Food Regulation. Neal D. Fortin

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СКАЧАТЬ addition, water, when used as a food ingredient, is a food, and thus, is subject to all the same requirements of the FD&C Act as any other food ingredient. Similarly, for ice added as an ingredient, the FDA has jurisdiction over packaged ice as a food.

2.2 WHAT MAKES AN ARTICLE A FOOD OR A DRUG?

      The Nutrilab starch blockers case below highlights the importance of the definitions in determining how a product will be regulated. Nutrilab claimed their starch blockers were a food because the product was derived from beans. The court, however, found that starch blockers were a drug under the FD&C Act because the “tablets and pills at issue were not consumed primarily for taste, aroma, or nutritive value” … but “they are taken for their ability to block the digestion of food and aid in weight loss.” Foods are normally digested, but starch blockers blocked the digestion, which shows intent to affect the structure or function of the body. Starch blockers were, therefore, deemed to be drugs under section 201 (g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)].

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       Nutrilab, Inc. v. Schweiker

       713 F.2d 335 (1983)

      Judges: CUMMINGS, Chief Judge; POSNER, Circuit Judge; and FAIRCHILD, Senior Circuit Judge

      Opinion: CUMMINGS

      Plaintiffs manufacture and market a product known as “starch blockers” which “block” the human body’s digestion of starch as an aid in controlling weight … . The only issue on appeal is whether starch blockers are foods or drugs under the Federal Food, Drug, and Cosmetic Act. Starch blocker tablets and capsules consist of a protein which is extracted from a certain type of raw kidney bean. That particular protein functions as an alpha‐amylase inhibitor; alpha‐amylase is an enzyme produced by the body which is utilized in digesting starch. When starch blockers are ingested during a meal, the protein acts to prevent the alpha‐amylase enzyme from acting, thus allowing the undigested starch to pass through the body and avoiding the calories that would be realized from its digestion.

      Kidney beans, from which alpha‐amylase inhibitor is derived, are dangerous if eaten raw. By August 1982, FDA had received seventy‐five reports of adverse effects on people who had taken starch blockers, including complaints of gastro‐intestinal distress such as bloating, nausea, abdominal pain, constipation and vomiting. Because plaintiffs consider starch blockers to be food, no testing as required to obtain FDA approval as a new drug has taken place. If starch blockers were drugs, the manufacturers would be required to file a new drug application pursuant to 21 U.S.C. § 355 and remove the product from the marketplace until approved as a drug by the FDA.

The statutory scheme under the Food, Drug, and Cosmetic Act is a complicated one. [FDCA § 201; 21 U.S.C.]⁸ Section 321(g)(1) provides that the term “drug” means ….

      (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph; but does not include devices or their components, parts, or accessories.

      The term “food” as defined in Section 321(f) means

      (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.

      Section 321(g)(1)(C) was added to the statute in 1938 to expand the definition of “drug.” The amendment was necessary because certain articles intended by manufacturers to be used as drugs did not fit within the “disease” requirement of Section 321(g)(1)(B). Obesity in particular was not considered a disease. Thus “anti‐fat remedies” marketed with claims of “slenderizing effects” had escaped regulation under the prior definition. The purpose of part C in Section 321(g)(1) supra was “to make possible the regulation of a great many products that have been found on the market that cannot be alleged to be treatments for diseased conditions.”

It is well established that the definitions of food and drug are normally not mutually exclusive; an article that happens to be a food but is intended for use in the treatment of disease fits squarely within the drug definition in part B of Section 321(g)(1) and may be regulated as such. Under part C of the statutory drug definition, however, “articles (other than food)” are expressly excluded from the drug definition (as are devices) in Section 321(g)(1). In order to decide if starch blockers are drugs under Section 321(g)(1)(C), therefore, we must decide if they are foods within the meaning of the part C “other than food” parenthetical exception to Section 321(g)(1)(C). And in order to decide the meaning of “food” in that parenthetical exception, we must first decide the meaning of “food” in Section 321(f).

      Congress defined “food” in Section 321(f) as “articles used as food.” This definition is not too helpful, but it does emphasize that “food” is to be defined in terms of its function as food, rather than in terms of its source, biochemical composition, or ingestibility. Plaintiffs’ argument that starch blockers are food because they are derived from food—kidney beans—is not convincing; if Congress intended food to mean articles derived from food it would have so specified. Indeed some articles that are derived from food are indisputably not food, such as caffeine and penicillin. In addition, all articles that are classed biochemically as proteins cannot be food either, because for example insulin, botulism toxin, human hair, and influenza virus are proteins that are clearly not food.

      Plaintiffs argue that 21 U.S.C. § 343(j) specifying labeling requirements for food for special dietary uses indicates that Congress intended products offered for weight conditions to come within the statutory definition of “food.” Plaintiffs misinterpret that statutory Section. It does not define food but merely requires that if a product is a food and purports to be for special dietary uses, its label must contain certain information to avoid being misbranded. If all products intended to affect underweight or overweight conditions were per se foods, no diet product could be regulated as a drug under Section 321(g)(1)(C), a result clearly contrary to the intent of Congress that “anti‐fat remedies” and “slenderizers” qualify as drugs under that Section.

      If defining food in terms of its source or defining it in terms of its biochemical composition is clearly wrong, defining food as articles intended by the manufacturer to be used as food is problematic. When Congress meant to define a drug in terms of its intended use, it explicitly incorporated that element into its statutory definition. For example, Section 321(g)(1)(B) defines drugs as articles “intended for use” in, among other things, the treatment of disease; Section 321(g)(1)(C) defines drugs as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”… . Further, a manufacturer cannot avoid the reach of the FDA by claiming that a product which looks like food and smells like food is not food because it was not intended for consumption… . In United States v. Technical Egg Prods., Inc., the defendant argued that the eggs at issue were not adulterated food under the Act because they were not intended to be eaten. The court held that there was a danger of their being diverted to food use and rejected defendant’s argument.

      Although it is easy to reject the proffered food definitions, it is difficult to arrive at a satisfactory one. In the absence of clear‐cut Congressional guidance, it is best to rely on statutory language and common sense. The statute evidently uses the word “food” in two different ways. The statutory definition of “food” in Section 321(f) is a term of art, and is clearly intended to be broader than the common‐sense definition of food, because the statutory definition СКАЧАТЬ