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
医療製品部門、製品のラベル管理
当社を導入し、SAP と統合して以来、私たちは製造施設全体でラベル管理を拡大することができ、同時に新しいお客様の要望や追加の規制要件にうまく対応することができようになりました。
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
当社は現在、医療機器のグローバル市場へのアクセスを確実にし、必要に応じてラベルの内容をカスタマイズすることができるようになったため、製品承認の迅速化と規制遅延の削減につながっています。
Mark Illgner
ラベル開発シニアエンジニア
品質と生産の面において、当社はすべてのデータを一元管理し、現地で展開しています。これにより、常に正しいデータが印刷され、規制遵守が確保されています。
Lucy Webb
Technical Manager