Login Get in touch
Digicomply Insights

Understanding FDA Labeling Requirements for Food Product Claims: Compliance and Regulations

June 11 2024

In the highly regulated landscape of the food industry, understanding and complying with FDA labeling requirements for food product claims is crucial for maintaining consumer trust and ensuring market success. This article delves into the...

In the highly regulated landscape of the food industry, understanding and complying with FDA labeling requirements for food product claims is crucial for maintaining consumer trust and ensuring market success. This article delves into the intricate requirements set forth by the FDA, focusing on compliance and regulations as outlined in Title 21, Chapter I, Part 101 of the Code of Federal Regulations (CFR).

Overview of FDA Labeling Regulations

The FDA's labeling regulations are designed to ensure that consumers have access to accurate and non-misleading information about the food products they purchase. Part 101 of Title 21 CFR provides comprehensive guidelines on food labeling, covering aspects such as ingredient declarations, nutritional information, allergen labeling, and specific claims about the health benefits and nutritional content of food products.

Nutritional Labeling and Education Act (NLEA)

The Nutritional Labeling and Education Act (NLEA) is a cornerstone of the FDA's food labeling regulations. Enacted to help consumers make informed choices, the NLEA mandates the inclusion of a nutrition facts panel on most packaged food products. This panel provides essential information on:

  • Caloric content: Total energy provided by the food product.
  • Macronutrients: Amounts of fats, including saturated and trans fats, carbohydrates, proteins, and sugars.
  • Micronutrients: Key vitamins and minerals present in significant amounts.
  • Sodium content: Critical for consumers monitoring their salt intake.

The NLEA also regulates the format and placement of this information, ensuring it is easily accessible and understandable to consumers.

Key Elements of FDA Food Labeling Requirements

  1. Ingredient Declaration: All ingredients must be listed by their common or usual names in descending order of predominance by weight. This ensures transparency about the product's composition.

  2. Allergen Labeling: The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires that foods containing major allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans) must clearly disclose this information. This helps protect consumers with food allergies.

  3. Nutrition Facts Label: The format and content of the nutrition facts label are strictly regulated. This includes specific serving sizes, daily value percentages, and mandatory inclusion of certain nutrients. Changes to the nutrition facts label in recent years have focused on highlighting added sugars and updating daily values based on newer dietary guidelines.

  4. Nutrient Content Claims: These claims describe the level of a nutrient in a product using terms such as "low fat," "high in fiber," or "reduced sodium." The FDA provides specific definitions and conditions for these claims to prevent misleading information.

  5. Health Claims: Statements that describe the relationship between a food substance and reduced risk of a disease or health-related condition must be substantiated by scientific evidence and approved by the FDA. For example, a claim that a product can lower the risk of heart disease must be based on reliable scientific studies and comply with the criteria set by the FDA.

  6. Structure/Function Claims: These claims describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, such as "calcium builds strong bones." While these claims do not require pre-approval by the FDA, they must be truthful and not misleading.

Compliance Strategies for Food Companies

Ensuring compliance with FDA labeling regulations involves several critical strategies:

  • Regular Training and Updates: Companies must keep their labeling teams informed about the latest FDA regulations and guidelines. This includes understanding updates to nutritional science that may affect label content and format.

  • Robust Quality Control: Implementing thorough quality control processes can help ensure that all labels meet FDA requirements. This includes regular audits and reviews of labeling practices.

  • Accurate Documentation: Maintaining detailed records of ingredient sourcing, nutritional analyses, and scientific substantiation for claims is essential for demonstrating compliance during FDA inspections.

  • Utilizing Regulatory Intelligence: Leveraging tools like the SGS Digicomply Regulatory Intelligence Hub can provide companies with up-to-date information on regulatory changes, compliance requirements, and industry best practices.

Explore the Full Scope of U.S. Regulatory Guidelines with SGS Digicomply

To ensure a comprehensive understanding and adherence to the latest standards in food labeling, industry leaders should leverage SGS Digicomply's Food Regulatory Guides. Among these, the "Labeling and Labeling Claims" guide within the United States of America Regulatory Guide offers an exhaustive resource covering various critical topics for maintaining regulatory compliance.

Food product claims USA Regulatory Guide

This guide details regulations on:
  • Finished Products
  • Packaging food process additives
  • Packaging made of recycled materials (rPET and other recycled materials)
  • Packaging claims
  • Industry associations and NGOs standards for packaging materials and recycling
  • Government pre-approval requirements
  • Packaging related sustainable/environmentally friendly design
  • Food Contact Regulations
  • Single use plastic

These guides are crafted to deliver a consistent and comprehensive overview of the regulatory landscape, facilitating a clearer understanding of the market-specific frameworks. This makes it easier for businesses to navigate complex compliance requirements, ensuring smooth operations across global markets.

Explore how it works with our demo of regulatory guides.

Additionally, as part of the broader Regulatory Intelligence Hub solution, SGS Digicomply offers a robust regulatory database that spans over 150 jurisdictions. This sophisticated AI-powered platform simplifies the process of data research and retrieval, empowering your compliance initiatives with the latest standards and requirements.

Explore our demo of the Regulatory Intelligence Hub to enhance your compliance strategies and ensure adherence to global regulations.


Navigating the complexities of FDA labeling requirements is an ongoing challenge that requires vigilance, expertise, and a commitment to transparency. By adhering to these regulations, food companies not only comply with legal standards but also build trust with consumers, fostering a market environment that values accuracy and honesty. Embracing these practices ensures that companies remain at the forefront of industry standards, promoting both public health and brand integrity.

Tags: food safety, FDA, labelling, FDA regulations, fda guidelines, food label, Food Claims


Manage all your SGS Subscriptions

Go to SGS Subscription Center
Food Safety Dashboard 1 (1)

All-in-one Food Safety & Regulatory Compliance platform

SGS Digicomply is a collaborative AI-Platform providing real-time monitoring, predictive risk management, and regulatory compliance for streamlined market entry and quicker time to market

Explore platform