tailer's regular price, designated as "regular price," in a position contiguous to the "cents-off" marked commodity. EFFECTIVE DATE: This revision of paragraph (b) (1) will become effective June 30, 1972. (2) Other savings representations which appear on the label or labeling of a package, e.g., "bonus offer," "twofor-one sales," "one-cent sales," etc., are subject to the provisions of this section. Due to the infinite variety and scope of such promotions, the label format of such representations may differ from that set forth in subparagraph (1) of this paragraph for "cents-off” promotions; however, such representations shall include all material facts relative to the offer and shall in no way be misleading. (3) For the purposes of this section, the terms "ordinary and customary" and "regular" when used with the term "price" mean the price at which a consumer commodity has been openly and actively sold in the most recent and regular course of business in a particular retail outlet or a trade area for a reasonably substantial period of time (at least 30 days). For consumer commodities that fluctuate in price, the ordinary and customary price shall be the lowest price at which any substantial sales were made during said 30 days. or (c) Shipments of consumer commodities bearing "cents-off," coupon, other savings representations to a given geographic trade area made by the sponsor initiating such promotion shall be in no greater volume than 50 percent of the total units of that identical consumer commodity distributed in the same geographic trade area during any period of 12 consecutive months comprising a calendar, fiscal, or market year. (d) The "cents-off," coupon, or other savings promotion may not be employed by a sponsor on consumer commodities for distribution to a specific geographic trade area until after 1 month has elapsed since their last distribution of that identical consumer commodity bearing a savings representation to the same geographic trade area. No more than three such promotions for that identical consumer commodity may occur within a 12-month period comprising a calendar, fiscal, or market year, and the total period of time for such promotions of that identical consumer commodity shall not exceed 6 months within that 12month period. (e) A newly developed consumer commodity, one which has been changed in a functionally significant respect, or one which is newly introduced into a given geographic trade area may be the subject of an "introductory offer" type promotion. Such offers are not considered subject to the provisions of paragraphs (a) through (d) of this section, provided: (1) Each such labeled offer is clearly and conspicuously qualified with the phrase "Introductory Offer,” and (2) If the introductory offer promotion is in the form of a "cents-off" representation, each such labeled offer shall include clearly and conspicuously in immediate conjunction therewith the phrase " - Off the After-Introductory-Offer Price;" and (3) Labeled representations do not exceed a period of 6 months duration. Any subsequent price reduction promotion of the consumer commodity is subject to the provisions of paragraphs (a) through (d) of this section and shall be preceded by the 30-day period required for a determination of the ordinary and customary selling price in that retail establishment. At the time of making the introductory offer promotion, the sponsor must intend in good faith to offer the commodity alone, immediately following the introductory offer promotion, for a reasonably substantial period of time (at least 30 days) at the anticipated afterintroductory-offer price. The sponsor of the introductory offer promotion and all subsequent levels of commerce shall sell the commodity at a reduction from their anticipated after-introductory-offer price which reduction shall be at least equal to the savings differential represented on the package or labeling. The sponsor and all subsequent levels of commerce shall maintain invoices and records for at least 1 year subsequent to the end of the year (calendar, fiscal, or market) in which such introductory offer occurs. (f) A representation on the label or labeling that the consumer commodity is being offered for retail sale at a reduced price by virtue of a redeemable coupon shall not be used unless the coupon is redeemable at retail unconditionally or upon the purchase or subsequent purchase of either that product or other consumer commodities involved in the promotion. It is provided, however, that in lieu of unconditional redemption at retail, the sponsor may request that coupons be mailed via first class mail to some central point for redemption only if the consumer is reimbursed for the cost of the first class postage. Such coupon offers which bear expiration dates or which are contingent upon the purchase of other consumer commodities involved in the promotion shall bear a prominent and conspicuous statement fully disclosing all material conditions included in the coupon offer. Such statement shall be in conjunction with the representation wherever it appears on the label or labeling of the consumer commodity. (Sec. 5, 80 Stat. 1298; 15 U.S.C. 1454) [36 F.R. 25221, Dec. 30, 1971] EFFECTIVE DATE: This revision is effective 30 days after date of publication except (e) and (f) which will become effective March 31, 1972. For the convenience of the user the superseded text is set forth below: § 1.1d "Cents-off," coupon, or other savings representations. Any food, drug, cosmetic, or device that bears on the label or labeling a representation that the consumer commodity is being offered for retail at a reduction in retail price is subject to the following conditions: (a) A "cents-off" coupon, or other savings representation that states or implies a reduction in the ordinary and customary retail price may be used by a manufacturer, packer, distributor, or retailer, hereinafter known as the sponsor, initiating such promotion only if (1) an ordinary and customary retail selling price of such consumer commodity has been established, (2) the sponsor's selling price and the selling price at all subsequent levels of commerce such as wholesalers and jobbers has been reduced by at least the savings differential represented on the package or labeling, and (3) the sponsor and all subsequent levels or commerce keep and maintain invoices or other records for each promotion and for all successive promotions which occur within a 12-month period for at least 1 year beyond the termination date of the last of such promotions set by the sponsor in order to show that the invoice cost to the retailer has been reduced in an amount sufficient to enable the retailer to pass the savings on to the purchaser. (b) (1) A price reduction representation shall be presented on the package to show the ordinary and customary retail price and the savings to the consumer as follows: shelf marker placed in conspicuous and prominent position contiguous to the retail display of the consumer commodity. (2) For the purposes of this section, the terms "ordinary and customary" and "regular" when used with the term "price" means the price at which a consumer commodity has been openly and actively sold in the most recent and regular course of business in a particular market or a trade area for a reasonably substantial period of time; that is, at least 30 days. For consumer commodities that fluctuate in price, the ordinary and customary price shall be the lowest price at which any substantial sales were made during said 30 days. (c) Shipments of consumer commodities bearing "cents-off," coupon, or other savings representations to a given geographic trade area made by the sponsor initiating such promotion shall be in no greater volume than 50 percent of the total units of that identical consumer commodity distributed in the same geographic trade area during any period of 12 consecutive months. (d) The "cents-off," coupon, or other savings promotion may not be employed by a sponsor on consumer commodities for distribution to a specific geographic trade area until after 1 month has elapsed since their last distribution of the same consumer commodity bearing a savings representation to the same geographic trade area. No more than three such promotions for the same consumer commodity may occur within a 12-month period, and the total period of time for such promotions of any given size consumer commodity shall not exceed 6 months within that 12-month period. (e) A newly developed consumer commodity, one which has been changed in a functionally significant respect, or one which is newly introduced into a given geographic trade area may be the subject of an introductory-offer type promotion. Such offers are not considered subject to the provisions of paragraphs (a) through (d) of this section, provided labeled representations (1) are qualified by a phrase such as "introductory offer," (2) include the suggested postintroduction retail price, and (3) do not exceed a period of 6 months duration. Any subsequent price reduction promotion of the consumer commodity is subject to the provisions of paragraphs (a) through (d) of this section and shall be preceded by the 30-day period required for a determination of the ordinary and customary selling price in that retail establishment. At the time of making the introductory offer promotion, the sponsor must intend in good faith to offer the commodity alone, immediately following the introductory offer promotion, for a reasonably substantial period of time, that is, at least 30 days, at the anticipated postintroductory price. The sponsor and all subsequent levels of commerce shall maintain invoices and records for at least 1 year beyond the termination date of such introductory offers. (f) A representation on the label or labeling that the consumer commodity is being offered for retail sale at a reduced price by virtue of a redeemable coupon shall not be used unless the coupon is redeemable at retail unconditionally or upon the purchase or subsequent purchase of either that product or other consumer commodities involved in the promotion. Coupon offers which bear expiration dates or which are contingent upon the purchase of other consumer commodities involved in the promotion shall bear a prominent and conspicuous statement fully disclosing all material conditions included in the coupon offer. Such statement shall be in conjunction with the representation wherever it appear on the label or labeling of the consumer commodity. (Sec. 5, 80 Stat. 1298; 15 U.S.C. 1454) [36 F.R. 12289, June 30, 1971] § 1.le Package size savings. Any food, drug, cosmetic, or device that bears on the label or labeling a representation that the consumer commodity is being offered at a lower price per unit of weight, measure, or count because of economy resulting from the size of the container or quantity of its contents is subject to the following conditions: (a) The container may bear a representation of economy by virtue of its size (for example, "economy size," "economy pack," "big value," "thrifty pack," "bargain size," "budget pack," etc.) only if: (1) The sponsor of the economy size promotion at the same time offers the same brand of that commodity in at least one other packaged size or labeled form. (2) Only one packaged or labeled form of that brand of commodity is labeled with an "economy size" representation. (3) The sponsor of the economy size promotion and all subsequent levels of commerce sell the commodity labeled with an "economy size" representation at a price per unit of weight, volume, measure, or count which is substantially reduced (i.e., at least 5 percent) from the actual price of all other packaged or labeled units of the same brand of that commodity offered simultaneously. (b) The sponsor of the economy size promotion and all subsequent levels of commerce such as wholesalers and jobbers shall maintain for at least 1 year invoices or other records showing that the wholesale price per unit of weight, measure, or count in the economy size package is such that the retailers can sell the economy size container at a significantly lower price per unit. (Sec. 5, 80 Stat. 1298; 15 U.S.C. 1454) [36 F.R. 25222, Dec. 30, 1971] EFFECTIVE DATE: This revision is effective March 31, 1972. For the convenience of the user the superseded text is set forth below: § 1.1e Package size savings. Any food, drug, cosmetic, or device that bears on the label or labeling a representation that the consumer commodity is being offered at a lower price per unit of weight, measure, or count because of economy resulting from the size of the container or quantity of its contents is subject to the following conditions: (a) The container may bear a representation of economy by virtue of its size (for example, "economy size," "economy pack," "big value," "thrifty pack," "bargain size,” "budget pack," etc.) only if an ordinary and customary retail selling price has been established for both regular or other size containers, and the economy size containers and the price per unit of weight, measure, or count in the economy size container is lower to a significant degree, at least 5 percent, than the ordinary and customary price per unit of weight, measure, or count of the least expensive per unit of weight, measure, or count of the other retail size(s) for the identical consumer commodity. Only one packaged or labeled form of that brand of commodity may bear such an economy representation, and it shall be conspicuously presented and in no way misleading. For the purposes of this section, the price per unit of weight, measure, or count shall be based upon the ordinary and customary retail selling price which shall be the arithmetical mean of the prices at which the consumer commodity in the containers was sold in that particular retail outlet for the 30-day period immediately preceding the price marking. (b) The sponsor of the economy size promotion, and all subsequent levels of commerce such as wholesalers and jobbers, shall maintain for at least 1 year invoices or other records showing that the wholesale price per unit of weight, measure, or count in the economy size package is such that the retailers can sell the economy size container at a significantly lower price per unit. (Sec. 5, 80 Stat. 1298; 15 U.S.C. 1454) [36 F.R. 12290, June 30, 1971] DEFINITIONS AUTHORITY: §§ 1.2 and 1.3 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted. § 1.2 Labeling; label; definitions. (a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) “Label" means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity. (Secs. 4, 6, 80 Stat. 1297, 1299, 1800, secs. 403, 602, 52 Stat. 1047, 1050, 1054; 15 U.S.C. 1453, 1455, 21 U.S.C. 343, 352, 362) [32 F.R. 10731, July 21, 1967] The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there is a material weight of opinion contrary to such representation. (Sec. 201, 52 Stat. 1041, as amended; 21 U.S.C. 321) [20 F.R. 9526, Dec. 20, 1955] PROHIBITED ACTS AND PENALTIES AUTHORITY: 1.4 to 1.6 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted. § 1.4 Guaranty. In case of the giving of a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it. (Sec. 301, 52 Stat. 1042, as amended; 21 U.S.C. 331) [20 F.R. 9526, Dec. 20, 1955] 8 1.5 Guaranty; definition, and suggested forms. (a) A guaranty or undertaking referred to in section 303 (c) (2) of the act may be: (1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery, or (2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty or undertaking. (b) The following are suggested forms of guaranty or undertaking under section 303 (c) (2) of the act: (1) Limited form for use on invoice or bill of sale. (Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce. (Signature and post-office address of person giving the guaranty or undertaking) (2) General and continuing form. The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or on the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed as of the date of such shipment or delivery, to be, on such date, not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce. (Signature and post-office address of person giving the guaranty of undertaking) (c) The application of a guaranty or undertaking referred to in section 303 (c) (2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes adulterated or misbranded within the meaning of the act, or becomes an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce. (d) A guaranty or undertaking referred to in section 303(c)(3) of the act shall state that the shipment or other delivery of the color additive covered thereby was manufactured by a signer thereof. It may be a part of or attached to the invoice or bill of sale covering such color. If such shipment or delivery is from a foreign manufacturer, such guaranty or undertaking shall be signed by such manufacturer and by an agent of such manufacturer who resides in the United States. (e) The following are suggested forms of guaranty or undertaking under section 303 (c)(3) of the act: (1) For domestic manufacturers: (Name of manufacturer) hereby guarantees that all color additives listed herein were manufactured by him, and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act. (Signature and post-office address of manufacturer.) (2) For foreign manufacturers: (Name of manufacturer and agent) hereby severally guarantee that all color additives listed herein were manufactured by (name of manufacturer), and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act. (Signature and post-office address of manufacturer.) (Signature and post-office address of agent.) (f) For the purpose of a guaranty or undertaking under section 303(c)(3) of the act the manufacturer of a shipment or other delivery of a color additive is the person who packaged such color. (g) A guaranty or undertaking, if signed by two or more persons, shall state that such persons severally guarantee the article to which it applies. (h) No representation or suggestion that an article is guaranteed under the act shall be made in labeling. [20 (Sec. 303, 52 Stat. 1043; 21 U.S.C. 338) § 1.6 Presentation of views under section 305 of the act. (a) Presentation of views under section 305 of the act shall be private and informal. The views presented shall be confined to matters relevant to the contemplated proceeding. Such views may be presented by letter or in person by the person to whom the notice was given, or by his representative. In case such person holds a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy thereof, shall be made a part of such presentation of views. (b) Upon request, seasonably made, by the person to whom a notice appointing a time and place for the presentation of views under section 305 of the act has been given, or by his representative, such time or place, or both such time and place, may be changed if the request states reasonable grounds therefor. Such request shall be addressed to the office of the Food and Drug Administration which issued the notice. (Sec. 305, 52 Stat. 1045, as amended; 21 U.S.C. 335) [20 F.R. 9527, Dec. 20, 1955] FOOD AUTHORITY: §§ 1.7 to 1.16 issued under secs. 4, 6, 80 Stat. 1297, 1299, 1300, secs. 403, 602, 701, 52 Stat. 1047, 1050, 1054, 1055 as amended; 15 U.S.C. 1453, 1455, 21 U.S.C. 343, 352, 362, 371, unless otherwise noted. § 1.7 Food in package form; principal display panel. The term "principal display panel" as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term "area of the principal display panel" means the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side; (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; (c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious "principal display panel" such as the top of a triangular or circular package of cheese, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. [32 F.R. 10731, July 21, 1967, as amended at 32 F.R. 13278, Sept. 20, 1967] |