Food Label Development

Full Label Compliance Service

Standard ($1,095)  – With this service, you can feel confident that your label is fully-compliant and ready for retail sale in the U.S. This comprehensive option Includes creating the Nutrition Facts label and Ingredient/Allergen statement, as well as a two-phase label review. After the first review, you’ll receive a report with recommended changes, followed by a second review after the changes have been implemented. This service is appropriate for standard food and beverage products.

Non-standard (add $500) – This upgrade applies to complex food and beverages requiring extra consideration, including:

  • Baby foods and infant formulas
  • Complex recipe formulas
  • Dietary supplements
  • Multi-packs
  • Extensive label claims
  • Dual-language labels for Canada or Mexico
  • Special calculations, such as % juice, % DV for voluntary nutrients, and PDCAAS scores
  • Child nutrition labeling

Additional package sizes ($500 per size): This includes a nutritional analysis and label review for additional size(s) of the same product.

What’s included in this service?

  • Nutrition Analysis – Through database analysis or lab analysis reports, we calculate values for all required nutrients, including:
    • Calories 
    • Total fat
    • Saturated fat
    • Trans fat
    • Cholesterol
    • Sodium
    • Total carbohydrate
    • Dietary fiber
    • Total sugars
    • Added sugars
    • Protein 
    • Vitamin D
    • Calcium 
    • Iron
    • Potassium
    • Additional nutrients available for an added fee
  • Nutrition Facts Label – We use your recipe formula, processing information, and ingredient specs (as needed) to conduct a nutritional analysis. Because we use electronic database analysis, a product sample is not required. You will receive nutrition data per serving and per 100g, as well as a fully-compliant, formatted Nutrition Facts label.
  • Ingredient & Allergen Statement – We create the most concise and consumer-friendly ingredient statement allowed by FDA. This service also includes an allergen statement and guidance on any necessary health warnings.
  • Net Contents Statement 
  • Product Naming & Label Claims – We provide regulatory guidance for naming your product to ensure compliance with FDA standards of identity or common/usual names. We also review and provide guidance on label claims related to nutrient content, health, and structure/function.
  • Label Layout Instructions – The first phase of our two-phase label review will include an initial review of your label or step-by-step, written instructions for designing your label prototype. These instructions include guidance on all regulated-aspects of your label.
  • Bioengineered Compliance statement (if applicable) – Based on your raw material specifications, we assess ingredients and determine bioengineered labeling statements required by the National Bioengineered Food Disclosure Law.
  • Final Label Review – Once your label artwork is complete, we conduct a second label review to ensure compliance.
  • Recordkeeping – We provide recordkeeping as required by FDA’s 2016 Final Rules for nutrition labeling.
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Label Compliance Review 

Standard ($895) –  U.S. FDA-regulated single food product. Available in English only.

Non-standard (add $400) – These products include baby foods and infant formulas, fortified foods, dietary supplements, multi-packs. Bilingual options available for English, Spanish, and French for the U.S., Mexico, and Canada. Product also comes with USDA label approval forms, extensive claims and complex formulas.

Additional package sizes (add $400 each) – Includes an artwork review for the second and subsequent package size for the same product.

  • Preliminary Label Review – Evaluation and recommendations of label components and copy for a single label. Includes a written report that outlines changes required for regulatory compliance.
  • Final Label Review – Once your label artwork is complete, we will conduct a final label view to ensure compliance – before you print.
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Nutrition Facts Label

Standard ($445) – U.S. FDA-regulated single food product; as-packaged calculations for mandatory components on Nutrition Facts; Available in English only.

Non-standard (add $200) These products include baby foods and infant formulas, fortified foods, dietary supplements and multi-packs. This option is bilingual – English, French, and Spanish for the U.S., Canada, and Mexico. We include USDA label approval forms and special calculations for % juice, protein quality, diet exchanges, child nutrition labeling, voluntary nutrients, dual declaration, and extensive claims and complex formulas.

Additional package sizes (add $200 each) This includes Nutrition Facts Label and artwork review for the second and subsequent package size for the same product.

  • Nutrition Analysis – Through either database analysis or your own lab analysis, we determine the nutrient content of food, breaking it down into the important Nutrition Facts categories. Other nutrients are available and can be analyzed at an additional cost. Our nutrient database calculation method is via ESHA’s Genesis R&D software.
    • Calories 
    • Total fat
    • Saturated fat
    • Trans fat
    • Cholesterol
    • Sodium
    • Total carbohydrate
    • Dietary fiber
    • Total sugars
    • Added sugars
    • Protein 
    • Vitamin D
    • Calcium 
    • Iron
    • Potassium
  • Nutrition Facts Label – Based on our database nutrition analysis of your recipe formulation or your 100-gram lab data, along with your package size and label dimensions, we determine the serving size, apply rounding rules, calculate % Daily Values, and then prepare a Nutrition Facts Label that is fully compliant with the Nutrition Labeling and Education Act. You will receive a graphic file to provide to your printer, artist, or package designer, along with back-up documentation for your file.
  • Recordkeeping – We will provide recordkeeping as required by FDA’s 2016 Final Rules for nutrition labeling.
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Ingredient Statement

Standard ($445) – U.S. FDA-regulated single food product

Non-standard (add $200) These products include baby foods and infant formulas, fortified foods, dietary supplements, multi-packs. Bilingual options available for English, Spanish, and French for the U.S., Mexico, and Canada. Product also comes with USDA label approval forms, extensive claims and complex formulas.

  • Allergen Compliance – The ingredient statement we prepare for you will comply with the Food Allergen Labeling and Consumer Protection Act. We will include text for an allergen statement and advise on any necessary label warnings for health risk ingredients.
  • Ingredients Statement – Based on your recipe formulation and raw material specifications, we prepare the most concise and consumer-friendly ingredient statement that is allowed based on FDA regulations. You will receive text that you can provide to your printer, artist, or package designer, along with back-up documentation for your file.
  • Bioengineered Compliance – Based on your raw material specifications, we assess ingredients and determine bioengineered labeling statements required by the National Bioengineered Food Disclosure Law.
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Helpful guidance for non-standard services

% Juice – Required for beverages that purport to contain a fruit or vegetable juice.

Protein Quality – Required for products that make a protein claim.

Diet Exchanges – Exchange equivalents using standards of the American Diabetes Association and the Academy of Nutrition and Dietetics.

Child Nutrition (CN) Labeling – Profile of your product for both nutrient-based and food-based plans in schools.

Voluntary Nutrients – Includes specific requests for nutrients not required within the Nutrition Facts Label.

Dual Declaration – Includes a second column on the Nutrition Facts Label showing both as packaged and as prepared values.

Extensive Claims – For guidance on relevant claims and their substantiation requirements.

Complex Formula – Nested recipe with multiple components.