Entering the U.S. market with a new product takes more than a compelling brand or striking packaging design. This would also mean complying with the Food and Drug Administration’s packaging standards, especially when such packaging materials come into direct contact with food, supplements, or other regulated goods. What might look environmentally friendly or visually appealing to the marketer’s eye may nevertheless fall short of meeting expectations of U.S. regulators and finally trigger enforcement action, recalls, or blocked distribution.
Not just a matter of aesthetics or marketing, packaging in the U.S. is part of the product’s safety and regulatory profile. For a brand preparing a launch, understanding the definition, scope, and implications of “FDA compliant custom packaging” is a necessary foundational step.
What is FDA-Compliant Custom Packaging?
Packaged goods within the scope of U.S. regulation may involve materials and components that come into contact with food, beverages, or other consumables. According to the FDA, an FCS is defined 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.”
In other words: If the package or any of its parts can conceivably migrate or leach into the food or beverage, such as adhesives, coatings, inks, plastics, or paperboard – then the package falls under the FDA’s regulatory purview. The CFR makes clear that most packaging materials addressed by Title 21 CFR Parts 174-186 constitute indirect food additives.
In addition, the regulatory status of packaging cannot be considered separately from each component of the material, as the FDA has made it explicit that “the overall regulatory status of a food contact material is dictated by the regulatory status of each substance that comprises the article.”
Pre-market review is often required when a new substance is intended for food contact use. One principal route is the FDA’s Food Contact Notification (FCN) program: if a company submits the required data and the agency does not object within 120 days, the material may be legally marketed.
Who It Applies To (Brands, Packaging Suppliers, Contract Packers)
The responsibility to follow FDA regulations goes well beyond the brand name on the box. It includes:
• Packaging material suppliers who formulate or manufacture films, coatings, inks, and adhesives.
• Converters or subcontractors that convert raw materials into packaging components or printed containers.
• There are contract packers or contract manufacturers who do the filling, sealing, labeling, and handling of the packaging.
• Brand owners or importers who bring the finished packaged product to market in the U.S.
The regulatory status depends, among others, on the intended use, condition of contact, environment, migration potential, and exposure; hence, each link in the supply chain has a role to play.
When all the components and steps are appropriately scrutinized and documented from raw chemical to finished boxed product, the resultant package qualifies as “FDA-compliant packaging” for the subject use. Without that, the packaging may look acceptable, but can still present regulatory risk.
Why FDA Compliance Matters for Brands
Consumer Safety & Brand Reputation
Packaging is an integral part of product safety. A material that allows the migration of unwanted chemicals into food, or that degrades under conditions of use, has the potential to harm consumers. FDA’s regulations assure a “reasonable certainty of no harm” when a packaging material is used as intended.
If packaging fails-be it contamination, migration, degradation, or misguided labelling brand’s reputation is vulnerable. Consumers assume not only that the product inside is safe, but also that the packaging is safe. A highly publicised packaging-related incident can erode trust across the entire product line rather than just the affected SKU.
Legal /Regulatory Risks: Recalls, Fines, Import Holds
Non-compliance with the packaging requirements may result in the following FDA regulatory actions: import detention, voluntary and/or mandatory recalls, warning letters, or refusal of admission into the U.S. market. In case of food contact use for any substance not properly authorised or beyond conditions for which authorisation has already been granted, the FDA may withdraw authorisation of substances or take other measures under the relevant law. U.S.
Example of enforcement: FDA says it may re-evaluate authorised food contact substances if new science raises safety questions, and may revoke authorisation if the “reasonable certainty of no harm” standard is no longer met. U.S. Food and Drug Administration
Market Access – USA Distribution
Gaining access to the U.S. market means meeting not just product-based standards, but also packaging requirements. The FDA dictates not just the food or drug that goes into the package, but the packaging materials themselves when they may come in contact with the food, drink, or drug.
If packaging fails compliance, the product will be delayed or blocked from entry–even if the product itself is compliant with its regulations. For importers, a lack of proper documentation or authorization in packaging material means detention of shipment, increased cost, and time to market. Therefore, packaging is not “just an afterthought” but a strategic consideration for U.S. launches.
In the context of packaging, basic understanding and recognition of what constitutes FDA-compliant packaging, and who bears the responsibility across the supply chain, are fundamental to any brand preparing for the U.S. product launch. The section that follows discusses in detail packaging requirements particular to respective industries that fall under FDA regulation.
Key FDA Complaint Custom Packaging Requirements by Industry
Food & Beverage Packaging (Food Contact Substances, Migration, etc.)
Packaging intended to come into contact with food in the US falls under the purview of the FDA when the materials used are FCSs that are defined as any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if their use is not intended to have a technical effect in the food.
Key points to understand:
Materials falling under these rules must either be authorized via the “Food Contact Notification” program or otherwise be exempted under the “Threshold of Regulation” route.
• The applicable regulatory framework can be consulted in Title 21 CFR Parts 174-186, among others.
• When migration testing is necessary: The FDA reviews data demonstrating the amount of food contact substance that migrates into food under the intended conditions of use, as well as toxicological data for safety at exposure levels that may be expected.
• Recycled polymers that are used in packaging for food contact are similarly regulated: a favorable letter from the FDA may be required to demonstrate that the recycled process is safe for use in food contact applications.
• The brand or packaging owner has to make sure each component of the packaging material complies: the “overall regulatory status” of a food contact material is determined by the regulatory status of each substance that makes it up.
In the context of food & beverage packaging, compliance is demonstrated by selecting the right material grade for the food type and contact conditions, such as time, temperature, and nature of the food-whether it contains acids or fats. Besides that, migration/exposure data have to be within acceptable limits. Furthermore, materials have to be documented to be either authorised or exempt for the intended use, and traceability in the supply chain should exist.
Cosmetics Packaging: Labeling & Packaging Overlap
Cosmetic regulation in the United States is done primarily under two laws: the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).
Key Packaging- and Label-related Requirements:
• Labels shall be in the English language, prominently and conspicuously placed to enable the consumer to readily notice and understand the required statements under normal conditions of purchase.
• Ingredient declaration in descending order of predominance, except that fragrance/flavour components have special rules.
• The name and place of business of the manufacturer, packer, or distributor must appear.
• Any claims on the label (for example, “cruelty-free,” “hypoallergenic,” “organic”) cannot be false and misleading; if a cosmetic product claims therapeutic or structural function (for example, “treats acne”), it may be regulated as a drug rather than a cosmetic.
• While the packaging material is less directly regulated for cosmetics compared with food contact, it may still be subject to applicable law and fair packaging expectations when it could affect consumer safety or mislead by way of labeling/presentation.
For cosmetic packaging design, therefore, proper integration with label content and layout should be ensured to have the required content-net quantity, ingredient listing, firm name & address, and warnings if applicable-matching in style with the packaging (tube, jar, bottle) to ensure compliance.
Medical Devices / Pharmaceuticals (If the brand crosses into regulated device or drug territory)
Packaging that is part of regulated devices or drugs has much greater regulatory demands. Labeling and packaging for medical devices are regulated by the FDA under Title 21 CFR, principally Part 801 (Labeling) and Part 820 (Quality Systems).
The key requirements for packaging/labelling associated with device-related packaging include:
• Labels identify manufacturer, packer, or distributor name and place of business, and must be conspicuous and legible during customary conditions of distribution, storage, and use.
• The packaging shall preserve sterility (when relevant), protect the device to the point of use, and support device identification, traceability, and user instructions.
• Controls of the quality system-material examination, usage criteria, labeling issuance, and packaging operations apply under 21 CFR 211 for drugs and under device rules for devices.
• The packaging label of most of the devices should therefore bear this code since they fall under UDI requirements for traceability.
For packaging pharmaceuticals, additional requirements must be met (for example, Title 21 CFR 211, §211.122 Materials Examination and Usage Criteria and §211.130 Packaging and Labeling Operations).
Brands crossing into device/pharmaceutical territory will have to look at packaging as part of their regulated product, not just the wrapper. Packaging becomes part of compliance, shelf life, sterility/storage, user instructions, recalls, and change control.
Other Applicable Categories (such as Dietary Supplements; OTC Drugs)
Even if a product is considered a dietary supplement or OTC drug, the packaging and labeling must adhere to the guidelines of the FDA for those respective categories. Labeling laws – ingredient list, net quantity, name of manufacturer, etc. – are in effect; if the product is to be ingested or absorbed, packaging components that come in direct contact with the product are also subject to regulation. The FPLA and the FD&C Act apply to these groups. Thus, packaging cannot contain misbranding or any other deceptive practice.
Brands operating in many regulated categories thus have to map packaging requirements across the most demanding regulations applicable. Material compliance + label compliance + category regulatory compliance-all overlap.
Common mistakes in compliance for custom packaging
Incorrect use of “FDA-approved” plastics/materials
A common misconception is that a material being “FDA approved” – or “food grade” – means compliance automatically for any use. Actually, the FDA rarely “approves” materials in generic form — the approval is for a specific substance in a specific use under specific conditions – time, temperature, food type. When a material is being used outside those conditions, it may not be compliant.
Reliance on supplier claims without verification of conditions of use for packaging is risky-materials may be marketed as “suitable for packaging” without documented clearance for the conditions of use authorized by the FCS inventory.
Poor supplier documentation or traceability
Brand owners rely on suppliers for material specification and compliance support in most custom packaging. When material changes happen, such as changes in resin grade or additive package, or a supplier does not have full documentation of the FCN or authorized use, traceability breaks. That can lead to an unverified migration risk, undocumented material changes, or an inability to respond to regulatory queries.
Labeling & artwork issues: missing required statements, misleading claims
Packaging frequently includes artwork, branding, and labels. Errors such as not including net quantity, failing to declare ingredients (cosmetics), failing to include firm name/address, or including claims that make the product a regulated “drug” can lead to misbranding or regulatory action. For instance, cosmetics cannot make structure/function claims unless they want to move into drug regulation.
Overlooking indirect food contact substances/migration issues
Even packaging that does not appear to touch food may have indirect contact, such as through adhesives, inks, and coatings migrating into food. Regulators hold that any substance contacting food under reasonably foreseeable conditions must be authorized or exempted. One common error is ignoring these “hidden” layers.
Not monitoring changes in materials or packaging processes
Packaging design and materials evolve. If a brand does not implement robust change-control procedures, a seemingly minor packaging design change (material supplier, print ink, conversion process) may place the packaging outside of its authorised use, triggering the need for a new FCN or other regulatory submission.
These errors undermine compliance, increase the risk of enforcement, and threaten product launches or market continuity.
How to Ensure Custom Packaging Meets FDA Standards
Performing a Regulatory Review / Packaging Risk Assessment
Start by mapping the intended use of the packaging: food contact or not, device or cosmetic category, conditions of use (temperature, time, product type), geography (U.S.). Identify all of the materials, conversions, and suppliers in the chain. Conduct a risk assessment matrix: material type, contact conditions, migration potential, regulatory authorizations/exemptions, supplier documentation, and change control.
Choosing Compliant Materials & Verifying Food Contact Status
For food contact packaging: Check the FDA inventory of FCSs listed in 21 CFR and the online database of authorised substances. If a substance or material is out of the scope of what’s authorized, submit FCN or obtain an exemption via the “Threshold of Regulation” process. U.S. Food and Drug Administration Obtain supplier documentation: FCN number (if applicable), conditions of use (if applicable), results of migration testing, recycled polymer opinions (if applicable)
Working with Qualified Packaging Suppliers & Asking for Documentation
Supply-chain verification will be necessary, and should include requests for suppliers to provide full specification sheets, certificates of compliance, migration test reports, change-notification procedures, and supplier audit evidence. Confirm they have change‐control processes to notify them if the materials evolve. If appropriate, outsource independent migration or extractables testing.
Labeling Review & Ensuring Packaging Meets FDA Label Regulation Requirements
Labeling should be per FDA regulation: for food, assure nutrition, ingredients, net quantity, and manufacturer/distributor information, see Food Labeling Guide; for cosmetics, assure ingredient declaration, name, and address, no misleading claims. For devices and drugs, ensure the label contains all the required statements, manufacturer, UDI if applicable, expiration, storage, and handling instructions. MT+1 Integrate packaging artwork and materials so that labels remain legible, durable under distribution/ storage conditions.
Change Control & Ongoing Compliance Monitoring
Develop and implement a change-control process: supplier material changes, process changes, packaging design, or artwork changes are all initiators of review for regulatory impact. Keep a compliance file documented: material specs, test reports, supplier correspondence, and audit records. Periodically review the regulatory landscape for changes: new FDA guidance, emerging chemical concerns.
Record-Keeping, Audits, Supplier Agreements
Document agreements with suppliers or contract packers on compliance, notification of changes, and audit rights. Retain records of each lot of material, migration test data, supplier certification, printing/ink records, and date of artwork approval. Internal or external audits of packaging processes ensure compliance is not merely an activity but a system maintained over time.
When all these factors come together-material authorisation, label compliance, supply-chain documentation, change-control processes-custom packaging can meet U.S. FDA standards for the relevant industry category. Failure to integrate these layers risks not only technical non-compliance but also regulatory disruption, delayed market access, damaged brand reputation, and costly recall events.
Following this structured roadmap will ensure that packaging is treated as a regulatory asset and not just a design consideration.
Extra Considerations & Emerging Trends
Sustainability & Recycled Content: How the Food and Drug Administration (FDA) Regulates Recycled Plastics in Food-Contact Materials
The trend toward sustainability is driving many brands to explore recycled plastics in packaging. Recycled content used in food-contact materials, however, remains subject to robust regulatory scrutiny. According to the FDA guidance titled Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations), the process by which recycled plastics are made suitable for food contact must provide evidence that the process removes any incidental contaminants that may occur, that the migration of substances from the material into food is negligible (for example, ≤ 0.5 ppb in many cases), and that the material is acceptable for the intended food application.
Although the FDA has not issued a separate rule pertaining only to the use of recycled plastics in food-contact applications, the agency regulates these plastics, like virgin materials, based on a “reasonable certainty of no harm” for the intended conditions of use.
This would in practice mean that whenever post-consumer resin is to be used for food packaging, recycling shall be validated; surrogate contaminant testing and migration modelling or input control need to be done, and a no-objection or favorable opinion from the DA can be sought.
For brands, the takeaway is that recycled content is possible — but cannot be assumed safe for an intended food-contact application without documented compliance, processing validation, supplier evidence, and migration testing.
Digital Printing, Smart Packaging, Tamper-Evident Features
Advances in printing-digital, flexographic, with variable data-smart packaging such as QR codes linking to traceability or consumer engagement, and tamper-evident features such as seals, over-wraps, and indicators impacting the way packaging is designed and regulated. For instance, in the realm of OTC drug and device packaging, the regulation under 21 CFR 211.132 dictates that a product have tamper-evident packaging for retail-accessible items and that the labeling adequately identify a tamper-evident feature.
Smart packaging can incorporate materials or electronics, for example, RFID tags, that alter the material composition of a package system such that regulatory review may be invoked when those materials are in contact with food or other regulated product contents. The trend toward digital printing also heightens concerns about inks, varnishes, and adhesives meeting migration or indirect-contact substance requirements under regulations pertaining to food contact packaging.
Therefore, emerging technologies need to be evaluated not only for their marketing appeal but also for regulatory compatibility with packaging materials (food contact, device/medicinal contact, etc.), label integrity, tamper evidence, and traceability.
Overview of Global Supply Chains & Importer Responsibilities under the FDA
Even if a brand is U.S.-based, many packaging components may come from overseas. According to the FDA, if the packaging materials do not comply with U.S. standards, imported products packaged in those materials are subject to FDA inspection, detention, or refusal of entry. Supplier documentation, audit trails, compliance with material-approval or notification programs, such as a food contact substances inventory and FCNs, along with any changes within the chain, are the responsibility of the owner or importer of the packaging.
Global supply chains bring added risk: material substitutions, translation of documentation, differing quality standards, and cross-border logistics all have to be managed. A converter overseas, for instance, may change resin grade or additive package; without an FDA-recognised FCN or equivalent safety assessment supporting that change, the packaging may become non-compliant.
Liability and Recall Preparedness
Packaging is a key part of product safety and regulatory compliance. When packaging material fails, through migration, contamination, incorrect labeling, or tamper-evidence breach, this can lead to recalls, FDA enforcement, consumer liability, or reputational damage to the brand. Maintaining documentation, traceability, supplier warranties, and a recall-ready process is therefore not optional.
For instance, the FDA noted that packaging and labeling operations were among the major sources of recalls in the pharmaceutical industry.
But companies should regard packaging as part of the regulated product’s risk management system, rather than as purely a design or marketing activity. This means that a recall plan should include packaging material failure as one of its scenarios, and that the supply-chain risk assessment should cover packaging component failure, migration over time, supplier changes, and labelling/packaging mix-ups.
Checklist & Action Plan for Brands Launching Custom Packaging
Pre-Launch Checklist Items
• Document all materials in contact, directly or indirectly, with the product: food, beverage, cosmetic, device, drug.
• Check material status: Is a Food Contact Substance Notification (FCN) required? Is the material listed in the 21 CFR inventory with the intended use/condition?
• For recycled plastics, validation of the recycling process, controlling contaminants, migration testing, and modeling and documented must be present.
• Review packaging design for label compliance: net quantity, ingredient list (cosmetics/food), manufacturer/distributor name/address, tamper-evident statements (for OTC/devices).
• Verify tamper-evident features when necessary, under 21 CFR 211.132 (OTC drugs/devices).
• Conduct change-control plan: documentation for supplier changes, material changes, artwork revisions, and conversion process changes.
• Engage supply-chain audits: packaging material supplier, converter, contract packer, logistic handlers. Ensure traceability of lots, certificates of compliance, and supplier change-notification clauses.
• Budget/Time for Migration Testing: Validation of Smart-Packaging Elements, Label Mock-ups, Regulatory Review.
• Recall/withdrawal scenario: Prepare for packaging failure, label mix-up, migration exceedance, and tamper-evident breach. Document steps, responsible parties, and communication plan
Whom to Engage
• Packaging engineer-material selection, conversion process, structural design, tamper/evident features
• Regulatory consultant or subject-matter expert: evaluate food contact, device/drug contact, recycled plastics compliance, review FCN/notifications
• Legal counsel: contract terms with suppliers/packers, recall liability, import compliance, labeling claims
• Label/graphics expert: ensure that label layout meets FDA requirements, tamper-evidence statements, and variable-data printing compliance.
• Supply-chain auditor/quality assurance: supplier audits, material traceability, change-control process oversight, documentation repository.
Timeline & Budget Considerations
• Build a backward timeline from the launch date: material qualification → supplier agreement → prototyping → migration testing/validation → label artwork review → package conversion trials → pack line qualification → final sign-off → distribution.
• Allocate budget items: material certification-FCN/NOE review, migration/extractables testing, process validation of recycled plastic, artwork/label proofing, tamper evidence feature cost, supply chain audit cost, import compliance/manifest cost, recall preparedness.
• Contingency budget/time reserved for supplier changes or regulatory findings – e.g., unexpected migration, printer ink change.
• Prioritize early engagement of regulatory review, as late-stage material change can significantly derail timelines and increase cost.
Conclusion
This is much more than mere design aesthetics and shelf appeal that the introduction of customized packaging to the U.S. market requires. The most important thing is compliance with the FDA’s framework of food-contact materials, packaging of regulated goods, and emerging technologies such as recycled plastics, smart packaging, and tamper-evident features. Central in this regard are the following key takeaways:
• There must be documented safety, authorization, or appropriate exemption for the packaging materials in contact with regulated goods; recycled content must meet the same safety thresholds required of virgin materials.
• There are technological advances, such as smart packaging, digital printing, and evidence of tampering, that require evaluation of regulatory compliance, not just marketing benefit.
• Importers and brands that rely on international supply chains must have robust documentation of suppliers, change-control systems, and traceability. Packaging failures or substitutions may prompt FDA action and bar access to the marketplace.
• Recall readiness, liability risk management, and brand reputation protection rely on adequate packaging–manage packaging as part of the regulated product system, rather than as an afterthought.
• The concrete action plan comprises a pre-launch checklist, a multidisciplinary team comprising engineering, regulatory, legal, QA, an agreed timeline, and a budget that are very important to reduce cost, minimize launch risk, and protect brand value.