FDA regulations for food safety in the food industry 

Everything you need to know about FDA guidelines, FDA-compliant products, and food safety

The FDA (Food and Drug Administration) is the US government authority that oversees products and activities in sectors such as:

• Food industry
• Pharmaceutical industry
• Medical device industry
• Cosmetics
• Tobacco
• Biological products
• Radiation-emitting products
• Veterinary medicine

Although FDA guidelines are US regulations and are not legally required in Europe, they often play an important role for companies operating internationally. Many products and materials are used worldwide, supplied to international customers, or exported to the United States. In those cases, it is often asked whether a product is FDA-compliant.

In this article, you will learn what the FDA is, what “FDA-compliant” means, who it is relevant for, and how FDA requirements relate to European food legislation.

What is the FDA?

The Food and Drug Administration (FDA) is a federal regulatory authority of the United States. Within the field of food safety, the FDA oversees food products, food packaging, machinery, and equipment used for food processing.

This also includes materials that come into direct or indirect contact with food (Food Contact Materials). The FDA has established rules for these materials in the Code of Federal Regulations (CFR), Title 21, often referred to as FDA 21 CFR.

These regulations define which substances are permitted, under what conditions they may be used, and what maximum migration limits into food are allowed.

What does “FDA-compliant” mean?

A product or material is FDA-compliant when it meets the relevant FDA requirements for food contact, as laid down in FDA 21 CFR.

In practice, this means the material is suitable for direct or indirect contact with food, does not release harmful substances into food, and is made only from raw materials permitted by the FDA.

Important to note: FDA-compliant does not mean the product is officially “approved” by the FDA, and there is no official FDA label or certificate.

The FDA works differently from many European certification systems. In practice, the manufacturer declares that the product complies with applicable FDA requirements, often supported by material data, tests, and specifications.

FDA is not a European standard – so why is it still relevant?

In Europe, food safety is ensured through a combination of legislation and systems such as HACCP, in which risks within food processes are systematically analysed and controlled. Many companies also work with certification standards such as BRCGS, where food safety, hygiene, and process control are assessed through audits.

Europe also has specific legislation for materials that come into contact with food, such as:

• EU Regulation 1935/2004
• EU Regulation 2023/2006 (GMP)
• EU Regulation 10/2011 (plastics)

In short, FDA guidelines are not legally required in Europe. However, they are often relevant in practice, for example when companies export to the United States, supply to international customers, or work with multinationals. They can also be important when operating under international quality standards and when using one product globally.

In these situations, FDA compliance is often requested as an additional international reference, alongside European legislation.

How FDA food regulations are structured

Although FDA regulations are extensive, food contact requirements generally focus on three key themes in practice:

1. Material safety and composition
   The FDA defines which substances may be used in materials such as plastics, rubbers, and coatings that come into contact with food. These substances are listed in positive lists within FDA 21 CFR.
2. Migration limits and health protection
   Materials must not transfer harmful substances into food above established limits. This applies across different food types, temperatures, and contact times.
3. Scope of use
   The FDA distinguishes between direct and indirect food contact, reusable materials, single-use applications, and industrial processing..

Who is FDA relevant for?

FDA guidelines are primarily relevant for organisations operating in international supply chains, including:

• Food processing companies exporting to the US
• Manufacturers of equipment for the food industry and food contact materials
• Logistics companies within international supply chains
• Suppliers to multinationals
• Organisations working under international audits or standards

For companies operating only within Europe and not exporting, FDA compliance is generally not required, but it can still serve as an additional quality indicator.

Hygiene and use within an FDA context

Just like European food safety standards, hygiene plays an important role. Materials must not only be safe in terms of composition, but also suitable for use in hygienic environments.

That is why FDA compliance is often combined in practice with additional requirements related to cleanability, wear resistance, durability under repeated use, and resistance to moisture and temperature.

For products such as gloves, tools, bins, buckets, and utensils, FDA compliance is an important selection criterion for international use.

How can you comply with FDA requirements within your organisation?

To demonstrate compliance with FDA guidelines within your organisation, it is important to ensure that several basic conditions are in place:

• Materials must comply with FDA 21 CFR
• Suppliers must be transparent about composition
• Documentation must be available (declarations, datasheets)
• FDA claims must be worded correctly (e.g. “FDA-compliant”, not “FDA certified”)

For companies in the food industry, FDA compliance is mainly a strategic choice that increases international applicability. 

FDA and European standards: not a replacement, but an addition

FDA guidelines do not replace European legislation. In Europe, EU Regulation 1935/2004, EU Regulation 2023/2006, and enforcement through national authorities always apply.

In practice, many manufacturers choose to develop products that comply with both European legislation and FDA requirements, so they can be used globally.

Vikan and Detectamet supply products that meet applicable FDA requirements for use in the food industry. Both brands are internationally recognised and develop materials and product designs that align with food safety requirements. This makes their products widely usable, including in environments where FDA compliance is required.