U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
June 19, 1996
Small Business Food Labeling Exemption
Under 21 CFR 101.9(j)(1), a business may be exempt from the requirement of including a "Nutrition Facts" panel on its food packages. This exemption is based on number of employees and number of product units sold. This exemption deals only with the necessity of having the "Nutrition Facts" panel, and has no effect on the mandatory labeling information (i.e., common name of product, net contents, ingredient statement, name and address of responsible firm).
Currently, the exception applies to businesses with fewer than 100 employees and products fewer than 100,000 units. No exemption may be taken if a company has more than the number of employees listed regardless of number of units produced.
The exception also 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 number of employees is based on the average number of full time equivalent employees.
A "product" is a food with the same brand name and statement of identity.If any nutrient content claim (e.g., "low fat") or health claim is made, this exemption is not applicable.A "unit" is a package or, if unpacked, the form in which the product is offered for sale.
"Company" includes domestic and international affiliates.
Businesses must file an annual notice with FDA that they are claiming an exemption based on number of employees and units of product.
A suggested format for this notice is on reverse side of the page.
Sample Format
Send to:Office of Food Labeling (HFS-150)
Center for Food Safety ant Applied Nutrition
Food and Drug Administration
200 C St. SW.Washington, DC 20204
1. Name of Firm: Enter recognized legal name of firm.
2. Firm Address: Enter mailing address for principal place of business.
3. Name of the food product for which exemption is claimed. Enter the name of each food product for which an exemption is claimed. Continuation sheets may be used if necessary.
4. Name and address of manufacturer: Provide the names and addresses of the manufacturers of the food products for which an exemption is being claimed if they are different than the firm that is submitting the claim for exemption.
5. Number of Full-Time Equivalent Employees: Enter the approximate average number of persons employed by the firm for the year preceding the year for which an exemption is being claimed
__________(Average number of Full-Time Equivalent Employees)
__________________(One year time period - From/To)
6. Approximate Total Number of Product Units of each product sold in the United States for which the "Nutrition Facts" panel exemption is being claimed. One year time period is the same as in #5, above.(Use continuation sheets as necessary)
| Product Description | No. of Units |
| ____________________________________ | __________ |
| ____________________________________ | __________ |
| ____________________________________ | __________ |
The undersigned certifies that the above information is a true and accurate representation of the operations of
(name of Firm)_______________________________________
The undersigned will notify the Office of Food Labeling of the date on which the average number of full-time equivalent employees or the number of units of food products sold in the United States exceeds the applicable number for the exemption which is being claimed herein.
(Signature)__________________________________________
7. Certification. The request for exemption is to be signed by a responsible individual for the firm that can certify the authenticity of the information presented on the request. The individual signing the request will commit to notify the Office of Food Labeling when the numbers of full-time equivalent employees or total numbers of units of product sold in the United States exceed the applicable numbers for an exemption.
Hypertext updated 1997-NOV-20