FAQs

Placing an order is an easy process through our secure server.

• Start by choosing the service needed for each product
• Enter your contact information and choose your payment method
• Provide your product information, as directed in the online form (Don’t worry, you’ll have a chance to upload additional files later.)

We offer a range of services to meet each clients’ unique needs. Many clients choose our Full Label Compliance service, which takes the product information you provide and delivers the components required for a fully compliant food label. The service includes nutrition analysis, a Nutrition Facts label, an ingredient statement including allergen labeling compliance, and help with product naming and label claims. The package also includes a two-phase, comprehensive label review.

For ongoing regulatory support, many clients choose our Retained Regulatory Support service. This service includes in-depth regulatory research and guidance on an “on call” basis – we’re here whenever a regulatory question or food labeling need arises!

To start the process you will need to gather the following information about your product:

1. Recipe formulation
2. Processing method(s)
3. Packaging specifications.

It may help to download our Order Guide. After you submit your order, a regulatory specialist will let you know if additional information is needed and can answer any questions you may have. We’re here to help every step of the way!

No, product samples are not needed. Food Consulting Company uses database nutritional analysis based on your product’s recipe formulations. This method is a better predictor of nutritional content than laboratory analysis of a single sample and is also lower cost.

Standard Service is delivered in 8 business days. If you prefer an expedited service, you may choose either Priority Service in 4 business days or Overnight Service delivered by the end of the next business day.

To sell an FDA-regulated product in the U.S., the product label must contain five label components:

1. Statement of identity
2. Statement of net content
3. Nutrition Facts label
4. Ingredient statement with allergen labeling compliance
5. Name and address of manufacturer, packer, or distributor

Labeling rules state where each component must be placed, minimum type size requirements, and more.

In addition to the requirements for FDA-regulated foods, USDA requires four additional elements:

1. Handling statement
2. USDA inspection legend
3. Plant establishment number
4. Safe handling instructions when required

The Food Safety and Inspection Service (FSIS) division of USDA holds authority over meat, poultry, and processed egg products. FDA holds authority over other foods.

When meat or poultry is part of a mixed dish product (e.g., pepperoni pizza, chicken noodle soup), the recipe formulation determines whether it is regulated under USDA or FDA. In general, mixed food products with more than 2% cooked meat or poultry (3% raw) are regulated by USDA, while products with 2% or less cooked meat or poultry (3% or less raw) are regulated by FDA.

USDA-regulated products require FSIS label approval prior to marketing, whereas FDA-regulated products do not.

It is not possible to create one label that will satisfy both U.S. and Canadian labeling requirements. Each country has different labeling requirements, such as how the Nutrition Facts label is formatted, rounding rules, units for reporting nutrients, and % Daily Values. Regulations also differ for ingredient/allergen declarations, net contents statements, and nutrition and health claims.

The same five label components are required for FDA and CFIA-compliance;  however, there are many nuances in the regulations between U.S. and Canada related to content, formatting, placement, etc.

In the past, this was allowable in some circumstances; however, as of August 2014, changes in Mexico’s regulations made it no longer possible to have one label that satisfies both countries’ requirements.

The same five label components are required for FDA and Mexico regulations, although there are many nuances between U.S. and Mexico related to content, formatting, placement, etc.

To sell a retail product regulated by FDA, the product label must contain five components:

1. Statement of identity
2. Statement of net content
3. Nutrition Facts label
4. Ingredient statement with allergen labeling compliance
5. Name and address of manufacturer, packer or distributor

Labeling rules state where each component must be placed, minimum type size requirements, and more.

Whether you want to sell your product wholesale or retail, the same five label components are required for inner packaging (i.e., the package that appears on store shelves):

1. Statement of identity
2. Statement of net content
3. Nutrition Facts label
4. Ingredient statement with allergen labeling compliance
5. Name and address of manufacturer, packer or distributor

For wholesale items, the outer packaging (i.e., shipping containers used solely for transportation) does not require these mandatory label components.

For products sold to foodservice, 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. However, most manufacturers of foodservice items voluntarily include nutrition information, as many customers require it to comply with restaurant menu labeling regulations.

There are no special provisions for Internet or mail order sales. By law, all foods sold in the U.S. must be in full compliance with FDA labeling requirements, as specified in the U.S. Code of Federal Regulations, regardless of the method of sale.

Products sold in farmers markets are required to comply with the same FDA/USDA labeling regulations, unless they qualify for a small business exemption.

Regardless of whether the product is produced domestically or outside the U.S., FDA/USDA labeling requirements specified in the U.S. Code of Federal Regulations apply.

A low volume exemption from nutrition labeling might apply if the business has less than 100 employees and sells fewer than 100,000 units/year in the U.S. For these exemptions, a notice must be filed each year with FDA. There are also exemptions for small domestic manufacturers, packers and distributors (not importers) with fewer than 10 full time employees who sell less than 10,000 units annually in the U.S. In these circumstances, a notice does not need to be filed with FDA.

When considering an exemption for nutrition labeling, it is important to recognize that the presence of any nutrient content claim, health claim, or other nutrition information disqualifies the product from this exemption. Also, despite a nutrition labeling exemption, product labels must still comply with all other mandatory FDA labeling regulations.

FDA provides a small business exemption for small retailers that meet the qualifications. Specifically, nutrition labeling is not required if the product will be sold only by retailers that have total annual gross sales of $500,000 or less or total annual food gross sales of $50,000. A small business exemption notice does not have to be filed with FDA.

When considering an exemption for nutrition labeling it is important to recognize that the presence of any nutrient content claim, health claim, or other nutrition information disqualifies the product from this exemption. Also, despite a nutrition labeling exemption, product labels must still comply with all other mandatory FDA labeling regulations.

To get a UPC barcode, you will first need to become a member of GS1 US Partner Connections (previously Uniform Code Council). You will then receive a numerical company prefix for use in creating your own UPC barcodes. While the UPC barcode is not an FDA/USDA regulatory requirement, most retailers will not stock products without a barcode.

The need for a freshness date depends on the product category. In general, FDA-regulated products do not require a freshness date; however, including these dates can be helpful, as retailers use this information to rotate stock and consumers use it to be assured of product freshness.

When you reformulate or rebrand your product, you must change your product labeling to match the contents of the package. This includes evaluating the nutrition information, ingredient and allergen statements, product name, and all claims to determine what needs to change on your label to ensure regulatory compliance.