[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR166.40] [Page 541-543] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 166_MARGARINE--Table of Contents Subpart A_General Provisions Sec. 166.40 Labeling of margarine. Subpart A_General Provisions Sec. 166.40 Labeling of margarine. Subpart B_Requirements for Specific Standardized Margarine 166.110 Margarine. Authority: 21 U.S.C. 321, 341, 343, 347, 348, 371, 379e. The Federal Food, Drug, and Cosmetic Act was amended by Pub. L. 459, 81st Congress (64 Stat. 20) on colored oleomargarine or margarine by adding thereto a new section numbered 407. Among other things, this section requires that there appear on the label of the package the word ``oleomargarine'' or ``margarine'' in type or lettering at least as large as any other type or lettering on the label, and a full and accurate statement of all the ingredients contained in such oleomargarine or margarine. It provides that these requirements ``shall be in addition to and not in lieu of any of the other requirements of this Act''. (a) Under section 403(g) of the Federal Food, Drug, and Cosmetic Act, any article that is represented as or purports to be oleomargarine or margarine must conform to the definition and standard of identity for oleomargarine [[Page 542]] or margarine promulgated under section 401 of the act (Subpart B of this part), and its label must bear the name ``oleomargarine'' or ``margarine''. (b) The identity standard for oleomargarine or margarine applies to both the uncolored and the colored article. (c) In considering the requirement that the word ``oleomargarine'' or ``margarine'' be in type or lettering at least as large as any other type or lettering on the label, it must be borne in mind that at least three factors are involved--the height of each letter, the area occupied by each letter as measured by a closely fitting rectangle drawn around it, and the boldness of letters or breadth of the lines forming the letters. The type or lettering used should meet the following tests: (1) The height of each letter in the word ``oleomargarine'' or ``margarine'' should equal or exceed the height of any other letter elsewhere on the label. (2) The area of the closely fitting rectangle with respect to any of the letters in the word ``oleomargarine'' or ``margarine'' should equal or exceed the area of such rectangle applied to the same or a corresponding letter elsewhere on the label. (3) The letters in the word ``oleomargarine'' or ``margarine'' should be equal to or exceed in prominence and boldness, such as breadth of lines forming the letters, the same or corresponding letters elsewhere on the label. (d) [Reserved] (e) The word ``oleomargarine'' or ``margarine'' (and thus the other information called for by the statute) should appear on each panel of the package label that might reasonably be selected by the grocer for display purposes at the point of sale. (f) The amendment covering colored oleomargarine or colored margarine states that, ``for the purposes of * * * section 407 of the Federal Food, Drug, and Cosmetic Act, as amended, the term `oleomargarine' or `margarine' includes: (1) All substances, mixtures, and compounds known as oleomargarine or margarine; (2) all substances, mixtures, and compounds which have a consistency similar to that of butter and which contain any edible oils or fats other than milk fat if made in imitation or semblance of butter''. Notwithstanding the difference between this definition and the definition and standard of identity for oleomargarine or margarine promulgated under section 401 of the act, it was the clear intent of Congress that any article which is represented as or purports to be oleomargarine or margarine is misbranded if it fails to comply with the definition and standard of identity for oleomargarine or margarine even though it may meet the statutory definition. (g) Section 407(a) states that ``Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to the same extent to the provisions of this act as if it had been introduced in interstate commerce''. (h) Section 407(b)(4) requires that each part of the contents of the package be ``contained in a wrapper which bears the word `oleomargarine' or `margarine' in type or lettering not smaller than 20-point type''. The Food and Drug Administration interprets this to mean that the height of the actual letters is no less than 20 points, or 20/72 of 1 inch. (i) The wrappers on the subdivisions of oleomargarine or margarine contained within the package sold at retail are labels within the meaning of section 201(k) and shall contain all of the label information required by sections 403 and 407 of the Federal Food, Drug, and Cosmetic Act, just as in the case of 1-pound cartons, except that wrappers on the subdivisions contained within the retail package shall be exempt from compliance with the requirements of section 403 (e)(1), (g)(2), (i)(2), and (k) of the act with respect to the requirements for label declaration of the name and place of business of the manufacturer, packer, or distributor and label declaration of ingredients when (1) the subdivisions are securely enclosed within and are not intended to be separated from the retail package under conditions of retail sale; (2) the wrappers on the subdivisions are labeled with the statement ``This Unit Not Labeled For Retail Sale'' in type size not less than one- sixteenth inch in height. The word ``Individual'' may be [[Page 543]] used in lieu of or immediately preceding the word ``Retail'' in the statement. [42 FR 14477, Mar. 15, 1977, as amended at 46 FR 31005, June 12, 1981; 47 FR 32421, July 27, 1982]