food,” whereas regulations provide that “syrup” is the term for a “food that is liquid or is an aqueous solution or liquid food.” The petition would also have required that FDA eliminate the use of “corn sugar” as an alternate name for dextrose. FDA noted that “corn sugar” has been used to describe dextrose for over 30 years. Changing HFCS to “corn sugar” could put consumers with hereditary fructose intolerance at risk because these individuals currently understand “corn sugar” to be a fructose‐free ingredient. FDA, Response to Petition from Corn Refiners Association to Authorize “Corn Sugar” as an Alternate Common or Usual Name for High Fructose Corn Syrup (HFCS), May 30, 2012.
3.4.5 Name and Address of the Responsible Party
The labeling of a responsible party is required mostly so that consumers have a point of contact if they find something wrong with the product.
The name, street address, city, state, and ZIP code of the manufacturer, packer, or distributor are required. The street address may be omitted by a firm listed in a current city or telephone directory. A firm whose address is outside the United States may omit the ZIP code.56
If the food is not manufactured by the person or company whose name appears on the label, the name must be qualified by “Manufactured for,” “Distributed by,” or a similar expression.
A website address is not required information. In addition, a web address cannot replace or substitute for any of the required information.
3.4.6 Labeling Special Circumstances
Product Dates and Codes
Sell‐by or use‐by dates may voluntarily be included on food labels. However, other than for infant formula, there is no federal requirement for such dating.57 However, a “pack date” is required for poultry products and thermally processed, commercially sterile USDA‐regulated products to identify production lots and facilitate trace‐back activities in the event of foodborne illness.58
Product dating is either closed or open. “Open dating” is designed to communicate to consumers. “Closed dating” is a code for manufacturers to identify the date, time, and location of production. In open dating, dates are stated alphanumerically, such as “Oct. 15,” or numerically, such as “10‐15” or “1015.” In code dating, the information is coded in letters, numbers, and symbols so that usually only the manufacturer can translate it. For example, “Packed on 12/15/2020” is an open date, and “22:5220125” is a closed date code.
A wide variety of food date label descriptors are used. There is no uniform or universally accepted terminology. The common descriptors are the following:
“Sell By” or pull date is the last day that the manufacturer recommends that the food be displayed for sale and is used for inventory management. It is not a safety date. This date must allow additional time for consumer storage and use at home, so if the food is bought on the pull date, it still can be eaten at a later date. The product must be safe for consumers to use for a reasonable period of time beyond the sell‐by date.
“Best if Used By” or “Best if Used Before” date is a recommended late date to use a product while at peak flavor or quality. This is a quality assurance or freshness date and not a safety date except for when used on infant formula. This date shows how long the manufacturer thinks a food will be of optimal quality. This doesn’t mean, however, that the product shouldn’t be used after the suggested date.
Expiration date. This is the last day on which a product should be eaten. Some state governments regulate these dates for perishable items, such as milk and eggs. FDA regulates only the expiration dates of infant formula.
Closed dating, such as cans codes, indicate when and where the product was canned. These codes are not meant for as “best by” dates. Thermally processed, low‐acid foods and acidified food in hermetically sealed containers must have a code that identifies the establishment where packed, the product contained therein, the year packed, the day packed, and the period packed.59 FDA encourages manufacturers to put product codes on other packaged foods, especially for products with a long shelf life. In the case of a recall, this makes it easier to quickly identify and track down the product and take it off the market.
NOTES
1 3.12 Food Waste Reduction. According to the USDA, consumers are responsible for nearly 90 billion pounds of food waste each year, which equates to 20 percent of the U.S. food supply. While perfectly good food goes to waste, approximately 40 million Americans are food insecure. USDA, EPA, and FDA announced a partnership, formalizing education and outreach efforts as part of a larger effort, which aims to reduce food loss and waste through community investments, education and outreach, voluntary programs, public–private partnerships, tool development, technical assistance, event participation, and policy discussion. The announcement comes on the heels of ongoing congressional efforts to address food waste, including the introduction of legislation designed to end consumer confusion by creating a national standard for date marking of food. One effort to combat food waste is encouraging manufacturers to use labels that clearly indicate when dates refer to quality, rather than safety, in an effort to dissuade consumers from prematurely disposing of safe food products.
2 3.13 Front‐of‐pack nutritional labeling. At least 20 front‐of‐pack (FOP) nutrition rating or guidance systems have been developed in recent years. Most were designed by food manufacturers but some by government agencies and nutrition groups. The ostensible intent is to help consumers quickly compare products’ nutritional attributes and make healthier choices. Typically, symbols are used to communicate ratings.
3 Generally, these rating systems and symbols are unregulated if not false or misleading. However, a 2009 FDA front‐of‐package labeling initiative resulted in 17 warning letters to food manufacturers for violations in these FOP labels. FDA cited unauthorized health claims and nutrient content claims but also products with nutrient content claims that failed to identify other nutrients, such as saturated fat, which were present in the products at high levels.
4 Another concern with FOP systems is how the various FOP systems focus on different nutrients. The Institute of Medicine (IOM) found that the variations in the nutrient emphasized by different systems may confuse consumers. In addition, many systems trumpet beneficial nutritional aspects, such as vitamins or fiber content, while ignoring unappealing aspects, like high sodium or sugar levels. The IOM recommended a single, consistent system that focused on information that would help consumers decrease their risk for chronic diseases. Thus, the system would need to focus on nutrients of concern for over consumption: cholesterol, sodium, saturated fat, and calories. Of course, most food companies would prefer an affirmative approach rather than a “Tell us how your product is bad for us” approach. INSTITUTE OF MEDICINE, FRONT-OF-PACKAGE NUTRITION RATING SYSTEMS AND SYMBOLS: PROMOTING HEALTHIER CHOICES (2012).
3.5 MISBRANDED FOOD: PROHIBITED REPRESENTATIONS
3.5.1 SEC. 403. Misbranded
Section 403(a) of the FD&C Act prohibits statements in labels or labeling that are “false or misleading in any particular.” Failure to reveal “material facts” about a food product can be misleading or can also be a violation under
