CHAPTER IV-FOOD DEFINITIONS AND STANDARDS FOR FOOD SEC. 401. [21 U.S.C. 341] Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container. No definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried vegetables, or butter, except that definitions and standards of identity may be established for avocados, cantaloupes, citrus fruits, and melons. In prescribing any standard of fill of container, the Secretary shall give due consideration to the natural shrinkage in storage and in transit of fresh natural food and to need for the necessary packing and protective material. In the prescribing of any standard of quality for any canned fruit or canned vegetable, consideration shall be given and due allowance made for the differing characteristics of the several varieties of such fruit or vegetable. In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Secretary shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. Any definition and standard of identity prescribed by the Secretary for avocados, cantaloupes, citrus fruits, or melons shall relate only to maturity and to the effects of freezing. ADULTERATED FOOD SEC. 402. [21 U.S.C. 342] A food shall be deemed to be adulterated-1 (a)(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health. 2 (2)(A) 3 if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical res etc. 1 See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of “(a)”, “(b)”, 2 So in law. See section 3(i)(1) of Public Law 103-80. Probably should be "; or". 3 Subparagraph (2) appears so as to reflect the probable intent of the Congress. Section 404 of Public Law 104-170 (110 Stat. 1514) had amendatory instructions whose probable intended effect was to strike the existing subparagraph (2) and to insert a substitute subparagraph (2). These included instructions to strike "(2)(A) if it bears" and all that follows through “(3) if it consists", but "(3) If it consists" was the language that actually appeared. (Previously, section 3(i) of Public Law 103-80 (107 Stat. 776) had amended subparagraph (3) by striking "if it" and inserting "If it".) idue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409. (b)(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. (c) If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a). (d) If it is confectionery, and (1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health; (2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale; or (3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this Act, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowing or prohibiting the use of particular nonnutritive substances. (e) If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food. (f)(1) If it is a dietary supplement or contains a dietary ingredient that (A) presents a significant or unreasonable risk of illness or injury under (i) conditions of use recommended or suggested in labeling, or (ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use; (B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; (C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5, United States Code, to affirm or withdraw the declaration; or (D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement. In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis. (2) Before the Secretary may report to a United States attorney a violation of paragraph 1 (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding. (g)(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2). (2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code. 1 So in law. Probably should be "subparagraph". (h) If it is an article of food imported or offered for import into the United States and the article of food has previously been refused admission under section 801(a), unless the person reoffering the article affirmatively establishes, at the expense of the owner or consignee of the article, that the article complies with the applicable requirements of this Act, as determined by the Secretary. MISBRANDED FOOD SEC. 403. [21 U.S.C. 343] A food shall be deemed to be misbranded-1 (a) If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which section 411 applies, its advertising is false or misleading in a material respect or its labeling is in violation of section 411(b)(2). (b) If it is offered for sale under the name of another food. (c) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated. (d) If its container is so made, formed, or filled as to be misleading. (e) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, except that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. (f) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (g) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 401, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food. etc. (h) If it purports to be or is represented as (1) a food for which a standard of quality has been prescribed by regulations as provided by section 401, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; (2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 401, and it falls below the standard of fill of container ap 1 See footnote for paragraph (h)(3) regarding the stylistic use of a list consisting of “(a)”, “(b)”, plicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or (3) a food that is pasteurized unless (A) such food has been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation promulgated under this Act; or (B)(i) such food has been subjected to a safe process or treatment that (I) is reasonably certain to achieve destruction or elimination in the food of the most resistant microorganisms of public health significance that are likely to occur in the food; (II) is at least as protective of the public health as a process or treatment described in subparagraph_(A); (III) is effective for a period that is at least as long as the shelf life of the food when stored under normal and moderate abuse conditions; and (IV) is the subject of a notification to the Secretary, including effectiveness data regarding the process or treatment; and (ii) at least 120 days have passed after the date of receipt of such notification by the Secretary without the Secretary making a determination that the process or treatment involved has not been shown to meet the requirements of subclauses (I) through (III) of clause (i) 1. For purposes of paragraph (3)1, a determination by the Secretary that a process or treatment has not been shown to meet the requirements of subclauses (I) through (III) of subparagraph (B)(i)1 shall constitute final agency action under such subclauses. (i) Unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence on the 1 References are so in law. See section 10808(b)(3) of Public Law 107-171 (116 Stat. 530). In order to be consistent with other cross-references within section 403 above, each reference in section 403(h)(3) to a paragraph, subparagraph, clause, or subclause should be a reference to a subparagraph, clause, subclause, or item, respectively. See, for example, cross-references in paragraph (q) (relating to nutrition information) and paragraph (r) (relating to nutrient levels and health claims). Section 403 was enacted in 1938 and has organizational units and cross-references that are not in accordance with modern practice. In modern practice, “(a)" is a subsection, “(1)” is a paragraph, “(A)” is a subparagraph, “(i)” is a clause, “(I)” is a subclause, “(aa)” is an item, and “(AA)” is a subitem. The references in section 403(h)(3) follow this practice. In modern practice, all of the section 403 text would be considered an undesignated subsection, and the list that begins after "A food shall be deemed to be misbranded" would consist of paragraphs (1), (2), etc. In section 403, however, the original authors of the 1938 Act used a list consisting of (a), (b), etc., and the authors referred to “(a)” as a paragraph, “(1)” as a subparagraph, “(A)” as a clause, and "(i)" as a subclause. (Express references to organizational units below the “(i)” level have been avoided.) The original authors followed this approach in each section in this Act whose text was a list consisting of (a), (b), etc. Such sections include sections 201, 301, 402, 403, 501, 502, 601, and 602. Some of these sections have numerous internal cross-references. Rather than conforming each of these to the modern practice, the usual approach in making amendments to these sections has been to follow the approach used by the original authors of the 1938 Act. |