Introduction
The regulatory environment for the beauty industry is evolving at a rapid pace in 2026. For decades, the Food and Drug Administration (FDA) had limited authority over the cosmetic sector. However, the Modernization of Cosmetics Regulation Act (MoCRA) has granted the agency broad new powers. One of the most critical updates is the new draft guidance on records access during an FDA cosmetics inspection. This document outlines how investigators can request, review, and copy sensitive company data to ensure public safety.
Manufacturers must realize that the “voluntary” era of compliance is over. In the past, companies could often choose which records to share with investigators. Today, the FDA has the legal right to access safety substantiation, adverse event reports, and manufacturing logs. Understanding the nuances of this draft guidance is essential for any brand that wishes to avoid 483 observations or warning letters. This guide provides a deep dive into the new records access requirements and how they impact your daily operations.
The Legal Framework of MoCRA and Records Access
MoCRA provides the FDA with the statutory authority to inspect cosmetic facilities and access records related to safety. The draft guidance clarifies the scope of this authority. It specifies that investigators can access records if they believe a product is adulterated or misbranded. Furthermore, if a product poses a threat of serious adverse health consequences, the FDA can demand immediate access to all relevant data. This is a major shift that aligns the cosmetic sector with other highly regulated industries.
Failure to provide these records during an inspection is now a prohibited act. If your team is unfamiliar with how the FDA handles high-stakes data audits, you may find How to Prepare for FDA Data Integrity Inspections in Drug Manufacturing in 2026 useful. While cosmetics and drugs have different standards, the FDA’s approach to “truthful” record-keeping is becoming remarkably similar across all categories.
Key Records Subject to FDA Scrutiny
The draft guidance identifies several categories of records that are now subject to mandatory access. Safety substantiation records are at the top of the list. Every brand must have scientific evidence proving that their products are safe for intended use. If an investigator visits your site, they will ask to see these dossiers. They will check for toxicological profiles, skin sensitivity tests, and stability data to ensure the product remains safe over its shelf life.
FDA Draft Guidance for Industry: Cosmetic Facility Registration and Product Listing (2025 Update) – Link to Source
Investigators also have the right to review adverse event reports. Under MoCRA, brands must report serious health events to the FDA within 15 business days. During an FDA cosmetics inspection, investigators will cross-check your internal complaint logs with the reports submitted to the agency. To see how common failures in this area lead to enforcement, read Common Deficiencies Cited in FDA Cosmetic Inspections and How to Avoid Enforcement Actions.
Aseptic Processing and Manufacturing Records
For products like eye-area cosmetics or those intended for infants, manufacturing records are a major focus. The FDA wants to see batch records, cleaning logs, and environmental monitoring data. They are looking for evidence that your facility follows Good Manufacturing Practices (GMP). While the specific mandatory GMPs for cosmetics are still being finalized, the draft guidance makes it clear that investigators will access any record related to product contamination.
FDA Cosmetics Compliance Program Guidance Manual (CPGM) 7329.001 – Link to Source
Poor record-keeping in the lab or on the production floor is a fast track to a warning letter. This level of scrutiny is identical to what food processors face under FSMA. For a better understanding of how the FDA identifies systemic failures in manufacturing, look at FDA Food Facility Inspection Observations: Top Preventive Control Violations from Recent Reports. Both sectors are now under immense pressure to prove quality through documented evidence.
Digital Systems and Audit Trails
In 2026, most manufacturers use digital systems to manage their data. The draft guidance specifies that the FDA has the right to access electronic records. This includes not just the final reports, but the “metadata” and audit trails behind them. Investigators want to see who entered the data, when it was entered, and if it was ever modified. If a digital record is missing an audit trail, the FDA may view it as unreliable or fraudulent.
Managing these digital risks requires a validated IT infrastructure. If your facility uses automated systems for batch tracking or lab analysis, you must ensure they are compliant. Read Automation vs. Compliance: Managing FDA Risks in Digital Systems to understand how to bridge the gap between efficiency and regulation. A well-validated system makes an FDA cosmetics inspection much smoother by providing organized, tamper-proof records.
Responding to Records Requests During an Inspection
When an investigator makes a request for records, your team should have a clear protocol. The draft guidance suggests that manufacturers should provide records in a “timely and organized” manner. This means you should have a designated “Records Room” and a lead person responsible for gathering data. If you take too long to provide a record, it can be interpreted as an attempt to hide information, which triggers deeper scrutiny.
Modernization of Cosmetics Regulation Act (MoCRA) Section 607: Records Access – Link to Source
If an investigator detains a product because you could not provide a safety record, you must have an action plan. Check Post-Inspection Action Plans After an FDA Export Detention or Import Alert for Food Imports for strategies on resolving such crises. The legal process of responding to an FDA detention is very similar across all product categories. Quick and accurate documentation is your best defense.
Supply Chain Transparency and Vendor Records
The draft guidance also impacts how you manage your suppliers. The FDA can ask for records related to raw material sourcing and testing. You must be able to prove that your ingredients are not contaminated with heavy metals or prohibited substances. Brands are legally responsible for the accuracy of their ingredient lists, even if the data comes from a third-party supplier.
This requirement forces brands to audit their vendors more strictly. To see how other sectors manage these complex supply chain risks, read How New FDA Drug Facility Inspection Findings Are Impacting Pharma Supply Chain Compliance. A rigorous vendor qualification program is the only way to ensure your records are accurate from the source. In 2026, the FDA views a failure in the supply chain as a failure of the brand owner.
Analyzing Pharmaceutical Trends for Cosmetics
The cosmetic industry is currently where the pharmaceutical industry was twenty years ago regarding documentation. The FDA is applying “Pharma-lite” standards to beauty products. By looking at pharmaceutical trends, cosmetic QA managers can predict where the FDA will focus next. Recent trends show a heavy emphasis on “Quality Management Maturity” and proactive risk assessment.
Journal of Cosmetic Science: The Convergence of Pharma and Beauty Regulations (2025) – Link to Source
What FDA Pharmaceutical CGMP Inspection Trends Reveal from the Latest Warning Letters (2025-2026) – Link to Source
Manufacturers who adopt these high-level standards early will have a competitive advantage. They will experience fewer disruptions and build stronger trust with regulators. Preparing your facility for an FDA cosmetics inspection requires a shift in mindset. You must treat every record as if it will be read by a federal judge. This level of discipline ensures long-term market access and protects your brand’s international reputation.
Conclusion
The FDA draft guidance on records access is a clear signal that the cosmetics industry is entering a new era of accountability. MoCRA has given investigators the keys to your filing cabinets, and they intend to use them. By organizing your safety dossiers, validating your digital systems, and training your staff on records management, you can navigate an FDA cosmetics inspection with confidence. Compliance is no longer just a checkbox; it is the foundation of a modern, successful beauty brand in 2026.
FAQs
1. Does the FDA have the right to see my trade secret formulas? Under MoCRA, the FDA has broad access to records related to safety. While they respect trade secrets, they can access specific ingredient data if they believe a product is dangerous or mislabeled.
2. What happens if I refuse to provide a record to an FDA investigator? Refusal to provide required records is a prohibited act. It can lead to an immediate 483 observation, a warning letter, or even a court injunction against your facility.
3. Do these record-access rules apply to foreign manufacturers? Yes. Any facility that exports cosmetics to the United States must comply with MoCRA. The FDA can inspect foreign sites and request records through the importer.
4. How long must I keep my cosmetic safety records? Most regulations suggest keeping records for at least three to five years, but you should check specific MoCRA mandates as the FDA finalizes the rules in 2026.
5. Are “Professional Use Only” products subject to the same records access? Yes. Products sold to salons and professionals must meet all MoCRA safety and labeling standards, and their manufacturing records are subject to inspection.
6. Can the FDA request records remotely, or only during an on-site visit? The draft guidance focuses on on-site inspections, but the FDA is increasingly using “Remote Regulatory Assessments” to review digital data before arriving at a facility.
References & Links
- FDA Cosmetics Warning Letters Archive: Link to FDA – A database showing real-world consequences for record-keeping failures.
- MoCRA Official Implementation Portal: Link to FDA – The primary source for the latest updates on records access and facility registration.
- FDA Draft Guidance on Records Access for Cosmetics: Link to FDA – The official document detailing the scope of investigator authority during audits.
- Personal Care Products Council (PCPC) Compliance Tools: Link to PCPC – Industry guidance on how to organize your records for an FDA visit.
- 21 CFR Part 1: General FDA Enforcement Regulations: Link to eCFR – The legal foundation for all FDA inspections and records requests.
- International Nomenclature Cosmetic Ingredient (INCI) Standards: Link to INCI – Ensure your records use correct nomenclature to avoid mislabeling citations.
- Federal Register: MoCRA Statutory Mandates: Link to Federal Register – The official record of the legal changes that granted the FDA new records access powers.
