Overview
This is a test… it is only a test…
Received an inquiry from your customer asking if you've "tested" your product to make sure it's "FDA approved"? You've come to the right place. But the answers to your testing questions might not be exactly what you expected…
Let's Take a Quick Test!
To begin, let's take a short test.
- True or False: Food-contact materials must be "approved" by FDA.
False. Food-contact materials are not approved by FDA; instead, they are demonstrated to be compliant with applicable requirements (or exempt from such requirements) when used as intended. - True or False: Food-contact materials must always be tested first in order to be "permitted" for use by you or your customers.
False. Testing has a time and place but is neither a prerequisite nor necessary in every situation.
How did you do? If you got one or both answers wrong, read on!
"Testing One…" (Why Don't We Always Test?)
We don't always test because testing is not always required to establish a suitable FDA status for your food-contact material or article when used as intended.
In fairness, it's only reasonable to believe – at least until you read this article – that testing is a necessary path to establishing FDA compliance. After all, food-contact materials are regulated consumer products, and many regulated products need to pass certain testing criteria to be used as intended. The reality, however, is that if food-contact materials could all be tested according to a single standard – and passing that test meant that you could use them the way you intend – you wouldn't need the lawyers (!). But like the near limitless ways in which food-contact materials are produced and used, there is simply no "one size fits all" solution.
Instead of thinking about testing as a first (or required) step toward establishing a suitable FDA status for the intended use of a food-contact material or article, think of it, instead, as a tool that may be beneficial (or perhaps necessary — in certain instances), to help establish a suitable FDA status for the intended use of that material or article by you or your downstream customers. Like all tools, testing is best deployed under those specific circumstances where it is: (1) necessary; or (2) the most efficient way to generate specific data that is needed to establish a suitable FDA status for the intended use.
"Testing Two…" (What Comes Before Testing?)
Companies should start not with testing, but instead, by asking and answering the threshold question: "what is the most appropriate strategy to establish a suitable FDA status for the intended use of my food-contact material or article?"
It's important to note that a "food-contact material," in this instance, can represent a raw material, an intermediate product, or a finished product intended for the ultimate consumer. Regardless of the company's position in the supply chain, this threshold question applies all the same. Fortunately for the lawyers, this threshold question is where our area of expertise comes in, and the question that – if answered properly – can save a tremendous amount of time, money, and effort in the long run.
Correctly determining the appropriate strategy for establishing a suitable FDA status for the intended use is analogous to identifying the correct map to use when navigating your next road trip. While it's true that there may be many ways to get from Point A to Point B, it's equally true that there are faster options, slower options, and options that will simply run you around in circles.
Resist the temptation to press the gas pedal until you're pointed in the right direction.
As we've discussed in many previous StepLadder Series articles, a food-contact material or article must be suitable for the intended use. This means that the material or article must: (1) comply with a food additive regulation or Food Contact Notification (FCN); or (2) meet the criteria for exemption from the need for premarket authorization (read more about various exemptions, such as the "No Migration" position, Generally Recognized as Safe (GRAS) status, or the Constituents Policy by clicking these links). There are situations where testing is useful to support a suitable FDA status for the intended use of a food-contact substance. However, not all situations warrant the use of testing.
It is for this specific reason that we begin most projects not with testing, but instead, by asking our clients a series of questions, including:
- What is the composition of the food-contact material or article?
- How is it manufactured, and what are the specific manufacturing components and steps?
- How is the food-contact material or article intended to be used?
- As an intermediate component of a separate material?
- In contact with what Food Types and under what Temperature Conditions of Use?
We use this information to help determine whether the food-contact substance would be considered a food additive under the Federal Food, Drug, and Cosmetic Act. Testing may or may not be helpful to make this determination, and testing may or may not be sufficient to make this determination. This is necessarily a case-by-case determination that needs to be evaluated by considering all of the facts at hand.
The good news is that we can almost always identify the path forward that is most likely to result in establishing a suitable FDA status on your behalf, and we can determine fairly early in this process whether testing will even be helpful and sufficient.
"Testing Three…" (When Do We Test?)
For compliance purposes, testing is often appropriate in specific situations in which the following criteria are met:
- The food-contact substance is not already authorized for the intended use under a food additive regulation or an FCN; and
- It is necessary to demonstrate that the potential migration – or presence in the diet – of a substance is not sufficiently low to warrant relying on an applicable exemption or exception; and
- It is not possible to demonstrate that an exemption or exception is appropriate based on:
- Upper-bound (100%) migration and dietary concentration calculations; or
- Diffusion (or other suitable) computational modeling.
In other words, if it is necessary to determine how much of a food-contact substance could potentially migrate to food or remain present in the diet, and it's not possible to calculate that level based on known parameters, then it may be appropriate to consider testing to help measure these values. Such testing may include, for example, migration testing and/or extraction testing.
Even where testing is warranted, careful analysis and reporting should be conducted in a manner consistent with FDA's Chemistry Guidance document, and should take the following into consideration:
- Identity and composition of the test samples and control samples;
- The identity of food simulating solvents;
- Volume-to-sample surface area ratio;
- Time and temperature of the test;
- Analytical methods, including the Limit of Detection (LOD) and Limit of Quantification (LOQ);
- Calibration and validation, including acceptable ranges for recovery; and
- The content of the test report, especially if such report will later be used to support an FCN submission to FDA.
These are very specific, very technical and very important considerations that our team – including members of our scientific staff – are well-versed in describing to our clients (and their choice of testing laboratory) in the form of a test protocol. While we don't test here at Steptoe, we can certainly provide support and assistance to those that do.
For purposes of demonstrating Good Manufacturing Practice and Suitable Purity, entirely separate testing may be needed to show control over your manufacturing processes, quality specifications, and the like.
As the old adage goes, and when testing really is necessary: "measure twice… cut once."
Testing Takeaways
The next time someone asks whether your food-contact substance has been "tested for FDA approval," you can politely (but confidently) let them know that the right question to ask is "whether the food-contact substance complies with applicable FDA requirements when used as intended." Testing may well be one way to get there – but it isn't always the fastest!
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About the Steptoe StepLadder Series
Steptoe LLP is pleased to publish the StepLadder series of articles for our clients, prospective clients, and interested companies as a way of educating attorneys and non-attorneys alike about legal and regulatory principles related to food packaging in meaningful ways. While there are many sources of information available online, the StepLadder series is intended to be accessible to, and understandable by all, to help support business decisions related to food packaging compliance.
This information is provided for educational purposes only, is not legal advice, and does not establish an attorney-client relationship with Steptoe. Our lawyers made us write that. If you have legal questions, please consult an attorney. Preferably from a team well-versed in food packaging regulation – and definitely from a group of attorneys that have a good sense of humor. Because you are what you eat… unless your food packaging isn’t a ‘food additive,' in which case you’re not food packaging.
