Food Label Development FAQs

Get answers to common questions about our Food Label Development Services. If your question isn't answered here, Contact us.

What product information will you need from me?

 

To produce the nutritional information for your product, Food Consulting Company needs details about your recipe formulation, processing and packaging. Required information includes:

  • Your RECIPE FORMULATION  More

  • Your PROCESSING  More

  • Your PACKAGING  More

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.

 

Download complete order guide. View 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 content.

 


What do I need to meet 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 FDA-compliant labeling:

  • 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 Retained 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 FDA compliance.


Is FDA approval of food labels required?

 

FDA does not require or provide a service for the Agency’s 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 produce 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 www.fda.gov.

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.

 

When meat 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 closed-face sandwiches.

 

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 the label.
 


What label information is needed to sell products wholesale? Is the same label information necessary for selling to foodservice?

There are five mandatory label components required for both wholesale and foodservice items. These include:

1) product identity

2) net contents statement
3) nutrition facts (exempt on some foodservice items)

4) ingredient/allergen statement

5) name/address of the manufacturer or distributer

 

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 does.

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 database analysis?

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 Federal Regulations.

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 designer.
 


How do I know if I qualify for the small business exemption for nutrition labeling?

 

FDA explains the small business exemptions for nutrition labeling here. 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 FDA.

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 labeling.

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 product.

  • 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 to carry products that are not labeled with Nutrition Facts.

  • 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. barcodes. See www.uc-council.org for more information.
 


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