Safe, reliable, and compliant products manufactured in the United States find their beginning with the materials that were utilized to package that product, FDA-approved. Whether it be food packaging, a dietary supplement, or even a cosmetic, the type of packaging in which something comes will determine how long it stays fresh and how safe it will be to consume. The FDA requires that all materials coming into contact with food or other consumables meet criteria for safety under the FD&C Act at the federal level.
In this light, FDA approved packaging materials ensures that contamination, migration of noxious substances, and spoilage of products do not occur. Besides consumer safety, compliant materials in packaging help in building a brand reputation for trust, transparency, and adherence to national safety laws. Non-compliance may well result in costly recalls, damage to brand credibility, and possible legal actions against it.
Major packaging-related regulation by the FDA includes its FCS framework under Title 21 of the CFR, Parts 174-186, with respect to indirect food additives, coatings, adhesives, and polymers in packaging. The main focus in this respect is to ensure that whatever is in contact with food-or indeed indirectly with food through layers of materials-does not affect health.
What does FDA approved packaging material mean?
A material manufactured and cleared under U.S. regulations to be used in direct or indirect contact with food or consumable products is considered an FDA-approved material. The term FCS is defined under 21 U.S.C. § 348(h)(6) as “any substance 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 any technical effect in the food itself.”
That means if the material does not impart taste, color, or odor to the food, then the food packaging materials are excluded from consideration and hence full food additive approval is not required on them. However, the packaging materials are subjected to scientific scrutiny so that migration of the constituents of packaging into the food product would not exceed the safe limits.
FDA recognizes several routes for determining the safety of packaging materials:
1. Food Additive Petition (FAP)– Formal submission to FDA seeking approval of a new food contact substance or use. When an additive petition is approved, that additive becomes a permanent part of the regulations in 21 CFR Parts 174–186.
2. FCN Program: The most common modern route of approval is the FCN program. Under this system, a manufacturer simply serves a notice on the FDA of an intended FCS use. It is automatically authorized for that use unless objections are raised within 120 days.
3. ToR Exemption: The FDA can exempt the manufacturer from a detailed review for those substances that would migrate into food at very low levels, below 0.5 parts per billion, where the material poses limited risk.
FDA Compliant versus FDA Approved
Note the distinction between “FDA compliant” and “FDA approved.”
FDA-compliant materials are those that meet FDA regulations for use in food or drug contact applications. Not all FDA-compliant materials have FDA “approval” documents. Example: resins included in the listings of 21 CFR 177 for a given use are considered compliant for that use.
All materials approved by FDA would have undergone formal FAP or FCN submission and review processes.
Currently, manufacturers of packaging products refer to the plastics as being “FDA-compliant.” Most are manufactured based on previously cleared formulations listed in the CFR database.
Common FDA approved packaging materials include: PET, HDPE, PP, Glass, Aluminum
All these materials from the various industries meet the FDA standard in terms of safety, resistance to chemical breakdown, and toughness. Each one of them has some favorable properties that have particular applications for certain kinds of products.
Polyethylene Terephthalate – PET
Besides being light and transparent, resisting impact, and withstanding moisture, PET also is one of the most-used FDA-compliant materials in food and beverage containers. PET does not chemically react with food or beverages, plus it is a very good barrier for oxygen and carbon dioxide, which has made it popular for bottled water, juice, and supplement containers.
Accordingly, the FDA classified PET under 21 CFR 177.1630 as an acceptable polymer for repeated food-contact applications. Further, it is recyclable and, under FDA’s No Objection Letter system, can be processed for use as rPET in food packaging.
High-Density Polyethylene
HDPE is a rigid resin that offers great resistance against a wide variety of chemicals and also has very low moisture absorption. Typical applications include milk jugs, supplement bottles, and cosmetic containers. HDPE is FDA-compliant according to 21 CFR 177.1520. Due to its structure, it provides an excellent barrier to light and oxygen, hence maintaining product stability.
HDPE furthers sustainability imperatives through toughness that allows easy recyclability and reusability in other applications for secondary packaging.
Polypropylene (PP)
Another tough yet lightweight polymer, PP also possesses exceptionally high heat resistance and resists a broad range of chemicals. The list of its uses includes yogurt cups, medicine bottles, microwave containers, and many more. PP is under the regulation of rule 21 CFR 177.1520 recognizing safety for repeated use with food and beverages by the FDA.
Its high melting point means that it does not distort in such processes as sterilization and hot filling; it is suitable for food and pharmaceutical applications.
Glass and Aluminum Containers
Glass is one of the safest packaging materials due to its inertness. It does not leach chemicals into food or absorb flavors, let alone change the content. For this reason, the FDA regards glass as generally GRAS in food-contact applications. In the case of canned foods and beverages, aluminum packaging gives very good protection against light, oxygen, and microorganisms, provided it is coated with FDA-compliant lacquers or epoxy resins under 21 CFR 175.300.
Coatings, Adhesives, and Inks
Indirect additives include coatings, adhesives, and printing inks, considered separately under 21 CFR Parts 175–178. For example:
21 CFR 175.105 Adhesives used in packaging
21 CFR 175.300 Resinous and polymeric coatings
21 CFR 178.3297 – Colorants and pigments for polymers
From coatings to laminates to printing inks, every component of multi-layer packaging has to follow the proper FDA regulations relative to migration and compositional limits concerning consumer safety.
Plastic, Glass, and Eco Alternatives: How Do They Compare?
Decisions about the above packaging materials are replete with trade-offs, as besides sustainability, performance and safety also come into play. This can vary from different materials like plastic to glass or even to bio-based alternative films, which all have different strengths and weaknesses for food, supplement, and cosmetic applications.
Strengths and weaknesses regarding food, supplement, and cosmetic uses.
Advantages of PET, HDPE, and PP include light construction, resistance to impacts, cost-effective, and versatility in design. They surely do make shipment easier in that breakages would be reduced, while allowing custom shapes of supplements and cosmetics. But plastics may require careful evaluation of barrier properties-one each regarding moisture, oxygen, and light-and safe migration performance under conditions of use. Glass, on the other hand, is chemically inert, readily sterilizable, and very prized for long-term storage of sensitive formulations, such as vitamins or cosmetics.
Glass provides a fantastic barrier to gases and light-mostly amber or opaque-and does not raise any questions about polymer leachables. Its drawbacks are that it is fragile, heavier in shipping weight, has a higher risk of breakage, and less flexible for novel shapes or closure options.
Eco-alternatives such as biobased resins, compostable films, and post-consumer recycled plastics are only some options that continue to rise in popularity because of their sustainability. Yet, many are still undergoing performance validation, with several open questions related to barrier properties, mechanical durability, supply-chain consistency, and regulatory status for food or supplement contact uses.
Recycled plastics and FDA’s “No Objection Letter” process for rPET
The only regulatory agency that formally reviews recycling processes for plastics to be used in direct food contact is the US FDA. Where the evidence in its “Use of Recycled Plastics in Food Packaging (Chemistry Considerations)” guidance indicates that the recycling process produces sufficiently pure resin for contact applications, it issues Letters of No Objection.
One important point: An LNO is not a blanket material “approval”; it means the FDA has no current objections for the specific process and intended use. Steptoe+1 Recent industry reports show an uptick in issuance of LNOs for recycled polymer processes beginning early in 2024. Brands considering PCR plastics must review the recycling process documentation, confirm the intended use falls within the LNO conditions and verify material quality and traceability.
Bioplastics, Compostable Films, and Bio-based Resins under FDA Review
Development continues on all types of biobased feedstock packaging materials, including but not limited to polylactic acid, bio-PE, compostable films, and mono-material laminate systems. Regulatory clearance for direct food contact or supplement contact is generally less mature.
To the extent these are FCSs, FDA’s framework would apply: migration studies, toxicology reviews, exposure assessments, suitability evaluation under 21 CFR Parts 174-186. For example, a brand considering using a compostable film in a snack package would need to demonstrate barrier performance, resistance to migration, and compatibility with the food or supplement product over intended conditions of storage/use. Absent robust data and approvals, many brands position bio-alternatives in secondary packaging versus primary food-contact layers.
Selecting Materials that Are Safe and Sustainable
Material selection involves a balancing of safety or regulatory compliance with performance, brand functionality, design/esthetics, and sustainability, including recycled content and recyclability.
Migration limits, barrier properties, and compatibility testing
Any time a packaging material comes into contact with a food, supplement or cosmetic product, the potential for chemical migration into the product must be considered. “Review of a food contact substance,” says the FDA, “includes … analyzing testing data that demonstrates the amount of migration of a food contact substance to food … and toxicological data to ensure that the consumer exposure resulting from this migration is safe.”
Although regulations do not always stipulate numeric limits on migration for every given material, they do call for proof that “there is a reasonable certainty of no harm” under conditions of use. Barrier properties of the material-its resistance to oxygen, moisture, light or chemical attack-must match the formulation’s stability needs. For example, a moisture-sensitive vitamin blend packaged in a low-barrier film may degrade prematurely.
Material traceability and supplier qualification under GMPs
The brands should spell out the qualifications of the suppliers, the specification of the material, change control procedure and traceability system. Components of packaging will be documented on suitability for food/ supplement contact-food contact notification (FCN) and LNO (Letter of No Objection). GMPs relevant to packaging-us and Record lots of materials used, audit suppliers, document packaging conversion or decoration processes and document artwork versions. Traceability leads to the supply-chain transparency with readiness for audit or regulatory queries.
Balancing Sustainability with FDA Compliance and Performance
Sustainability goals, such as increased recycled content, minimal packaging, mono-material formats, or compostable films, are now at the heart of the brand strategies. It is very important not to allow sustainability to weaken the key functions: product protection, regulatory compliance, and label integrity.
Consider a mono-material pouch made from a recycled film; it may achieve recyclability goals but fails any required migration tests-or if the labeling becomes illegible due to finish on the film, then the packaging may create regulatory risk. To protect compliance and brand value, sustainability decision-making should be embedded in packaging engineering, regulatory review, and performance testing.
Material Testing and Certification
It is recommended that testing and certification of packaging materials likely to come in contact with food, supplements, or cosmetics be done before being brought to the market. Validation shall be done through documented evidence.
Included among these are extractables/leachables, migration testing, and toxicology review.
Extractables/leachables testing involves what chemicals may leach from packaging under defined conditions. Migration testing simulates the contact of the packaging with product or a food‐simulant under relevant use conditions such as time, temperature, and food type. FDA “Preparation of Premarket Submissions for Food Contact Substances – Chemistry Recommendations” guidance describes recommended protocols; examples are sampling at 2, 24, 96, and 240 hours in migratory conditions. U.S. Food and Drug Administration Toxicology review links migration results to exposure assessments and evaluates risk relative to safe thresholds.
Third-party laboratories and FDA’s Center for Food Safety and Applied Nutrition’s
Extractables and migration tests are performed in third-party accredited laboratories. Compilation of data is carried out for the completion of regulatory submissions known as FCNs or internal compliance. Notifications for their safety and adequacy are evaluated by FDA’s CFSAN. To do that, the brand owner needs to compile validated test results along with traceable documentation and declarations from suppliers.
Documentation and certification for FDA audits
Materials used to package regulated products should be documented and available for regulatory review: resin manufacturer’s certificate of compliance, FCN number for that resin, test reports-migration/extractables, LNO letter for recycled plastic, supplier lot traceability, artwork, and packaging conversion records. It constitutes good documentation, forming the basis of readiness for inspection and strengthening brand integrity. Material certification can also involve proof of compliance with 21 CFR parts containing authorized substances, such as Part 177 (polymers) and Part 175 (coatings).
Emerging Trends in FDA-Compliant Packaging
Smart packaging, recycled resin approvals, and digital traceability
From embedded QR codes and digital traceability systems to interactive smart features, a range of technologies is being tried on by the packaging industry, promising not only brand enhancement but also additional consumer protection. These more recent innovations do not override the regulatory requirements but add further layers to the supply chain transparency. For example, the Food and Drug Administration admits that food-contact materials can contain recycled plastics, adding: “Through a voluntary program, the FDA reviews recycling processes to ensure that the recycled material is suitable for use in food contact applications.”
More and more FDA approvals for recycled resin, otherwise known as “No Objection Letter” or a favorable opinion route form part of the brand discussions relating to sustainability. However, the agency makes quite clear that such opinions are process-specific, and not broad material clearances.
Meanwhile, digital packaging-for example, a QR code linked to batch information or even material certification and sustainability credentials-is becoming increasingly common for tracking. In these cases, a digital layer will support audit readiness and supply-chain transparency. But the core components of the label-identity, quantity, and ingredient disclosure-need to remain on the package in physical form and be clearly communicated.
Updates on PFAS-free coatings and microplastic safety research
One of the most far-reaching changes in regulations has to do with per- and polyfluoroalkyl substances, better known as PFAS. Grease-proofing food-contact substances containing PFAS are no longer sold in packaging in the United States, according to an FDA announcement. In February 2024 the agency confirmed that 35 Food Contact Notifications pertaining to PFAS-containing substances used in grease-proof paper and paperboard packaging are no longer effective, marking a major step in addressing long-term exposure risk.
Science increasingly puts into the spotlight the microplastics used in packaging and their possible migration into food and beverages. Although FDA has continued reviewing the issue, brands are seeking future-proof designs that re-evaluate polymer selection, surface treatments, and recycling process controls because of emerging risks.
FDA sustainability initiatives and recent Food Contact Notifications
FDA’s Inventory of Effective Food Contact Substance Notifications is a searchable database of materials cleared for specific uses. U.S. Food and Drug Administration Brands looking to innovate-in areas including recycled content, mono-material formats and digital traceability-refer to these notifications or make certain that developed processes provide the needed validation in order to demonstrate compliance. “Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)” (July 2021) remains one of the key documents concerning sustainable material initiatives.
Taken together, these trends suggest that compliance does not stand still: the regulatory and material landscape continues to shift at an increasing pace, and packaging systems which embed sustainability, traceability, and material safety will continue to grow in relevance.
FAQs
Q 1: Is the reprocessed plastic FDA-approved for food contact?
No, not by default. FDA allows post-consumer recycled plastics under the food contact system but it is said that “acceptability would depend on the exact recycling process plus the intended use.” Guidance requires the manufacturer to show that “the finished material is suitable for use in food-contact applications.”
Q 2: How would you determine whether a given packaging resin is listed under 21 CFR Parts 174-186?
The FDA inventory of effective FCS notifications lists the substances authorized under those parts, along with the notifier, use limitations and conditions. Brands and converters should refer to the inventory and review the applicable conditions of use.
Q 3: Does FDA approve packaging suppliers or materials?
FDA does not, in general, “approve” packaging suppliers. It reviews the uses of substances through Food Additive Petitions or FCNs; materials listed in 21 CFR may be used within the conditions of use specified. Material compliance and supplier traceability should be assured by the brand companies rather than by blanket approval of suppliers.
Q 4: What does the FDA require as far as documentation is concerned regarding packaging audits?
Material documentation shall include resin manufacturer certifications, FCN or other clearance references, recycling process validation if appropriate, migration/compatibility test data and packaging conversion lot traceability. As the FDA said, it is traceability and documentation that are essential in any determination as to whether a substance can be safely used for its intended purpose. Steptoe
Conclusion
Material selection and compliance are one of the most important parts of sustainable innovation along the journey of safe and compliant packaging. Key take-aways:
Regulatory accuracy is important in that proper clearance for packaging materials-whether virgin or recycled-is an assurance of safety and compliance.
The two values of sustainability and traceability will be competitive differentiators but based on validated processes, material suitability, and documentation.
From PFAS migration to microplastics, a host of emerging risks, together with constantly changing regulations, act as an indication that the packaging systems should be designed for agility and transparency.
This includes certified sourcing, routing verification for compliance, and packaging with integrated traceability that enables brand trust and longevity of integrity in the U.S. market.
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