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3.5 MISBRANDED FOOD: PROHIBITED REPRESENTATIONS 3.5.1 SEC. 403. Misbranded

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Section 403(a) of the FD&C Act prohibits statements in labels or labeling that are “false or misleading in any particular.” Failure to reveal “material facts” about a food product can be misleading or can also be a violation under section 201(n) of the Act. Under section 403(a), a food will be deemed misbranded if its labeling is “false or misleading in any particular.” Additionally, a product will be considered misbranded if:

 offered for sale under the name of another food product,

 it is an imitation of another food (unless clearly labeled as an imitation), and

 if the container is misleading in any particular, such as in size, fill, or form.

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Federal Food, Drug, and Cosmetic Act

MISBRANDED FOOD

SEC. 403. [343] A food shall be deemed to be misbranded—

1 If (1) its labeling is false or misleading in any particular, or …

2 If it is offered for sale under the name of another food.

3 If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated.

4 If its container is so made, formed, or filled as to be misleading.

5 If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

6 If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

7 If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 401, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.

8 If it purports to be or is represented as—a food for which a standard of quality has been prescribed by regulations as provided by section 401, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; ora food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 401, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; …

9 Unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings without naming each: To the extent that compliance with the requirements of clause (2) of this paragraph is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.

10 If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses.

11 If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: except that to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Secretary. The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring shall not apply in the case of butter, cheese, or ice cream… .

[Emphasis added.]

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Food Regulation

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