FDA Food Labeling Guide: What You Need to Know

Navigating FDA food labeling regulations can be overwhelming, especially with ever-changing requirements. Mistakes in labeling can lead to compliance issues, fines, or product recalls. This guide simplifies the process, breaking down key FDA labeling rules, best practices, and common pitfalls to avoid. Whether a small business or an established manufacturer, you'll learn how to confidently create FDA-compliant labels, ensuring accuracy, transparency, and legal compliance for your food products.

What does the FDA Food Labeling Guide mean?

Food labeling is more than just providing information about a product. It ensures transparency, builds consumer trust, and plays a key role in shaping perceptions. This is especially important for regulated products like infant formula and medical foods overseen by the FDA. Clear and accurate labeling also supports fair packaging practices across the United States.

The FDA’s guide to food safety labeling includes a detailed table of contents and guidance documents to help businesses follow regulations. It may also offer translation provisions in multiple foreign languages, making compliance easier for diverse markets. By following these guidelines, businesses can assure consumers of their product’s quality and safety.

Food Labels: More Than Just Information

Food labels provide essential information that helps consumers make informed choices. They detail nutritional content, ingredient lists, and allergen warnings, making it easier for individuals to maintain a balanced diet and avoid unwanted ingredients. Additionally, the USDA Agricultural Research Service plays a crucial role in ensuring that labels must also meet specific requirements set by the FDA to ensure accuracy and compliance.

Beyond consumer benefits, food labels promote transparency between manufacturers and buyers. Accurate, FDA-compliant labeling builds trust, enhances credibility, and strengthens a brand’s reputation. By following labeling regulations and meeting specific requirements, businesses not only ensure compliance but also improve their market success.

Key FDA Labeling Requirements for Food Products

FDA labeling requirements for food products include mandatory elements like nutritional data, ingredient lists, and allergen information. They also cover optional but regulated claims about nutrient content and health benefits, all of which must adhere to specific requirements. To meet FDA standards, product labels must feature key elements like the Statement of Identity and Net Quantity of Contents, placed in designated sections such as the Principal Display Panel (PDP) and Information Panel. Let’s explore these claims and requirements in more detail.

Product Name
This is the name people use to identify your food item. It must be clearly visible on the front of the packaging, also known as the Principal Display Panel.

Quantity of Contents
This tells consumers how much product is inside, not counting the packaging. It should be on the front label and follow FDA rules about measurements and placement.

Ingredient List
All ingredients must be listed from highest to lowest weight. This can be placed on the front or the information panel on the side. If an ingredient contains other ingredients, they should be mentioned either under the main ingredient or included in the full list.

Manufacturer, Packer, or Distributor Details
Labels must show the name and address of the company responsible for making, packing, or distributing the product. This information should be on the front or side panel. If another company makes the product for you, the label should state, “Manufactured for [Your Company Name].”

Nutrition Facts, usually found on the back, include information about nutrition labels detailing nutrients, vitamins, minerals, and macronutrients. Some products may not need this label, but it is important to check the FDA rules to confirm.

FDA-Regulated Label Claims

Label claims, including the use of the term Nutrient Content Claims, are essential for advertising and promoting conventional food products, but the FDA strictly regulates their use to prevent misleading or false marketing. Depending on the product category, there are three primary types of FDA-regulated label claims: Nutrient Content Claims, Health Claims, and Structure/Function Claims. Each type has specific definitions and labeling requirements that manufacturers must follow when highlighting their products' nutrient content or potential health benefits.

Nutrient Content Claims

Nutrient content claims highlight the nutritional value of a food product, such as "low fat" or "high in dietary fiber." These claims must adhere to FDA regulations, ensuring accuracy and consistency in labeling. The use of specific terms "light" or "good source of" is governed by strict guidelines to prevent misleading consumers. Understanding nutrient content claims is crucial for both manufacturers and consumers to make informed decisions about their dietary choices.

Health Claims

Health claims associate a food or food component, including saturated fat, with a specific health-related condition. The FDA authorizes these claims after reviewing scientific evidence supporting the relationship. Here are three examples:

• Diets low in sodium may reduce the risk of high blood pressure.

• Diets rich in calcium and vitamin D help lower the risk of osteoporosis.

• A diet low in total fat may reduce the risk of cancer.

When adequately regulated and validated, these claims help consumers make informed dietary choices that can positively impact their overall health.

Structure/Function Claims

Structure/function claims describe the role of a nutrient or dietary ingredient in supporting normal body structure or function, such as preventing issues like birth defects. While these claims do not require FDA pre-approval, they must be substantiated and include a disclaimer stating that the FDA has not evaluated the claim. They should not mention a disease and must remain truthful and non-misleading. Ensuring compliance with all legal and regulatory standards is essential for accurate and lawful food labeling.

Packaging and Label Requirements

To comply with FDA guidelines, food labels must include essential details such as the brand name, serving size, type size, and common household unit measurements. Labels should be structured with distinct sections, including the Principal Display Panel (PDP) and the Information Panel, ensuring clarity and compliance.

• Required Elements: Labels must feature key components such as the nutrition facts label and ingredient statement.

• Typography and Placement: Specific rules govern the font size, placement, and language used on labels.

• Regulatory Specifications: Labels must meet additional FDA requirements related to formatting and presentation.

Understanding these regulations helps ensure that packaging is compliant and informative for consumers. Let’s explore two essential aspects of packaging in detail.

Principal Display Panel (PDP)

The PDP refers to the portion of the packaging that's most likely to be seen by a buyer at purchase time. Here, the Statement of Identity and Net Quantity of Contents, which indicates the amount of food, are displayed prominently. For rectilinear packages, PDP area is calculated by multiplying height by width; for cylindrical containers, it's 40% of the product of height times circumference. Below is a simple illustrative table showing the required elements and their placement on the PDP:

Required Element	Rules
Statement of Identity	Must be placed prominently; Font height should be half the size of the largest font
Net Quantity of Contents	Must be placed in the bottom 30% of the PDP

Information Panel

Located immediately to the right of the PDP, the Information Panel contains important details such as the Nutrition Facts Label, Allergen Declaration, Ingredient Statement, and Name and Address of the manufacturer or distributor. These elements, along with additional information, need to be clear and accessible to consumers, informing them comprehensively about the product they're purchasing.

Required Element	Rules
Nutrition Facts Label	Can be placed on PDP or Information Panel near the Ingredient Statement
Allergen Declaration	Should be placed either in the Ingredient Statement or a separate “Contains” statement
Ingredient Statement	It must be placed on the same panel as the manufacturer’s information
Name and Address of Manufacturer	Most often goes on Information Panel

How Do Small Businesses Print FDA Food Labels?

For small businesses in the food industry, ensuring FDA-compliant labels is essential. The process involves more than just listing ingredients—it requires precise formatting, font sizes, and adherence to FDA regulations. Businesses can opt for professional label-printing services specializing in FDA-compliant labels or use dedicated label design software to create their own. Regardless of the method, every label must meet FDA standards for accuracy and compliance.

Can You Print FDA-Compliant Food Labels?

Printing food labels in-house can be an efficient and cost-effective solution using the right tools. High-quality label printers and specialized software ensure labels meet legal requirements while maintaining professional quality.

• Software for Custom Labels – Programs like BarTender, NiceLabel Designer and Loftware Cloud allow businesses to design and print FDA-compliant food labels quickly.

Black and White Label Printing – OmegaBrand also provides efficient options for black and white labels, including:

• Godex G500 Desktop Printer – Ideal for small businesses requiring sharp and durable label prints.

• Godex GX4200i Industrial Printer – A robust option for businesses needing high-volume, long-lasting labels.

Color Label Printing – For high-quality colored labels, OmegaBrand offers reliable solutions with Epson ColorWorks printers:

• Epson C6500

• Epson C8000

• Epson C6000

These printers are ideal for food safety labels, GHS BS5609-compliant chemical labels, and more.

By choosing the right printing solutions, small businesses can create FDA-compliant food labels efficiently while ensuring clarity, accuracy, and regulatory compliance.

How Businesses Can Maintain FDA-Approved Labeling Standards?

Ensure Accurate Nutrition Information

• Provide precise details on calories, macronutrients, vitamins, and minerals.

• Follow FDA guidelines for the  Nutrition Facts label format and serving sizes.

List Ingredients in the Correct Order

• Ingredients must be listed by weight, from highest to lowest quantity.

• Use common and recognizable names for clarity.

Comply with Allergen Labeling Requirements

• Declare major food allergens (e.g., milk, eggs, nuts, wheat, soy).

• Follow the Food Allergen Labeling and Consumer Protection Act (FALCPA) rules.

Follow Proper Label Placement & Formatting

• Include mandatory elements like the Principal Display Panel (PDP) and Information Panel.

• Ensure font size, contrast, and spacing comply with FDA readability standards.

Use FDA-Approved Claims Correctly

• Only use Nutrient Content Claims, Health Claims, and Structure/Function Claims if they meet FDA guidelines, especially when considering the final rule regarding nutrient claims.

• Avoid misleading or unverified statements about health benefits.

Update Labels to Meet Changing Regulations

The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It allows you to regularly review the current content and revise labels to ensure continued compliance with the agencies of the federal government.

How Can OmegaBrand Simplify FDA-Compliant Labeling?

At OmegaBrand, we provide high-quality, FDA-compliant labeling solutions that ensure accuracy in ingredient lists, nutrition facts, and allergen declarations. Our labels help businesses meet regulatory standards effortlessly while maintaining transparency and professionalism.

Whether you need labels for packaged snacks, frozen foods, or organic products, our durable and precise designs keep essential information clear and legible in any storage condition.

With OmegaBrand’s trusted labeling solutions, businesses can enhance consumer confidence, stay compliant with FDA regulations, and establish a strong market presence with reliable, professional packaging. Contact us today!

Conclusion

Food labeling goes beyond informing consumers about their purchases—it ensures transparency, builds credibility and shapes market perceptions. Critical products like infant formula and medical foods are regulated under the Federal Food and Drug Administration, and Cosmetic Act and the FDA, ensuring safety and compliance in the United States.

The FDA’s comprehensive food labeling guide, including guidance documents and regulatory updates, serves as a roadmap for businesses navigating compliance. It references the Federal Register, outlines translation provisions, and provides effective dates for new regulations, as well as search results relevant to compliance inquiries.

Food manufacturers must ensure their labels meet FDA regulations, including adherence to standard of identity, nutrition labeling information, allergen declarations, and ingredient transparency. Compliance with FDA rules on nutrient claims, health claims, and raw produce labeling is especially crucial for businesses with less than $10 million in annual sales.

Frequently Asked Questions

What responsibilities do food manufacturers have in labeling?

Small businesses making their foray into the food industry should invest time and resources into understanding and implementing the FDA’s labeling requirements on behalf of federal agencies, which also involves working with the FDA’s dockets management staff. This includes not just the packaging and label claims but also the procedures for printing FDA-compliant food labels.

How can I determine whether a food label claim is accurate?

The FDA regulates label claims to prevent misleading information. To verify the accuracy of a food label claim, consumers can familiarize themselves with the FDA's specific definitions and conditions for label claims, and check if the claim on their product aligns with these.

Are there any exemptions from food labeling regulations?

Yes, certain exemptions do exist in food labeling regulations. These can depend on factors such as the type of food product, its packaging, and the size of the business. For the most accurate information, businesses should refer to the FDA's resources on food labeling exemptions.