Packaging and labeling are much more than a nice wrap or display; they are at the very heart of product safety, branding integrity, and legal responsibility. The serious consequences of non-compliant packaging may include misbranding, customs rejection, recall campaigns, enforcement actions, or reputational damage for an online seller or e-commerce brand operating in the United States. FDA Packaging compliance supports both functional needs of the product, such as protection, preservation of quality through shipping, and maintaining contents, and regulatory functions of conveying required information and ensuring materials are safe for contact.
Therefore, compliance risks undoubtedly rise as the products pipelined through numerous fulfillment hubs cross borders, sit on websites, and then unfold before end consumers. Thus, getting packaging and labeling compliance right with US regulations from the start is a way to avoid costly corrections, delays, or regulatory liability for a company.
The aim is to provide an understandable and up-to-date description of such requirements with links to authoritative sources in order for online sellers to understand how to build compliant packaging/label processes for the U.S. market.
How Online Sellers are regulated by the FDA
The Legal Framework: Federal Food, Drug, and Cosmetic Act (FD&C Act) & Other Statutes
The cornerstone of FDA authority is in the Federal Food, Drug, and Cosmetic Act, codified under Title 21 U.S.C. Chapter 9. Under the FD&C Act, the FDA has authority to regulate food, drugs, medical devices, cosmetics, and other products in interstate commerce. The Act prohibits the movement of adulterated or misbranded products-adulteration often refers to safety issues, and misbranding refers to packaging/labelling that is false, misleading, or incomplete.
Besides the FD&C Act, the Fair Packaging and Labeling Act plays a role in the packaging and labeling of many consumer commodities, requiring statements like product identity, manufacturer/distributor name, and net quantity. For those online sellers whose products are shipped or distributed across state lines or internationally into the U.S., these federal laws are applicable, anthe d FDA will expect compliance in packaging and labeling. Failure to comply with these obligations may result in regulatory action-warning letters, seizure, recall, fines-or impede market access.
Which Products Fall Under FDA Packaging/Labeling Jurisdiction (foods, cosmetics, devices, supplements)
While not all products sold online are within the direct purview of the FDA regarding packaging and labeling, many are. For example:
Foods, including dietary supplements, are under the purview of the food regulations of the FDA. The packaging and labels are also included under the food contact substance regulations, as well as labelling regulations.
Cosmetic products are regulated under the FD&C Act and are to carry essential labeling statements on the container/packaging of such; label requirements are given under 21 CFR 701, etc.
Labelling and packaging for medical devices and other regulated products also fall under the specific regulation controls, sometimes with differing requirements from “consumer goods”, for example, 21 CFR Part 211 for drugs/packaging materials.
The important thing, from an online seller’s perspective, is that any product positioned under one of these categories has to comply with the relevant packaging and labelling rules. In many cases, especially in e-commerce, several categories may apply-for example, cosmetics sold through an online marketplace might also ship food contact packaging. It is very important to make sure precisely which regulatory classification applies and to follow the associated rules.
E-commerce Challenges Faced Specifically by Online Sellers
Online commerce also poses special packaging and labelling challenges that go beyond those of traditional retail:
The package may well be listed digitally, shipped via several logistic steps, and received by an end consumer and not a retailer. This would mean that packaging has to protect the product, the label has to remain legible after transit, and third-party fulfillment has to preserve label integrity.
Images on an online listing should appropriately reflect the packaging and label statements. Any discrepancy in the image relative to packaging may raise potential issues of “misleading labeling” under the FD&C Act.
Products may cross state or international borders. For instance, a seller outside the U.S. shipping into the U.S. will need to account for U.S. regulatory requirements, including packaging materials that are safe for food contact if applicable, or labeling in English with the required information.
Returns and Repackaging: Additional concerns about reused packaging, damaged labels, or different containers lead to problems of misbranding or adulteration.
It may be more important for direct-to-consumer shipments, where the product is sent directly to a consumer’s home, to have tamper-evident measures than it is in retail shelf environments.
Inventory management and lot traceability are important: in the event of packaging that is not in compliance, an online merchant will have to manage recall flows or stop distribution quickly across many shipping nodes.
These challenges include that the packaging and labeling strategies must be considered in detail for the e-commerce environment, not simply transferred from traditional retail packaging without review.
Packaging and Labeling for Online Sales
Physical Packaging Requirements (materials, safety, contact substances)
Physical packaging is a way of enclosing and delivering a product by addressing the materials, construction, protective elements, and safety features. For products containing food or that have food contact surfaces, the FDA regulates the material makeup of packaging through its “Food Packaging & Other Substances that Come in Contact with Food” program. The agency requires that a substance coming into contact with food, in one way, must be authorized or otherwise safe for its intended use.
Thus, a packaging material intended to come into contact with food would generally need to comply with regulations under Title 21 CFR Parts 170 – 199. In this respect, an online seller must make sure packaging material-appropriate for food, dietary supplement, or any product coming into contact with food-is used: it should not leach harmful substances, be structurally adequate for shipping, and protect the product.
Documentation on food contact materials, conditions for safe use (temperature, pH, food type), and requirements for registration/certification may be relevant. In addition to the foregoing, international sellers shipping to the U.S. would want to take care that packaging materials meet U.S. requirements and not rely on non-U.S. standards. Tamper evidence, secure closures, child-resistant packaging where required for certain hazardous products, and packaging suited to shipment (e.g., cushioning, moisture protection) are part of the physical packaging compliance matrix in e-commerce.
Labeling Requirements on the Physical Package-mandatory statements, net quantity, manufacturer info
Labeling is an important part of compliance, and it is for the physical container/pack, not just on the listing or website. According to the FDA “Guidance for Industry: Food Labeling Guide”, food labels shall bear required statements: identity of the food, net quantity of contents, name and place of business of the manufacturer/packer/distributor, ingredient listing, nutrition facts panel, and allergen declarations.
For cosmetics, the FDA summary of cosmetics labeling provides that the label shall bear the name of the product, the net quantity of contents on the principal display panel, the name and place of business of the manufacturer/packer/distributor on the information panel, and the country of origin, if applicable. In the context of e-commerce packaging, this means the outer shipping package and consumer-facing product box/envelope must still carry the required labeling information in a durable, legible format.
Claims made on the packaging must not be false/misleading. The Fair Packaging and Labeling Act further provides that net quantity shall be expressed both in U.S. customary and metric units where applicable. Federal Trade Commission.n Because many e-commerce packages may be smaller, variations in layout could occur, but the required information cannot be omitted. Sellers shall ensure labels survive shipping, are readable, and the format meets regulation, e.g., minimum type size, placement, and prominence, as set forth in the applicable regulations.
Product Photos and Label Accuracy in Online Listings
Why the Online Visual Listing Needs to Match the Label & Packaging
In the world of e-commerce, the product listing represents the first touch between a brand and the consumer. The image of the packaging and label viewed in the digital marketplace must be truly representative of the physical product that arrives at the consumer’s door.
If the visual listing shows a label claim, design, or wording different than what actually appears on the package, that disparity alone may create misbranding under the entity [ “organization”, “Food and Drug Administration”, 0] (FDA) regulations. For example, the FD&C Act gives the FDA authority to take action against any product whose “labeling is false or misleading in any particular” — a trap into which online listings can fall too easily.
Moreover, the FDA has specifically requested information about how food label information is presented on e-commerce platforms. In a recent Federal Register rulemaking, the FDA discussed the “content, format, and accuracy of food label information that is presented to consumers through online grocery shopping platforms.” Federal Register
This serves to ensure that, from a compliance-safe risk management perspective, the product photo, description, outer box, and inner label are all in sync to minimize regulatory risk, warning letters, import refusals, and recalls. This will also help support consumer trust and lower the logistical or reputational costs due to incorrect packaging or label claims.
Common Mistakes – Misleading photos, truncated labelling, missing info
Several common issues arise in the context of online e-commerce product listings. These include:
Misleading photography: The listing photo shows a promotional label or claim that is larger, more prominent, or different than what appears on the real product packaging. That difference means the consumer may be deceived. Under the FDA’s “misbranding” standard, a product’s labelling is misbranded if it bears “false or misleading” statements.
Truncated or partial label presentation: Images on foods or cosmetics may be missing an ingredient list, net quantity statement, or name of manufacturer. Alternatively, images may only show the front of the package and not display required fields. For foods or cosmetics, when all required panel information is not shown on the actual package, it creates a risk of non-compliance.
The website does not show all the label information required. Examples include allergen warnings, nutrition facts panel, country of origin, and net quantity. Otherwise, the website shows an image without outer packaging, which is an abstract representation. One reason imports are refused, according to the data on FDA import refusal, is because of “missing nutritional information”.
Inconsistent design: The picture online may not be consistent in design with what is shipped; for example, shipping could use different packaging than what was shown, after bulk fulfilment, repackaging, and label changes that may or may not appear in the online catalogue. Inconsistency here invites consumer complaints or even regulatory interest.
Alternative packaging available, listing shows older version: The item has variations of packaging; for example newly updated label or different branding, but the listing shows the older version. That might raise some questions as to whether the “principal display panel” is what the consumer gets.
Each of these mistakes has the potential to increase the likelihood of the product being considered misbranded or improperly labeled under federal law and will chip away at the integrity of the brand in the digital marketplace.
Tips & Best Practices for Photographs, Zooms, Label Close-ups
The following best practices will minimize risk and provide a professional online listing that meets regulatory expectations:
Images would include high-resolution shots of the full pack-out packaging, which is the outer box or envelope, the front principal display panel, the information panel that contains ingredients, manufacturer name, net quantity, warnings, and any secondary panels. Such images help the consumer and support compliance.
The close-up shots of the critical elements, such as net quantity, allergen statements, name & address of the manufacturer/distributor, lot/batch number, and expiration date, all should be legible and exactly match the actual product.
Verify Listed Photo against Actual Shipment: The photo listed on the web must match what is being shipped, especially if several versions are available. If there is more than one version, the listing must identify which version is photographed or which one will be shipped.
Consistent label claims: Any claim made online, such as “now improved formula”, “25% more”, “serves 30”, should be precisely matched on the physical packaging. If the online image depicts a promotional sticker graphic and the actual product in the store doesn’t, that can create mismatch issues.
Showing multiple angles allows the consumer to view side and back panels, which display the content necessary for an informed purchase, and avoids surprises upon delivery.
For e-commerce systems that support zoomed-in or 360-degree views: label information should be readable at multiple zooms. Small print warnings should be similarly readable.
Include clear shipping/package photos when the outer shipping carton is brand-neutral but the inner product packaging is branded. This helps avoid confusion at delivery and gives more transparency to the product.
Retain archived copies of listing images, including dates of image updates. This will help you establish proof, in case of a regulatory inquiry or complaint, that the listing represented the product shipped at the time.
Prelisting Audit: Compare images/text in online listing to actual packaging and labeling for alignment. Document any variation and justify it.
Thus, an e-commerce retailer, by adhering to these practices, ensures that what the consumer gets is exactly what they see; it also helps in fulfilling regulatory requirements with regard to correctness and transparency in labeling.
Legal Implications of Misrepresentation or Non-compliance
Failure to make sure the listings are correct and the packaging/label is aligned can lead to serious legal consequences on a regulatory basis. Important points are:
The FD&C Act, and its implementing regulations, consider a product to be misbranded if its labeling (which includes packaging as well as online representations) is false or misleading in any particular.
In the context of online listings, the FDA’s April 2023 Request for Information on “Food Labeling in Online Grocery Shopping” suggests that the agency is actively considering how platform-based listings must present accurate label information and that inaccurate online labeling may trigger enforcement action.
Deceptive imagery online can be the basis of warning letters, product recalls, seizures, import refusals – for imported products – or regulatory sanctions. For example, almost all products are refused upon importation if labeling or packaging is not in compliance with set regulations.
Non-compliance may result in brand reputation damage, more returns, increased scrutiny leading to suspensions from marketplaces, and loss of consumer trust.
For example, differences between what is claimed online and what actually is on the packaging may sometimes expose the brand to liability under consumer protection laws, false advertising statutes, or state-level deceptive trade practice acts. While not purely FDA enforcement, at times, regulatory agencies coordinate
For regulated product categories – such as medical devices, drugs, and some cosmetics, for instance – the stakes are higher: misrepresentation online can be considered a change in “intended use” that may bring about new regulatory requirements or enforcement.
In other words, the online presentation of the product is part of the regulatory puzzle in its entirety: precise and uniform visuals and label information are not simply best practice; they form part of compliance.
Returns Handling, Tamper-Proof and Secure FDA Packaging Compliance
Returns in eCommerce: How to Manage Packaging, Labels, and Re-stocking Safely
E-commerce returns introduce a substantial degree of complication associated with packaging and labeling compliance when the returns are restocked or resold. Key considerations include:
Return product packaging should be checked to ensure that the label is intact, legible, and unchanged. In an event where the label is torn, lacks information critical to the label, or the label has been tampered with in any way, the product may no longer conform to the requirements established for labeling.
Re-boxing into a new box or re-sealing in such a way that alters the presentation or labelling of the original product box creates compliance risk unless the new package also meets all label requirements – net quantity, manufacturer information, lot/traceability, etc.
A procedure for items shipped in outer fulfillment packaging–for example, an unbranded shipper box over and above the branded product box–must exist that ensures the consumer receives the original or compliant branded packaging, the label is not obscured, altered, or destroyed during shipment or return.
Lot numbers or batch numbers shall remain with the product lots being repackaged or refurbished, to facilitate recall, and for recordkeeping purposes also.
Returns policy: This should state when the materials can be accepted back. In case the packaging/seals are broken, the label is illegible, or the inner container is altered, it may have to be destroyed rather than put into stock. These practices cover consumer safety, brand integrity, and compliance.
Documentation for the repackaged items should be done, indicating that the label information is unchanged and that the product is in its original state. This would help if audited or challenged by regulators to prove the integrity of the saleable item returned to stock.
Tamper Evident Packaging: When Required and Why
A number of categories of products require either tamper-evident or tamper-resistant packaging. For many consumer goods being sold online, it is fast being regarded as best practice. Key points:
Tamper-evident packaging is called for OTC human drug products under 21 CFR § 211.132. The rule calls for one or more indicators or barriers to entry that provide visible evidence of tampering.
Cosmetics – Tamper-resistant packaging for some cosmetics is detailed under the FDA Compliance Policy Guide section CPG 590.500, which cites 21 CFR 700.25.
FDA Compliance Policy Guide section CPG 450.500 outlines policy for tamper-resistant packaging of certain OTC human drug products.
The rationale: Tampering can adulterate and contaminate the product and thus harm the consumer. In online direct-to-consumer shipments, which bypass retail display scrutiny, tamper-evident packaging is even more critical.
Even though a product category is not strictly required to have tamper-evident features, incorporating such features – shrink wrap bands and breakable seals are examples – into the pack will help demonstrate robustness of the packaging system and reduce regulatory or consumer liability.
Tamper-evident packaging labelling must include a statement alerting the consumer to the specific feature(s) used – for example, “For your protection, this bottle has an imprinted seal around the neck”. This statement must be so placed that it remains with the product even if the tamper-evident feature is breached or missing.
Shipping – Damage Resistance and Maintenance of Label Legibility
Shipping online introduces a set of risks not necessarily faced by physical retail channels, including movement across carriers, multiple handling points, variable environmental conditions, and extended shelf and/or transport times. Some key practices relevant to compliance include:
Outer shipping packaging must be designed so that the internal consumer-facing package is not subjected to crushing, moisture, or abrasion that could render label text, bar codes, lot numbers, or expiration dates illegible. A damaged label may be considered an inadequate label under regulatory standards.
Ensure that packaging is sealed and remains intact throughout transportation; if primary packages arrive open or compromised during transportation, such as torn packages or peeling of labels, it may raise suspicion of either tampering or problems in maintaining product integrity.
The printing of labels should use robust inks/print processes to ensure that the results of transit handling (e.g., rubbing, scuffing) do not obliterate required label information. Blurred or missing text could precipitate noncompliance.
Conditions of shipment: Temperature, humidity, and stacking impact the design of packaging to protect the product and the label. If a product requires temperature-controlled logistics and the label cannot withstand heat or condensation, and it gets destroyed, one could be liable.
Tracking and documentation post-shipment: Keep records that prove the product moved through acceptable channels, and it arrived in compliant packaging. Inspect returns for damage, and check whether the label is intact and in compliance.
When shipping a product to the Fulfilment Centre, repacked or co-packed together with other items – for example, bundle deals – ensure that the label is still in view, undistorted, and no additional packing obscures required information.
Post-Sale Compliance: Recordkeeping, Batch/Lot Info, Traceability
Post-sale compliance is equally important as the sale itself. An online seller should have practices to support traceability, recall capability, and evidence of compliance. They include:
Specify batch/lot number, manufacturing date code, expiration date, and packaging version number for each shipment to facilitate tracing of individual units in case of a defect or regulatory problem.
Store an archive of package versions and label versions with dates, such that it would be possible to show what packaging version was shipped to which customer. Later, if there is a packaging change, list images are updated and the version history documented.
Record returns and restocking, and document the final disposition on returns that are not resold but may be destroyed, recycled, or repackaged. This helps in audit readiness, reducing risks in mixing non-compliant units back into inventory.
Because these can serve to document recalls or investigations, packaging/label design records, packaging supplier specification, tamper-evident feature specification – where applicable – and shipping package design with records of fulfilment are indicative of proactive compliance.
Submission of reports, adverse event tracking, or consumer complaints related to packaging/labeling for regulated products-foods, cosmetics, devices, drugs is expected according to FDA regulations. The same logic applies to non-regulated consumer goods, although the requirement for traceability may be less frequent.
Any change to packaging or labeling-even including minor changes, such as color or change in layout-is documented under change control, and the regulatory implications of such changes are assessed. For example, if there is a change in the label claim, then this could trigger new regulatory review or pre-clearance requirements.
Real World Compliance Examples
Case Studies of Successful eCommerce Brands Doing Packaging Right
While publicly documented examples of e-commerce brands excelling at packaging compliance are less common, they generally follow a few clear patterns: transparent labeling, robust tamper evidence, adherence to online versus offline consistency, and full traceability.
For example, one brand may change its packaging version but ensure every photo in the online listing is of the exact version shipped; another may use a dedicated lot number and print it on every unit so as to be able to facilitate quick recall if needed. These build trust with consumers, reduce returns, and minimize regulatory risks. Including these operational measures-version control, label audit, shipment verification-means steps to ensure regulatory compliance are baked into the brand’s supply chain, not retrofitted onto it.
Examples of FDA Actions or Recalls due to Packaging/Labeling Errors
Various enforcement actions and recalls illustrate the regulatory risks presented when packaging or labeling does not meet the requirements of the regulations:
In December 2020, Whole Foods Market received a warning letter from the Food and Drug Administration for repeatedly selling misbranded foods under its store brand label. Undeclared allergens in labelled products were an issue of concern – it had recalled more than 30 store-brand products were recalled due to failure to declare major allergens.
A recap of recalls through Q3 2025 notes that packaging-related failures, including mislabeling and particulate contamination linked to packaging breaches, as well as sterility failures in devices, continue to be a driver of enforcement.
Even packaging facilities themselves have been cited: for example, the facility of GenPak Solutions was cited with a warning letter in 2016 for CGMP violations, including inadequate packaging controls, misbranding, and releasing repackaged drug products without proper assurance of quality.
The following examples illustrate that packaging and labeling errors are not theoretical risks but translate into real recalls, warning letters, and business disruption.
Conclusion & Next Steps for Online Sellers
Compliance with packaging and labeling for online sellers in the U.S. is secured within the regulatory framework comprising the FD&C Act, the FDA’s rules on materials and labeling, and the increasingly scrutinized e-commerce channel.
The different disparate elements in packaging and labeling have to do with physical packaging materials, particularly food contact; accurate and complete labeling that covers net quantity, manufacturer or distributor, and ingredient/allergen list, among others, with contact information; consistency of packaging and labeling with the visuals of online listings; special logistics considerations in an e-commerce environment, including shipping damage, returns, and tamper evidence.
Any misstep in those areas-a photo of a listing that does not match the shipped product, missing statements in a label, non-complying packaging materials-could lead to possible enforcement actions, recalls, or reputational harm. Real-life cases demonstrate how brands and packaging facilities have fallen short and consequently received regulatory scrutiny or worse.