Updated: Jul 15
The Food and Drug Administration (FDA) is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA's jurisdiction.
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The FDA receives many questions from manufacturers, distributors, and importers about the proper labeling of their food products. This guidance is a summary of the required statements that must appear on food labels under these laws and their regulations. To help minimize legal action and delays, it is recommended that manufacturers and importers become fully informed about the applicable laws and regulations before offering foods for distribution in the United States.
FDA regulates the safety of substances added to food. FDA also regulate how most food is processed, packaged, and labeled. Myperfectpack team ensure that printed labels meet the below regulations.
The FDA regulates most packaged foods sold in the United States and has specific requirements for what elements a package must contain (e.g. a Nutrition Facts panel, ingredient statement, etc.). In order to sell your food products, you must comply with the FDA’s packaging law unless your operation is exempt .
FDA-regulated food packages must contain these 5-6 components:
* Statement of identity, or name of the food.
* Net quantity of contents, or amount of product.
* Nutrition Facts.
* Ingredient & Allergen Statement.
* Name and address of the manufacturer, packer, or distributor.
* In some instances, warning and safe handling statements.
The regulations are a little complicated, but this blog should help offer clarity. We will cover the basics of packaging regulations, including:
PACKAGING AREAS DEFINED
Before we discuss placement, it’s important to understand what each area is called and where it is on the package.
PDP (PRINCIPAL DISPLAY PANEL)
This is the area most likely to be seen by a buyer at the time of purchase. For a rectangular container like a cereal box, the PDP area is the product of the height times the width. For a cylindrical container like a can, the PDP area is 40 percent of the product of the height times the circumference.
The information panel is the panel (or space, if the package is cylindrical) immediately to the right of the PDP
REQUIRED PACKAGING ELEMENTS AND PLACEMENT
STATEMENT OF IDENTITY
The Statement of Identity is the legal name of the food (example: Nilla Wafers), the common name of the food (example: peanut butter), or, when the other two are not appropriate, a description of the food (example: whole green peas). This is not the same as the brand name (example: Kellogg’s).
Note: The Statement of Identity is not to be confused with the brand. (Example: “Corn Flakes” is the Statement of Identity, “Kellogg’s” would be the brand.)
Placement: The Statement of Identity must be placed on the PDP as one of the primary art elements. The font type height should be, at a minimum, half the size of the largest font on the package.
NET QUANTITY OF CONTENTS
Net quantity is simply the amount of food in the package, shown as a weight, fluid measure, or the number of items.
Placement: This is placed in the bottom 30 percent of the PDP in a type height determined by total PDP area, per this chart:
NUTRITION FACTS LABEL
The Nutrition Facts Label is used to communicate important information about the food consumers eat. The FDA also governs what label format to use on your product based on package size and contents.
The Nutrition Facts Label must show:
Serving size (Consult the RACC to determine this) : In general, you will need to use the FDA’s table of Reference Amounts Customarily Consumed Per Eating Occasion (RACC) to determine the appropriate serving size for your product. Nutrients listed on your label will reflect this serving size. Serving Size needs to also include “common household measure or common household unit.”
Example: 1 piece (in addition to the gram weight of the serving size defined in RACC).
Servings per container :This is the number of servings of the food item (based on the serving size) that the package contains
Mandatory nutrients (total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, potassium)
Nutrition Facts label are: • total calories
• total fat • saturated fat
• trans fat • cholesterol • sodium • total carbohydrate • dietary fiber • total sugars • added sugars • protein • vitamin D • calcium • iron • potassium
Placement: In general, place the Nutrition Facts Label on the PDP or the Information Panel, near the ingredient statement.
You must display the ingredient statement on the same panel as the manufacturer’s information. The ingredients are listed in descending order of weight in a type at least 1/16” tall and easy to read. Placement: In general, place the Ingredient Statement on the PDP or the Information Panel, near the Nutrition Facts label
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) mandates that packaged food items must declare, in plain language, the presence of any major food allergens (Milk, Egg, Fish, Crustacean shellfish, Tree nuts, Wheat, Peanuts, Soybeans, Sesame) on the product packaging.
Placement: In general, place the Allergen Declaration on the PDP or the Information, near the Nutrition Facts Label. Allergens may appear either:
In a parenthetical directly after the name of the ingredient within the ingredient statement. Example: Peanut butter (peanuts), casein (milk), spice (sesame)…
In a separate “Contains” statement. Example: Contains peanuts, milk, and sesame.
NAME AND ADDRESS OF THE MANUFACTURER, PACKER, OR DISTRIBUTOR
The food package must show the name of the manufacturer (or packer/distributor, accompanied by a qualifying phrase that states the firm’s relationship to the product, e.g., “manufactured for” or “distributed by”) and the full street address.
The food package must show the following:
Name and address of the manufacturer, packer or distributor. Unless the name given is the actual manufacturer, it must be accompanied by a qualifying phrase that states the firm’s relation to the product, e.g., “manufactured for” or “distributed by”;
City or town;
State (or country, if outside the United States); and
ZIP code (or mailing code used in countries other than the United States).
Placement: Most often, this goes on the Information Panel, but, again can appear on the PDP.The placement of the manufacturer’s information determines the placement of the Ingredients List.
Warning and safe handling statements
Some packages require warnings and safe-handling statements. These include:
Food containing or manufactured with a chlorofluorocarbon or other ozone-depleting substance.
Protein products labeled as weight-loss products.
Foods containing psyllium husk.
ADDITIONAL PACKAGING ELEMENTS
NUTRIENT CONTENT CLAIMS
A Nutrient Content Claim is any statement regarding a nutrient level in your food (examples: “low fat,” “high fiber,” “sugar-free”).
Regulations determine what claims are valid.
Claims can be displayed on the PDP, Information Panel or anywhere else on the package, in a type size that can’t be larger than twice the size as the font used for the Statement of Identity.
Important: If you choose to use a Nutrient Content Claim on your package, you must have a Nutrition Facts Panel showing that nutrient and its value.
No government regulatory agency requires that your food package have a barcode. Most retail establishments, however, will. The barcode must be placed in a manner where it doesn’t interfere with the required elements.
BEST BEFORE, EXPIRATION, OR SELL-BY DATE
Some states require dates on some foods. You will need to check into the specific regulations for your state and food. As far as placement on the package, the date cannot interfere with required labeling elements and must show the month, day, and year immediately adjacent to an explanatory phrase (“best before,” “sell by,” etc.)
Frequent Ask Quenstions :
GENERAL FOOD LABELING REQUIREMENTS
1.Where should label statements be placed on containers and packages?
Answer: There are two ways to label packages and containers: a. Place all required label statements on the front label panel (the principal display panel or PDP), or, b. Place certain specified label statements on the PDP and other labeling on the information panel (the label panel immediately to the right of the PDP, as seen by the consumer facing the product).
2.What are the PDP and the alternate PDP?
Answer: The PDP, is that portion of the package label that is most likely to be seen by the consumer at the time of purchase. Many containers are designed with two or more different surfaces that are suitable for display as the PDP.
3.What label statements must appear on the PDP?
Answer: Place the statement of identity, or name of the food, and the net quantity statement, or amount of product, on the PDP and on the alternate PDP.
4.Which label panel is the information panel?
Answer: The information panel is the label panel immediately to the right of the PDP, as displayed to the consumer. If this panel is not usable, due to package design and construction, (e.g., folded flaps), then the information panel is the next label panel immediately to the right
5.What is information panel labeling?
Answer: The phrase “information panel labeling” refers to the label statements that are generally required to be placed together, without any intervening material, on the information panel, if such labeling does not appear on the PDP. These label statements include the name and address of the manufacturer, packer or distributor, the ingredient list, nutrition labeling and any required allergy labeling.
6.What type size, prominence and conspicuousness is required?
Answer: For information panel labeling, use a print or type size that is prominent, conspicuous and easy to read. Use letters that are at least one- sixteenth (1/16) inch in height based on the lower case letter “o”. The letters must not be more than three times as high as they are wide, and the lettering must contrast sufficiently with the background so as to be easy to read. Do not crowd required labeling with artwork or non-required labeling.
7.What is the prohibition against intervening material?
Answer: Information that is not required by FDA is considered intervening material and is not permitted to be placed between the required labeling on the information panel (e.g., the UPC bar code is not FDA required labeling).
8.What name and address must be listed on the label?
Answer: Food labels must list: a. Name and address of the manufacturer, packer or distributor. Unless the name given is the actual manufacturer, it must be accompanied by a qualifying phrase which states the firm's relation to the product (e.g., “manufactured for” or “distributed by”); b. Street address if the firm name and address are not listed in a current city directory or telephone book; c. City or town; d. State (or country, if outside the United States); and e. ZIP code (or mailing code used in countries other than the United States).
9.What is the name of the food statement called and where must it be placed?
Answer: The statement of identity is the name of the food. It must appear on the front label, or PDP as well as any alternate PDP
10.Should the statement of identity stand out?
Answer: Use prominent print or type for the statement of identity. It shall be in bold 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 important features on the PDP. Generally, this is considered to be at least 1/2 the size of the largest print on the label.
11.What name should be used as the statement of identity?
Answer: The name established by law or regulation, or in the absence thereof, the common or usual name of the food, if the food has one, should be used as the statement of identity. If there is none, then an appropriately descriptive name, that is not misleading, should be used. Brand names are not considered to be statements of identity and should not be unduly prominent compared to the statement of identity
12.Where should the statement of identity be placed on the label?
Answer: Place the statement of identity on the PDP in lines generally parallel to the base of the package
13.When are fanciful names permitted as the statement of identity?
Answer: When the nature of the food is obvious, a fanciful name commonly used and understood by the public may be used
14.Is it necessary to use the common or usual name instead of a new name
Answer: The common or usual name must be used for a food if it has one. It would be considered misleading to label a food that has an established name with a new name. If the food is subject to a standard of identity it must bear the name specified in the standard.
15. Should modified statements of identity be used for sliced and unsliced versions of a food?
Answer: Labels must describe the form of the food in the package if the food is sold in different optional forms such as sliced and unsliced, whole or halves, etc.
16.What food must be labeled as an “imitation”?
Answer: Generally a new food that resembles a traditional food and is a substitute for the traditional food must be labeled as an imitation if the new food contains less protein or a lesser amount of any essential vitamin or mineral.
17.What type size and degree of prominence is required for the word “imitation” in the product name?
Answer: Use the same type size and prominence for the word “imitation” as is used for the name of the product imitated
18.Are there restrictions on label artwork?
Answer: Do not use artwork that hides or detracts from the prominence and visibility of required label statements or that misrepresents the food.
19.Where should the country of origin be declared on an imported food?
The country of origin statement must be conspicuous. If a domestic firm's name and address is declared as the firm responsible for distributing the product, then the country of origin statement must appear in close proximity to the name and address and be at least comparable in size of lettering.
20.What is the net quantity of contents and how is it expressed?
Answer: The net quantity of contents (net quantity statement) is the statement on the label which provides the amount of food in the container or package. It must be expressed in weight, measure or numeric count. Generally, if the food is solid, semisolid or viscous, it should be expressed in terms of weight. If the food is a liquid it should be expressed in fluid measure (e.g., fl oz).
21.Where is the net quantity of contents statement placed on the label?
Answer: The net quantity statement (net quantity of contents) is placed as a distinct item in the bottom 30 percent of the principal display panel, in lines generally parallel with the base of the container.
22.Should the net quantity of contents be stated in both grams and ounces?
Answer: Food labels printed must show the net contents in both metric (grams, kilograms, milliliters, liters) and U.S. Customary System (ounces, pounds, fluid ounces) terms. The metric statement may be placed either before or after the U. S. Customary statement, or above or below it. Each of the following examples is correct (additional examples appear in the regulations): • Net wt 1 lb 8 oz (680g) • Net wt 1 lb 8 oz 680 g • 500 ml (1 pt 0.9 fl oz) • Net contents 1 gal (3.79 L)
23.Why is it necessary to calculate the area of the PDP?
Answer: The area of the PDP (calculated in square inches or square centimeters) determines the minimum type size that is permitted for the net quantity statement (see next question). Calculate the area of the PDP as follows. The area of a rectangular or square PDP on a carton is the height multiplied by the width (both in inches or both in centimeters). To calculate the area of the PDP for a cylindrical container, use 40% of the product of the height by the circumference
24.What is the minimum type size? Answer: For the net quantity statements, the minimum type size is the smallest type size that is permitted based on the space available for labeling on the PDP. Determine the height of the type by measuring the height of the lower case letter "o" or its equivalent when mixed upper and lower case letters are used, or the height of the upper case letters when only upper case letters are used.
25.What are the conspicuousness and prominence requirements for net quantity statements?
Answer: Choose a print style that is prominent, conspicuous and easy to read. The letters must not be more than three times as high as they are wide, and lettering must contrast sufficiently with the background to be easy to read. Do not crowd the net quantity statement with artwork or other labeling (minimum separation requirements are specified in the regulation)
26.What is included in the net quantity of contents statement?
Answer: Only the quantity of food in the container or package is stated in the net quantity statement. Do not include the weight of the container, or wrappers and packing materials. To determine the net weight, subtract the average weight of the empty container, lid and any wrappers and packing materials from the average weight of the container when filled with food
27.Is water or other packing medium included in determining the net quantity of contents in a food container?
Answer: The water or other liquid added to food in a container is usually included in the net quantity declared on a label.
28.What is the ingredient list?
The ingredient list on a food label is the listing of each ingredient in descending order of predominance. “INGREDIENTS: Pinto Beans, Water, and Salt”
29.What is meant by the requirement to list ingredients in descending order of predominance by weight?
Answer: Listing ingredients in descending order of predominance by weight means that the ingredient that weighs the most is listed first, and the ingredient that weighs the least is listed last .
30.Where is the ingredient list placed on the label?
Answer: The ingredient list is placed on the same label panel as the name and address of the manufacturer, packer or distributor. This may be either the information panel or the PDP. It may be before or after the nutrition label and the name and address of the manufacturer, packer or distributor.
31.Should water be listed as an ingredient?
Water added in making a food is considered to be an ingredient. The added water must be identified in the list of ingredients and listed in its descending order of predominance by weight. If all water added during processing is subsequently removed by baking or some other means during processing, water need not be declared as an ingredient.
32.Should the common or usual name always be used for ingredients?
a regulation that provides for a different term. For instance, use the term “sugar” instead of the scientific name “sucrose.”“INGREDIENTS: Apples, Sugar, Water, and Spices”
If you need consulting to design your label as per guidelines set by FDA, feel free to write us or contact us. We do print label in hiqh quality .
Refernece : FDA guidelines
Some of example shown via illustration :