-making authority is delegated, 21 C.F.R. 2.120(a)(1), followed the notice-and-comment procedure outlined by § 4(c) of the Administrative Procedure Act, 2 5 U.S.C. § 553(c), in promulgating the challenged regulations. First he published a statement in the Federal Register, 37 Fed.Reg. 26618, on December 14, 1972, giving notice of his proposal to adopt regulations which would require that, pursuant to the "prescription drug" law, § 503(b)(1) of the Act, 21 U.S.C. § 353(b), 3 Vitamins A and D in dosage units in excess of 10,000 IU and 400 IU, respectively ("higher dosage forms" herein) be restricted to prescription sale and deemed misbranded unless the label of the container in which they were sold or dispensed bore appropriate disclosure and warnings.

The Commissioner's initial statement advised that, according to medical literature, the ingestion of large dosages of Vitamins A and D over long periods could have serious toxic effects and that these vitamins were available over the counter in dosage forms many times the daily allowance recommended and published by the Food and Nutrition Board of the National Academy of Sciences-National Research Council ("NAS/NRC" herein). According to the Commissioner's statement the excess dosage forms were the subject of widespread promotion to the public for prophylaxis and treatment of a variety of diseases and disorders. The American Academy of Pediatrics had published a statement warning physicians regarding the various forms of toxicity that could result from intake of the large amounts of Vitamin A being recommended by vendors to the public in the press, on radio and on TV. Many types of serious adverse effects from ingestion of excessive amounts of Vitamins A and D were listed, including some that resulted in death. The recommended daily allowance ("RDA" herein) published by the Food and Nutrition Board of the NAS/NRC as between 4,500 and 5,000 IU of Vitamin A for older children and adults, 6,000 IU during pregnancy and 8,000 IU during lactation. For Vitamin D preparations the RDA was 400 IU for all age groups. The Commissioner placed on public view an extensive bibliography of the medical literature employed by the FDA in formulating its proposed regulations. The Commissioner's statement invited interested persons to file with the HEW within 60 days any written comments they might desire to submit with respect to the proposals, together with memoranda and briefs, all of which would be available for public inspection.

Over, 2,500 written comments were submitted by a wide cross-section of the public, including consumers, physicians, nurses, pharmacists, pharmaceutical manufacturers, health food store operators. Various organized consumer and other groups, including the Academy of Pediatrics, American Medical Association, and the Pharmaceutical Manufacturers Association also responded. Both plaintiffs in this case submitted extensive comments opposing the regulations. According to the Commissioner; the comments fell into three general categories: (1) Those who viewed the proposed regulations as suitable. This group included the American Medical Association, the American Academy of Pediatrics, various consumer groups, physicians and others; (2) Those who agreed that vitamins could be toxic, but at higher levels that those proposed by the Commissioner. In this group were the majority of the drug manufacturers and trade associations plus some consumers; and (3) Those who disagreed with the proposals entirely, taking the view that such vitamin preparations are food and that consumption of desired quantities is an individual right. These comments came mostly from consumers and health food establishments.

In a report published in the Federal Register on August 2, 1973, 38 Fed.Reg 20723, the Commissioner summarized the comments received by the FDA, concluded that the proposed regulations were in the public interest, and ordered that they become effective on October 1, 1973. In response to contentions that Vitamins A and D were foods rather than drugs, and thus not subject to regulation as "prescription drugs," the Commissioner referred to orders which he had published on January 19, 1973, promulgating as regulations §§ 80.1, 125.1 and 125.3 (21 C.F.R. §§ 80.1, 125.1 and 125.3). 4 He concluded that vitamins in daily amounts between the upper and lower limits specified in § 80.1 (i. e., 1,250 to 8,000 IU of Vitamin A and 200 to 400 IU of Vitamin D) were adequate for all nutritional needs of normal individuals and that nutrients at these levels could be considered as dietary supplements or foods for special dietary use. With respect to the higher level dosages, which were to be dispensed only upon prescription, however, he stated:

                                                TABLE CONTINUED
                -------------------------------------------------------------------------------
                Adults and children 4
                or more years of age--                            Pregnant or lactating
                U.S. RDA                                             women--U.S. RDA
                ----------------------                            ---------------------
                        Lower                      Upper        Lower                     Upper
                        Limit                      Limit        Limit                     Limit
                -------------------------------------------------------------------------------
                        2,500        5,000         5,000        5,000        8,000        8,000
                        -----        -----         -----          400          400          400
                           15           30            45           30           30           60
                           30           60            90           60           60          120
                          0.2          0.4           0.4          0.4          0.8          0.8
                         0.75         1.50          2.25         1.50         1.70         3.00
                          0.8          1.7           2.6          1.7          2.0          3.4
                         10.0         20.0          30.0         20.0         20.0         40.0
                         1.00         2.00          3.00         2.00         2.50         4.00
                          4.5          3.0           6.0          9.0          8.0         12.0
                          200          400           400        -----        -----        -----
                        0.150        0.300         0.450        0.300        0.300        0.600
                          5.0         10.0          15.0         10.0         10.0         20.0
                        0.125        1.000         1.500        0.125        1.300        2.000
                        0.125        1.000         1.500        -----        -----        -----
                           75          150           225          150          150          300
                            9           18            27           18           18           60
                          100          400           600          100          450          800
                        -----        -----         -----        0.125        1.300        2.000
                          1.0          2.0           3.0          1.0          2.0          4.0
                          7.5         15.0          22.5          7.5         15.0         30.0
                1 When labeled for use by infants, a dietary supplement shall contain not
                 less than the lower limit designated for a nutrient in this column nor more
                 than 100% of the infant U.S. RDA for a nutrient as prescribed in Sec.125.1(b)
                 except that the level of biotin, when used, shall be 0.05 mg per daily
                 recommennded quantity
                2 Optional for adults and
...

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