The phrase food contact compliance gets used in packaging conversations with a frequency that suggests broad understanding and a specificity that suggests the opposite. Most brands who produce food products understand that their packaging needs to be food safe. Fewer understand what food safe means legally, what the distinction between direct and indirect food contact creates for compliance obligations, and why the liability for ensuring compliance sits with the brand using the packaging rather than with the supplier who manufactured it.
The FDA’s regulatory framework for food contact materials is built on a foundational principle that most packaging buyers don’t encounter until they’re already in trouble with it: any substance that can reasonably be expected to migrate from packaging into food is regulated as a food additive under the Federal Food, Drug and Cosmetic Act, and must be demonstrated safe for that specific use before the packaging is put on the market. This applies to inks, coatings, adhesives, paperboard treatments, polymer additives, and colorants. It applies whether the packaging touches food directly or sits outside another layer that does. And it applies whether or not the FDA has visited the facility that made the packaging or inspected the specific product that used it.
What Is Indirect Food Contact and Why Does It Matter?
The distinction between direct and indirect food contact determines which regulatory requirements apply to a specific packaging component, and it operates differently from how most buyers assume when they first encounter it.
Direct food contact means the packaging surface is in physical contact with the food itself. The interior of a cereal box liner, the inside of a paper popcorn bag, the interior surface of a folding carton containing unwrapped biscuits. These surfaces are in direct contact with food and face the most stringent compliance requirements.
Indirect food contact means the packaging component isn’t touching food directly but can reasonably be expected to transfer substances into food through migration. Clearance for food contact materials is required for those that are considered additives, also referred to as indirect additives, which are those that can reasonably be expected to migrate into the food stuff. The critical word is expected, not confirmed. A substance doesn’t need to have been proven to migrate into food to be regulated. It needs to have a reasonable expectation of migration based on the packaging’s intended use.
This reasonable expectation standard is where the practical compliance challenge begins. The exterior printing inks on a folding carton whose interior surface contacts food fall under indirect contact regulation because inks can migrate through porous paperboard. The adhesive used to seal a box whose contents include unwrapped food items falls under indirect contact regulation because adhesive components can migrate through the board structure. The coating applied to the outside of a paper food bag to provide grease resistance falls under indirect contact regulation if there’s reasonable expectation that coating components can reach the food through the paper.
What the 21 CFR Framework Actually Requires
All food packaging materials must comply with 21 CFR, the Code of Federal Regulations. The FDA regulates every material that directly or indirectly contacts food. Food contact substances require either FDA approval, GRAS status, or a Food Contact Notification before they can legally be used in packaging.
The regulatory pathways available for establishing compliance of a food contact substance are specific and hierarchical. Components of a food packaging material used in compliance with a regulation in 21 CFR Parts 174 to 179 need no further FDA review. Most of the regulated indirect food additives can be found in the Indirect Additive Database. This means the first step for any packaging component is checking whether its specific substance and intended use is already covered by an existing regulation in Parts 174 through 179, which cover the major indirect additive categories including paper and paperboard components, adhesives, coatings, and polymers.
If a specific substance and use combination isn’t already covered by an existing regulation, the alternatives are GRAS status, Prior Sanction, the Threshold of Regulation exemption, or a Food Contact Notification submitted to the FDA. A substance used in a food contact article may be exempted by FDA from the need of an FCN or a petition as a food additive if the use in question has been shown to result in a very low concentration of 0.5 parts per billion. This threshold of regulation exemption is practically significant for substances present in very small quantities whose migration into food at detectable levels is essentially impossible given their concentration in the packaging material.
The pre-market approval pathway under 21 CFR Parts 170 to 199 covers substances the FDA has explicitly approved. Common examples include LDPE, PP, PET, and wax coatings. The GRAS pathway applies where scientific consensus holds that the substance is safe, covering materials like cellulose and starch-based components. The Food Contact Notification pathway requires the manufacturer to file a safety notification subject to a 120-day FDA review, most commonly used for new polymers and novel coatings.
Where Paper and Paperboard Compliance Specifically Lives
The paper and paperboard category is where most folding carton and corrugated packaging manufacturers operate, and the specific requirements that apply to paper-based food packaging components sit in 21 CFR Part 176 rather than in the general food additive framework.
21 CFR Part 176 covers indirect food additives for paper and paperboard components. Specifically, the information from manufacturing records should determine if the food-contact surface of the paper or paperboard contains substances that are GRAS in food and for their intended use in paper and paperboard used in food packaging.
This manufacturing records requirement is where the practical documentation chain begins for packaging buyers. A brand ordering food packaging from a supplier needs to establish that the supplier’s manufacturing records demonstrate compliance for the specific paper or paperboard materials used in their product. General food-safe declarations from suppliers aren’t equivalent to documentation demonstrating compliance with 21 CFR Part 176’s specific requirements for the materials in use.
The inks used on paper and paperboard food packaging sit in a separate compliance space that 21 CFR Part 176 doesn’t cover directly, because printing inks are applied to the finished packaging rather than being components of the paper or paperboard itself. Ink compliance for food packaging applications typically relies on the supplier’s formulation against FDA-approved substances and GRAS ingredients, or on specific ink formulations developed for food packaging applications whose components have been assessed against indirect food contact migration standards. When working with a custom packaging supplier, brands should ask whether the inks and coatings used are food-safe and approved for indirect food contact.
Who Bears the Compliance Liability
The compliance liability question is the one that most packaging buyers are least prepared for when they first encounter it, because the intuitive assumption is that the packaging supplier is responsible for ensuring their materials are compliant, and the brand using the packaging simply needs to choose a reputable supplier.
The actual liability structure is more complex and places a meaningful responsibility on the brand using the packaging. In practice, every resin, monomer, polymer, additive, antioxidant, colorant, processing aid, coating component, adhesive component, printing ink component, and recycled plastic input may need to be reviewed. The starting point is usually 21 CFR Part 174 and related indirect additive provisions for adhesives, coatings, paper and paperboard components, polymers, and production aids.
The responsibility for ensuring that a packaging component meets FDA requirements for its specific intended use is shared between the packaging supplier and the food brand. The supplier is responsible for using materials that comply with applicable regulations and for providing documentation supporting that compliance. The brand is responsible for ensuring the packaging it uses is compliant for its specific application, which means the brand can’t simply accept a supplier’s general food-safe declaration and transfer all compliance responsibility to the supplier.
This shared responsibility structure has direct commercial consequences when a compliance issue is identified. A brand that used packaging without verifying compliance documentation and whose product is recalled or flagged by FDA for a packaging-related compliance issue can’t shield itself from liability by pointing to the supplier’s sale of the packaging. The due diligence obligation rests with the brand, which means documentation collection from suppliers is a brand compliance obligation rather than an optional quality management step.
What Recycled Content Does to Compliance Obligations
Recycled content in food packaging materials introduces a compliance complexity that virgin material packaging doesn’t create, and its practical significance has increased as recycled content requirements from EPR legislation and retailer sustainability standards push more brands toward recycled content packaging specifications.
For recycled plastics used in food packaging, FDA evaluates the recycling process and may provide a No Objection Letter indicating that the agency has reviewed the process and has no questions at that time regarding its ability to produce recycled material suitable for food contact use. This No Objection Letter mechanism reflects the practical challenge that recycled plastic carries: the recovered material’s composition is inherently less controlled than virgin material’s composition because it reflects whatever the recovered plastic stream contained, and the recycling process needs to be demonstrated adequate to reduce any contaminants from previous use to safe levels.
Recycled paperboard for food packaging operates under a different but related compliance consideration. Post-consumer recycled paperboard is widely used in folding cartons and corrugated packaging, and its compliance for food contact applications depends on the source of the recycled fiber and the processing steps applied during recycling. Recycled paperboard that includes inks, coatings, and adhesives from its previous use cycle contains residual components from those treatments whose presence in the recycled board needs to be assessed against indirect food contact migration standards.
What Practical Documentation Does a Food Brand Need
The documentation that establishes a food brand’s due diligence compliance position for its packaging materials is specific enough that collecting it should be a standard part of every packaging supplier onboarding process rather than a retrospective exercise prompted by a compliance inquiry.
A compliance declaration or statement of composition from the packaging supplier that identifies the specific materials used, their applicable 21 CFR regulatory basis, and confirmation that they are used in compliance with the conditions of the applicable regulation provides the foundational documentation. This is different from a generic food-safe declaration that doesn’t cite specific regulatory provisions. Brands should ask their custom packaging supplier whether they can provide a materials compliance declaration if required by a retailer, whether their paperboard and corrugated materials are compliant with 21 CFR Parts 174 to 186, and whether inks and coatings used are food-safe and approved for indirect food contact.
Migration testing certificates, where a supplier can provide third-party laboratory testing demonstrating that specific substances from the packaging materials migrate into food simulants at levels below regulatory thresholds, provide a higher standard of documented compliance than regulatory self-declaration alone. For high-risk applications including hot food direct contact, fatty food contact, and long shelf life food contact, migration testing is a more robust compliance demonstration than regulatory citation alone.
Supplier facility registration with FDA is a baseline indicator of a supplier’s compliance infrastructure. Food packaging manufacturers should hold FDA facility registration and provide food-safe material certificates upon request. SQF or BRC certification represents a third-party food safety audit standard that provides additional assurance of a supplier’s manufacturing practice quality.
What State Law Adds to Federal Requirements
Federal FDA compliance is not the complete compliance picture for food packaging sold across the United States, because several states have enacted food packaging legislation whose requirements extend beyond or differ from federal standards in ways that affect brands distributing nationally.
Without a single set of regulations on permissible limits and reporting covering food contact materials in the US, compliance can be difficult. Differences between local and national laws mean that a product which may be compliant with the federal government may not be compliant in some states. Manufacturers and suppliers need to focus not only on national laws but also local laws.
California has led state-level food packaging regulation with restrictions including the prohibition on PFAS-containing food packaging that took effect in 2023, which applies to packaging sold in California regardless of where it was manufactured or where the brand is headquartered. Washington, New York, and Colorado have enacted similar PFAS restrictions whose specific effective dates and covered packaging categories differ from California’s framework. A brand whose food packaging contains PFAS-based grease resistance coatings that are technically compliant with federal FDA requirements may still be non-compliant for distribution in multiple states under their specific PFAS packaging prohibitions.
BPA restrictions at the state level add a further compliance layer for packaging whose resinous coatings or polymer components historically used BPA-containing formulations. The FDA also has regulations affecting the use of BPA in food contact materials. Under 21 CFR 175.300, epoxy resins derived from BPA and epichlorohydrin are prohibited from being used in packaging for powdered and liquid infant formula. States including Wisconsin have enacted broader BPA restrictions covering children’s food containers that apply independently of the federal prohibition’s narrower scope.