A food item is considered misbranded (21 U.S.C. §343)

• If its container is made, formed, or filled to be misleading (also see 21 CFR 100.100)

• If its labeling is false or misleading,

• If the package label does not include the name and place of business of the manufacturer, packer, or distributor; and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

• If it is intended for human consumption and offered for sale, unless its label bears nutrition information that provides the serving size; the number of servings per container; the total number of calories derived from any source, and derived from the total fat, in each serving size; the amount of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size; and any vitamin, mineral, or other nutrient required to be placed on the label if the Secretary determines that such information will assist consumers in maintaining healthy dietary practices.

• If any word, statement, or other information required by law to appear on the label is not prominently placed 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.

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

• If it is an imitation of another food, unless its label bears the word "imitation."

• If it purports to be a food for which a standard of identity has been prescribed, unless it conforms to such standard, and its label bears the name of the food specified in the standard, and the common names of optional ingredients.

• Unless its label bears the common or usual name of the food, and if fabricated from two or more ingredients, the common or usual name of each such ingredient and if the food purports to be a beverage containing vegetable or fruit juice, a statement with appropriate prominence of the total percentage of such fruit or vegetable juice contained in the food.

• If it purports to be a food for which a standard of quality has been prescribed and its quality falls below such standard, unless its label bears a statement that it falls below such standard.

• If it contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact;

• This requirement does not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.

• If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements.

• If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical and the common name and function of such chemical;

• Except no such declaration shall be required while the commodity is being displayed for sale at retail.

• Unless provided a legal exception, if it is a food intended for human consumption which is offered for sale and for which a nutrition and health-related claim is made.

• In the case of vitamins and minerals, its advertising is false or misleading.

• If it is a dietary supplement; and the label fails to list the name and quantity of each ingredient; or with respect to a proprietary blend of ingredients, the total quantity of all ingredients in the blend; or the label fails to identify the product by using the term ''dietary supplement;" or the label fails to identify any part of the plant from which the ingredient is derived; or .

• If it purports to be for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties in order fully to inform purchasers as to its value for such uses.

• If its packaging or labeling is in violation of an applicable package standards (15 U.S.C. §§1472 and 1473 - child-proofing and exception for elderly).

Basic strategies to protect against misbranded foods

• Mandate and monitor labeling
• Monitor advertising and promotional claims

Last updated February 6, 2010