FDA, MoCRA & GMP Compliance Expert Witness

Ethan Alden-Danforth, PhD — Cosmetic & OTC Personal Care Products

I provide expert witness and consulting services for litigation and regulatory matters involving FDA cosmetics law, the Modernization of Cosmetics Regulation Act (MoCRA), and Good Manufacturing Practice (GMP) compliance. As a senior cosmetics industry executive with over 15 years of experience in regulated manufacturing environments, I offer authoritative analysis of what the regulations require, how they are applied in practice, and where companies fall short.

MoCRA, enacted in December 2022, significantly expanded FDA's authority over cosmetic products and imposed new obligations on manufacturers and distributors — including facility registration, product listing, safety substantiation, serious adverse event reporting, and GMP compliance. Litigation and regulatory disputes arising from MoCRA obligations are an emerging and growing area where technically qualified expert analysis is essential.

Litigation & Regulatory Areas

MoCRA Compliance
Analysis of obligations under the Modernization of Cosmetics Regulation Act, including facility registration, product listing, safety substantiation requirements, and responsible person obligations.
GMP Compliance
Review of manufacturing practices against FDA's cosmetic GMP guidance and 21 CFR Part 111 (OTC drug GMP), including batch records, cleaning validation, and quality systems.
Safety Substantiation
Evaluation of product safety files, toxicological assessments, and safety substantiation documentation for adequacy under MoCRA and FDA standards.
Serious Adverse Event Reporting
Analysis of SAER obligations, reporting timelines, adequacy of post-market surveillance systems, and failure-to-report liability under MoCRA.
Cosmetic vs. OTC Drug Classification
Expert analysis of whether a product is properly classified as a cosmetic or OTC drug, and the regulatory and liability implications of misclassification.
FDA Enforcement Actions
Technical support for matters arising from FDA warning letters, import alerts, consent decrees, and enforcement actions related to cosmetic or OTC drug products.

Qualifications

I hold a PhD in Organic Chemistry from Johns Hopkins University and currently serve as Vice President of R&D for a cosmetic contract manufacturer. My career has been spent in regulated cosmetic and OTC manufacturing environments, where I have direct experience implementing GMP programs, managing FDA inspections, maintaining product safety files, and advising on MoCRA compliance obligations. I have worked alongside regulatory counsel on FDA-related matters and bring an operator's perspective to regulatory expert witness engagements.

Related Services

Contact

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Shelburne, VT • Nationwide Engagements
Phone: 610-246-5600
LinkedIn: linkedin.com/in/ethan-ad-phd
JurisPro: jurispro.com/expert/ethan-alden-danforth-9364