Neal D. Fortin

Food Regulation


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States tended to show that only 44% of the total volume of the accused container and that only 75% of its practical volume was filled with mints; that the remainder of the usable space was taken up with hollow cardboard dividers and hollow end pieces. The United States introduced substantial uncontradicted evidence to show that purchasers of the mints, opening the boxes, expected to find far more mints in them than were there. In view of this it is obvious, if there were nothing more in the case, that the containers might well fall within the interdiction of the statute.

      The trial court did not make any finding that the Delson slack package was justified by considerations of safety. The court stated only: “From the evidence I conclude that the type of container construction employed by the claimant(s), which the Government accuses in this case, is efficacious to a degree for the protective purposes contended for by the claimant(s) and was not adopted and is not being used for the purpose of deceiving prospective purchasers respecting the contents of the container. The court did find that the container is “efficacious to a degree.” But this is not enough. The court has to find that the container’s efficacy outweighs its deceptive quality. Further, it has to find that the available alternative efficacious means are not less deceptive than those actually employed.

      Since the court below has not made the necessary findings of fact to support the legal conclusions which it has reached, we will vacate the judgment and remand with the direction to proceed as the facts and the law require.

      * * * * *

      Note that 174 Cases Delson Thin Mints precedes enactment of the FPLA in 1966. The FPLA authorizes the FDA to promulgate regulations to prevent nonfunctional slack filling of food, drug, and cosmetic packages. FDA has not proposed such regulations.

      3.7.1 Product Requiring Warning Statements

      A number of food products require warning statements. For example:

       self‐pressurized containers;

       certain protein dietary supplements;

       iron dietary supplements;

       shell eggs;

       aspartame—food that contain aspartame must bear the declaration “Phenylketonurics: Contains Phenylalanine.”;

       food with 50 grams or more of sorbitol;

       diet beverages containing a combination of nutritive and non‐nutritive sweeteners;

       foods containing dry or incompletely hydrated psyllium seed husk, and bearing a health claim on the association between soluble fiber from psyllium husk and reduced risk of coronary heart disease;

       ozone‐depleting substances must follow labeling requirements established by the EPA; and

       non‐pasteurized fruit and vegetable juices.

      3.7.2 Food Labeling Warning and Notice Statements, 21 C.F.R. 101.17

      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: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… . [Certain exceptions and variations omitted.]

       (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… . [Certain exceptions omitted.]

       (c) Food containing or manufactured with a chlorofluorocarbon or other ozone‐depleting substance. Labeling requirements for foods that contain or are manufactured with a chlorofluorocarbon or other ozone‐depleting substance designated by the Environmental Protection Agency (EPA) are set forth in 40 C.F.R. part 82.

       (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… .(3) The label and labeling of food products represented or intended for dietary (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. …

       (g) Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens. (1) For purposes of this paragraph (g), “juice” means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrate of such liquid or puree.(2) The label of:Any juice that has not been processed in the manner described in paragraph (g)(7) of this section; orAny beverage containing juice where neither the juice ingredient nor the beverage has been processed in the manner described in paragraph (g)(7) of this section, shall bear the following warning statement:

       WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

       (3) The warning statement required by this paragraph (g) shall not apply to juice that is not for distribution to retail consumers in the form shipped and that is for use solely in the manufacture of other foods or that is to be processed, labeled, or repacked at a site other than originally processed, provided that for juice that has not been processed in the manner described in paragraph (g)(7) of this section, the lack of such processing is disclosed in documents accompanying the juice, in accordance with the practice of the trade.

       (4) The warning statement required by paragraph (g)(2) of this section shall appear prominently and conspicuously on the information panel or on the principal display panel of the label of the container, except that:(i)For apple juice or apple cider, the warning statement may appear in labeling, including signs or placards, until September 8, 1999;For all juices other than apple juice or apple cider, the warning statement may appear in labeling, including signs or placards, until November 5, 1999.

       (5)