for example, the information and the product originate from the same source or the information is designed to promote the distribution and sale of the product, even if such sale is not immediate….
Accordingly, FDA believes that, in certain circumstances, information about FDA‐regulated products that is disseminated over the Internet by, or on behalf of, a regulated company can meet the definition of labeling in section 201(m) of the FD&C Act. [Emphasis added.] For example, if a company were to promote a regulated product on its website, and allow consumers to purchase the product directly from the website, the website is likely to be “labeling.” The website, in that case, would be written, printed, or graphic matter that supplements or explains the product and is designed for use in the distribution and sale of the product.
To provide an example from the other end of the spectrum, some product‐specific promotion presented on non‐company websites that is very much similar, if not identical, to messages the agency has traditionally regulated as advertisements in print media (e.g., advertisements published in journals, magazines, periodicals, and newspapers) would be viewed as advertising. These are just examples at the extremes and, as discussed below, the agency will proceed on case‐by‐case basis in determining what is “labeling.” …
FDA has explored developing a guidance on promotion of FDA‐regulated products on the Internet, but has decided not to issue a document at this time. The agency believes that any rule or guidance on this issue would be quickly outdated due to the ongoing rapid changes in the Internet and its use. As a result, issuing a rule or guidance may stifle innovation and create greater confusion among industry and the public. For the time being, FDA will continue to use a case‐by‐case approach based on the specific facts of each case….
FDA appreciates your interest in this area.
Sincerely yours,
Margaret M. Dotzel
Associate Commissioner for Policy
* * * * *
QUESTIONS AND NOTES
1 3.1. Accompanying. In the definition of “labeling,” what does “accompanying” mean?
2 3.2. Food Labeling Guide. For an illustrated overview of the food labeling terms and basic requirements, see FDA’s A FOOD LABELING GUIDE AVAILABLE AT www.fda.gov.
3.4 AFFIRMATIVE LABEL REQUIREMENTS
Food labeling is a complex area, but the affirmative label requirements for food are few in number and relatively constant since 1938. The basic five affirmative requirements for all food packages are identity, quantity, ingredients, nutrition labeling, and responsible party.
All required label information must appear on the food label in the English language. With a few exceptions, if the label of a food bears representations in a foreign language, the label must also bear all of the required statements in the foreign language, as well as in English.7 In addition, the required label information must be conspicuously displayed and in terms that the ordinary consumer is likely to read and understand under ordinary conditions of purchase and use.8
3.4.1 Label Terms
Two terms describing the label are important for understanding the label requirements: principal display panel (PDP) and information panel.
Principal Display Panel (PDP)
The PDP is the portion of a package label that is “most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.”9 Some packages are designed with two or more different surfaces suitable for the PDP; these are known as alternate principal display panels.10 The statement of identity and net quantity (metric and inch‐pound units) are required to be on the PDP.11 All other required information must be on the PDP or the information panel.
Information Panel
The information panel is generally the area contiguous to and immediately to the right of the PDP. The following information must be placed on the information panel, unless placed on the PDP12:
Ingredients list
Nutrition labeling
Responsible party—name and address of the manufacturer, packer, or distributor
All the required information appearing on the information panel must appear in one place without other intervening material.13 For instance, a marketing slogan cannot be placed between the Nutrition Facts panel and the ingredient statement. Additional words cannot be placed in the ingredient statement beyond the common or usual names of the ingredients. For example, in the ingredient statement listings, “pure honey” or “Wisconsin wheat,” the words “pure” and “Wisconsin” are intervening material. (So long as truthful and not misleading, the extra terms, like “pure” and “Wisconsin,” may be used elsewhere on the label.) Accurately labeling an ingredient as “organic,” however, is allowed and is permitted in the ingredient statement.
3.4.2 Statement of Identity
The “statement of identity” is the term for the legally required name of the food. The statement of identity must appear on the PDP.14
Prominence
The underlying requirement regarding prominence is that all mandatory information must be printed and arranged with prominence and conspicuousness, rendering it likely to be read and understood by the average consumer.15
The statement of identity must appear on the PDP in bold print or type. The type size must be reasonably related to the most prominent printed matter on the front panel, and should be one of the most prominent features on the PDP (generally, this is interpreted to be at least one‐half the size of the largest print on the label).16 The statement of identity also must be in lines generally parallel to the base of the package as it is displayed.17
Standardized Foods
A “standard of identity” essentially is a set of recipe and naming requirements for a food product put into a regulation. Those foods with standards of identity are called “standardized” foods.
If
