Anna Benevente

Director of Labeling, Ingredient and Product Review

U.S. FDA Food Labeling Regulations – Top 5 Things to Know

Jul 13, 2015

In order to help food companies properly label their products for U.S. distribution, Registrar Corp compiled a list of the top five U.S. Food and Drug Administration (FDA) food and beverage labeling requirements.

1. Labels must bear a Statement of Identity

Every food label must bear a statement of identity, also known as the name of the product. The common or usual name of the food should be used if it has one. The statement of identity must be placed on the principal display panel (PDP), as well as any alternate PDP. The statement of identity must be in bold type and should be one of the most prominent features on the PDP.

Some foods have standards of identity. Standards of identity define criteria that a product must meet in order to identify by a certain name. For example, in order to identify as “blue cheese,” a product must, among other things, have a maximum moisture content of 46 percent by weight, must contain the mold Penicillium roquefortii, and be at least 60 days old. Products with standards of identity include, but are not limited to, milks and creams; types of cheeses; ice cream and other frozen desserts; breads, rolls, and buns; and cereal flours.


2. Labels must bear the required Nutrition Facts Chart

FDA requires food labels to bear a Nutrition Facts Chart. Nutrition Facts Charts contain information such as a serving size, the number of calories the product contains, and the amount of fat, sodium, protein, and other ingredients in the product. FDA has a specific format that Nutrition Facts Charts must follow. This includes everything from the order of the content to the font sizes. Nutrition Facts Charts should be placed with the ingredient list and the name and address of the manufacturer, packer, or distributor on the PDP or the information panel of the food label. If there is insufficient space, Nutrition Facts Charts may be placed on an alternate panel that is easily viewable to the consumer.

In February 2014, FDA proposed the following changes to the Nutrition Facts Chart:

  • Include “added sugars”
  • Update the daily values for sodium, dietary fiber, and Vitamin D
  • Include the amount of potassium and Vitamin D
  • Remove “Calories from Fat”
  • Update serving sizes to more realistically reflect American consumption

FDA is expected to publish a final rule regarding these changes in March 2016.

3. Labels must list each ingredient used in a food product

FDA requires that every ingredient contained within a food or beverage be disclosed on the label in descending order of predominance by weight. Ingredients should always be listed by their common or usual name unless a regulation provides a different term. For example, “sugar” is often used in place of “sucrose.” It’s important to always include major food allergens in the ingredient list, no matter how small the amount. Unlisted allergens are the leading cause of FDA-requested recalls. Major food allergens include milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans.

4. Labels must be printed in English

FDA requires that all mandatory words, statements, and other information on labels appear in English. A label may include other languages along with English, but if a foreign language is used anywhere on the label, all of the required information on the label must appear in that language as well.

5. Labels cannot bear inappropriate claims

FDA has strict regulations for claims made on food labels. Some types of claims may be used as long as a product meets certain criteria, while other claims require FDA evaluation. There are three main types of claims that can be made on food labels:

  • Health Claims, which characterize the relationship of any substance to a disease or health-related condition and are limited to claims about disease risk reduction. Health claims must be supported by scientific evidence and must be reviewed by FDA before they are used.
  • Nutrient Content Claims, which characterize the level of a nutrient in a food (e.g., “low fat”, “good source of fiber”, etc.).
  • Structure/Function Claims, which describe the role of a nutrient or dietary ingredient intended to affect normal structure of function in humans.

It’s important to be careful about the wording of claims. Claims that state or imply that a product can diagnose, cure, mitigate, or treat a disease may cause a food product to be regulated as a drug. In this case, the product would be considered an unapproved new drug and therefore adulterated if distributed into U.S. commerce.

FDA food labeling regulations can be complicated. Registrar Corp can review a food label for the elements above and more, and modify the label for FDA compliance. Registrar Corp Label and Ingredient Review Specialists will compare the food label against federal regulations, as well as FDA guidance documents, warning letters, and import alerts. After a label review, clients receive a report with suggested edits, along with a print-ready graphic file of the revised label. For questions about or assistance with FDA food labeling regulations,  contact Registrar Corp at +1-757-224-0177.  Live Help is available 24-hours a day at

This blog was originally published as a press release.


Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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