FDA Compliant vs Approved: What Is the Difference?

When government agencies make product rules and guidelines, companies must follow them. This keeps consumers safe and healthy. Depending on the exact regulations and the products, this can differ slightly from industry to industry.

People associate two prominent terms with the FDA: FDA Compliant and FDA Approved. A company should understand these terms and their impact on future products and processes. Read further or watch the video below to understand these familiar terms.

We will refer to three terms throughout the article: product, packaging and material. “Product” refers to complete items ready to go into the market for purchase. “Packaging” is a container that stores products. “Material” refers to a piece of plastic, glass or other matter used to create products or packaging.

FDA: The Food & Drug Administration

Before we compare FDA Compliant vs FDA Approved, it is important to discuss FDA-regulated products in the market. 

The FDA is a government agency under the US Department of Health and Human Services. The United States Food & Drug Administration (FDA) creates regulations for:

• Food products
• Drugs
• Biologics
• Medical devices (these devices include hearing aids, respiratory devices and defibrillators)
• Cosmetics
• Veterinary products
• Tobacco products
• Electronic products that give off radiation (X-ray machines, alarm systems and dryers for example)

All of these industries work with the FDA to hold themselves accountable to maintain certain safety standards. The administration requires each industry to meet the product requirements that they set.

In recent years, the FDA has been at the forefront of the COVID pandemic as well as product recalls across these industries.

The administration’s major tasks include:

• Approving ready-to-sell products before they enter the market
• Regulating products that already exist, ensuring that they are safe and effective as intended

Three terms have grown in popularity over the years: FDA Compliant, FDA Approved and Food Grade.

What Does FDA Compliant Mean?

FDA Compliant means that the material, packaging or product meets FDA regulations. In the food and food packaging industries, The FDA Compliant term can also apply to a manufacturing process or facility.

FDA Compliant materials, packaging and products follow FDA regulations, pass inspections, have proper food labels or have had all proper forms submitted to the administration.

Products that are classified as FDA Compliant do not undergo a formal review by an FDA expert or agent, but meet all FDA regulations.

What Does FDA Approved Mean?

Products or devices can be FDA Approved. A simple FDA Approved definition for a product or device is that they have gone through a thorough FDA review, especially for food contact. The FDA does not offer an official review for every specific consumable product, only those that require FDA Approval.

The FDA mandates that specific food, pharmaceutical, and medical products need to be FDA Approved to meet specific requirements. Some of these include medical devices, new prescription drugs and food additives. Food additives can refer to ingredients or certain substances added to food.

An important note to add is the fact that FDA Approved items are also FDA Compliant. This is because FDA Approved items are still held to the regulations set by the FDA.

Key Differences Between FDA Compliant & FDA Approved

At first glance, it can be easy to assume that FDA Compliant and FDA Approved are the exact same thing. Here are some clear distinctions between the terms FDA Approved vs Compliant.

• "Compliant" with FDA rules and regulations for food contact or human use
• No review process from an FDA expert or agent
• Manufacturers and companies are required to meet all FDA regulations
• Examples include materials, packaging or products (plastics, drums, food containers, etc.)

• Lengthy review and approval processes to make sure it is safe for human consumption or use
• "Approved" for intended uses, such as for direct food contact
• Not all products require FDA Approval
• Examples include FDA Approved medical devices, device manufacturing, FDA Approved pharmaceuticals, medical drugs, food additives and color additives

Food Grade

Food Grade is a phrase that holds companies and manufacturers accountable for creating food contact materials or packaging. A common question that comes up with this term is "Does FDA Compliant mean food grade or does FDA Approved mean food grade?" Food Grade is not a term created by the FDA. It is an unofficial way of calling a material or packaging FDA Compliant.

Manufacturers must avoid adding materials that can prohibit consumption. One example can be a wide variety of dyes and colorings.

One example of a food grade material is tin (also known as tinplate). The Cary Company offers food-grade tin cans that hold a wide variety of items.

It is important to note that not all tin cans are food-grade. The inside lining can help determine whether or not a tin can is Food Grade. This type of material is popular for coffee, dry products, oils and more.

So...What Materials are FDA Compliant?

Here are some examples of FDA Compliant materials used to create popular packaging and containers.

As a scratch and shatter resistant material, Polyethylene Terephthalate (PET) is a great choice for beverages and spices. PET is semi-rigid, lightweight and essential for beverage bottles, spice jars and honey bottles among others.

Containers made of High Density Polyethylene (HDPE) are versatile for different industries, including chemical and automotive to food and pharmaceutical. It is a durable and chemically resistant plastic that is common for bottles, small containers and IBC Totes.

Polypropylene (PP) is a translucent plastic that is well known for its impact and chemical resistance. It is a popular choice in the fast-food industry for tamper-evident round containers, tubs and jars. It is also common for hot fill beverages.

Finally, The Cary Company offers safe glass containers. Glass is versatile throughout industries and is an eco-friendly and all-natural material. Whether it is in a bottle or jar, glass can hold items ranging from beverages and sauces to fruits and vegetables.

View Our FDA Compliant Containers!

The Cary Company offers a variety of FDA Compliant and food grade containers and packaging for your business. Choose the right one for your food or beverage item today!