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.