In this episode, I sit down with FDA compliance attorney Heather Butos to unpack two topics most cosmetic pros ignore until it’s too late: INCI (ingredient) names and MOCRA (the new cosmetic law).

We talk about how ingredient naming is not just labeling, it’s a strategic business decision that can make or break product marketing. Heather breaks down how the Personal Care Products Council influences naming conventions, why companies struggle to sell ingredients when they can’t describe them well, and what’s actually allowed under FDA rules.

We also dive into the Modernization of Cosmetics Regulation Act (MOCRA). We discuss what’s already in effect, what’s still vague, and why this transition period is both confusing and critical. Along the way we share real-world GMP audit stories, how COVID shaped compliance, and why walking the factory floor gives better regulatory insight than just reading guidance documents.

This is not your typical cosmetic compliance talk. If you make or sell cosmetics, personal care products, or ingredients, pay attention.

Show Notes (Bulleted)

• What are INCI names and why they exist
• The Personal Care Products Council and how INCI naming works
• How ingredient naming crosses into marketing strategy
• Real-world examples of label creativity and regulatory risk
• Making sense of MOCRA — what’s live, what’s stuck
• Why registration, adverse event reporting, and safety substantiation matter now
• What we still don’t know about cosmetic GMP enforcement
• GMP audits vs desk compliance — why experience matters
• U.S. vs EU regulatory contrast (quick take)
• Tips for staying compliant while FDA rules evolve

What You’ll Learn

• How to think about ingredient names as part of your product strategy
• What’s actually required vs what’s still vague in cosmetic regulation
• How the naming process works with industry groups
• How MOCRA changes the compliance landscape
• Real compliance lessons from factory audits

Resources Mentioned

• Personal Care Products Council
• MOCRA (Modernization of Cosmetics Regulation Act)
• Cosmetic registration and listing
• Adverse event reporting basics

Who This Is For

• Cosmetic brand owners and founders
• Ingredient suppliers and formulators
• Regulatory affairs professionals
• Legal and compliance teams
• Anyone confused by cosmetic labeling rules

Recommended Chapters (Timestamped)

Use these in Buzzsprout chapter markers:

0:00 — Intro
1:30 — What INCI ingredient names are
3:30 — How ingredient naming affects marketing
7:00 — Creative labeling and regulatory limits
10:00 — GMP audits and manufacturing reality
13:50 — What MOCRA is
16:30 — Which MOCRA rules are live
19:00 — What’s still vague or coming
21:30 — EU vs US differences
24:00 — Tips for compliance
27:00 — Outro

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Life sciences M&A is picking up again, but today’s deals look nothing like they did two years ago.

In this episode, Darshan Kulkarni sits down with Stephanie Trunk, Partner at ArentFox Schiff, to unpack what’s really driving renewed deal activity and what buyers are still missing in diligence. From U.S. manufacturing incentives and drug pricing exposure to China risk, DOJ enforcement, compliance culture, and AI, this conversation goes beyond headlines and into deal reality.

If you are buying, selling, or advising life sciences companies, this episode is a must-listen.

Key Topics Discussed

• Why life sciences M&A slowed down and why it’s back
• The shift from mega-deals to asset-specific acquisitions
• Why U.S. manufacturing location now affects deal value
• Accelerated approvals and “Buy America” incentives
• Drug pricing risks buyers can no longer ignore
• ASP, inflation rebates, Medicaid rebate cap removal, and 340B pressure
• Political risk in drug pricing and government scrutiny
• China partnerships, data transfer rules, and biosecurity concerns
• Direct-to-patient models and new HIPAA exposure
• Using Sunshine Act and other public data in diligence
• Compliance programs, culture, and successor liability
• Why compliance issues still rarely kill deals
• The emerging role of AI in diligence and enforcement
• The IP diligence problem no one wants to solve

Why This Episode Matters

Life sciences deals are no longer just about science and revenue projections. Manufacturing geography, pricing exposure, compliance culture, data security, and enforcement risk now directly shape valuation and post-close outcomes.

Ignoring these issues does not make them go away. It just shifts the risk to the buyer.

Guest

Stephanie Trunk
Partner, ArentFox Schiff
Life Sciences | CMS | OIG | Reimbursement | Fraud & Abuse

Stephanie advises pharmaceutical, biotech, and device companies on regulatory risk, government pricing, and transaction diligence.

📧 stephanie.trunk@afslaw.com

🔗 ArentFox Schiff Life Sciences Blog

Host

Darshan Kulkarni
Founder, Kulkarni Law Firm
Host, DarshanTalks

📧 darshan@kulkarnilawfirm.com

🔗 LinkedIn: Darshan Kulkarni

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If life sciences compliance, enforcement, or deals matter to your business, subscribe for more conversations like this.
Questions or ideas for future episodes? Reach out anytime.

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A brief discussion on the various cosmetic ingredients used by cosmetic manufacturers and the concerns FDA has recently found as a result of their own study into the process

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