Cosmetics & FDA MoCRA Compliance Consulting

At FDA Compliance Group, our FDA consultants have all worked for the FDA or have extensive industry cosmetics experience. We are a full-service consulting firm helping cosmetic and beauty companies meet FDA cosmetic compliance, MoCRA requirements, and Fair Packaging and Labeling Act (FPLA) obligations.

We can assist with helping you evaluate the safety of your formulations, review labels and website claims, submit color additive petitions, and help you determine whether your product is a cosmetic, OTC drug, or cosmetic/drug combination product. We can also assist with the 2022 Modernization of Cosmetics Regulation Act (MoCRA), including facility registration, product listing, and adverse event reporting requirements. FDA Compliance Group will also help with key regulations including prohibiting adulterated or misbranded products and requiring manufacturers to substantiate product safety, ensuring proper labeling and ingredient declarations.

Contact an FDA expert to discuss your MoCRA and FDA cosmetic compliance needs.

Understanding MoCRA and FDA Cosmetic Compliance

MoCRA is a compliance regulation for cosmetics companies that we can help you navigate. MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022 and is the most significant expansion of FDA authority over cosmetics since 1938. Key requirements include:

Facility registration and product listing with FDA
Good Manufacturing Practices (GMPs) for cosmetics
Safety substantiation before products go to market
Adverse event reporting and record keeping
Fragrance allergen labeling and accurate ingredient declarations

FDA Compliance Group will help you understand how these requirements apply to your products and build workable processes to comply.

FDA cGMP Compliance Audits and Gap Analyses

Through FDA compliance audits and gap analyses, we can assess the level of FDA compliance of your manufacturing, quality, and laboratory systems and counsel on the steps needed to fully comply with FDA requirements for cosmetics or cosmetic/drug combinations. Our services include:

MoCRA and FDA cosmetic compliance audits
cGMP audits and gap analyses
Due diligence audits for mergers and acquisitions
Mock FDA inspections and FDA inspection readiness
Product safety evaluations and documentation
Labeling and ingredient declaration reviews

Our goal is to identify gaps, prioritize risks, and help you implement realistic corrective actions.

FDA Inspections and FDA Warning Letters

FDA Compliance Group can guide you through the complicated process of responding to an FDA Form 483 (Inspectional Observations) or an FDA Warning Letter related to your cosmetic operations. Often, a well-constructed 483 response or FDA Warning Letter response can preclude additional regulatory action by the FDA.

We provide FDA Form 483 and Warning Letter response strategy and drafting support, FDA inspection preparation and on-site training, on-site or remote support during FDA inspections, and can assist with post-inspection remediation plans and follow-up if needed.

FDA Adverse Events

The experts at FDA Compliance Group can confirm that your record keeping and serious adverse event reporting (S/AER) is in full compliance with FDA cosmetic regulations and MoCRA. In case of a product recall or other regulatory action, we can provide best practices advice on the steps that need to be taken.

Our support includes S/AER process review and documentation, adverse event trending and assessment, and recall planning with crisis support.

FDA Specifications, Procedures, and Documents

We can write and help you implement cGMP-compliant procedures, work instructions, and protocols tailored to your products and processes. Our team supports you with quality and cGMP procedures for cosmetics and combination products, batch records, laboratory protocols, and “crisis management” plans. We specialize in Out-of-Specification (OOS) investigational report preparation.

FDA Research, Development and Claims Support

We provide project management services and strategic planning for all cosmetic research and development activities that are regulated by the FDA, including cosmetic labeling and claims review, cosmetic regulatory review of formulations and ingredients, stability programs and batch records, and deviation reporting and investigation.

Our goal is to align innovation with regulatory expectations from early development through commercialization.

FDA Qualification and Validation

We qualify and validate all of your processes, procedures, and equipment and ensure they are adequately documented. Our services cover:

Finished product testing
Weighing and blending operations
Facility and equipment cleaning methods
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Computer system qualification and validation for 21 CFR Part 11 compliance, including data collection and storage systems, ERP software, and laboratory information systems

Contact our FDA experts to discuss MoCRA compliance, FDA cosmetic compliance, and how the FDA Compliance Group can support your cosmetic or beauty brand today.