Section 403(q) of the Federal Food, Drug and Cosmetic Act requires that packaged foods and dietary supplements bear nutrition labeling unless they qualify for an exemption. 21 CFR 101.9(j)(1) and 21 CFR 101.9(j)(18) for foods and 21 CFR 101.36(h) for dietary supplements outlines the requirements to qualify for the exemption. A business may be exempt from the requirement of including a "Nutrition Facts" panel on its food packages and "Supplement Facts" panel on its dietary supplement packages.
The exemption under 21 CFR 101.9(j)(1) applies to retailers with annual gross sales of less than $500,000, or with annual gross sales of food to consumers of less than $50,000. The exemption under 21 CFR 101.9(j)(18) and 21 CFR 101.36(h) is based on the number of employees and number of product units sold. The exemption applies to businesses with fewer than 100 employees and products fewer than 100,000 units. The number of employees is based on the average number of full time equivalent employees. No exemption may be taken if a company has more than the number of employees listed regardless of number of units produced.
A "product" is a food with the same brand name and statement of identity.
A "unit" is a package or, if unpacked, the form in which the product is offered for sale.
"Company" includes domestic and international affiliates.
If any nutrient content claim (e.g., "low fat") or health claim is made, the small business exemption is not applicable. Also, this exemption deals only with the necessity of having the "Nutrition Facts/Supplement Facts" panel, and has no effect on the mandatory labeling information (i.e., statement of identity, quantity of contents, ingredient statement, name and address of responsible firm).
The firm claiming the exemption must file a notice with the Food and Drug Administration annually. A suggested form to use to claim the exemption may be obtained from the following sources:
You can also submit your firm's small business exemption notification by fax, email or postal mail.
The address to mail your notification:
Center for Food Safety and Applied Nutrition
Food and Drug Administration
HFS--810
5100 Paint Branch Parkway
College Park, Maryland 20740-3835
If we do not hear from you, we will no longer list your firm as a small business with products that are exempt from mandatory nutrition labeling.
Appendix II - Model Small Business Food Labeling Exemption Notice
Instructions for completion. (Please type or clearly print)
Name of firm: Enter the recognized legal name of your firm.
Firm address: Enter the mailing address for the principal location of your firm. Also, provide telephone, FAX numbers and e-mail address.
Type of firm: Place a check mark or "x" in each block that is applicable to your firm. For example, if your firm manufactures all products that it sells, place a check mark after "Distributor."
Twelve-month time period for which you are claiming exemption: Enter the specific time period for which you are requesting exemption for your products. For products initially introduced into interstate commerce before May 8, 1994, this time period will be from May 8 of the current year to May 7 of next year: e.g., "FROM 05/08/02 TO 05/07/03." For new products, the time period should start with the date on which sales in the United States are expected to begin: e.g., "FROM 04/01/02 TO 03/31/03."
Average number of full-time equivalent employees for twelve-month period: Enter the average number of full-time equivalent employees of your firm and all of its affiliates for the year preceding the year for which an exemption is claimed under item 4. The average number should include all employees of your firm and its affiliates (e.g., owners; officers; and all other personnel such as secretarial, production, and distribution employees). Firms are affiliates of each other when, either directly or indirectly, (1) one firm has the power to control the other, (2) a third party controls or has the power to control both, or (3) an identity of interest exists such that affiliation may be found.
The Average number of full-time equivalent employees is to be determined by using the following formula: Total number of employee/hours paid divided by 2080 hours = average number of full-time equivalent employees. For example, 254, 998 paid employee/hours divided by 2080 = 122. If the total number of actual employees for your firm and its affiliates is less than 100, you may enter the total number of actual employees instead of calculating the average number of full time employees; e.g., if your firm has 24 employees that work full-time and 12 employees that work part-time, you may report 36 total actual employees instead of calculating the average number of full-time equivalent employees.
Report of units sold (Continuation sheets using the same format for item 6 may be used if necessary):
Product: Under the column for product, enter the name, including the brand name, for each food product for which your firm is claiming an exemption. A food product is a food in any sized package which is manufactured by a single manufacturer or which bears the same brand name; which has a similar preparation method. In considering whether food products have similar preparation methods, consider all steps that go into the preparation of the food products, from the initial formulation steps to any finishing steps; for example, products having differing ingredients would be considered different food products and counted separately in determining the number of units.
No. of Units: provide the approximate sales of your firm, in terms of units for the product for the year immediately preceding the time period for the exemption entered under item 4, provide an approximation of the sales expected to be made during the time period in item 4. For example, if the time period being claimed in item 4 is April 1, 2001, to March 31, 2002, for a product that is going to be sold beginning April 5, 2001, provide an approximation of sales for the period from April 1, 2001, to March 31, 2002.
The approximate total number of units is the summation of the number of units of the various package sizes of the food product in the form in which it is sold to consumers; for example, the total of all 2-pound bags of flour plus all 5-pound bags of flour plus all 10-pound bags of flour should be provided as the number of units sold by your firm in the United States. There may also be occasions where a food is sold in bulk or by individual pieces rather than in packaging; e.g., flour may be sold in bulk displays at grocery stores. In such a case, the number of units should be determined on the basis of the typical sales practice for the specific food product; e.g., if 2000 pounds of flour are sold from bulk displays at grocery stores, and the typical practice for sales to consumers is to price the flour on a per pound basis, then the bulk sales would represent 2000 units. If the firm sells the same product in package form, then the bulk sales, 2000 units in the above example, should be added to the sum of the number of units of flour sold by the firm in the United States.
Manufacturer: Under the column designated "Manufacturer" enter the letter that corresponds with the name of the manufacturer of the product. The letter "A" is used to designate the firm submitting the notice if it is the manufacturer of the product. If the firm submitting the notice is not the manufacturer of the product, use the letter from Item 7 (B or C) from the continuation sheets for Item 7, that corresponds to the name and address of the manufacturer of the product.
Name and address of manufacturer (s) or distributor(s) of products(s) in item 6 if different from firm claiming exemption: Continuation sheets may be used if necessary. Provide the name and addresses of the manufacturers of the food products for which exemption is being claimed if they are different from the firm claiming the exemption. If the name of the manufacturer is unknown, provide the name of the firm from which the product is purchased. Insert the letter corresponding to the name of the manufacturer ("A" corresponds to the firm submitting the notice) or distributor in the appropriate block for the name of the product under item 6.
Contact person: Enter the name of a person that can act as a contact for your firm if any questions arise concerning the information included in the notice.
Certification: The form is to be signed by a responsible individual for the firm that can certify to the authenticity of the information presented on the form. The individual signing the form will commit to notify the Office of Nutritional Products, Labeling and Dietary Supplements when the numbers of full-time equivalent employees or total numbers of units of products sold in the United States exceed the applicable number for an exemption.
This document was issued on July 1, 2002
For more recent information on Food Labeling
See http://www.cfsan.fda.gov/label.html