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AMERICAN HEALTH PRODS. CO. v. ARTHUR HULL HAYES

November 14, 1983

AMERICAN HEALTH PRODUCTS CO., INC., GENERAL NUTRITION CENTER, INC., GENERAL NUTRITION CORP., MELVA NATURAL PRODUCTS, INC., NATURE'S BOUNTY, INC., NUTRITION HEADQUARTERS, INC., PHOENIX LABORATORIES, INC., R-KANE PRODUCTS, INC., and SUNRISE CHEMICAL, INC., Plaintiffs, against ARTHUR HULL HAYES, Commissioner of Food and Drugs, and FOOD AND DRUG ADMINISTRATION, Defendants.


The opinion of the court was delivered by: SOFAER

MEMORANDUM OPINION AND ORDER

ABRAHAM D. SOFAER, D.J.:

 On July 1, 1982, the Food and Drug Administration ("FDA") announced its decision to classify as drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (hereinafter the "Act"), a group of products generally known as "starchblockers." 21 U.S.C. § 321(g)(1)(C). A short time later plaintiffs, who manufacture starchblockers, brought this action for a declaratory judgment that their products are a "food" under the Act and therefore exempt from its premarketing approval requirements. The United States moved for a preliminary injunction against the sale of these products. After a hearing on the merits the government withdrew its motion and all the parties agreed to submit the substantive legal issue for final judgment. Subsequently, numerous actions from other districts have been consolidated with this one, on the premise that the decision here will control the results in those actions. *fn1"

 The starchblockers under consideration here are derived from White Northern beans. The FDA maintains that the manufacturers make starchblocker tablets and powder by isolating and extracting the inhibitory protein from its natural source, as the labels of several of their products state. The manufacturers contend that a large proportion of the starch is simply removed from the beans in order to produce a flour with a high concentration of protein; starchblocker pills are then made by adding various binders and excipients. Whether characterized as extraction or concentration, it is undisputed that the process entails crushing the beans, heating them, removing their hulls, and then separating the starch constituents from the protein constituents by air-classification.

 The beans contain a protein that inhibits the normal functioning of alpha-amylase, an enzyme produced by the pancreas. Alpha-amylase aids in the digestion of starch by breaking it down into glucose, which the body then absorbs and utilizes for energy. Plaintiffs market their product as an aid to weight reduction, claiming that, since the protein prevents the alpha-amylase from acting, starchblockers allow some starch to pass through the body undigested, enabling dieters to avoid calories. The protein thus functions as an antinutrient by interfering with the normal digestion, absorption, and utilization of starch.

 Section 201(g)(1)(C) of the Act defines the term "drug" in part to mean "articles (other than food) intended to affect the structure or any function of the body of man or other animals." 21 U.S.C. § 321(g)(1)(C). The immediately proceeding subsection defines "food" as "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." Id. § 321(f). The starchblocker manufacturers concede that their products are intended to affect a human bodily function, but contend that the products are "food" and thus fall within the parenthetical exclusion of subsection (g)(1)(C). The government argues that the statutory definition of food does not encompass starchblockers, and seeks to enjoin their sale until the FDA approves them as "drug." Unless a manufacturer can demonstrate that its product is "generally recognized as safe and effective," see id. § 321(p), classification as a drug requires the manufacturer to cease marketing its product until the FDA approves its new drug application. See Id. § 355(a). *fn2"

 In deciding whether the FDA's determination that starchblockers are drugs is "in accordance with law," 5 U.S.C. § 706(2)(A), the FDA's interpretation merits substantial deference, National Nutritional Foods Association v. Weinberger, 512 F.2d 688, 701-02 (2d Cir.) cert. denied, 423 U.S. 827, 46 L. Ed. 2d 44, 96 S. Ct. 44 (1975). A court must only ensure that the agency's action was "governed by an intelligible statutory principle." National Nutritional Foods Association v. Mathews, 557 F.2d 325, 337 (2d Cir. 1977). Here the government contends that subsection (g)(1)(C) contemplates dual classification; in addition to classifying as drugs all those products that affect bodily structure or functions and are not common foods, and Act is said also to classify as drugs within the part (C) definition even a "food" product, if it is sold with specific representations as to its physiological effects. The manufacturers argue, on the other hand, that the definition of "food" in subsection (f), which refers to common usage, governs the reach of the parenthetical exclusion in part (C). Therefore, they urge, if an article is a "food" under subsection (f), it cannot be regulated as a drug under subsection (g)(1)(C) regardless of any representations as to its structural or functional effects made in connection with its sale.

 The government's contention is untenable. Though most sections of the Act countenance dual classification, no other contains a parenthetical like that Congress inserted in part (C). Ignoring that parenthetical would render meaningless the distinctions Congress has attempted to delineate. Nevertheless, the government is correct in claiming that starchblocker pills are a "drug" under the Act, because the pills are not a "food" in any sense cognizable under the statute. Accord Nutrilab, Inc., v. Schweiker, 713 F.2d 335 (7th Cir. 1983).

 I. Propriety of Dual Classification.

 A. The Case Law

 The government urges a construction of section 321(g)(1)(C) analogous to that of section 321(g)(1)(B). Under part (B) a product promoted for and therefore intended to be used for a therapeutic purpose -- for example, an orange sold as a cure for the common cold -- may be regulated as a drug although it is undoubtedly also a food. See, e.g., National Nutritional Foods Association v. Mathews, 557 F.2d at 334; United States v. Hohensee, 243 F.2d 367 (3d Cir.) cert. denied, 353 U.S. 976, 1 L. Ed. 2d 1136, 77 S. Ct. 1058 (1957). This result is consistent with the language of the relevant definitions, because an orange sold in such a manner is both "used for food" and "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man." But part (C) differs from its putative analogue in one glaring respect: it includes a parenthetical explicitly and unqualifiedly excluding "food" from its coverage.

 The cases upon which the government relies for its contentions provide little if any support for the proposition that a food may be regulated under part (C). With two exceptions, they either rest on part (B), see, e.g., Hohensee, 243 F.2d at 368-70 & n.1, or involve cosmetics, see, e.g., United States v. An Article . . . Sudden Change, 409 F.2d 734, 739 (2d Cir. 1969), and thus involve no explicit exception. While the court in United States v. Article of Drug BZD Silogen and Zymaferm, No. 74-L-136 (D. Neb. Sept. 1, 1976), declared intended use "[t]he touchstone under the statute" even though the manufacturer tried to bring its product within the part (C) parenthetical exclusion for food, it relied primarily on this same line of cosmetic cases and cases under part (B) without discussing the possibility of a distinction. And the court in United States v. "Vitasafe Formula M", 226 F. Supp. 266, 278 (D.N.J. 1964), rev'd on other grounds, 345 F.2d 864 (3d Cir. 1965), found that the "lipotropic factors" contained in a food article were "drugs within the meaning of 21 U.S.C. § 321(g) in that their only known use is to affect the structure and function of part of the body." While the court referred to part (C), regulation of the entire food article was not really at issue, since the statute would reach a determinate active ingredient within it. Cf. Premo Pharmaceutical Laboratories, Inc. v. United States, 629 F.2d 795, 799 (2d Cir. 1980).

 The government argues that even an explicit statutory exclusion such as the one in part (C) should not be read to preclude regulation where necessary to effectuate the broad protective purposes of the Act. Thus, according to the government, even were starchblockers classifiable as a food as a general matter, the manufacturers' labeling claims here reveal an intended use which brings them within the reach of the statute. The government finds support for its position in AMP Inc. v. Gardner, 389 F.2d 825 (2d Cir.), cert. denied, 393 U.S. 825, 89 S. Ct. 86, 21 L. Ed. 2d 95 (1968), and United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, 22 L. Ed. 2d 726, 89 S. Ct. 1410 (1969).

 Both AMP and Bacto-Unidisk addressed the superficially analogous question whether a product was properly classified a "drug" or excluded as a "device" under section 321 of the Act. Just as the parenthetical of subsection (g)(1)(C) excludes "food" from the coverage of that provision, the final clause of subsection (g)(1) excludes "devices" from the reach of the entire definition. The product at issue in AMP used nylon disk and thread to ligate severed blood vessels during surgery. The Second Circuit at least implicitly recognized that the product came within the literal terms of the definition of "device" in section 321(h), but it looked to the purpose of the statute to conclude that the product nevertheless was regulable as a drug within the terms of subsection (g). 389 F.2d at 826-30. In Bacto-Unidisk, the Supreme Court came to a similar conclusion with respect to a sensitivity disc used in laboratory tests to determine the proper antibiotic drug to administer to a given patient. Also guided by statutory purpose, and employing the analysis used in AMP, the Court explicitly rejected the contention that, since the sensitivity disc was "plainly a "device" it was "by definition necessarily not a "drug." 394 U.S. at 798-99; see id. at 793-98. A careful reading of those opinions makes clear, however, that the courts was responding to specific indications in the legislative history that Congress intended the premarketing approval requirements for drugs to apply as well to devices.

 The AMP court noted, first, that early versions of the Act, which underwent significant revision between its original introduction in 1933 and its final passage in 1938, contained no separate definition of "device" but included the term within the definition of "drug", 389 F.2d at 827-28; second, that the parallel but independent definition of "device" was added in response to objections based only on the linguistic incongruity of denominating as drugs certain of the contraptions which the drafters intended the Act to cover, id. at 828-29; and third, that at the time the separate definition was added the distinction between drugs and devices had no practical significance because all the operative provisions of the bill applied equally to both, id. at 829. Some time after the drafters had separated the drug and device definitions, they added the premarketing approval provisions for drugs as a result of the deaths in late 1937 of nearly one hundred people from consumption of an untested drug. See 21 U.S.C. §§ 321(p), 355. See generally Report of the Secretary of Agriculture on Deaths Due to Elixir Sulfanilamide-Massengill, reprinted in 5 A Legislative History of the Food, Drug, and Cosmetic Act and Its Amendments ("Legislative History"). The AMP court observed, however, that these provisions employed the term "new drug" . . . without any attention to ...


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