FDA Food-Contact Packaging Basics: A Plain-Language Compliance Walkthrough

What counts as a food-contact substance

FDA treats a food-contact substance as any substance that comes into contact with food and is not intended to have a technical effect in that food. That definition reaches beyond the box or pouch itself. FDA's examples include food packaging and its components, processing equipment, food preparation surfaces and cookware. They also include substances added to or applied on packaging surfaces, such as adhesives, colorants, certain uses of antimicrobials, and antioxidants. For other applied materials, such as coatings or inks, ask your supplier how their food-contact status is documented for your use.

Packaging can combine several materials. A folding carton may include paperboard, an interior coating, an adhesive seam and printed exterior inks. We recommend listing these components and asking the supplier or a qualified reviewer which food-contact requirements apply to the finished construction, considering potential food exposure and intended conditions of use. Do not assume either that every layer requires separate authorization or that a layer outside the direct-contact surface needs no review.

• Primary packaging layer that directly contacts the food
• Coatings, liners and barrier films applied to that layer
• Adhesives, inks and colorants on or near the food-contact surface
• Secondary packaging that does not touch food, noted in your file with your supplier's view of whether it needs food-contact documentation

How authorization works under federal law

A food-contact substance that is a food additive must be authorized for that use before it is marketed in the United States. Authorization is usually obtained by submitting information to FDA through a food contact notification. As part of that process FDA conducts a scientific safety assessment that includes analyzing migration testing data showing how much of the substance moves into food under intended use, along with toxicological data to evaluate consumer exposure. FDA also reviews environmental information submitted under the National Environmental Policy Act.

For a brand owner, the key takeaway is that authorization attaches to a specific use, not to a material in general. A resin cleared for short-term room-temperature contact with dry food may not be cleared for hot-fill or long-duration fatty-food contact. Your review should therefore record the intended food type, contact duration, temperature and whether the package is single-use or reusable.

• Food contact notification process with migration and toxicological data
• Safety standard of reasonable certainty of no harm under intended conditions of use
• Environmental review under NEPA as part of the notification process
• Use-specific authorization: conditions of use govern whether a clearance applies

Matching conditions of use to your material

The single most useful habit in food-contact review is writing down the conditions of use before you pick a material. FDA's own framework for evaluating recycled plastics asks for exactly this: intended temperature of use, type of food contacted, duration of contact, and whether the article is for repeated or single-use applications. The same four questions work for virgin materials.

A simplified illustrative comparison: suppose a hypothetical dry granola is packed at room temperature in a paperboard carton with a polyethylene inner liner, contact time roughly three months. That use profile is different from a hot-filled sauce at 185 degrees Fahrenheit in the same liner, and different again from a reusable container washed hundreds of times. None of these is automatically acceptable or unacceptable; the point is that the material's food-contact support must match the profile you wrote down. When a supplier letter cites a clearance, read the conditions attached to it and compare them line by line.

Recycled content and PCR plastic

Recycled plastics in food packaging get extra scrutiny because of three concerns FDA identifies: contaminants from the PCR material may appear in the final food-contact product, PCR material not regulated for food contact may be incorporated into the article, and adjuvants in the PCR plastic may not comply with food-contact regulations. FDA considers each proposed use of recycled plastic case by case and issues informal advice on whether a recycling process is expected to produce PCR plastic of suitable purity.

If you want to use PCR plastic in food-contact packaging, plan to obtain documentation from your supplier covering the same points FDA asks for: a description of the recycling process and source controls, evidence of contaminant removal such as surrogate testing or migration data where appropriate, and the proposed conditions of use. Note that FDA no longer evaluates tertiary recycling processes for PCR PET or PEN or issues individual letters for those, because it has determined those processes produce suitable purity; that is a specific determination for those materials and processes, not a blanket pass for all PCR. Do not treat any of this as a compliance determination you can make yourself; your review file documents the basis for your choice, and counsel or a consultant can confirm the conclusion.

• Ask for source controls showing only food-compliant input plastic was recycled
• Request contaminant-removal evidence appropriate to the process
• Confirm the PCR resin's conditions of use match your product
• Keep the supplier documentation in your file, dated and versioned

Compostable and environmental claims on food packaging

Environmental claims require a separate review from food-contact suitability. Washington Ecology's cited overview describes restrictions on biodegradable, degradable, decomposable, oxo-degradable and similar terms. It also describes industrial-composting certification, FTC Green Guides, labeling and producer-declaration requirements for covered compostable products. The overview distinguishes film bags, other films and food service products. It identifies ASTM D6400 for film bags and ASTM D6400 or D6868 for other covered films and food service products, with different color, text, logo and marking provisions. It also identifies restrictions on compostable-style labeling for non-compostable products. This is a planning summary, not a complete statement of current law. Before selecting a claim or printing artwork, confirm the product category, applicable exceptions, certification standard, declaration obligations and exact marking specifications with current Washington Ecology guidance and qualified legal review. Do not infer an exemption from material composition alone.

If you sell into multiple states, treat compostable labeling as a channel-by-channel review question rather than a single national answer. Confirm the requirements for each state you distribute in, and check your retail or marketplace agreements for any additional claim rules. A package can be perfectly fine as food contact and still create a labeling problem if the environmental claim does not meet the rules of the state where it is sold.

• For Washington, check whether your product is covered by industrial-composting certification requirements before making a compostable claim
• In Washington, color and word requirements vary by product type; check each other state of sale separately
• Washington Ecology's overview identifies restrictions on biodegradable, degradable, decomposable, oxo-degradable and similar terms; confirm current applicability before printing
• Non-compostable packaging should avoid compostable-style color cues and wording

A hypothetical review walkthrough

Consider a simplified, purely illustrative example. A hypothetical small brand plans a dry snack bar in a printed paperboard carton with an inner film liner, sold in two states, one of which has a compostable labeling law. The brand builds a one-page review sheet per layer. - Liner: the supplier provides a food-contact letter citing support for dry foods at ambient temperature with contact up to one year. Those stated parameters align with the proposed twelve-month contact period, but the reviewer still checks the actual food classification, use pattern and other limitations. This does not establish the snack bar's shelf life. - Paperboard: the carton supplier provides documentation for the board's intended use, recorded even though the liner sits between board and food. - Ink: exterior inks sit on the outside of the carton. The sheet records ink placement, the ink specification and the supplier's support for the intended construction; exterior placement alone does not settle suitability. - Adhesive: the seam adhesive supplier letter addresses ambient dry-food contact, and the reviewer checks its remaining conditions against the intended construction and use. Separately, the brand wanted PCR content in the liner. The supplier's documentation does not cover the brand's exact conditions, so the brand defers PCR to a later project pending better documentation.

The arithmetic is simple, but the discipline matters. There are four layers (liner, paperboard, ink, adhesive) and four conditions per layer, giving sixteen condition checks. There is one open item, PCR, which is flagged rather than guessed at. The example is illustrative only and is not a compliance determination. It shows the shape of a review workflow, not a conclusion you can copy. Multiplying layers by tracked conditions gives the size of your documentation task, which is why we recommend a spreadsheet.

• One row per material layer, one column per condition of use
• Attach each supplier letter to its row
• Flag any layer where documentation does not match conditions
• Decide whether to substitute, get better documentation, or defer

Practical checklist before you order

This checklist is Teal's editorial planning framework for organizing a food-contact review. It helps you assemble the right questions and documents; it does not itself determine compliance, and the FDA sources cited here support only the specific underlying principles described above, not your final decision.

Work through the list with your packaging supplier and, where the stakes justify it, with regulatory counsel.

• Write the conditions of use first: food type, temperature, contact duration, single or repeat use
• List every layer that contacts food or sits near it under stress conditions
• Request a current letter of guarantee or food-contact support for each layer
• Match each letter's stated conditions against your written conditions of use
• For PCR content, request source controls and contaminant-removal documentation
• For compostable claims, confirm certification, labeling and color rules for each state of sale
• Check retail or marketplace agreements for additional claim requirements
• Version and date every document in a review file you can produce later

Scope limits

This guide covers U.S. food-contact basics for packaging decisions and does not address food labeling requirements such as nutrition facts panels, allergen statements or ingredient declarations, which are separate bodies of regulation. It does not cover drugs, dietary supplements, cosmetics or medical foods, each of which has its own framework. Nothing here is a compliance determination, legal advice or a safety certification for any specific product. Temperature limits, shelf life and contaminant thresholds depend on the specific material, clearance and use, and must come from the supplier documentation and qualified review, not from this article. State and channel requirements change; confirm current rules in your own agreements and with the relevant authorities before printing.

Questions about FDA food-contact packaging compliance basics