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Full Label Compliance

Standard ($995) U.S. FDA-regulated single food product; as-packaged calculations for mandatory components on Nutrition Facts; English only

Non-standard (add $500) products include baby foods and infant formulas, fortified foods, dietary supplements, multi-packs, bilingual U.S., bilingual Canadian, Mexican, USDA label approval forms, special calculations (% juice, protein quality, diet exchanges, child nutrition labeling, voluntary nutrients, dual declaration), extensive claims and complex formulas.

Additional package sizes (add $500 each) includes Nutrition Facts Label and artwork review for the second and subsequent package size for the same product.

The Full Label Compliance service includes:

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: calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium. 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. This industry-standard software contains validated nutrient values from USDA Standard Reference, manufacturers' specification sheets, and literature sources. For purchased multi-component ingredients, we acquire the 100-gram nutritional information from your suppliers. Together, these data are used along with processing and packaging information to derive the nutrient values that appear on the Nutrition Facts Label.

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.

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.

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.

Product Naming & Label Claims - We will provide FDA regulatory guidance for naming your product to ensure that the product identity you use will comply with FDA standards of identity or common/usual names for non-standard foods. We will also provide any guidance you need for nutrient content claims, health claims, structure/function claims, and other regulated label statements (organic, natural, etc.) as a part of this package.

Net Contents Statement - We will develop a fully-compliant net contents statement for your package.

Label Layout Instructions - You will receive a written set of instructions that your package designer can follow when designing your label prototype. This will include information about placement and minimum type size for all required label components.

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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Label Compliance Review       

Standard ($795)  U.S. FDA-regulated single food product; English only

Non-standard (add $400) products include baby foods and infant formulas, fortified foods, dietary supplements, multi-packs, bilingual U.S., bilingual Canadian, Mexican, USDA label approval forms, extensive claims and complex formulas.

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

The Label Compliance Review service includes:

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 - Final check to ensure regulatory compliance on the same product label.

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Nutrition Facts Label

Standard ($395) U.S. FDA-regulated single food product; as-packaged calculations for mandatory components on Nutrition Facts; English only

Non-standard (add $200) products include baby foods and infant formulas, fortified foods, dietary supplements, multi-packs, bilingual U.S., bilingual Canadian, Mexican, special calculations (% juice, protein quality, diet exchanges, child nutrition labeling, voluntary nutrients, dual declaration) and complex formulas.

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

The Nutrition Facts Label service includes:

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: calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. 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. This industry-standard software contains validated nutrient values from USDA Standard Reference, manufacturers' specification sheets, and literature sources. For purchased multi-component ingredients, we acquire the 100-gram nutritional information from your suppliers. Together, these data are used along with processing and packaging information to derive the nutrient values that appear on the Nutrition Facts Label.

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.

ORDER NOW

 

Ingredient Statement

Standard ($395) U.S. FDA-regulated single food product

Non-standard (add $200) product include baby foods and infant formulas, fortified foods, dietary supplements, multi-packs, bilingual U.S., bilingual Canadian, Mexican, and complex formulas.

The Ingredient Statement service includes:

Ingredient 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.

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.

ORDER NOW