YOUR NEED TO KNOW FACTS FOR FDA-LABELING

Allergen Information

• All food products containing any of the 8 leading food allergens (egg, fish, peanuts, shellfish, wheat, dairy, soy and tree nuts) must now be identified on the product's packaging. LabelCalc "red flags" any of these sources, and allows you to modify your allergen statement for accuracy.
• As a result of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of any ingredients that contain protein derived from the above 8 allergens. This statement should appear after or adjacent to the list of ingredients, and read "contains…" followed by name of the source of the food allergen.
• In the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). In the case of fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp), the specific name must also be listed.
• A company and its management may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act if one of its packaged food products does not comply with the FALCPA labeling requirements.
• If you believe an ingredient to be an allergen or if it will be processed in the same facility as an allergen ingredient it is your responsibility to label your product to note the potential cross contamination with a known Allergen.

Nutrient Rounding and Facts Panel Display Information

• Rounding nutrient values is one of the required steps in formulating your Nutrition Facts Panel. Rounding involves translating the nutrient analysis into simplified labeling values.
• Different rounding rules apply to different nutrients and/or different concentrations of the same nutrient.
• The number of servings must be rounded to the nearest whole number, unless the number of servings is between 2 and 5 servings; in this case the number of servings may be rounded to the nearest 0.5 serving.
• As of January 1, 2006 the declaration of Trans Fat must be present on your Nutrition Facts Panel by rounded gram weight.
• FDA compliant nutrition facts panels must contain the following 15 nutrients in order and display the appropriate units of measure: Calories (calories from fat), Total Fat (g), Saturated Fat (g), Trans Fat (g), Cholesterol (mg), Sodium (mg), Total Carbohydrates (g), Dietary Fiber (g), Sugars (g), Protein (g), Vitamin A (%DV), Vitamin C (%DV), Calcium (%DV), and Iron (%DV).
• There are only 5 FDA compliant label formats (regular, horizontal, linear, side-by-side, and tabular). LabelCalc will generate all of these formats for each recipe. Wording on nutrition labels may be abbreviated, however, abbreviations must match FDA requirements.
• FDA regulations require products to state % Daily Values of each nutrient listed on the label based on a 2000 calorie diet.
• % Daily Values allow consumers to visualize how much of a day’s nutrients a product provides.

Ingredient Statement and Nutrient Claims Information

• The ingredient list must be placed on the same label panel as the name and address of the manufacturer, packer or distributor. The ingredient list draws on 2 other requirements: 1. Ingredients are listed in order of predominance by weight. 2. The common or usual name for ingredients must be listed, for instance, use the term "sugar" instead of the scientific name "sucrose."
• A Nutrient Content Claim is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (for example: "low fat" or "high in oat bran").
• Only foods that have been specially processed, altered, formulated or reformulated to lower the amount of nutrient in the food, remove the nutrient from the food, or not to include the nutrient in the food may bear "Low" or "Free" claim (for example: "low sodium potato chips") – "Fat-free broccoli" is not permitted.
• A Serving Size and the Reference Amount (provided by the CFR Guide Part: 101.12) is required for "Free" nutrient claims. Because of the importance of making a "Free" claim, the FDA states that the mathematical rules must be applied to both the Reference Amount and the labeled Serving Size.
• If you believe an ingredient to be an allergen or if it will be processed in the same facility as an allergen ingredient it is your responsibility to label your product to note the potential cross contamination with a known Allergen.

COMMON LABELING QUESTIONS

• Will the FDA analyze my products for my nutrition label?

  No. FDA does not have the resources to analyze products upon request.

• Can the FDA recommend an analytical laboratory and must a laboratory be approved to perform nutrient analysis?

  No. The FDA does not approve, and is not in a position to endorse or recommend, specific laboratories.

• Can I use ingredient databases to calculate the values for nutrition labeling?

  Yes! If manufacturers choose to use ingredient databases, they can compare values from databases for the same foods obtained from laboratory analyses.

Need help? Feel free to call us at 1-888-804-0001 or contact us here to speak to a compliance labeling specialist.