Stay ahead of evolving FDA regulations with Loftware’s industry-leading labeling solutions. Designed for manufacturers and brands in food & beverage, pharmaceuticals, and medical devices, our cloud-based platform delivers the accuracy, control, and speed you need to ensure compliance, reduce risk, and protect your consumers - every step of the way.
The U.S. Food and Drug Administration (FDA) is the federal agency responsible for protecting public health by ensuring the safety, effectiveness, and proper labeling of food, beverages, pharmaceuticals, medical devices, and other consumer products.
For companies in regulated industries, the FDA sets strict guidelines around what must appear on product labels - including nutritional information, allergen declarations, ingredient lists, and health claims. These labeling standards are designed to promote transparency, prevent consumer harm, and support informed purchasing decisions.
Loftware helps businesses stay ahead of evolving FDA regulations with labeling solutions that ensure compliance, reduce risk, and streamline global supply chain operations.
Optimize accuracy and reduce errors by linking your labeling system directly with your ERP, MES, or PLM platforms. Automatically populate FDA-mandated fields such as batch numbers, nutrition facts, allergen declarations, and ingredient lists - ensuring every label reflects up-to-date, verified data.
Easily adapt to evolving mandates like Front-of-Pack (FOP) nutrition labeling using Loftware’s rules-based engine to adjust label size, layout, and content automatically. As the FDA promotes structured, standardized formats for better data consistency and accessibility, Loftware enables you to simplify labeling without managing countless static files.
Avoid costly recalls and ensure end-to-end compliance with U.S. and international regulations including CGMP, CFR 21, FSMA, UDI, GHS, FALCPA, EU 1169, the FDA traceability rule, SPL electronic labeling, Natasha’s Law, and FOP. Loftware enables you to manage all your compliance efforts from a single, secure platform - designed to scale with your business.
Gain enterprise-wide visibility into labeling activity to support faster audits, proactive recalls, and anti-counterfeiting efforts. Loftware’s centralized control framework ensures traceability from production through distribution - critical for FDA recordkeeping and reporting requirements.
Respond to updates like the FDA’s new definition of “healthy” without burdening IT. Business users can easily apply label changes, validate claims, and maintain compliance using universal templates - accelerating time-to-market and reducing the risk of manual errors.
Be ready for what’s next - from updated allergen labeling guidance to new plant-based product claims. Loftware’s configurable, cloud-based labeling solutions support rapid compliance with current and future FDA regulations - ensuring long-term flexibility and peace of mind.
With Loftware's cloud-based labeling solutions, we have been able to ensure compliance with FDA regulations and accelerate our go-to-market process.
Michael R. Kinnett
Product Labeling, Medical Products Division
Since installing Loftware and integrating with SAP, we have been able to expand our labeling footprint across our manufacturing facilities while successfully complying with new customer requests and additional regulatory requirements.
Tim Cukr
IT Professional
Loftware has significantly reduced our label turnaround time by 70%, ensuring that we meet FDA compliance requirements efficiently and accurately.
Randy Cochran
Project Manager
We can now ensure global market access for our medical devices and tailor label content as required, leading to faster product approval and reduced regulatory delays.
Mark Illgner
Senior Labeling Development Engineer
At a quality and production level, we have all the data centrally managed and deployed locally, ensuring the correct data is printed and in regulatory compliance at all times.
Lucy Webb
Technical Manager
