Utah Department of Agriculture and Food

This email address is being protected from spambots. You need JavaScript enabled to view it., Labeling Specialist
(801) 860-7075 or (801) 538-7124
(801) 538-4949 fax

Small Business Exemption - Simplified Version of the criteria found in:

21 Code of Federal Regulations (CFR) 101.9 (a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.

CAUTION/WARNING - ANY NUTRIENT CONTENT CLAIM OR HEALTH CLAIM MADE ON BEHALF OF THE PRODUCT VOIDS ALL EXEMPTIONS AND A NUTRITIONAL STATEMENT BECOMES MANDATORY.

Food manufacturers may claim a renewable 12-month exemption from the Nutrition Facts portion of required food labels if they satisfy the following criteria:

  1. Food labels, labeling, and/or advertising bear no nutrition or nutrient content claims or other nutrition information, and no health claims.

  2. Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who has annual gross sales not more than $500,000 to consumers; or annual gross food sales to consumers of not more than $50,000.

  3. Or, Low volume food products as defined below:

    1. From May 8, 1995, to May 7, 1996, employed fewer than 200 full-time equivalent employees (FTE's) and fewer than 200,000 units of that product sold in United States;

    2. All other food products, if for the preceding 12 months, employed fewer than 100 FTE's and fewer than 100,000 units of that product were sold in the United States;

    3. Food product not sold in last 12 month period, fewer than 100,000 units of such product are reasonably expected to be sold in the United States, during the year.

  4. And, The company provides the FDA with notice of products that meet above criteria,

  5. Except that if the person in not an importer and has fewer than 10 FTE's does not have to file a notice for any food product with annual sales of fewer than 10,000 total units.

This email address is being protected from spambots. You need JavaScript enabled to view it., Labeling Specialist
(801) 860-7075 or (801) 538-7124
(801) 538-4949 fax

21 Code of Federal Regulations (CFR) Part 101.9 Nutrition Labeling, Small Business Exemption

The "final" rule was published in the Federal Register, Wednesday, August 7, 1996 and became effective October 7, 1996.

21 CFR 101.9(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section. (j) The following foods are exempt from this section or are subject to special labeling requirements:

(j)(1)(i) is amended to read: Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section.

(j)(18) Food products that are low-volume (that is, they meet the requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of this section); that, except as provided in paragraph (j)(18)(iv) of this section, are the subject of a claim for an exemption that provides the information required under paragraph (j)(18)(iv) of this section, that is filed before the beginning of the time period for which the exemption is claimed, and that is filed by a person, whether it is the manufacturer, packer, or distributor, that qualifies to claim the exemption under the requirements for average full-time equivalent employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and whose labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim.

  1. For food products first introduced into interstate commerce before May 8, 1994, the product shall be exempt for the period:
    1. Between May 8, 1995, and May 7, 1996, if, for the period between May 8, 1994, and May 7, 1995, the person claiming the exemption employed fewer than 300 full-time equivalent employees and fewer than 400,000 units of that product were sold in the United States; and
    2. Between May 8, 1996, and May 7, 1997, if, for the period between May 8, 1995, and May 7, 1996, the person claiming the exemption employed fewer than 200 full-time equivalent employees and fewer than 200,000 units of that product were sold in the United States.

  2. For all other food products, the product shall be eligible for an exemption for any 12-month period if, for the preceding 12 months, the person claiming the exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States, or in the case of a food product that was not sold in the 12-month period preceding the period for which exemption is claimed, fewer than 100,000 units of such product are reasonably anticipated to be sold in the United States during the period for which exemption is claimed.

  3. If a person claims an exemption under paragraphs (j)(18)(i) or (j)(18)(ii) of this section for a food product and then, during the period of such exemption, the number of full-time equivalent employees of such person exceeds the appropriate number, or the number of food products sold in the United States exceeds the appropriate number, or, if at the end of the period of such exemption, the food product no longer qualifies for an exemption under the provisions of paragraphs (j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18 months from the date that the product was no longer qualified as a low-volume product of a small business to comply with this section.

  4. A notice shall be filed with the Office of Food Labeling (HFS-150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 and contain the following information, except that if the person is not an importer and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units:

Definitions:
21CFR 101.9 (j)(18)(iv)(F)(vi)

  1. Unit means the packaging or, if there is no packaging, the form in which a food is offered for sale to consumers.
  2. Food product means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods.
  3. Person means all domestic and foreign affiliates, as defined in 13 CFR 121.401, of a firm or other entity, when referring to a firm or other entity that is not a corporation.
  4. Full-time equivalent employee means all individuals employed by the person claiming the exemption. This number shall be determined by dividing the total number of hours of salary or wages paid directly to employees of the person and of all of its affiliates by the number of hours of work in a year, 2,080 hours (i.e., 40 hours x 52 weeks).

This email address is being protected from spambots. You need JavaScript enabled to view it., Labeling Specialist
(801) 860-7075 or (801) 538-7124
(801) 538-4949 fax

  1. All packaged products must have a complete and correct label before being offered for sale. This includes the common or usual name of the product; name and address of the producer, manufacturer, or distributor; a net quantity statement; and an ingredient statement (unless it is a single ingredient product).

  2. All ingredients must be listed by their common or usual name in descending order of predominance by weight (from heaviest to lightest). Any ingredient which itself contains two or more ingredients:
    1. shall declare the common or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance;
    2. or by incorporating into the statement of ingredients in descending order of predominance in the finished food, the common or usual name of every component of the ingredient without listing the ingredient itself. (Use only one of these formats per label please.)

  3. The words "may contain" are only to be used in compliance with 21 CODE OF FEDERAL REGULATIONS (CFR) 101.4 (b), for example the allowance for fats/oils to be listed with "may contain" ______, _____, and/or ______ oils" when a manufacturer is unable to adhere to a constant pattern or fats or oils in the product. List each fat and oil by its common name, i.e. corn oil, cottonseed oil, beef fat, etc. Fats and oils that are fully or partially hydrogenated must indicate it by use of the words "hydrogenated" or "partially hydrogenated" before the kind of oil is listed.

  4. Labels intended for one product cannot be used to label a different product (i.e. a plain cheesecake label cannot be used for a cheesecake with a fruit topping; writing topping flavor on the ingredient statement is not sufficient. Nor is it correct to use an apple pie label on a cherry pie and write the word "cherry" on label.)

  5. Recipe or ingredient substitutions without correct labeling for new combination is prohibited (i.e. using Muenster cheese in a sandwich or salad whose label indicates the presence of Swiss cheese). Labels must correctly represent the product in the package.

  6. Sandwiches must include the ingredients for the bread as well as the other makings, meats, cheeses, condiments, lettuce, tomatoes, pickles, etc.

  7. Bulk self-service bins (whether candy, bakery, etc.) must list all ingredients in each product in type no smaller than 1/8 inch based on the height of the lower case letter "o" for the type style used if both upper and lower case letters are used, or 1/8" in height when using all upper case letters.

  8. "Thank You" labels in lieu of correct labels with all required information are prohibited. Unlabeled packaged product cannot be offered for sale.

  9. Covering or obscuring required label information by covering it with store stickers or coupons creates a misbranded product.

  10. Full service counters must have complete, correct ingredient information available for all products, so that if any customer should ask questions about the ingredients in any product, those questions can be answered completely and accurately.

  11. Net Quantity Statements and Method of Sale must be appropriate for the type of item sold (i.e. weight or count, fluid measurement, volume or area measurement, etc.)
    1. Labeling of net quantity must be clear, bold, conspicuous, legible and correct for both standard pack packages (i.e. each package of cheese is labeled 2 pounds and sold for $8.00);
    2. or random weight packages (i.e. New York Steak selling for $7.98 per pound and labeled with different net weight in each package, same price per pound, total computed price based on weight of individual package.)

This email address is being protected from spambots. You need JavaScript enabled to view it., Labeling Specialist
(801) 860-7075 or (801) 538-7124
(801) 538-4949 fax

Foods That Are Exempt From The Nutritional Facts Statement Or Are Subject To Special Labeling Requirements


These exemptions do not affect the requirements for any other label information.

21 Code of Federal Regulations (CFR) 101.9 (a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.

CAUTION/WARNING - ANY NUTRIENT CONTENT CLAIM OR HEALTH CLAIM MADE ON BEHALF OF THE PRODUCT VOIDS ALL EXEMPTIONS AND A NUTRITIONAL STATEMENT BECOMES MANDATORY.

  1. Total retail sales less than $500,000 annually or total food sales less than $50,000 annually.
  2. Low Volume Foods that meet the requirements for the small business exemption. (See article on Simplified Small Business Exemption Requirements for more information)
  3. Food served in restaurants.
  4. Food served in other establishments for immediate human consumption (schools, hospitals, cafeterias, trains, airplanes, bakeries, delicatessens); or where foods are generally consumed immediately or while the consumer is walking away (lunch wagons, ice cream shops, mall cookie counters, vending machines, sidewalk carts, convenience stores, food delivery systems).
  5. Foods that are ready to eat, offered for sale to consumers, but not for immediate consumption when they are processed and prepared primarily in a retail establishment and not offered for sale outside that establishment.
  6. Foods that contain insignificant amounts of all of the nutrients and food components required to be included in the Nutrition Facts statement (Such as: coffee beans, tea leaves, plain unsweetened instant coffee & tea, condiment-type dehydrated vegetables, flavor extracts, & food colors).
  7. Certain medical foods and infant formulas especially formulated for infants with inborn errors of metabolism.
  8. Foods, other than infant formula, for infants and children less than 4 years of age have special Nutrition Facts requirements.
  9. Food products shipped in bulk form that are not for distribution to consumers in such form and that are for use solely in the manufacture of other foods or that are to be processed, labeled, or repacked at another site.
  10. Raw fruits, vegetables, and fish, provided that nutrition information required by this law, be displayed to the consumer at the point of purchase, either on the product, or as a poster, card, sign, tag, booklet, etc.
  11. Packaged single ingredient product of fish or game meats that are not covered in the USDA Meat and Poultry Labeling Rules and Regulations.
  12. Outsides of egg cartons that have the top conforming to the shape of the eggs, provided that the information is furnished inside the carton.
  13. Unit containers in a multi-unit food package, as long as the multiunit container bears all the required nutrition information.
  14. Food products sold from bulk containers; provided, nutrition information required by this law be displayed to the consumer at the point of purchase, either on the container or as a poster, card, sign, tag, booklet, etc.

This email address is being protected from spambots. You need JavaScript enabled to view it., Labeling Specialist
(801) 860-7075 or (801) 538-7124
(801) 538-4949 fax

The State of Utah through the Utah Code Annotated (UCA) has adopted the regulations promulgated under the Federal Fair Packaging and Labeling Act as set forth in the Code of Federal Regulations (CFR). In addition, with the passage of the Nutrition Labeling and Education Act (NLEA) of 1990, the Food and Drug Administration (FDA) has announced new rules and regulations which have completely overhauled the science of designing labels, especially the use, format, and design of the Nutrition statement

The following information is required by law to be on a food label before the product is offered for sale:

  • Statement of Identity (Common or usual name of product). (21 CFR 101.3)
  • The net quantity statement. (21 CFR 101.105)
  • An ingredient statement (unless it is a single ingredient product). (21 CFR 101.4)
  • The name and address (street address, city, state, and zip code) of the manufacturer, packer, or distributor. If the name and address of the business is listed in a local telephone directory, the street address may be omitted from the label. (21 CFR 101.5)
  • Nutrition Statement: Most products must also have a Nutrition Facts statement following the FDA approved format. (21 CFR 101.9)
  1. The product name must appear on the principal display panel (PDP = the portion of the label expected to be displayed when the product is offered for sale.) It must be prominent and in bold type and be an appropriate descriptive name that is not misleading. It should be printed generally parallel to the base of the package and at least 1/2 the size of the largest print on the label.
  2. The net quantity statement must be appropriate for the type of product. Generally, products that are solid, semi-solid, viscous, or a mixture of liquid and solid, are labeled by net weight (unless trade custom allows them to be labeled by count.) Liquids are generally labeled in fluid volume. Some products are required to be labeled by dry volume, length, area, etc. Any net content statement that does not permit price and quantity comparison is forbidden.

    The net quantity is to be stated as a definite amount - do not use qualifying statements such as: "when packed," "approximately," "minimum," or words of similar import. Nor shall any unit of weight or measure be qualified with terms that tend to exaggerate the amount of the commodity, such as: "jumbo," "giant," "full," etc. On the average the quantity of the commodity in the package must at least equal or exceed the labeled quantity with no unreasonable shortages in any package even when overages in other packages compensate for such shortage.

    The net quantity statement must appear in the bottom 1/3 of the PDP label in the largest whole units of both the US System of Measures and the metric equivalent. This means the net weight will show the total number of ounces if product net weight is less than one pound, or show pounds and ounces if the net weight is one pound or more. Either US or metric quantity may be printed first, the equivalent quantity following in parenthesis. Do not use periods behind abbreviations or "s" to indicate plurals. Metric abbreviations must be printed in lower case letters, except you may use either "l" or "L" to indicate "liter" and "ml" or "mL" for milliliter.

    The print size required for the net quantity statement is based on the area of the principal display panel (PDP) of the package itself, not on the size of the label. Print size is based on the height of the smallest letter used, lower case letter "o", unless only upper case letters are used. The statement must be prominent, conspicuous and easy to read. An area equal to the height of the required lettering above and below the quantity statement must be left free of other print.

  3. Area of Principal Display Panel Type Size Required
    5 square inches or less Not less than 1/16 inch
    More than 5, but not more than 25 sq. in. Not less than 1/8 inch
    More than 25, but not more than 100 sq. in. Not less than 3/16 inch
    More than 100, but not more than 400 sq. in. Not less than 1/4 inch
    Over 400 square inches Not less than 1/2 inch

    The next three items may be on the PDP or on the information panel (IP = the portion of the package immediately to the right of the PDP). Nonessential, intervening print and/or art work are not permitted between the required labeling items (e.g., the UPC bar code is not required labeling). The smallest print size allowed for this information is 1/16 inch, again based on the lower case letter "o" when both upper and lower case letters are used.

  4. All ingredients must be listed by common or usual name in descending order of predominance by weight (from heaviest to lightest). Any ingredient which itself contains two or more ingredients:
    1. shall declare the common or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance;
    2. or by incorporating into the statement of ingredients in descending order of predominance in the finished food, the common or usual name of every component of the ingredient without listing the ingredient itself. (Use only one of these formats per label please.)

  5. The name and address (street address, city, state - or country, if outside the United States, and zip code - or mailing code used in countries other than the United States) of the manufacturer packer, or distributor. If the business name and street address are found in a local telephone directory, the street address may be omitted. Unless the name given is the actual manufacturer, accompany it with "manufactured for" or "distributed by" to show the relationship to the product.

  6. Nutrition Statement: FDA requires a Nutrition Statement on almost all food offered for sale. The statement must follow the approved FDA format. Some foods categories are exempt from the nutrition statement:
    • foods produced by small businesses
    • foods served in restaurants and/or sold ready for immediate consumption
    • certain foods sold directly to consumers from the location where they are prepared (delis and bakeries);
    • foods that provide no significant nutrition (plain, unsweetened coffee; most single ingredient spices, etc.)
    Any health or nutrition claim or nutrition information on product labeling or advertisements void these exemptions.

NOTE: For more detailed information on labeling requirements, look here.