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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DISCUSSION QUESTION
1 3.14 In any particular. Section 403(a)(1) of the Federal FD&C Act deems a food misbranded, if the labeling is false or misleading “in any particular.” What does “in any particular” mean?
“Misleading” covers not just false claims but also when “by ambiguity or inference [a label] create(s) a misleading impression.”60 In addition, a label may be deemed misleading for what it fails to disclose. That is, a label can be literally true but still be misleading when it does not disclose an important fact that is “material” to consumers.
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FD&C Act § 201(n)
(n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.
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As the case below demonstrates, the courts have upheld a strict standard for misleading labels. Note how statements may be technically accurate, but still mislead.
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United States v. 95 Barrels Alleged Apple Cider
265 U.S. 438 (1924) 61
Mr. Justice BUTLER delivered the opinion of the court:
This case arises under Food and Drugs Act June 30, 1906… . The United States filed information … for the condemnation of 95 barrels of vinegar. Every barrel seized was labeled:
“Douglas Packing Company Excelsior Brand Apple Cider Vinegar Made from Selected Apples Reduced to 4 Percentum Rochester, N. Y.”
The information alleged that the … vinegar was made from dried or evaporated apples, and was misbranded in violation of section 8, in that the statements on the label were false and misleading, and in that it was an imitation of and offered for sale under the distinctive name of another article, namely, apple cider vinegar….
The question for decision is whether the vinegar was misbranded. The substance of the agreed statement of facts may be set forth briefly. Claimant is engaged in the manufacture of food products from evaporated and unevaporated apples. During the apple season, from about September 25 to December 15, it makes apple cider and apple cider vinegar from fresh or unevaporated apples. During the balance of the year,
