Neal D. Fortin

Food Regulation


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FDA’s Jurisdiction and the Definition of Food

      The scope of FDA’s authority over food derives in large measure from the definition of “food” in the Federal FD&C Act. Therefore, the definition bears importance in determining the reach and limits of the FDA’s jurisdiction and authority.

      To a large extent, the use of a product will determine the regulatory category into which it will fall. The manufacturer’s representations and the intended use also play an important part of determining the classification. On occasion, a manufacturer may benefit from changing its representations so that their product falls into a different category. For example, a laxative gum can escape the definition of food by being represented unequivocally as a drug product.

      NOTE AND QUESTION

      1 2.1 The broad definition of “food” under the FD&C Act provides a broad scope of authority to the FDA. As worded, does this broad scope overlap with the U.S. Department of Agriculture (USDA) FSIS’s authority?

      2.1.3 Specific Food Classifications

       Meat, Poultry, and Processed Eggs

      The statutes are the primary demarcations of agency jurisdiction. However, areas remain where the agencies’ authority under the law overlaps. To conserve resources, the agencies further divide their responsibility based on Memoranda of Understandings (MOUs). The MOU agreements allow the agencies to increase efficiency by eliminating overlapping activities.

       Water

      In 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.

      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)].

      * * * * *

       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.

      (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