Navigating New Compliance Standards in Food & Pharma Labeling
In the packaging world, change is the new constant. From farm-to-fork traceability in food to unit-level serialization in pharma, 2024–2025 is bringing a wave of new labeling regulations. This article breaks down key updates in the U.S. and abroad – and how print providers and packaging specialists can adapt. We’ll explore recent FDA food labeling guidelines (FSMA traceability, allergen labeling, nutrition facts), the Drug Supply Chain Security Act (DSCSA) deadlines for pharmaceuticals, global standards like GS1 Digital Link and sustainability labels, plus real-world compliance mishaps. Finally, we’ll see how DPi’s variable inkjet systems (Digital Print, Inc.) support compliance with high-resolution, serialized printing and seamless integration into packaging lines.
FDA Food Labeling Updates (2023–2025)
Food manufacturers are facing new rules aimed at safety and transparency. The U.S. FDA has rolled out significant changes in recent years for food labeling. Key developments include:
FSMA Traceability Rule: In late 2022, the FDA finalized a new Food Traceability rule under the Food Safety Modernization Act (FSMA) Section 204. This rule mandates enhanced recordkeeping for certain high-risk foods, enabling rapid trace-back during outbreaks. Originally, all entities handling foods on the FDA’s Traceability List had to comply by January 20, 2026 (FDA Intends to Extend Compliance Date for Food Traceability Rule | FDA). However, recognizing the complexity, FDA announced in March 2025 an intention to extend the compliance date by 30 months (to mid-2028) to give the food industry more time. The rule doesn’t explicitly force on-label barcodes, but it demands a higher degree of supply chain coordination and data tracking. As a result, many producers are adopting 2D codes and lot codes on packaging to link to traceability records for faster, more accurate recalls.
Allergen Labeling (FASTER Act): Allergens remain a top compliance priority. In 2023, sesame became the ninth major allergen that must be clearly labeled on food packages, per the FASTER Act. This update means packaging artwork and ingredient lists had to be reworked across thousands of products. The stakes are high: undeclared allergens are now the leading cause of food recalls in the U.S., making up 63% of FDA food recalls in 2023 (Undeclared Allergens Are the Leading Cause of Recalls in 2023). Even a minor misprint or formatting error in the allergen declaration can trigger a costly recall. For example, failing to bold or name an allergen in the ingredients list is a compliance violation. Precision in allergen labeling – from typography to terminology – is essential to avoid endangering consumers and incurring penalties.
Nutrition Facts Formatting: The FDA’s revamped Nutrition Facts label is now fully in effect for all food manufacturers. The first major redesign in over 20 years, the new label format (mandated by rules updated in 2016) had compliance deadlines in 2020 (for large companies) and 2021 (for smaller ones) (Changes to Nutrition Facts Label Coming January 2021 - Gravel & Shea PC). As of 2023, every packaged food should display the updated panel. What changed? Key updates include a larger font for “Calories” and “Servings,” more realistic serving sizes, a new line for “Added Sugars” with % Daily Value, and in some cases dual-column labeling showing per-serving and per-package nutrition info. Vitamin D and potassium are now required, while vitamins A and C became optional, reflecting current public health needs. These formatting changes required label re-designs and, in many cases, new printing plates or templates. Print providers had to ensure high-resolution printing for the redesigned labels (especially as fonts got larger and bolded) and manage updated variable data (like revised Daily Values). Non-compliance – such as using the old format or misaligning the new elements – could invite FDA enforcement or warning letters.
Bottom line: U.S. food labeling compliance in 2024 demands agility. Companies must implement robust version control for label content (to track changes in allergens or nutrition info) and be ready to update labels quickly when rules change. Digital printing technology plays a vital role here by allowing fast changes and short-run printing of updated labels, reducing the risk of obsolete inventory. Print service providers can add value by guiding clients through these updates and ensuring FDA-compliant label layouts.
Pharmaceutical Packaging Serialization: DSCSA Deadlines (2024–2025)
Pharma is entering the era of full traceability, one package at a time. The Drug Supply Chain Security Act (DSCSA) – enacted in 2013 – set a 10-year roadmap for securing the U.S. pharmaceutical supply chain. By 2024–2025, the final milestones for DSCSA are coming due, reshaping how drug packaging is coded and tracked:
Unit-Level Serialization: Since 2017, drug manufacturers have been serializing prescription drug packages with unique product identifiers (including a GTIN/NDC, serial number, lot, and expiry in a 2D DataMatrix barcode). By 2019, wholesalers and repackagers were only trading serialized product, and by 2020 dispensers were expected to verify these identifiers for returns (DSCSA Frequently Asked Questions | McKesson). This means every individual saleable unit (bottle or box) carries a unique code printed on its label or carton – a massive increase in variable data printing compared to lot-level coding of the past.
Electronic Interoperable Traceability (2024 Enforcement): The DSCSA’s final requirement, originally set for November 27, 2023, is for an interoperable electronic track-and-trace system at the package level. By this date, all trading partners (manufacturers, distributors, pharmacies) are required to exchange transaction data electronically only, no more paper records (DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems | FDA). Recognizing industry needed more time to troubleshoot systems, FDA announced a 1-year “stabilization period” – effectively pausing enforcement until November 27, 2024. During this grace period, supply chain partners have been implementing and refining systems to capture and share the chain-of-ownership data for each drug package. After November 2024, regulators expect full compliance: pharmacies must be able to verify a drug’s origin and movement, and suspect or illegitimate products should be traceable within hours through electronic records.
2025 Phase-In for Partners: In late 2024, the FDA granted additional short-term exemptions for certain sectors to ensure a smooth phase-in. For example, manufacturers and repackagers have until May 27, 2025 to meet the new data exchange requirements, wholesalers until August 27, 2025, and larger dispensers until November 27, 2025 (DSCSA Frequently Asked Questions | McKesson). This staggered timeline means that through 2025, the industry will be debugging and fully operationalizing serialized track-and-trace. By the end of 2025, essentially every prescription drug package in the U.S. supply chain should be not only serialized but actively tracked in an electronic system.
Packaging and Workflow Impacts: For packaging teams, the DSCSA requirements have driven investments in printing and inspecting 2D barcodes on packaging lines. These DataMatrix codes (often just a 0.5” square) must be printed at high resolution and graded for quality so they can be scanned reliably down the line. Many manufacturers have installed inline thermal inkjet or laser coders on their packaging equipment to add these variable codes in real time. This requires robust integration between IT systems (for generating/verifying serial numbers) and printing equipment. Additionally, barcode verification systems (cameras and software) are used alongside printers to ensure each code is present and readable. Workflow-wise, serialization has introduced new steps: commissioning serial numbers, associating them with bundles/cases/pallets, and managing the data uploads to traceability networks. Print providers serving pharma clients have had to deliver extremely consistent print quality and may offer technologies like UV-cured inks for permanence and high-contrast printing on glossy cartons. The margin for error is slim – a smudged or missing serial code can render a whole batch unsaleable. The effort is worth it, as serialization greatly enhances patient safety by preventing counterfeit or diverted drugs.
In summary, DSCSA’s 2024–2025 phase is a game-changer for pharma packaging, making variable data printing a non-negotiable. Unlike static lot codes, serialization means every package is unique – a perfect scenario for digital print solutions that can handle high-speed, item-specific printing and data management.
Global Standards and Sustainability Labeling
Regulatory pressures aren’t limited to the U.S. Global markets are also upping the ante on labeling standards – from next-gen barcodes to eco-friendly labels:
GS1 Digital Link & 2D Barcodes: The familiar UPC barcode is evolving into something much smarter. GS1 – the global standards body – has introduced the GS1 Digital Link standard, which essentially turns barcodes into web-enabled data carriers. The idea is to move from 1D barcodes (UPC/EAN) to 2D codes (like QR or DataMatrix) that can contain a wealth of information beyond just an ID number. Starting 2027, many retailers worldwide plan to begin accepting 2D codes at checkout as part of this transition (Why Use GS1 Digital Link 2D Codes – Today?). These codes can encode the product’s GTIN plus “dynamic” data (expiry dates, lot numbers, URLs, etc.) all in one symbol. For brands and consumers, this is powerful: a single scan of a QR code could provide nutrition details, traceability info, recall warnings, or promotional content. For instance, a shopper in 2025 might scan a yogurt’s QR code and see sourcing info or allergy warnings in their language – directly from the package. Printing these 2D codes requires precision (to ensure they’re scannable), and often a shift in packaging design (allocating space for a square code). Forward-thinking packagers are already adding 2D codes to meet retailer and regulatory expectations. The GS1 Digital Link standard ensures that the codes are standardized so any scanner or smartphone can interpret them (e.g., a GS1 DataMatrix on a pharma box encodes a URL with the GTIN and serial). Overall, embracing 2D “connected” packaging is becoming an international trend, blending regulatory traceability with consumer engagement.
Figure: A shopper scans a food product with a smartphone, accessing details via a 2D code on the packaging. Global standards like GS1 Digital Link enable a single QR/DataMatrix code to convey product identity, traceability data, and consumer information in one scan.
Sustainability and Eco-Labels: Around the world, regulators are pushing for labels that drive environmental sustainability. In the EU, for example, the upcoming Packaging and Packaging Waste Regulation (PPWR) will require that packaging include clear recycling labels and even digital links to recycling information. A new EU rule (Regulation (EU) 2025/40) effective Feb 2025 mandates that labels indicate material composition and recycling instructions, and it explicitly allows the use of QR codes to convey detailed info. By August 2026, packaging in the EU market must comply, meaning products will carry standardized symbols (or QR codes) telling consumers how to dispose or recycle each component (EU Establishes Two New Packaging Regulations — InfoLawGroup LLP). Other regions have similar moves: e.g., France already requires a Triman logo and recycling info on consumer packaging, and many countries are implementing plastic recycling marks or eco-labels for green claims. For print providers, this translates to additional content on labels (more logos, possibly additional languages or QR codes for multi-region packs) and the need for flexibility. Sustainability info might differ by market – one country might need a recycling code, another a deposit label – so variable printing or short-run localization is increasingly important. Beyond recycling, we also see eco-seals (like organic, fair trade, carbon footprint labels) which often involve certification codes or dynamic data (e.g. a unique certificate number). The trend is clear: labels are becoming carriers of environmental data as much as marketing, and regulation is enforcing honesty and clarity in this space.
International Compliance Notes: Every market has its nuances. For example, EU food labels must list 14 allergens and often require multilingual labeling, which is a challenge for design and print (variable data printing can help produce country-specific versions efficiently). UK’s NHS is discussing adding QR codes on medicine packs to link to digital leaflets, replacing paper inserts. Asia and Latin America have their own serialization and food label laws (e.g., China’s pharma traceability or allergen laws in Japan). The overarching message for global manufacturers: one-size-fits-all labeling is dead. To stay compliant, packaging may need region-specific variants or very sophisticated label designs that tick all regulatory boxes – making agile printing workflows and data management a must-have.
Real-World Compliance Challenges and Lessons
Regulatory requirements aren’t just theory – they carry real consequences when not met. Let’s look at a couple of examples that highlight why meticulous labeling and coding matter:
Allergen Mislabeling Recalls: In late 2022 and 2023, numerous food companies faced recalls due to undeclared allergens, often from simple packaging errors. In one case, a labeling mix-up led to undeclared peanuts in a snack, prompting a nationwide recall and public warnings. The prevalence of such errors led FDA to report 313 food recalls in 2023, with nearly half (49.2%) due to undeclared allergens (a 27% jump from the prior year). These incidents cost companies millions in lost product and damage to brand reputation. A common root cause is printing or inventory mistakes – e.g., the wrong label applied to a product, or an outdated label template that omitted a new allergen. The lesson: robust label version control and verification on the production line is critical. Many firms are now investing in vision systems that check each label’s text (OCR) to ensure allergens are declared, or using digital print systems so that any label change (like “Contains: Sesame”) is updated across all products instantly without old stock lingering.
Pharma Packaging Mix-up: In early 2024, Azurity Pharmaceuticals recalled a lot of an ADHD medication after a pharmacist discovered a mislabeled package – the bottle had the correct label for 30 mg tablets, but actually contained a different drug inside (Mislabeled Packaging Results in Recalled ADHD Medication | TechTarget). This kind of packaging error (wrong contents in a labeled bottle) is thankfully rare, but when it happens, it’s serious. It highlights the importance of accurate coding and inspection in pharma packaging. Had the bottles been verified by scanning the product code and checking the contents, the mix-up might have been caught before distribution. In the DSCSA era, an incorrect product in a serialized bottle might also raise flags when hospitals or pharmacies scan it expecting a certain product code. The Azurity case led to a voluntary nationwide recall – an expensive remedial action. It underlines why traceability systems and human oversight must work hand-in-hand. Every barcode, every label, and every package must be correct; a single lapse can become a health hazard.
Packaging Code Quality Issues: Another challenge companies face is ensuring the printed codes (barcodes or QR) meet quality standards. For instance, a food producer might implement a new traceability QR code, but if their printer’s resolution is too low or the code is printed on a wrinkled part of the package, scanners can’t read it. This can lead to compliance issues – e.g., if a warehouse must scan the code for a traceability log and fails, that product might be held. A real example: when the EU’s pharma serialization went live, some manufacturers initially struggled with low contrast or slightly off-size DataMatrix codes, causing false rejection of authentic meds at pharmacies. The fix was better printing equipment and stricter quality checks. The takeaway: invest in high-resolution, high-contrast printing and test your codes under real-world conditions (scanning devices, different lighting, etc.).
These examples reinforce that compliance is not optional – it’s an everyday discipline. Print and packaging providers should treat compliance features (barcodes, content, formatting) with the same importance as branding and design. Many are now building in redundancies: for example, having both a human-readable expiration date and a machine-scannable code, or double-checking label artwork against regulatory checklists before print runs. It’s also wise to stay proactive: follow regulatory news, audit your labels/codes regularly, and learn from others’ mistakes.
Reshaping Label & Packaging Workflows for 2024–2025
All these regulations are fundamentally changing how labels and packaging are produced. The days of mass-printing one static label design and slapping it on every product are waning. Instead, we see workflows evolving in several ways:
Increased Variable Data Printing: Requirements like serialization, lot-specific traceability codes, or dynamic QR codes mean that every package can be unique. Printing has to be flexible enough to handle changing data on the fly – whether that’s a serial number incrementing for each unit, or switching languages and logos for different markets in a print run. Traditional analog printing (like flexography or offset litho) isn’t suited for this level of variation without halting the press. This is driving adoption of digital printing technologies (such as high-speed inkjet or laser marking) inline with packaging processes. Variable data printing software is now a key part of the workflow, taking in data from ERP/MES systems (for batch codes, serials, etc.) and merging it into the print stream. The result: packaging lines now often feature a digital print station just for the variable info, either printing directly on the package or on a label that’s applied.
Shorter Print Runs & Just-in-Time Labeling: Because of frequent regulatory changes and product updates, companies are reducing the size of print batches to avoid waste. It’s risky to warehouse a year’s supply of pre-printed labels – if an allergen law changes or a new barcode is required, that inventory is scrap. Instead, many are moving to just-in-time label printing, producing only what is needed for the next few weeks or months of production. This minimizes obsolescence. It also means print providers receive more frequent orders with smaller quantities, and they need the agility to turn around new artwork quickly. Digital label presses and modular print systems shine in this environment, as they can economically print small batches with variable content. For the workflow, digital asset management of label templates and data becomes crucial so that updates propagate correctly and old versions are retired promptly.
Integrated Verification and Traceability: Modern labeling workflows increasingly include verification steps. It’s not enough to print a code or text; you must verify it. Hence, packaging lines now commonly include vision systems or barcode scanners right after the print station, automatically checking that each label or code is present, correct, and legible. The data from these inspections often feeds back to a database (creating an audit trail that a given item was printed and verified) – important for compliance audits. Some advanced setups even have automated rejection, where any package failing the scan is kicked off the line for rework. All this integration requires that printing equipment can communicate and sync with inspection equipment and control software. It’s a more complex workflow, but it dramatically improves quality assurance and ensures compliance requirements (like 100% serialization) are truly met.
Collaboration Across Departments: Compliance labeling has broken silos between packaging engineers, IT, regulatory affairs, and printing specialists. For example, implementing DSCSA might involve the IT team for serial number systems, the packaging team for choosing appropriate printers, and the regulatory team for ensuring the human-readable text meets FDA guidelines. Workflows are therefore more cross-functional. Change management processes for label content are formalized – e.g., any label change might require sign-off in a software system and gets version-controlled. Companies are even using label management software that serves as a single source of truth for all packaging content, linking to regional regulatory rules. This ensures that when a rule updates, they can quickly identify which labels need changing. Print providers serving these clients often plug into such systems to receive the latest approved artwork and data.
In essence, compliance demands have injected speed, precision, and accountability into labeling workflows. High-resolution printing, dynamic data handling, and automated checks are no longer “nice-to-haves” – they are becoming standard operating procedure for anyone in the food or pharma packaging supply chain.
In conclusion, the evolving regulatory landscape in food and pharma is challenging but navigable. It pushes the industry toward better practices – safer food, more secure medicine, and more informative packaging. Embracing modern printing and data technologies is key to keeping up. Those who invest in the right tools (like versatile variable printers) and processes will find that they can meet compliance requirements and achieve efficient production. The label and packaging workflows of 2025 will be smarter and more integrated than ever, and they’ll play a vital role in protecting public health and safety. In this environment, companies like DPi and their high-tech printing solutions are invaluable allies, helping transform regulatory demands into streamlined workflows.
The Variable Voice will continue to monitor these trends and solutions – because in the world of packaging, the only constant is change, and together we can stay ahead of the curve. Here’s to printing compliance with confidence!
Sources: Supporting information drawn from FDA regulations and industry analysis (DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems | FDA) (Undeclared Allergens Are the Leading Cause of Recalls in 2023), Packaging Digest and FDA communications (Why Use GS1 Digital Link 2D Codes – Today?) (EU Establishes Two New Packaging Regulations — InfoLawGroup LLP), and Digital Print, Inc.’s product literature (Compact Variable Inkjet — Digital Print, Inc) (Digital Print, Inc | We Drive Variable Printing), among others, as cited throughout.