What product information will you need from
To produce the nutritional information for your
product, Food Consulting Company needs
details about your recipe formulation,
processing and packaging. Required information
You can download an order guide and sample
product worksheet below. After you submit your
order with product worksheet, a regulatory
specialist will let you know if additional
information is needed and can answer any
questions you may have.
sample product worksheet.
I have a new product
and need help with food labels. Do I need to
send a sample of my product to you?
Food Consulting Company uses database analysis
of a product's recipe formulation so a sample is
not needed. Database analysis is a lower cost
alternative to laboratory analysis and is an
excellent predictor of a product's nutritional
What do I need to
FDA label regulations to sell my retail product?
To sell an FDA-regulated product by retail in
the United States the product label must contain
five label components. These are: statement of
identity, statement of net content, Nutrition
Facts, ingredient statement with allergen
labeling compliance, and name and address of
manufacturer, packer or distributor. Labeling
rules state where each component must be placed,
minimum type size requirements, and more.
Food Consulting Company's
Full Label Compliance service takes
the product information you provide and produces
the required components for you. The service
includes nutrition analysis, a Nutrition Facts
panel, an ingredient statement including
allergen labeling compliance, and help with
product naming and label claims. The package
also includes label layout instructions and a
final label review.
You have options to successfully produce
Food Consulting Company can help you from
start to finish with
Full Label Compliance. With this
choice, once you supply the necessary
information for a product you will receive
ready-to-print label components and a
guarantee for accuracy.
Produce your labels by referring to the
FDA website. Use FDA resources (Code of
Federal Regulations, FDA Guidance Documents,
and FDA's Food Labeling Guide) and contract
with Food Consulting Company for
Regulatory Support to get expert
advice as needed.
Refer to FDA's food labeling resources (Code
of Federal Regulations, FDA Guidance
Documents, and FDA's Food Labeling Guide)
for detailed information on labeling
requirements and proceed to produce your
product label. Submit your final label work
to Food Consulting Company for
Label Compliance Review to assure
Is FDA approval
of food labels required?
FDA does not require or provide a service for
the Agencys approval of food labels. However,
labelers must comply fully with the labeling
regulations on their own or through the help of
their choice. Food Consulting Company helps you
100% FDA compliant labels with
Full Label Compliance and
Label Compliance Review.
The requirements for food labeling are detailed
in the Federal Food Drug and Cosmetic Act, Code
of Federal Regulations, Food Labeling Guide,
Food Allergen Labeling and Consumer Protection
Act, and in FDA guidance documents all of which
can be accessed at
The Agency learns of non-compliant labels on
foods via random checks and checks during
inspections, and through tips from consumer
groups, individual consumers and competitors.
FDA issues warning letters to food packagers
when violations are discovered; the Agency
directs food packagers to correct non-compliant
labels or face further FDA action.
I've heard that some
products are regulated by USDA (instead of FDA).
Is this true?
Yes, it is true. The Food Safety and Inspection
Service (FSIS) of USDA has authority over meat
and poultry products and processed egg products,
and FDA has authority over all other foods.
or poultry is part of a mixed dish product
(e.g., pepperoni pizza, chicken noodle soup,
side dish with bacon), the product might fall
under FDA rather than USDA regulations. Where it
falls depends on the formulation. In general, mixed food products with more than
2% cooked meat or poultry (3% raw) are regulated
by USDA; products with 2% or less cooked meat or
poultry (3% or less raw) are regulated by FDA
but there are some exceptions such as
USDA-regulated products require FSIS label
approval prior to marketing.
Can I have one label that
will satisfy both U.S. and Canada?
It is not possible to create one label that will
satisfy both U.S. and Canadian labeling
requirements because: each country has different
requirements for formatting the Nutrition Facts,
the rounding rules are different, in some cases
the units for reporting nutrients differ, and
the countries have established different Daily
Values for some nutrients.
Also, the requirements for ingredient/allergen
declarations are different, and there are some
differences relating to net contents statements,
nutrition/health claims, and other aspects of
What label information is
needed to sell products wholesale? Is the same
label information necessary for selling to
There are five mandatory label components
required for both wholesale and foodservice
items. These include:
net contents statement
nutrition facts (exempt on some
name/address of the manufacturer or
For wholesale items, the outer packaging (i.e.,
shipping containers used solely for
transportation) does not require the mandatory
label components, however the inner packaging
For foodservice items, nutrition facts may be
omitted if the items will be further processed
(not sold in the packaging) and do not carry
nutrient content or health claims on the label
or labeling. However most manufacturers of
foodservice items choose to voluntarily include
nutrition information because their restaurant
customers are now requiring it to comply with
restaurant menu labeling regulations.
Does your company offer
shelf life testing?
Yes, Food Consulting Company offers a Shelf Life
Evaluation service. A food technologist
determines shelf life by testing a product
sample for pH, water activity, moisture, solids,
and other components; the findings are used
along with specifics about the product
ingredients, processing methods, and packaging
to determine the product shelf life.
Although labeling regulations do not include a
requirement for shelf life, voluntary inclusion
of a freshness date (Best Before or Use By) on
labels encourages retailers to rotate products
and lets consumers know when the time is up for
highest product quality.
Which is better for getting
nutrient values for my product, laboratory or
FDA does not require a specific method of
analysis for Nutrition Facts, but the Agency
does require label values to be accurate
within the tolerances specified in the Code of
When performed correctly, the database method is
typically a better predictor of the nutritional
analysis from multiple production runs than a
single laboratory analysis. This is because the
database method uses the statistical average for
commodity products that can vary with growing
conditions and other factors. FDA actually
encourages the use of nutrient databases as a
low-cost alternative to laboratory analysis. In
fact nearly all Food Consulting Company clients
choose this approach; exceptions are for
products that contain ingredients for which
nutrient data is not available or for foods that
undergo processing where the nutrient changes
cannot be confidently predicted.
When you select database analysis you will
provide your product formulations, raw material
specifications, and processing information to us
under strict confidentiality. We will
analyze your product to
determine the 100-gram data.
With laboratory analysis you will provide us
with the 100-gram data lab report.
Contact Us if
you need a referral for a new lab analysis.
In both cases we use the findings of the
analysis to develop the Nutrition Facts panel
for your product. As part of this work we
determine the FDA-regulated serving size and
servings per container, then calculate the
nutrient profile per serving, apply the rounding
rules, and determine percent daily values for
the required Nutrition Facts panel components.
Finally we produce a camera-ready Nutrition
Facts panel formatted according to your package
dimensions and FDA specifications. This is what
you provide to your printer, artist, or package
How do I know if I
qualify for the small
business exemption for nutrition labeling?
FDA explains the small business exemptions for
In brief, the product launcher may use the
exemption if the product will be sold only by
retailers that have total annual gross sales of
not more than $500,000, or annual gross sales of
foods of not more than $50,000. A low volume
exemption might apply if the product
launcher/company meets certain requirements for number
of employees and number of product units that
are sold annually in the United States. For some
exemptions, a notice must be filed annually with
When considering an exemption for nutrition
labeling it is very important to understand that
product labels must still be in compliance with
other FDA labeling regulations such as, but not
limited to, ingredient statement and allergen
Also, if any nutrient content claim (e.g., "low
fat"), health claim, or other nutrition
information is provided on the label, or in
packaging or advertising, the small business
exemption is not applicable for the product.
Product launchers who choose to forego the small
business nutrition labeling exemption, and
instead opt to include Nutrition Facts:
better meet consumers' expectations for
product information; consumers are
accustomed to knowing such things as
servings per container and serving size,
calories and fat grams per serving, etc.
They will wonder why the nutritional
information isn't on the label
and consequently may lose interest in the
position the new product as one that is
intended to have a serious market presence.
enable the company to highlight nutrition
information in labeling and advertising.
open more doors for product distribution;
many retailers have decided on their own not
products that are not labeled with Nutrition
make a smart up-front investment; once the
Nutrition Facts label is developed, it is
good for thousands of product unit sales.
Where can I find information
on the U.P.C. barcode?
The U.P.C. barcode is not a regulatory
requirement, but as a practical measure it
should be included on your food label. Retailers
will generally not stock your product without
it. The first step in getting a barcode is
becoming a member of GS1 US Partner Connections
(previously Uniform Code Council). Once you
become a member, you will receive a company
prefix for use in creating your own U.P.C.
www.uc-council.org for more information.