FDA Food Types and Conditions of Use

The StepLadder Series is a Steptoe publication focused on discussing food contact regulatory topics in plain language.

Have you ever received an FDA assurance statement or a message from your supplier that a product can be used in contact with food, subject to Food Type or Condition of Use limitations? If you’ve been working in the food-contact space for more than 10 minutes, probably yes.

But what does it mean, and what are you supposed to do with that information?

Why are there Food Types and Conditions of Use?

Before diving into the details of FDA's Food Types and Conditions of Use, it's helpful to understand why these exist, and why they matter. The answer, as it turns out, is physics. But the good news is that you don’t need to be a physicist to understand these concepts. For most types of food packaging, substances can and do migrate through and out of the packaging, into food (and sometimes backward, from the food into the packaging!) These substances potentially include tiny leftover pieces of a polymer, called an oligomer, along with additives, processing aids, and sometimes impurities and byproducts, as well.

Years of experience and some good experimentation (that's the physics part) taught us that certain substances migrate through and from food packaging to food faster than others depending on the type of food that the packaging holds, as well as the temperature conditions that the packaging is subjected to. In other words, some substances like hanging out with fats and oils better than acidic foods, and many like hanging out with food more when the food is hot. We do too.

What are FDA's Food Types and Conditions of Use?

FDA lists Food Types and Conditions of Use in two places:

• 21 C.F.R. § 176.170 (one of FDA’s paper and paperboard regulations), Table 1; and
• Online at https://www.fda.gov/food/packaging-food-contact-substances-fcs/food-types-conditions-use-food-contact-substances.

One common misconception is that describing Food Types and Conditions of Use on FDA assurance statements automatically means that you 'comply with' 21 C.F.R. § 176.170. That's not necessarily the case – and a topic for a future StepLadder article. But for various historical reasons, that's where FDA chose to list them! Food Types are defined by roman numerals; whereas Conditions of Use are defined by letters. They are as follows:

Food Types

• Food Type I: Nonacid, aqueous products; may contain salt or sugar or both (pH above 5.0).
• Food Type II: Acid, aqueous products; may contain salt or sugar or both, and including oil-in-water emulsions of low- or high-fat content.
• Food Type III: Aqueous, acid or nonacid products containing free oil or fat; may contain salt, and including water-in-oil emulsions of low- or high-fat content.
• Food Type IV: Dairy products and modifications:
  
  • Subtype IV-A: Water-in-oil emulsions, high- or low-fat.
  • Subtype IV-B: Oil-in-water emulsions, high- or low-fat.
• Food Type V: Low-moisture fats and oil.
• Food Type VI: Beverages:
  • Subtype VI-A: Containing up to 8 percent of alcohol.
  • Subtype VI-B: Nonalcoholic
  • Subtype VI-C: Containing more than 8 percent alcohol.
• Food Type VII: Bakery products other than those included under Types VIII or IX:
  • Subtype VII-A: Moist bakery products with surface containing free fat or oil.
  • Subtype VII-B: Moist bakery products with surface containing no free fat or oil.
• Food Type VIII: Dry solids with the surface containing no free fat or oil (no end test required).
• Food Type IX: Dry solids with the surface containing free fat or oil.

FDA does not maintain a specific list of what types of food are covered by each category. Some are obvious (water is Food Type I), while some are not (milk is Type IV-B, but butter is Type IV-A). Some can be complicated too – coffee beans may seem like a dry food at first blush, but they actually contain oils at the surface. In the absence of official agency guidance, one usually relies on a combination of prior FDA statements (when available), published examples from other regulatory jurisdictions, like the European Union (EU), and good old-fashioned common sense to make that determination. The bottom line is that even a seemingly black-and-white list of Food Types is open to some interpretation, and compliance decisions often need to be made on a case-by-case basis.

Conditions of Use

• Condition of Use A: High temperature heat-sterilized (e.g., over 212°F).
• Condition of Use B: Boiling water sterilized.
• Condition of Use C: Hot filled or pasteurized above 150°F.
• Condition of Use D: Hot filled or pasteurized below 150°F.
• Condition of Use E: Room temperature filled and stored (no thermal treatment in the container).
• Condition of Use F: Refrigerated storage (no thermal treatment in the container).
• Condition of Use G: Frozen storage (no thermal treatment in the container).
• Condition of Use H: Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use [including]:
  • Aqueous or oil-in-water emulsion of high- or low-fat.
  • Aqueous, high- or low-free oil or fat.
• Condition of Use I: Irradiation
• Condition of Use J: Cooking at temperatures exceeding 250°F.

Conditions of Use also have some interesting nuances that we will explore in further detail in future StepLadder articles. For purposes of this discussion, note that Conditions of Use A-G represent maximum temperatures of food that food packaging may hold, in decreasing order of temperature, and regardless of the order of thermal treatment in the container, if any. For example:

• If the packaging will be filled with food at room temperature, and then the food is held under room temperature, refrigerated, or frozen conditions, the packaging should be suitable for use at "Condition of Use E and below."
• Compare this with food that is filled in packaging at room temperature, and then sterilized in the package, in which case the packaging should be suitable for use at "Condition of Use B and below."

Conditions of Use H, I and J were added by FDA years later, to keep up with new technologies for cooking and reheating foods (e.g., microwave, microwave susceptors, and dual-ovenable trays), so they don’t follow the decreasing temperature order of Conditions of Use A-G. Another story for another day!

Interpreting Food Types and Conditions of Use

Many of the Food Type and Condition of Use limitations that you see on FDA assurance statements come about because of limitations that help ensure that migration of a substance from packaging to food will not exceed a certain amount. Remember – some foods migrate more readily than others; and certain foods migrate more at higher temperature. Therefore, Food Type and Condition of Use limitations are one way by which a food-contact material manufacturer can help fit a "square peg into a round hole," and establish a suitable FDA status for some packaging uses, even if they can't do so for all foreseeable uses.

Condition of Use A also is somewhat unique, because it can represent both food packaging that can be used at high temperatures (e.g., over 212°F), and also packaging that may be used on the basis of 100% (worst-case) migration calculations, where actual testing isn't necessary to demonstrate compliance (or impose any restrictions). In most instances, these types of food-contact materials are described as suitable for use at “Conditions of Use A-H."

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At the end of the day, Food Types and Conditions of Use can represent the difference between food-contact materials and articles that are FDA-compliant for certain uses, but not others. These considerations are great examples where end-use applications matter just as much as compositional compliance.

About the Steptoe StepLadder Series

Steptoe & Johnson 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.