The FDA Doesn't Have Regulations in Place for Food-Grade Bulk Bags: What You Should Know

As a consumer, you’re probably happy to hear that the Food and Drug Administration (FDA) has a variety of strict regulations in place for food packaging. The ultimate goal, of course, is to ensure food products are safe and to protect the people consuming them. 

However, even if you work in the food industry, you might be surprised to hear that the FDA doesn’t offer specific regulations for food-grade bulk bags. It’s a common misconception that some bulk bags are FDA approved. And because of this confusion, it’s important for shippers and suppliers to understand the basics of FDA food packaging regulations to ensure their products stay compliant.

Basic Food Packaging Regulations

First, let’s explore what the FDA does regulate in regard to food packaging. 

The Office of Food Additive Safety (OFAS), which is part of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), is responsible for ensuring “food contact substances” are safe. 

What exactly is a food contact substance? The Federal Food, Drug, and Cosmetic Act defines it as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” 

So basically, these are materials that will be used in food packaging in some way—materials that come in contact with food products but don’t have any sort of impact on them. Some examples of food contact substances include:

• Can coatings
• Sealants for lids and cans
• Adhesives
• Materials used to manufacture paper and cardboard

Here’s the part that many manufacturers find surprising: Although the FDA closely controls the use of food contact substances, it doesn’t issue any approval, certificate, or accreditation for flexible intermediate bulk containers (FIBCs) or FIBC liners. FDA-approved bulk bags don’t actually exist. And yet bulk bags are widely used for food packaging.

Why Are There No Regulations for Bulk Bags?

So why is there no such thing as an FDA-approved food-grade bulk bag? The FDA doesn’t regulate different types of packaging; instead, it determines compliance (or noncompliance) of the materials used in the packaging. This enables the agency to ensure a high degree of food safety overall without having to issue individual approvals on the enormous variety of packaging types that are used in the U.S.

One of those FDA-approved packaging materials is 100 percent virgin polypropylene, which is used in FIBC bulk bags. FDA Food Contact Regulation 21 CFR 177.1520 states that virgin polypropylene “may be safely used” as an article or a component of an article “intended for use in contact with food.”

In fact, the use of 100 percent virgin polypropylene resins is ideal for food products. That’s because no recycled materials are used to manufacture the bag. The use of virgin resins decreases the likelihood that the product will be contaminated—which can be an unfortunate side effect of using recycled materials.

Considerations for Shippers and Suppliers

The misconception of “FDA-approved” bulk bags can cause problems for shippers and suppliers. It’s not uncommon for packaging engineers and their teams to request FDA-approved bulk bags. And disturbingly, we’ve even seen some packaging companies describe their bulk bags as “FDA approved” on their websites and in product descriptions. 

However, the key here is that only materials, not packaging products, can gain FDA approval. It’s important for food suppliers and shippers to understand the distinction when they are exploring their packaging options. And they should always work with a trusted manufacturer of food-grade bulk bags that uses 100 percent virgin polypropylene resins. This will ensure that your packaging always stays in compliance with FDA regulations.