FDA Expands Records Access Authority for Cosmetic Products Under MoCRA

The U.S. Food and Drug Administration (FDA) has issued new draft guidance explaining how the agency plans to use its expanded authority to access and copy records related to cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For cosmetic manufacturers, importers, private-label brands, and contract manufacturers, the guidance signals a major shift toward increased regulatory oversight and documentation expectations. 

The draft guidance, titled “FDA Records Access Authority for Cosmetics Products,” outlines when the FDA may request records during inspections and investigations involving cosmetic products distributed in the United States. The agency explains that these authorities were added through MoCRA and now allow FDA investigators to access records connected to adverse events, safety substantiation, and potentially adulterated cosmetic products.

Historically, the cosmetic industry operated with far less FDA oversight than industries such as pharmaceuticals or medical devices. MoCRA changed that significantly by giving the FDA new powers related to facility registration, product listing, mandatory recalls, adverse event reporting, and records access.

What Records Can the FDA Access?

According to the draft guidance, the FDA may access and copy records involving:

  • Serious adverse event reports
  • Safety substantiation data
  • Consumer complaints
  • Investigation records
  • Manufacturing and distribution information
  • Documentation related to potentially adulterated products

The guidance also clarifies that refusal to provide requested records may be considered a prohibited act under the Federal Food, Drug, and Cosmetic Act.

The FDA states that it intends to protect confidential business information and trade secrets during inspections, but cosmetic companies should expect increased scrutiny regarding how records are organized, retained, and maintained.

Why This Matters for Cosmetic Businesses

For beauty brands and importers, the new guidance highlights the growing importance of compliance documentation. Even companies that outsource manufacturing or rely on overseas suppliers may still be responsible for maintaining records related to product safety and adverse events.

Businesses should understand that FDA record requests may extend beyond traditional manufacturing records and include:

  • Product testing documentation
  • Ingredient safety substantiation
  • Consumer complaint investigations
  • Supplier communications
  • Adverse event assessments
  • Internal quality control records (Passle)

Under MoCRA, records related to adverse events generally must be maintained for six years, or three years for certain small businesses.

Increased Focus on Safety Substantiation

One of the biggest operational changes under MoCRA is the expectation that cosmetic companies maintain evidence supporting the safety of their products. While the FDA still does not require premarket approval for most cosmetics, businesses must now be able to demonstrate that products are adequately substantiated for safety.

This means companies should maintain organized files containing:

  1. Ingredient safety reviews
  2. Product testing results
  3. Stability and microbial testing records
  4. Supplier certifications
  5. Consumer complaint investigations
  6. Adverse event documentation
  7. Manufacturing quality records

Companies without strong documentation systems may face increased compliance risks during FDA inspections or investigations.

Preparing for FDA Inspection and Records Requests

As FDA oversight of cosmetics continues expanding, cosmetic companies should begin reviewing their internal recordkeeping procedures now. Recommended preparation steps include:

  • Organizing adverse event reporting systems
  • Reviewing document retention policies
  • Maintaining centralized safety substantiation files
  • Verifying supplier and manufacturing documentation
  • Training staff on FDA inspection procedures
  • Reviewing marketing claims for compliance concerns

Importers and private-label brands should also work closely with contract manufacturers to ensure required records are accessible if requested by the FDA.

A New Era of Cosmetic Regulatory Oversight

The FDA’s draft guidance on records access authority reflects the agency’s continued implementation of MoCRA and its broader focus on cosmetic safety and accountability. The guidance makes clear that cosmetic companies are entering a new regulatory environment where documentation, traceability, and compliance systems are becoming increasingly important.

Businesses that proactively strengthen their recordkeeping practices and compliance programs will be better positioned to navigate inspections, reduce enforcement risks, and maintain consumer and retailer trust in a rapidly evolving cosmetic regulatory landscape.

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