USA Regulatory Guide: Use of Foods as Food Additives

The use of foods as food additives in the United States is regulated to ensure the safety and quality of the food supply. The Federal Food, Drug, and Cosmetic Act (FD&C Act) outlines the framework for how food ingredients are categorized and approved by the Food and Drug Administration (FDA). This article provides a comprehensive overview of the regulatory guidelines, approval processes, and compliance requirements for food additives in the USA.

Regulatory Framework

The FD&C Act categorizes food ingredients into several groups based on their intended use and the level of FDA oversight required. The primary categories are:

1. Food Additives: Substances added to food that are expected to become a component of the food or otherwise affect its characteristics. These require pre-market approval by the FDA.
2. Generally Recognized as Safe (GRAS): Substances that are generally recognized, by qualified experts, as safe under the conditions of their intended use. These do not require pre-market approval but can be voluntarily submitted to the FDA for evaluation.

Key Definitions

Food Additive: Defined by the FD&C Act as any substance the intended use of which results, or may reasonably be expected to result, directly or indirectly, in it becoming a component or otherwise affecting the characteristics of any food.

GRAS: Substances that are generally recognized, among qualified experts, as having been shown to be safe under the conditions of their intended use through scientific procedures.

Approval Processes

1. Food Additive Petition (FAP):

   • Required for any new food additive or new use of an existing additive.
   • The petition must include data demonstrating the safety of the additive.
   • The FDA reviews the petition in consultation with the U.S. Department of Agriculture for additives used in meat and poultry products.

2. GRAS Notification Program:

   • Although not mandatory, companies can voluntarily submit their GRAS conclusions to the FDA.
   • The notification should include a detailed explanation of why the substance is considered GRAS, supported by scientific evidence.
   • The FDA's GRAS Notice Inventory lists substances that have been reviewed and accepted under this program.

Substances Not Classified as Food Additives

The following are not included in the definition of a food additive:

• Ingredients that are GRAS.
• Prior-sanctioned substances authorized for use before the 1958 Food Additives Amendment.
• Color additives and pesticides regulated under separate pre-market approval requirements.
• Dietary ingredients in dietary supplements.

Compliance and Enforcement

Pre-Market Approval: Any substance that does not appear on the GRAS Notice Inventory or the FDA's list of approved food additives requires pre-market approval through a Food Additive Petition.

Post-Market Determinations: The FDA can determine that the use of a substance is not GRAS, leading to enforcement actions if the substance is found in the food supply.

Penalties: Non-compliance with these regulations can result in various penalties, including fines and product recalls.

Industry Resources

The FDA provides several resources to help determine the regulatory status of substances added to food:

• Food Additive Regulations: Listed in 21 CFR Parts 170-179.
• Color Additive Regulations: Listed in 21 CFR Parts 70-74.
• GRAS Inventory: A searchable database of substances recognized as GRAS.
• Substances Added to Food: An inventory of approximately 4,000 substances, including food additives, color additives, GRAS substances, and prior-sanctioned substances.

Conclusion

Navigating the regulatory landscape for food additives in the USA requires a thorough understanding of the FD&C Act and the FDA's approval processes. Compliance with these regulations ensures the safety and quality of the food supply, protecting public health. For detailed guidance and updates on regulatory changes, professionals can refer to resources such as the SGS Digicomply Regulatory Intelligence Hub.

For more detailed inquiries, stakeholders can reach out directly to the FDA or utilize the SGS Digicomply platform for comprehensive insights and updates. Feel free to get in touch now to learn about implementing the Regulatory Intelligence Hub for your company. Or explore the demo and try Regulatory Guides in action.

Access to the Most Comprehensive United States of America Food Regulatory Guide

The SGS Digicomply Food Regulatory Guide for the United States of America includes:

• Market Introduction
• Competent Authorities
• General Food Law: This includes general food safety laws, novel foods and introduction of new ingredients, e-commerce specific regulations, food operator registration requirements and control, food registration requirements, and dietary supplements and botanicals.
• Food Additives: This includes processing aids, permitted food additives, permitted flavourings, and use of foods as food additives.
• Labeling Requirements: This includes labeling of finished products, food product claims, labeling for food service and vending machines, labeling of samples not for sale, Halal, Kosher, vegan and vegetarian foods, and labeling of GMOs and bioengineered foods.
• Pesticides & Contaminants – Maximum Residue Levels: This includes pesticides, microbiological and safety requirements, veterinary drugs, trans-fatty acids, substances specifically not permitted for use in foodstuff, heavy metals, GMOs processes and procedures, and unclassified contaminants.
• Packaging and Packaging Sustainability: This includes finished products, packaging food process additives, packaging made of recycled materials (rPET and other recycled materials), and packaging claims. It also covers industry associations and NGO standards for packaging materials and recycling, government pre-approval requirements, packaging-related sustainable/environmentally friendly design, and food contact regulations such as single-use plastics.
• Import / Export Requirements: This includes requirements for foods import, trade agreements, and manufacturing intermediates (B2B).
• Product & Material Standards/Requirements: This includes fruits and vegetables, sweeteners including honey, bakery wares, meat substitutes, plant and novel proteins, prepared foods, fats and oils and fat emulsions, edible ices, beverages, ready-to-eat savories, confectionery, dairy products and analogues, cereals and cereal products, eggs and egg products, fish and fish products, meat and meat products, pet food/feed, livestock feed, nutritional uses and specific diets, and spices and other condiments.

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