The Wrap on FDA’s Packaging Regulations

Columns - Legal Briefs

After adhering to some basic requirements, manufacturers have a few different options for the type of materials they may use in packaging, writes Jennifer Allen, partner at Zwillinger Wulkan.

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October 12, 2021

Like most people, you probably know that the Food and Drug Administration (FDA) regulates food. But did you know that it also regulates food packaging? That’s because chemicals in packaging could migrate into our food under certain conditions. FDA defines a “food contact substance” at Code of Federal Regulations, 21, 170.3(e)(3) as “any substance that is 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.” This definition includes substances used in food packaging.

Generally speaking, regardless of the type of packaging involved or the specific component of that packaging, manufacturers are presumed to be following current good manufacturing practices. And, if no limit is specified, the quantity of any substance used in the packaging must not exceed the amount absolutely necessary to achieve the desired result. Provided the manufacturer adheres to those basic requirements, then it has a few different options for the types of materials it may use.

One option the manufacturer has is to use a material or component that is generally recognized as safe (GRAS) for use in food packaging under CFR, 21, 186, or that is used in accordance with a prior sanction or approval. Examples of GRAS substances include clay and Japan wax.

Or the manufacturer may use specific materials already approved by FDA. In CFR, 21, 175, 176 and 177, the FDA has authorized the use of different types of adhesives/coatings, paper, paperboard and polymers, respectively. Each of those types of products must be used in accordance with the strict conditions set forth in those parts. For example, synthetic paraffin is approved for use as a coating, but under CFR, 21, 175.250, there are strict technical requirements for the congealing point, oil content and absorptivity of the substance.

Alternatively, a manufacturer may submit a premarket notification for a food contact substance under CFR, 21, 170.100-106, known more colloquially as an FCN. Unlike substances approved for use by all under the sections mentioned earlier, a substance approved via an FCN is only approved for use by the manufacturer that submitted the FCN, and only under the precise conditions of use set forth in the FCN. If another manufacturer wants to use the exact same substance in the exact same manner, it must nevertheless submit its own FCN.

Finally, under CFR, 21, 170.39, manufacturers may seek an exemption for a particular substance that migrates from the food-packaging material into the food at minimal levels if they can show that the substance has not been shown to be a carcinogen, and there is no reason to suspect it may be carcinogenic; that it presents no other health and safety concerns; that it has no technical effect on the food; and that it has no significant adverse impact on the environment.

A word about per- and poly-fluoroalkyl substances, more commonly referred to as PFAS. PFAS are used in certain types of disposable dishware and in non-stick cookware. It is PFAS that allow you to enjoy that greasy piece of fried chicken on a paper plate without the grease soaking through the plate onto your clothes. But in recent years, PFAS have come under attack. That’s because the evidence suggests that these substances build up in the human body and in our water and soil and may be harmful to human health and to the environment. Certain PFAS are currently approved for use by FDA, but with mounting pressure from various stakeholders, that may well change in the coming years.