U.S. FDA Food Labeling Review

The food label for the US market must comply with FDA (Food and Drug Administration) requirements. The main sections of a food product label are:

  1. Name of food (Identity labeling of food)
  2. Net quantity
  3. Nutrition facts
  4. Ingredient list
  5. Allergy labeling
  6. Name and address of the manufacturer, packer or distributor
  7. Nutrient content claims
  8.  Health claims
  9. Food product dating

    Each of the sections is regulated! To attract the attention of customers and demonstrate the benefits of the product, manufacturers often want to use statements such as «Good for the Heart», «Dietary Product», «Gluten Free», «100% Natural» and others. Remember, that the criteria and terms of use are set for each of these claims! For unreasonable use of the mentioned claims and statements on the packaging, you risk receiving a warning or a penalty.

    For example, from January 1, 2020, the provisions of the “National Bioengineered Food Disclosure Standard” are enacted, requiring manufacturers to disclose the content of genetically modified organisms in packaged foods. Disclosure by text, symbol or electronic link is allowed. For this purpose, the term «Bioengineered food» is used in the USA.

Bioengineered food

Figure 1 — The symbolic of a bioengineered food disclosure

     There are many requirements for the Nutrition Facts section. For example, the law of the United States establishes such a thing as «Serving Size». The amount of product in the package must be matched to the standard serving size. In the nutrition label, you must indicate the number of standard servings (or their proportions) in the package.

Nutrition Facts 01

Figure 2 — Example of the Nutrition Facts section

    In 2004 the Food Allergen Labeling and Consumer Protection Act (FALCPA) was passed. FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a «major food allergen» declare the presence of the allergen in the manner described by the law. if your product contains one of eight major allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans), you must indicate it on the label.

    Only a small part of the requirements is listed here! Ognevenko Consulting offers you an FDA label development and review services (review the current label for compliance with current FDA requirements). The services do not include the graphic design of the label.

Service cost:

  1. Label review: 250 US Dollars per 1 label. Service includes:

— overview of all sections of the label;
— content correction recommendations and my comments;
— general requirements of the U.S. Federal and food labeling act.

  1. Development of the label: 400 US Dollars per 1 label. Service includes:

— development of textual content for all sections of the label;
— all the necessary requirements for the content, font size, and section layout;
— possible content options.

+7(983)108-83-13 (WhatsApp, Viber, Telegram, Signal), Evgeny Ognevenko


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