Form FDA 3570 FDA 3570 MODEL SMALL BUSINESS NUTRITION LABELING EXEMPTION NOTICE

OMB Approval No. 0910-0381

OMB Expiration Date: 08/31/2010
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Food Safety and Applied Nutrition

MODEL SMALL BUSINESS NUTRITION
LABELING EXEMPTION NOTICE
PLEASE TYPE OR CLEARLY PRINT IN BLANK SPACES
1. NAME OF FIRM
2. STREET ADDRESS OF FIRM
CITY

STATE

ZIP/POSTAL CODE

COUNTRY
TELEPHONE

FAX

E-MAIL

3. TYPE OF FIRM (Check all that apply)
Packer/Repacker

Retailer

Distributor

Importer

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Manufacturer

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4. TWELVE-MONTH TIME PERIOD FOR WHICH YOU ARE CLAIMING EXEMPTION – Provide the applicable time period for the
CURRENT YEAR. Example: 05/08/2005 - 05/07/2006 (MM/DD/YYYY - MM/DD/YYYY)
5. AVERAGE NUMBER OF FULL-TIME EQUIVALENT EMPLOYEES FOR 12 MONTH PERIOD
Include the owner of the firm as an employee. Do not list “0” employees.
6. REPORT OF UNITS SOLD (USE CONTINUATION SHEET IF NECESSARY).
If new business, estimate number of units to be sold in upcoming year.
NAME OF PRODUCT
NO. OF UNITS

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MANUFACTURER (A)

7. NAME AND ADDRESS OF MANUFACTURER(S), DISTRIBUTOR(S), OR IMPORTER(S) OF PRODUCT(S) IN ITEM 6 IF DIFFERENT
FROM FIRM CLAIMING AND EXEMPTION. (USE CONTINUATION SHEET IF NECESSARY.)
B NAME OF MANUFACTURER, DISTRIBUTOR, OR IMPORTER
ADDRESS

C NAME OF MANUFACTURER, DISTRIBUTOR, OR IMPORTER
ADDRESS
8. CONTACT PERSON

TELEPHONE

9. The undersigned certifies that the above information is complete and accurate. The undersigned will notify the Office of
Nutritional Products, Labeling and Dietary Supplements of the date on which the average number of full-time equivalent
employees or the number of units of products sold in the United States by my firm exceeds the applicable numbers for the
time period for which the exemption is being claimed.
SIGNATURE

TITLE

NAME (Type or clearly print)

DATE

FORM FDA 3570 (08/10)

PSC Graphics (301) 443-1090

EF

OMB Approval No. 0910-0381

OMB Expiration Date: 08/31/2010
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Food Safety and Applied Nutrition

INSTRUCTIONS FOR COMPLETING SMALL
BUSINESS NUTRITION LABELING EXEMPTION NOTICE
PLEASE TYPE OR PRINT CLEARLY AND FILL OUT COMPLETELY.
Enter the legal name of your firm.

Firm Address:

Enter the mailing address for the principal location of your firm. Also, provide the
telephone number, FAX number, and e-mail address.

Type of Firm:

Place a check mark or an “x” on each line that applies to your firm. For example,
if your firm manufactures all products that it sells, place a check mark after
“Manufacturer.”

12-Month Time Period
for which Firm is
Claiming an Exemption:

Enter the specific time period for which you are requesting an exemption for your
products. The time period for which you are claiming an exemption must be
current with the date that you are submitting your motice. The exemption
notice should apply to the current year.

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Name of Firm:

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For products for which a notice has been filed for the previous year, update the
previous dates for the same dates of the upcoming year. 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 10/01/04 - 09/30/05.”
Average Number of
}Full-Time Equivalent
Employees for
12-Month Periods:

Enter the average number of full-time equivalent employees for your firm and all
of its affiliates fo rthe year preceding the 12-month period for which an exemption
is claimed in item 4 (Refer to the sample small business exemption notice). For a
new business, enter the number of employees for the upcoming year. The average
number should include all employees for your firm and its affiliates, including the
owner(s); officers; and all other personnel such as secretarial, production, and
distribution. 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 determined by the
following formula: Total number of hours of salary or wages paid to the
employees of the firm and its affiliates divided by 2080 hours. For example,
254,998 paid 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. For example, if a 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.

FORM FDA 3570 (08/10)

PSC Graphics (301) 443-1090

EF

OMB Approval No. 0910-0381

OMB Expiration Date: 08/31/2010

INSTRUCTIONS FOR COMPLETING SMALL
BUSINESS NUTRITION LABELING EXEMPTION NOTICE (cont.)
Report of Units Sold (Continuation sheets using the same format for item 6 in the sample small business
notice may be used if necessary):
Product:
Under the column for product, enter the name, including the brand name, for
each product for which your firm is claiming an exemption. A product includes
all package sizes that are manufactured by a single manufacturer or which bears
the same brand name, which has the same statement of identity, and has a similar
preparation method. In considering whether products have similar preparation
methods, consider all steps that go into the preparation of the products, from the
initial formulation steps to any finishing steps; for example, products with different
ingredients would be considered different food products and counted separately in
determining the number of units.
Provide the approximate total number of units of the various package sizes of hte
product sold in the United States in teh 12-month period preceding that for which
the nutrition labeling exemption is claimed. For a new product, provide an estimate
of the number of units of the product expected to be sold in the United States in the
12-month period for which you are claiming an exemption.

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No. of Units:

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The approximate total number of units is the sum of the number of units of
the various package sizes of the food product in the form in which it is sold to
consumer. For example, the total number of all 2-pound, 5-pound and 10-pound
bags of flour should be provided as the total number of units of flour sold by a firm
in the United States.
There may also be occasions when a food is sold in bulk or by individual pieces
rather than in packaging. For example, flour may be sold in bulk displays at
grocery stores. In this case, the number of units should be determined on the basis
of typical sales practice for the product. For instance, 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 this product is also sold in packaged form, then 2000 units
should be added to the total number of units of flour sold by the firm in the United
States.

Manufacturer:

FORM FDA 3570 (08/10)

Under the column designated “Manufacturer,” enter the latter 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.

PSC Graphics (301) 443-1090

EF

OMB Approval No. 0910-0381

OMB Expiration Date: 08/31/2010

INSTRUCTIONS FOR COMPLETING SMALL
BUSINESS NUTRITION LABELING EXEMPTION NOTICE (cont.)
If the firm submitting the notice is not the manufacturer of the product, use the
letter from item 7 (please refer to sample small business exemption notice) (B or
C or additional letters may be used on a continuation sheet) that corresponds to the
name and address of the manufacturer, distributor, or importer of the products for
which an exemption is being claimed if they are different than the firm claiming the
exemption. If the name of the manufacturer is unknown, provide the name of hte
firm from which the product is purchased.

Contact person:

Enter the name of a person that can act as a contact for the firm if any questions
arise concerning the information included in the notice.

Certification:

The form is to be signed by a person that can act as a contact for the firm that can
certify that the information provided in the notice is complete and accurate. The
individual signing the notice will commit to notifying the Office of Nutritional
Products, Labeling and Dietary Supplements when the average number of fulltime equivalent employees or total number of units of products sold in the United
States by the firm exceed the applicable numbers for the time period for which the
exemption is being claimed.

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Name and Address
of Manufacturer(s),
Distributor(s), or
Importer(s) of Products
in Item 6 (please refer
to the sample small
business exemption
notice) if Different
From Firm Claiming
the Exemption:

FORM FDA 3570 (08/10)

PSC Graphics (301) 443-1090

EF

OMB Approval No. 0910-0381

OMB Expiration Date: 08/31/2010

SMALL BUSINESS NUTRITION LABELING EXEMPTION NOTICE
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.
Title 21 of the Code of Federal Regulations (21 CFR) 101.9(j)(1) and 21 CFR 101.9(j)(18) outline the requirements
for a small business nutrition labeling exemption for foods. The small business nutrition labeling exemption requirements for dietary supplements are outlined in 21 CFR 101.36(h)(1) and 21 CFR 101.36(h)(2).
The nutrition labeling exemptions found in 21 CFR 101.9(j)(1) and 21 CFR 101.36(h)(1) apply to retailers with
annual gross sales of not more than $500,000, or with annual gross sales of foods or dietary supplements to consumers of not more than $50,000. For these exemptions, a notice does not need to be filed with the Food and Drug
Administration (FDA).

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The nutrition labeling exemptions for low-volume products found in 21 CFR 101.9(j)(18) and 21 CFR 101.36(h)(2)
apply if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees
and fewer than 100,000 units of that product are sold in the United States in a 12-month period. For these exemptions, a notice must be filed annually with FDA.

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If a 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.

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A “product” is a food or dietary supplement in any size 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.
A “unit” is a package, or if unpackaged, the form in which the product is offered for sale to consumers.
A “firm” includes all domestic and international affiliates.

FORM FDA 3570 (08/10)

PSC Graphics (301) 443-1090

EF

OMB Approval No. 0910-0381

OMB Expiration Date: 08/31/2010

SMALL BUSINESS NUTRITION LABELING EXEMPTION NOTICE
If any nutrient content claim (e.g., “sugar free”), health claim, or other nutrition information is provided on
the label, or in labeling or advertising, the small business exemption is not applicable for a product.
These exemptions pertain only to nutrition labeling information, and have no effect on all other mandatory
information (i.e., statement of identity, net quantity of contents, infredient statement, and name and address
of manufacturer, packer or distributor).
The firm claiming the exemption must submit a completed notice to FDA annualy. If FDA does not receive
a completed notice each year, the exemption no longer applies. FDA DOES NOT NOTICY FIRMS WHEN
IT IS TIME TO FILE A NOTICE. FDA DOES NOT SEND CONFIRMATION THAT THE AGENCY HAS
RECEIVED YOUR COMPLETED NOTICE. PLEASE KEEP A COPY OF YOUR SUBMITTED NOTICE
FOR YOUR RECORDS.
The center for Food Safety and Applied Nutrition’s (CFSAN’s) website provides a sample nutrition labeling
exemption notice. You can also visit this website to check for a list of firms that have filed notices for their
low-volume products.

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Web-based Submission
Fax your notice to: 301-436-2639 or 301-436-2636
E-mail your notice to: [email protected]
Send your notice to:
Center for Food Safety and Applied Nutrition
Food and Drug Administration
HFS-820
5100 Paint Branch Parkway
College Park, MD 20740-3835

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If you have any questions, please call 301-436-2371

FORM FDA 3570 (08/10)

PSC Graphics (301) 443-1090

EF