Bringing a food or beverage product to market in the United States involves more than just formulation, flavor, and branding. One critical factor is the packaging-specifically, whether it complies with the regulatory framework laid down by the FDA. For materials, inks, coatings, adhesives, paperboards, and plastics that come into contact with food-whether as wrappers, containers, or processing conveyances-compliance with FDA standards is not optional.
If a material allows migration of a substance into food beyond authorised use, or lacks an approved route for food contact, then the packaged product faces regulatory risk. According to the FDA packaging regulations for food, a “food contact substance (FCS) … is 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 a technical effect in such food.”
Simple design and robust aesthetics may get consumers’ attention, but packaging’s first function is to meet safety, regulatory, and traceability requirements. The following sections provide an overview of key U.S. food-packaging regulations, define what constitutes approved materials, and set the stage for detailed steps toward a fully compliant packaging program.
Overview of FDA packaging regulations for food
Legal framework (FD&C Act, CFR Title 21)
The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the regulatory backbone for food packaging in the U.S. Section 409(h)(6) states that a food contact substance is a food additive if it migrates into food. fda.gov+1 Implementation and detailed rules are contained in Title 21 of the Code of Federal Regulations (21 CFR). Specifically, the section on “Indirect Food Additives” encompasses Parts 174 through 186. Food Packaging Forum+1 These regulations outline conditions of use, purity standards, migration limits, manufacturing practices, a nd whether a substance requires pre-market clearance (such as via a Food Contact Notification, FCN).
Under this framework, any substance that is likely to come into contact with food-or can conceivably migrate into food-is subjected to scrutiny in the regulatory system. This will depend greatly on precise “conditions of use” encompassing time, temperature, food type, and surface-food ratio.
Materials that become part of the food, or migrate into it, are treated as “indirect food additives”—thus, packaging is not just a shell, it is a regulated component.
What constitutes “food packaging” & “food contact materials”?
“Food packaging” normally refers to any article in contact with food, holding, transporting, or serving it. Under FDA policy, “food contact materials” (FCMs) include not only containers and wraps, but also processing equipment, coatings, adhesives, inks, liners-even those not intended to influence the food directly. The key is contact or reasonably foreseeable migration.
Examples would include paperboard with a grease barrier coating for packaging pizza, plastic trays, aluminum cans, or multilayer films, when used to package foods. The regulation indicates that substances applied to the surface of packaging, adhesives, or colorants can all be considered FCSs as well.
A practical implication: each constituent part of a packaging material—resin, ink, adhesive—must be evaluated for regulatory status. “The overall regulatory status of a food contact material is dictated by the regulatory status of each individual substance that comprises the article.”
Role of FDA in packaging compliance
The FDA administers the regulatory framework for food contact materials. The agency maintains inventories, issues guidance documents, reviews Food Contact Notifications, and publishes public letters or opinions regarding recycled-plastic processes used in food contact. For example, the FDA does a scientific safety assessment of migration data and toxicological evidence before authorizing the use of a substance in contact with food.
In practical terms, when a new substance or new use of an already accepted packaging material is proposed for food contact, the FCN process gives the FDA 120 days to object; the absence of objection makes the use lawful. Knowledge.halo.Science The agency enforces compliance via import detention, product recalls, and could revoke authorization if safety criteria are no longer met. The regulatory infrastructure enables a controlled functional barrier between packaging and food, ensuring a “reasonable certainty of no harm” under conditions of intended use.
Thus, it is not just a design concern; packaging is framed by legal, scientific, manufacturing, and supply-chain systems. Collaboration among brands, converters, and suppliers would have to take the regulatory framework into account, not as an afterthought.
Food-Grade Materials Approved
The FDA defines a Food Contact Substance (FCS) 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 a technical effect in such food.” Commonly, FCSs are treated as “indirect food additives”-meaning they are not intentionally added to food for taste, nutrition or preservation, but may migrate into food through contact. These must either be authorised via regulation (e.g., 21 CFR Parts 174-186), submitted via FCN, or claimed under Threshold of Regulation (TOR) exemptions.
The regulatory responsibility lies in demonstrating that migration is minimal and safe under intended conditions. Chemistry, toxicology, intended use, and manufacturing controls were some of the bases for clearance.
Commonly used materials: plastics, paperboard, coatings, inks
Materials for packaging vary widely:
Plastics: polyethylene, polypropylene, PET, multilayer films. These fall under the 21 CFR Part 177 (Polymers) for food-contact applications.
Paper and paperboard materials, often with coatings or barrier treatments, are regulated under 21 CFR Part 176.
Coatings, adhesives, and inks. Often regulated under 21 CFR Part 175 (Adhesives & Coatings) and Part 178 (Adjuvants/Production Aids) when they contact food or packaging surfaces.
Other components, such as metal coatings, laminates, and functional barriers, may require specific evaluation to ensure migration is controlled. The packaging law firm commentary warns that a claim of “suitable for food packaging” does not equal documented FDA clearance.
Given the diversity of materials and contact conditions, such as hot fill and frozen, high-fat foods, long shelf life, the compliance requires a careful evaluation of both material and use scenario.
Routes to compliance: 21 CFR Parts 174-186, Food Contact Notification (FCN) program
The main regulatory route for packaging materials is through the relevant Code of Federal Regulations (21 CFR). Indirect food additives (which include packaging materials) are covered in:
Part 174 — General provisions for indirect food additives.
Parts 175–179 — specific categories (coatings, paperboard, polymers, production aids, irradiation)
Parts 180, 182–186 – include interim food additives, GRAS substances, indirect substances affirmed as GRAS.
An important route of compliance is the Food Contact Notification (FCN) program: once a new FCS is submitted, if the FDA does not object within 120 days, the use becomes accepted in the U.S.
In addition, the FDA maintains an inventory of substances listed in 21 CFR -the Food Contact Substances inventory – that documents authorized uses.
Practically, packaging material should either:
be listed under a regulation that permits its use under specified conditions; or
Be the subject of an FCN allowing the intended food-contact use; and
Meet all other regulatory conditions (purity, migration limits, manufacturing practices, traceability).
Failure to do so may render the material non-compliant and expose the product to the risk of being deemed adulterated under the FD&C Act.
Recycled content & sustainability considerations
Sustainability is of increasing importance to food brands, with many packaging systems containing recycled content. From a regulatory perspective, the FDA regulates recycled polymers used in food-contact applications no differently than their virgin counterparts. The agency’s guidance document Use of Recycled Plastics in Food Packaging (Chemistry Considerations) outlines the need for the recycling process to be validated, for potential contaminants to be removed or controlled, and for migration modelling/testing to demonstrate safety.
Since the “favourable opinion” route for recycled processes is voluntary, brands have to independently verify that the supplier’s recycling process has an FDA-issued favourable opinion or equivalent documentation. Otherwise, using recycled material may raise regulatory exposure.
Ultimately, while the use of recycled content aligns with sustainable goals, it must be looked at through a regulatory lens: traceability, process validation, and compliance documentation are required.
Labeling and Nutritional Information Guidelines
The role of packaging is not only to protect the product but also to serve as a vehicle for critical consumer information disclosures. Consequently, under U.S. law, the package material and the printed label together are responsible for carrying required statements and disclosures while preventing misleading claims and ensuring traceability.
Packaging vs label: required statements and disclosures
The principal display panel of a packaged food must bear the product identity and the net quantity of contents, under the Fair Packaging and Labeling Act and its implementing regulation 21 CFR Part 101. The label (usually the information panel alongside the PDP) must bear the name and address of the manufacturer, packer, or distributor; ingredient list; and the Nutrition Facts panel. Any claims of “FDA-approved” on a label require caution—since the FDA rarely “approves” packaging materials or label content in advance for foods, claiming “FDA-approved packaging” may be misleading and attract regulatory scrutiny.
Nutrition Facts Panel, net quantity, manufacturer/distributor information
The Nutrition Facts label is required for most packaged foods that are under FDA regulation. Serving size and number of servings per container Calories Nutrients: fat, sodium, carbohydrate, protein, vitamins/minerals as defined in 21 CFR 101.9. Net quantity declaring must be in U.S. customary and metric measures; examples, “Net Wt 12 oz (340 g)” Name and address of manufacturer, packer, or distributor needs to be on the label for identity of the responsible company and contact for trace back if necessary.
Allergen declarations, health claims, “FDA-approved” terminology
The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires that the source of any major food allergen used as an ingredient must be declared on the label. As of the most recent guidance, sesame has been added to the list of major allergens. Vitamin Retailer Magazine Health-claims (e.g., “low fat”, “heart healthy”) must meet specific FDA criteria; otherwise, the label may be considered misbranded. The term “FDA-approved” should not be used loosely on packaging unless there is a truly applicable FDA authorization for that specific claim, material, or product—packaging material itself seldom receives broad “approval” separate from food contact clearance.
Front-of-package trends and import/export labeling considerations
Emerging regulatory attention is being paid to front-of-package (FOP) nutrition labeling. The FDA proposed a rule in January 2025, under which key nutrient indicators-saturated fat, sodium, and added sugars-would be required on the FOP of many packaged foods. For imported foods, labels must meet U.S. requirements just like those placed on domestic products. In addition, the FDA’s import monitoring programs consider labels that fail to declare net quantity, bilingual metric/U.S. unit, or allergen statements grounds for import detention.
Packaging artwork, materials, and labeling must be harmonized: for instance, if the packaging contains a language other than English, a secondary English panel may be required if not exempt. Labeling must remain legible under conditions of storage and use that are foreseeable.
Prevention of Contamination in Packaging Design
Packaging design is not simply a question of appearance; choices of design impact migration, hygiene, and integrity, and where relevant, food safety. It involves material selection, process controls, and supply-chain safeguards to avoid contamination.
Migration of substances from packaging into food (barrier, coatings)
Any substance that migrates from packaging into food is treated under the food-contact regulation framework. The FDA defines a food contact substance (FCS) as “any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food…” When the FDA evaluates an FCS notification, it examines the nature of migrating components, potential consumer dietary exposure, and safe levels of exposure.
For example, long-chain PFAS used as grease-proofing agents in paper and paperboard packaging had their authorisations phased out because of migration concerns. Coatings, adhesives, and inks may act as indirect contact layers and must undergo evaluation for migration potential.
Hygiene, cross-contamination, packaging integrity, and clean manufacturing
Packaging lines should ensure that materials are clean, free of contaminants, and guarded against cross-contact of allergens and undeclared ingredients. Integrity of the package shall protect contents from foreign material intrusion, spoilage, and tampering. While the regulations may not always refer to “packaging hygiene,” GMPs do apply. Any compromise in package integrity-rips, weak seals, or unprotected adhesives-can lead to contamination and regulatory noncompliance.
Supplier qualification, material traceability, and change control
Qualifying packaging material suppliers is critical: documentation on raw materials, migration testing, change notifications, lot traceability, and audit records must be maintained. A change in supplier, resin grade, ink formulation, or coating process may affect migration behaviour or regulatory status; change control is essential. The FDA emphasizes that a change in manufacturing process may affect the regulatory status of a food contact substance. Traceability means the ability to map which material lot was used in which product batch and to retain test and audit records to respond to any potential recall or inquiry.
Emerging risks: PFAS, microplastics, recycled resin safety
The area of packaging contamination risk is ever-expanding. PFAS used historically in grease-proofing paper packaging are in the phase-out process and under FDA scrutiny. The FDA continues to monitor migration from packaging materials into food and stands ready to revoke authorizations if exposure risks exceed safety margins. Microplastics and recycled resin safety is also under review: the FDA’s guidance on the use of recycled plastics in food packaging covers chemistry considerations, contamination controls, and suitability evidence. Accounting for these risks at the time of packaging design and material selection minimizes future compliance surprises and helps protect food safety.
Best Practices for Food Brand Compliance
A strong setup from the beginning ensures that packaging supports safe, legal market access and does not create barriers.
Pre-launch compliance checklist: material, label, supplier, audit
Key elements of a pre-launch checklist would include: confirmation that all food contact packaging materials have documented authorisation, or are exempt; label compartments – PDP, information panel – have required statements – net quantity, manufacturer, Nutrition Facts, allergens; confirmation of material specifications, migration test data, and change-notification procedures from suppliers; auditing of packaging conversion lines for integrity, traceability, hygiene. An integrated checklist supports staging material approvals, printing proofs, packaging trials, and final sign-off.
Documentation & record-keeping: supplier statements, FCNs, test data
Internal roles could include: packaging engineer, regulatory consultant, legal, and QA.
Compliance is multidisciplinary: packaging engineers ensure structure, material, and conversion processes will meet both functional and safety needs; regulatory consultants interpret FDA regulations, handle FCNs, and manage label compliance; and legal counsel reviews contract language, claims, liability, and import/export obligations. This cooperation across disciplines provides a cohesive packaging compliance system rather than piecemeal efforts.
Timeline & budget planning for the U.S. market launch
Follow-up on continuous monitoring: changes in regulations, suppliers, and audits
Compliance doesn’t stop at launch: to maintain visibility of changes to regulations such as the proposed front-of-package labeling rule, supplier changes-material, resin, ink-manufacturing process changes, or scientific updates, such as PFAS/microplastics, use an audit schedule and track all notifications of change from your suppliers. Also, retest for migration or compatibility, where applicable, due to these changes, to make certain the packaging program stays compliant through the life cycle of the product.
Case Studies & Real-World Examples
Recalls due to failure of packaging or non-conformity of labeling
Packaging failures and label errors remain some of the key drivers for regulatory actions. For instance, one recent analysis estimated that a number of high-profile food and beverage recalls in the second quarter of 2025 found their direct roots in problems with either packaging integrity or mislabeling, such as foreign-matter contamination in processed meat packs and a failure in the pressurization of an aluminum beverage can.
The FDA classifies recalls into one of three categories according to the level of hazard involved in the recall: Class I (most serious), Class II, and Class III.
For instance, one type of nationally distributed product, ice cream, was recalled due to an allergen mislabeling issue because of a packaging error; this would be one good example of how packaging design/labelling misalignment might increase the risk many-fold.
Frequently Asked Questions
Q 1: Is the packaging “FDA-approved”?
Packaging itself is rarely “cleared” generically. Instead, materials that come into contact with packaging can be subject to submission under the Food Contact Notification programme or may be cleared by an existing regulation under 21 CFR Parts 174-186. Packaging materials might also be considered non-compliant if their use exceeds conditions described in their authorization.
Q 2: What if the material is not listed in 21 CFR?
If a packaging material or component is not listed or described in 21 CFR, or an FCN has not been issued, it may nonetheless be used only if it is explicitly exempt, for example, by Threshold of Regulation, or otherwise justified on safety grounds. Otherwise, the finished product may be considered adulterated or misbranded under the FD&C Act and subject to recall or import detention.
Q 3: Can recycled plastics be used for food contact?
Yes — recycled plastics can be used in food-contact packaging, but the regulatory scrutiny is intense. FDA guidance in its Use of Recycled Plastics in Food Packaging Chemistry Considerations outlines that process validation, contaminant control, traceability, and evidence of safety are needed.
If the ingredients change, what changes to the labels are needed?
Conclusion
This means that packaging and labeling are not optional extras; they are part of product safety and regulatory compliance. Material authorization by FCN or regulation, package integrity, and label accuracy from an allergen, nutrition, and manufacturer information standpoint are core elements of U.S. food packaging compliance.
Packaging failures-whether migration of substances, mislabeling, or material substitution leading to recalls, brand damage, and regulatory action. Only by enabling proactive compliance for qualification maintenance, innovative approaches to packaging design, and continuous monitoring of regulatory development will true brand resiliency and market readiness be realized.
Call to action for food brands in the U.S. market: your investment in packaging compliance-through the development of strong mechanisms for oversight of suppliers, review of labels, and design of packaging-could likely ensure easier market access and protection of consumer safety and brand reputation. In other words, packaging needs to be treated as a regulated component of the food product itself: the key to success is early planning, clear documentation, and alignment with U.S. regulatory expectations.
One Comment