The FDA requires most packaged foods to display five mandatory label components to ensure consumers have accurate information about what they are eating. 

These components must be placed on specific parts of the package, such as the Principal Display Panel (PDP) or the Information Panel, and must meet strict font size and legibility rules.

• Statement of Identity: The common name of the food (e.g., “Tomato Soup”).
• Net Quantity of Contents: The amount of product in the package (by weight, measure, or count).
• Nutrition Facts Label: The chart showing calories, nutrients, and serving size.
• Ingredient List: A list of ingredients in descending order of predominance by weight.
• Identity of Manufacturer: The name and address of the manufacturer, packer, or distributor.

Beyond these basics, specific formatting and safety declarations are also required:

• “Dual Column” format: This applies to food packages that contain 200–300% of a single serving, ensuring consumers understand the nutritional impact of eating the whole package at once.

• Allergen Declarations: You must declare the presence of major allergens (including Sesame, effective 2023) either in the ingredient list or in a separate “Contains” statement.
• English Language: All mandatory information must appear in English (unless distributed solely in Puerto Rico).
• Prominence % Transparency: Regulatory information must be prominent enough to be read by the ordinary individual under customary conditions of purchase.

Create a free FDA-compliant label now to see how our nutrition label generation software automatically places these mandatory elements for you, or read our helpful guide on The Fundamentals of Food Product Labeling and Packaging.

While the FDA has strict requirements for nutrition and safety data, several common label elements are actually voluntary or regulated by other entities, not the FDA. 

These include:

• Expiration or “Best By” Dates: With the exception of infant formula, the FDA does not require specific expiration, “use by,” or “best before” dates. These are typically added voluntarily by manufacturers to indicate freshness.
• Barcodes (UPCs): Universal Product Codes are required by retailers for inventory tracking, but they are not mandated by federal FDA labeling laws.
• “Non-GMO,” “Organic,” or “Gluten-Free” Logos: Unless you are making specific claims that require substantiation, third-party certifications and marketing badges are optional.
• “Calories from Fat”: This line was removed in the 2016 regulatory update because research shows the type of fat is more important than the amount.
• Vitamins A & C: Deficiencies in these vitamins are now rare in the US, so they are no longer mandatory on the Nutrition Facts panel (unlike Vitamin D and Potassium, which are now required).

Create a free FDA-compliant label with Food Label Maker’s software to ensure your label covers all mandatory elements required by the FDA. 

To learn more about food labeling requirements, read our helpful guide on The Fundamentals of Food Product Labeling and Packaging or explore our Regulatory Hub for more FDA food labeling news.

• The FDA and USDA regulate food labels to protect public health and ensure fair trade practices. Their primary goal is to prevent misleading claims and to provide consumers with the factual information needed to make informed dietary choices. By standardizing how calories, fats, and allergens are reported, these agencies help consumers manage chronic diseases (like diabetes or heart disease) and avoid safety hazards.

  While the FDA regulates the majority of packaged foods, the USDA specifically oversees meat, poultry, and egg products. Both agencies enforce the Fair Packaging and Labeling Act (FPLA) to ensure that value comparisons can be made between competing products.

  Read our helpful guide on The Latest FDA Compliance Program Updates to determine whether your nutrition label is up to date or generate an FDA label for your food products.

In 2025, the FDA’s definition of the “healthy” nutrient content claim was updated

to align with current nutrition science. To voluntarily use the word “Healthy” on your packaging, your food product must now meet two main criteria:

• Food Group Equivalent: The product must contain a meaningful amount of food from at least one of the recommended food groups (fruit, vegetable, dairy, grain, or protein).
• Nutrient Limits: The product must adhere to strict limits on added sugars, saturated fat, and sodium.

This update replaces previous rules that focused solely on total fat levels, allowing nutrient-dense foods like salmon, avocados, and nuts—which were previously excluded—to now qualify as “healthy”.

Speak to one of our experts for advice on “healthy” claims on your food products, or try out our software to see how our nutrient analysis tool instantly checks if your recipe qualifies for the new FDA “Healthy” claim.

• The “Added Sugars” line is indented under “Total Sugars” as a way to show consumers how much sugar was added during processing versus how much occurs naturally (like lactose in milk or fructose in fruit). The word “Includes” before the Added Sugars value means that the added amount is part of the Total Sugars, not separate from it.

  For example, if a yogurt label says “Total Sugars 15g” and indented below it says “Includes 7g Added Sugars,” this means the yogurt has 8g of natural milk sugar and 7g of added sweeteners. The FDA recommends limiting “Added Sugars” to less than 10% of your total daily calories (50g per day for a 2,000-calorie diet).

  For more on this topic, read our helpful guide on How to List Added Sugars on Your Nutrition Facts Label or try out our software to see how it automatically calculates and adds Added Sugar declarations to your label.

The FDA updated the Nutrition Facts label to reflect new scientific links between diet and chronic diseases, such as obesity and heart disease. The old label was based on eating habits from the 1970s and 80s, which no longer matched the reality of how Americans eat today. 

The new label aims to reflect:

• Realistic Serving Sizes: Serving sizes were increased to reflect what people actually eat, not what they should eat (e.g., ice cream servings increased from ½ cup to ⅔ cup).
• A Focus on Calories: The calorie count is now larger and bolder because it is the most vital data point for weight management.
• Nutrient Updates: “Added Sugars,” Vitamin D, and Potassium are now mandatory because many Americans are deficient in them, while Vitamins A and C are no longer required as deficiencies are rare.

Use our FDA-compliant label generator or explore our pricing plans to see how our tool updates your old labels to match the new 2016 FDA format, or read our helpful guide on What are the New Changes to the FDA Nutrition Facts Label.

A common misconception is that you need to send your label to the FDA for approval before selling your product.

The FDA does not pre-approve food labels. It is entirely the manufacturer’s responsibility to ensure their label is compliant with all federal regulations (21 CFR 101.9) before the product hits the shelves.

If your label is found to be non-compliant during a random inspection or after a consumer complaint, the FDA may issue a Warning Letter or mandate a recall. This is why using compliant software or hiring a regulatory consultant is critical for risk management.

Don’t guess at compliance. Create compelling, audit-proof labels today with Food Label Maker’s verified templates. Create a label today or view our pricing plans to get started.

To read a label correctly, follow these steps to understand exactly what you are consuming:

• Start at the top: Check the Serving Size and Servings Per Container, as all nutritional numbers below are based on this specific amount.
• Check the Calories: Look for the large, bold calorie amount to understand the energy per serving.
• Use the % Daily Value (%DV) guide: 5% or less is considered “low,” while 20% or more is considered “high.” This helps you quickly determine if the food is high in nutrients you want (like Fiber) or high in nutrients you should limit (like Sodium).

Try our free label generator to see how raw ingredients are automatically converted into a clear, easy-to-read FDA label.

Any modification to your formula, whether it’s swapping a supplier, changing an ingredient, or adjusting the cooking process, requires an immediate review of your nutrition label. Even a small change in moisture loss or a sugar substitute can alter the final calorie count and %DV.

Using a dynamic FDA nutrition label generator simplifies this. Instead of recalculating manually, you simply update the ingredient in your recipe builder, and the software automatically regenerates the compliant label with the new values instantly.

Try out Food Label Maker’s software to instantly regenerate your compliant label whenever you tweak a recipe, or read our guide on The Latest FDA Compliance Program Updates to determine whether your nutrition label is up to date.

The FDA requires nutrition labeling for the vast majority of prepared foods and beverages sold in the United States. Common categories include:

• Snack packaging: Chips, nuts, granola bars, and confectionery.
• Drinks: Sodas, juices, flavored waters, and energy drinks.
• Canned & Frozen Goods: Soups, sauces, and prepared meals.
• Baked Goods: Breads, pastries, and cookies.

Some food products are exempt from needing nutrition labels. These include: raw fruits, vegetables and fish, foods in small retail businesses, coffee, tea and some spices and foods sold for immediate consumption (i.e restaurants).

For food businesses and manufacturers, knowing what to label is just as important as how to label. Create an FDA compliant label today with Food Label Maker, or read our comprehensive guide on FDA Labeling Exemptions for small businesses.

The most frequent violations that trigger FDA warning letters typically fall into three categories:

• Undeclared Allergens: Failing to list major allergens like peanuts, milk, or sesame.
• Formatting Errors: Using incorrect font sizes, failing to bold the “Calories” count, or omitting the mandatory “Added Sugars” line.
• Incorrect Rounding: FDA regulations have strict rules for rounding nutrients (e.g., rounding fat to the nearest 0.5g).

Eliminate the risk of human error with intuitive, compliant label generation software. Food Label Maker’s automated rounding and allergen detection tools ensure your labels are always audit-ready. Create a free label today to see these tools in action.

RACC stands for Reference Amount Customarily Consumed. It is a specific weight or volume determined by the FDA that defines how much of a food people typically eat in one sitting. It affects your label in two ways:

• Serving Size: Your serving size must be based on the RACC, not just an arbitrary amount you choose.
• Dual Column Requirements: If your package contains 200% to 300% of the RACC, you must provide nutrition facts for both “per serving” and “per container.”

Ensure your serving sizes are accurate. Utilize our software to automatically apply the correct RACC for your specific product category, or learn more about RACC with our helpful guide on Decoding Reference Amounts Customarily Consumed (RACC).

While massive overhauls (like the 2016 MFRPS regulatory update) happen infrequently, the FDA constantly releases new guidance documents, compliance policy guides, and updates to the “Healthy” definition. Keeping track of these shifting standards manually is difficult.

This is a key benefit of cloud-based nutrition labeling tools like the one offered by Food Label Maker. Our software is updated in real-time, granting you instant access to the latest regulatory frameworks. This ensures that every label you generate is built on the most current rules, protecting your business from outdated compliance practices.

Create a free label that automatically adheres to the latest FDA rules, or read through our FDA Regulatory Hub for the most up-to-date industry news.

Selling products with non-compliant labels can lead to severe consequences for your business, including:

• FDA Warning Letters: These are public records and can damage your brand reputation.
• Product Recalls: The costly process of removing products from shelves.
• Detainment: Goods may be stopped at the border if you are importing into the US.
• Retailer Rejection: Major retailers may refuse to stock your product if your label does not meet strict verification standards.

Protect your brand by creating audit-proof labels with our verified FDA nutrition label software, or view our pricing plans to find a solution that fits your risk management needs.