[Title 21 CFR 101.17] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED] [Subchapter B - FOOD FOR HUMAN CONSUMPTION] [Part 101 - FOOD LABELING] [Subpart A - General Provisions] [Sec. 101.17 - Food labeling warning and notice statements.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 2 1996-04-01 1996-04-01 false Food labeling warning and notice statements. 101.17 Sec. 101.17 FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions Sec. 101.17 Food labeling warning and notice statements. (a) Self-pressurized containers. (1) The label of a food packaged in a self-pressurized container and intended to be expelled from the package under pressure shall bear the following warning: [[Page 71]] Warning--Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 deg. F. Keep out of reach of children. (2) In the case of products intended for use by children, the phrase ``except under adult supervision'' may be added at the end of the last sentence in the warning required by paragraph (a)(1) of this section. (3) In the case of products packaged in glass containers, the word ``break'' may be substituted for the word ``puncture'' in the warning required by paragraph (a)(1) of this section. (4) The words ``Avoid spraying in eyes'' may be deleted from the warning required by paragraph (a)(1) of this section in the case of a product not expelled as a spray. (b) Self-pressurized containers with halocarbon or hydrocarbon propellants. (1) In addition to the warning required by paragraph (a) of this section, the label of a food packaged in a self-pressurized container in which the propellant consists in whole or in part of a halocarbon or a hydrocarbon shall bear the following warning: Warning--Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of this section is not required for the following products: (i) Products expelled in the form of a foam or cream, which contain less than 10 percent propellant in the container. (ii) Products in a container with a physical barrier that prevents escape of the propellant at the time of use. (iii) Products of a net quantity of contents of less than 2 ounces that are designed to release a measured amount of product with each valve actuation. (iv) Products of a net quantity of contents of less than one-half ounce. (c) Self-pressurized containers with a chlorofluorocarbon propellant. (1) In addition to the warning required by paragraphs (a) and (b) of this section, the label on each package of a food in a self- pressurized container in which the propellant consists in whole or in part of a fully halogenated chlorofluoroalkane (chlorofluorocarbon) shall bear the following warning: Warning--Contains a chlorofluorocarbon that may harm the public health and environment by reducing ozone in the upper atmosphere. (2) The warning required by paragraph (c)(1) of this section shall appear on an appropriate panel with such prominence and conspicuousness as to render it likely to be read and understood by ordinary individuals under normal conditions of purchase. The warning may appear on a firmly affixed tag, tape, card, or sticker or similar overlabeling attached to the package. The warning shall comply in all other respects with Sec. 101.2, e.g., type-size requirements. (3) The warning required by paragraph (c)(1) of this section is applicable only to self-pressurized containers that use chlorofluorocarbons in whole or in part as a propellant to expel from the container liquid or solid material different from the propellant, but the warning is not applicable to the use of chlorofluorocarbon as a stabilizer in food toppings and spreads. (d) Protein products. (1) The label and labeling of any food product in liquid, powdered, tablet, capsule, or similar forms that derives more than 50 percent of its total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, and that is represented for use in reducing weight shall bear the following warning: Warning: Very low calorie protein diets (below 400 Calories per day) may cause serious illness or death. Do Not Use for Weight Reduction in Such Diets Without Medical Supervision. Not for use by infants, children, or pregnant or nursing women. (2) Products described in paragraph (d)(1) of this section are exempt from the labeling requirements of that paragraph if the protein products are represented as part of a nutritionally balanced diet plan providing 400 or more Calories (kilocalories) per day and the label or labeling of the product specifies the diet plan in detail or provides a brief description of that diet plan and adequate information describing where [[Page 72]] the detailed diet plan may be obtained and the label and labeling bear the following statement: Notice: For weight reduction, use only as directed in the accompanying diet plan (the name and specific location in labeling of the diet plan may be included in this statement in place of ``accompanying diet plan''). Do not use in diets supplying less than 400 Calories per day without medical supervision. (3) The label and labeling of food products represented or intended for dietery (food) supplementation that derive more than 50 percent of their total caloric value from either whole protein, protein hydrolysates, amino acid mixtures, or a combination of these, that are represented specifically for purposes other than weight reduction; and that are not covered by the requirements of paragraph (d) (1) and (2) of this section; shall bear the following statement: Notice: Use this product as a food supplement only. Do not use for weight reduction. (4) The provisions of this paragraph are separate from and in addition to any labeling requirements promulgated by the Federal Trade Commission for protein supplements. (5) Protein products shipped in bulk form for use solely in the manufacture of other foods and not for distribution to consumers in such container are exempt from the labeling requirements of this paragraph. (6) The warning and notice statements required by paragraphs (d) (1), (2), and (3) of this section shall appear prominently and conspicuously on the principal display panel of the package label and any other labeling. [42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977; 49 FR 13690, Apr. 6, 1984; 49 FR 28548, July 13, 1984]