Frequently Asked Questions
General
What is LabelRx?
LabelRx is an AI-driven compliance platform that simplifies FDA regulatory reviews for health and wellness product labels. It helps businesses ensure their packaging and marketing materials meet FDA requirements with speed, accuracy, and peace of mind.
Who is LabelRx for?
LabelRx is built for supplement brands, skincare companies, nutraceutical firms, and other consumer wellness businesses that need to stay compliant with FDA regulations — whether launching a new product or maintaining an existing one.
Functionality & Features
How does LabelRx work?
LabelRx uses advanced AI (including OCR and NLP) to scan your product label, extract relevant data, and run it through a compliance engine mapped against the latest FDA guidelines. You receive an instant, detailed report outlining any regulatory risks or suggested changes.
What types of products does LabelRx support?
Initially, LabelRx focuses on dietary supplements, wellness products, and cosmetics — with future plans to expand into OTC drugs, pet products, and global compliance support.
Can LabelRx help with international compliance?
At this time, LabelRx is U.S.-FDA focused. However, we are planning Phase 2 expansions to include international standards like Health Canada and EMA (Europe).
What formats are accepted for upload?
LabelRx supports standard image formats (JPG, PNG) and PDF uploads for label scans or mockups.
AI & Accuracy
Is the AI reliable for regulatory interpretation?
LabelRx is trained on FDA documentation, warning letters, and compliance case law. Every review is backed by explainable AI logic and citation links to relevant FDA sources. However, for final legal sign-off, we recommend review by your regulatory advisor.
Does LabelRx offer human compliance review?
Yes. Users can optionally request a human compliance specialist to review the AI report and provide a final recommendation for high-risk products.
Security & Privacy
Is my product data secure?
Absolutely. LabelRx uses end-to-end encryption and secure cloud infrastructure. We do not share, sell, or use your uploaded label data for any purpose beyond your reviews.
Is LabelRx FDA-approved?
No. LabelRx is a third-party compliance tool. It is not affiliated with or approved by the FDA, but it operates using FDA regulations as its guiding framework.
Pricing & Access
How much does LabelRx cost?
Pricing is tiered depending on volume and use case (per-label, subscription, or enterprise API access). We offer free trial credits to new users for initial testing.
Can I integrate LabelRx into my product development workflow?
Yes. LabelRx will offer an API for enterprise clients who want to integrate regulatory checks directly into their internal tools, PLM systems, or approval pipelines.
Support & Roadmap
What kind of support does LabelRx offer?
We provide in-app guidance, AI chat support, and access to a compliance helpdesk. Enterprise clients receive a dedicated success manager.
What features are coming soon?
● Global compliance modules (EU, Canada, APAC)
● Batch label comparison tool
● Marketplace for third-party consultants
● AI-powered copy suggestion for compliant language
Getting Started
How do I start using LabelRx?
Visit LabelRx.com to create an account, upload your label, and get your first AI compliance report in minutes.
