Manually reviewing product labels against FDA requirements is tedious and time-consuming, requiring cross-referencing multiple regulations, guidance documents, and precedents. A single labeling error can result in warning letters, product recalls, or market delays. Regulatory attorneys and compliance professionals spend hours meticulously checking every claim, warning, and panel requirement to ensure full compliance.
FDA labeling compliance requires meticulous review of complex regulations across multiple product categories, with non-compliance risking warning letters, product seizures, and costly recalls. Manual reviews are time-intensive, requiring regulatory experts to cross-reference dozens of CFR sections, guidance documents, and enforcement precedents. Even minor labeling violations can trigger enforcement actions that damage brand reputation and halt product distribution.
CaseMark automates comprehensive FDA labeling compliance reviews by systematically evaluating every required element against current regulations. Our AI analyzes principal display panels, information panels, claims substantiation, and mandatory warnings to identify compliance gaps and legal risks. Receive actionable recommendations with specific regulatory citations in minutes, ensuring your product labeling meets all FDCA requirements before market entry.
This workflow is applicable across multiple practice areas and use cases
Healthcare attorneys advising hospitals, pharmacies, and healthcare providers need to ensure medical products, devices, and pharmaceuticals comply with FDA labeling requirements to avoid regulatory violations and patient safety issues.
Healthcare law heavily intersects with FDA regulations as healthcare providers and institutions must ensure all medical products they use or distribute meet FDA labeling compliance standards, making this workflow essential for healthcare regulatory counsel.
Class action attorneys prosecuting or defending cases involving mislabeled drugs, medical devices, dietary supplements, or food products require comprehensive FDA labeling compliance analysis to establish liability or defense strategies.
Many class actions are predicated on allegations of improper labeling, false claims, or missing warnings on FDA-regulated products, making labeling compliance review essential for both plaintiffs establishing violations and defendants demonstrating compliance.
Commercial litigators handling product liability, false advertising, or breach of contract cases involving pharmaceutical, medical device, or food products need to analyze whether labeling complied with FDA regulations at the time of sale or alleged harm.
FDA labeling compliance is frequently a critical issue in commercial disputes involving product defects, misrepresentation claims, or regulatory violations, where attorneys must establish whether products met legal labeling requirements.
M&A attorneys conducting due diligence on pharmaceutical, medical device, food, or supplement companies need to assess FDA labeling compliance risks that could affect valuation, create post-closing liabilities, or require remediation costs.
FDA labeling non-compliance represents significant regulatory risk and potential liability in acquisitions of companies in regulated industries, making compliance review a critical component of regulatory due diligence.
Corporate counsel for pharmaceutical, medical device, food, and supplement companies need ongoing labeling compliance review to advise on product launches, label updates, and regulatory risk management.
In-house corporate attorneys at FDA-regulated companies regularly face labeling compliance questions as part of product development, marketing approval, and general regulatory oversight responsibilities.
CaseMark's labeling compliance review covers prescription drugs, over-the-counter drugs, medical devices, dietary supplements, conventional foods, and cosmetics subject to FDA oversight. The analysis adapts to the specific regulatory framework applicable to your product category, including specialized requirements for different product classifications. Each review evaluates compliance with the Federal Food, Drug, and Cosmetic Act and relevant sections of 21 CFR.
The system analyzes all express and implied claims against FDA regulations governing health claims, nutrient content claims, and structure/function claims. It cross-references claims with authorized claim databases, evaluates required disclaimers, and identifies language that could cause a product to be considered an unapproved new drug or misbranded device. The analysis also assesses whether the overall impression created by labeling is truthful and not misleading under FDA standards.
Yes, the compliance review systematically verifies all mandatory warnings, contraindications, and cautions specific to your product category and ingredients. This includes allergen declarations, pregnancy warnings, drug interaction cautions, and population-specific warnings required by regulation or guidance. The analysis also considers whether additional warnings may be necessary based on foreseeable misuse scenarios, even if not explicitly mandated.
CaseMark's compliance review incorporates current FDA regulations from 21 CFR, recent guidance documents, and enforcement precedents from warning letters and compliance actions. The system accounts for recent regulatory amendments, including updated nutrition labeling requirements and evolving FDA positions on emerging product categories. Each review includes specific regulatory citations so you can verify the applicable requirements independently.
The review categorizes violations by severity, distinguishing critical issues that render products misbranded from minor technical deficiencies. You'll receive specific corrective action recommendations with regulatory citations, implementation timelines, and risk assessments regarding potential enforcement actions. The analysis also indicates whether FDA notification or pre-market approval may be required for proposed labeling changes, helping you plan your compliance strategy effectively.