A product is considered “mis-branded” if the Name and Place of Business are not properly stated on the product label. When selling a "private label" product the "distributor" is listed. These rules apply to both full size and sample products.
The FDA goes on to make the following clarifications (21 CFR 701.12)
The name and business address appearing on the label may be those of the manufacturer, packer or distributor.
The name of the firm must be the corporate name, and the address may be that of the principal place of business. Stating also the name of a corporation's particular division is optional.
The business address must include the street address, name of the city and state, and the ZIP code. The street address may be omitted if the firm is listed in a current city or telephone directory.
If the name and address is not that of the manufacturer, the name must be preceded by phrases such as "Manufactured for ...", "Distributed by ...", or other appropriate wording.
The Tariff Act of 1930 requires that imported products state on the label the English Name of the country of origin.
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