Act;
what makes an article a food, a drug, or a product outside the scope of the FD&C Act; and
the central role of intended use.
2.1.1 Definitions
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SEC. 201. [321] 2 For the purposes of this Act—
….
(f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any other such article.
(g) (1) 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 clause (A), (B), or (C) … .
(i) The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
….
(s) The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—
1 a pesticide chemical in or on a raw agricultural commodity; or
2 a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or
3 a color additive; or
4 any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph pursuant to this … or
5 a new animal drug; or
6 an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.
….
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2.1.2 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.
The statutory definition of “food” in FD&C Act section 321(f) is a term of art that is broader than the common‐sense definition of food. This creates pitfalls for the unwary. For instance, the definition of “food” includes chewing gum and food additives. Moreover, “food additives” includes substances that are not food ingredients but otherwise affect the characteristics of a food.3
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 U.S. Department of Agriculture (USDA) is responsible for meat, poultry, and processed eggs; however, which agency has jurisdiction over these foods is complex and sometimes uncertain. All foods are subject to the FD&C Act—meats are exempt from the FD&C Act provisions, but only to the extent that the Federal Meat Inspection Act (FMIA) applies.4
FDA generally has jurisdiction over live meat animals intended for food, but USDA has authority regarding the illegal transportation of diseased animals in commerce.5 USDA has exclusive jurisdiction over the slaughter and processing of meat animals. However, food additives are under the jurisdiction of the FDA; therefore, the USDA and FDA have joint jurisdiction for food additives in meat and poultry.
FDA has the main regulatory authority over the transport of food, but USDA has some jurisdiction over the illegal transport of meat in commerce.6 FDA has exclusive jurisdiction over retail establishments (when in federal jurisdiction). Nonetheless, USDA may still regulate USDA‐labeled packages that are found in retail establishments, but USDA lacks authority over the retail establishments directly.
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.
Under an FDA‐FSIS MOU for multi‐ingredient products that contain meat, the percentage of meat determines whether the product is subject to USDA jurisdiction. For example, a product containing 3 percent or less raw meat falls under FDA jurisdiction. These are agreements between the agencies rather than law. The most current MOUs can be found on the agencies’ websites.
Water
The Safe Drinking Water Act7 places the responsibility for the safety and purity of drinking water on the EPA. However, the FDA retains the authority over bottled drinking water. Differences between these two
