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) The word “WARNING” shall be capitalized and shall appear in bold type.
(6) The warning statement required by paragraph (g)(2) of this section, when on a label, shall be set off in a box by use of hairlines.
(7) (i) The requirements in this paragraph (g) shall not apply to a juice that has been processed in a manner that will produce, at a minimum, a reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, of the following magnitude:A 5‐log (i.e., 100,000‐fold) reduction; orA reduction that is equal to, or greater than, the criterion established for process controls by any final regulation requiring the application of Hazard Analysis and Critical Control Point (HACCP) principles to the processing of juice.
(ii) For the purposes of this paragraph (g), the “pertinent microorganism” is the most resistant microorganism of public health significance that is likely to occur in the juice.
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NOTES
1 3.28 Saccharin. In 1977, FDA proposed banning saccharin in food because animal studies indicated it might be a carcinogen and thus prohibited under the Delaney Clause. 42 Fed. Reg. 19996 (Apr. 15, 1977). Congress stopped the ban with enactment of the Saccharin Study and Labeling Act, 91 Stat. 1451 (1977), but which also required any food product that contained saccharin to be labeled, “USE OF THIS PRODUCT MAY BE HAZARDOUS TO YOUR HEALTH. THIS PRODUCT CONTAINS SACCHARIN WHICH HAS BEEN DETERMINED TO CAUSE CANCER IN LABORATORY ANIMALS.” FD&C Act section 403(o). There was also a requirement that the same warning statement be posted in every retail establishment selling food containing saccharin. In 1996, Congress repealed the retail notice requirement. 110 Stat. 882 (1996). In 2000, Congress repealed the labeling requirement. 114 Stat. 2763, 2763A‐73 (Dec. 21, 2000), the “SWEETEST ACT,” the Saccharin Warning Elimination via Environmental Testing Employing Science and Technology Act. This decision was supported by the recommendations of the 9th Report on Carcinogens prepared by the National Toxicology Program and the position of the World Health Organization.
2 3.29 Culture can play an important role in how warnings are applied and how effective they are. For example, the warnings on cigarette packs in Japan illustrate how Japan takes a gentle tone when it warns against smoking: “There is a fear it can damage your health, so let’s be careful not to smoke too much. Let’s obey smoking manners.” Other countries have taken a different tack. In Malaysia, for example, the government found that smokers shrugged off government warnings, so now packages warn that “women smokers have more facial wrinkling than non‐smokers” and warn male smokers that the habit may make them impotent. Lawrence Bartlett, Tobacco: One Million Chinese Deaths Make It Wrong, THE AUSTRALIAN (Aug. 23, 2004).
3.8 ALLERGENS
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
The FALCPA of 200472 amended the Federal FD&C Act to create a category of “major food allergens.” FALCPA require special identification of major allergens in food that contains a major food allergen or contains a derivative of a major allergen.
The act defines “major food allergen” as any of the following:
milk,
eggs,
fish,
crustacea,
tree nuts,
wheat,
peanuts, and
soybeans.
