Regulatory & Compliance: What Clean Beauty Brands Need to Know
In clean beauty, innovation often moves faster than regulation. But in 2025, the landscape is shifting. With new oversight, expanded labeling rules, and rising retailer expectations, compliance is no longer a back-office task—it’s a brand strategy.
Whether you’re launching your first SKU or scaling into mass retail, regulatory planning now plays a central role in product development, marketing, and risk management. Done right, it becomes a competitive edge. Done late, it can stall your launch—or worse.
Here’s what’s changing—and how smart brands are adapting:
1. MoCRA is Here—and It’s Only the Beginning
The Modernization of Cosmetics Regulation Act (MoCRA) is now in effect, and enforcement is beginning to tighten. For U.S.-based brands, this means product safety isn’t just assumed—it must be documented.
What’s required:
Responsible Person (RP) designation with contact details on packaging
Product listings submitted to the FDA for each SKU
Full safety substantiation file (including toxicology, micro, and stability)
Fragrance allergen labeling coming soon
Why it matters: MoCRA is bringing cosmetics closer to how supplements and OTC drugs are regulated. Brands without proper documentation are increasingly flagged by retailers, platforms, and distributors.
What to do:
Set up compliant SOPs for safety assessments, adverse event reporting, and ingredient review
Work with a regulatory consultant to prepare product dossiers
Ensure your packaging, marketing, and website claims are in sync with MoCRA language
2. Labeling is Under the Microscope
In a crowded space, labels are being scrutinized not just by regulators—but by consumers, retailers, and platforms. Every claim now carries risk if not properly supported.
What’s required:
Clear ingredient lists using INCI names
Required declarations for net quantity, manufacturer/RP address, and batch code
Avoidance of drug claims or implied structure/function language without substantiation
Allergen declarations for EU export and upcoming U.S. changes
Why it matters: Label compliance is one of the easiest areas to get right—and one of the most common areas brands get wrong. Mistakes delay launches, limit distribution, and erode retailer trust.
What to do:
Review all PDP (principal display panel) and secondary panel language against current guidance
Avoid casual claims like “anti-inflammatory” or “heals” unless legally defensible
Prepare variant-specific labels early if launching multiple scents or sizes
3. Claims Must Be Substantiated—Period
As beauty brands expand into clinical and wellness-adjacent territory, claim substantiation is no longer optional. Regulatory teams and retailers are asking to see the data behind every promise.
What’s changing:
Platforms like Amazon and Ulta requiring documentation for key performance claims
Growing enforcement around green claims (“non-toxic,” “chemical-free,” “eco”)
Higher standards for "dermatologist tested," "clinically proven," and "safe for sensitive skin"
Why it matters: The FTC and FDA are both tightening enforcement, especially around deceptive or unsubstantiated claims in personal care.
What to do:
Support claims with appropriate testing (clinical, in-use, or lab studies)
Use conservative, specific language ("helps reduce the appearance of redness" vs. "cures rosacea")
Build a claim substantiation file alongside your formula development—not after
4. Ingredient Safety Is a Shared Responsibility
With the spotlight on safety, brands can no longer assume that supplier documentation is enough. Retailers and regulators expect brands to understand not just what’s in their formula—but how those ingredients function and interact.
What’s expected:
Up-to-date SDS and COA files for every raw material
Ingredient review for dermal safety, cumulative exposure, and known sensitizers
Allergen assessments, especially for EU and upcoming U.S. fragrance rules
Why it matters: Ingredient safety isn’t just about compliance—it’s about customer trust. Brands that manage this well avoid recalls, customer complaints, and negative reviews tied to sensitivity or reactions.
What to do:
Review each formula’s complete toxicological and microbial profile
Stay ahead of restricted substances lists (EU Annexes, Sephora Clean, Credo, etc.)
Audit your supply chain annually for updates in compliance documentation
5. Retailer Requirements Now Mirror Regulatory Expectations
Clean beauty retailers are raising their own internal standards—sometimes beyond what’s required by law. Meeting these expectations is essential for growth.
What’s happening:
Retailers requiring safety substantiation, MoCRA compliance, and clean ingredient lists before accepting new SKUs
Sephora, Ulta, Target, and others requesting in-depth ingredient disclosure and justification
In-house audits or third-party reviews becoming a prerequisite for shelf placement
Why it matters: Clean is no longer just a claim—it’s a documentation package. Being retail-ready now means being compliance-ready, too.
What to do:
Prepare a retailer-specific compliance binder for your top SKUs
Align your regulatory, R&D, and marketing teams early in development
Use regulatory documentation as part of your brand’s value proposition—not just a formality
Final Thoughts: Compliance is the Cost of Credibility
Regulatory isn’t just about boxes to check—it’s about building a brand that can last. As clean beauty matures, compliance is becoming the difference between a launch that scales and one that stalls.
The brands thriving in 2025 are:
Planning for compliance from day one—not after the formula is done
Using regulation as a growth tool, not a barrier
Educating their teams on what’s required—and what’s changing
Documenting everything: safety, claims, traceability, and intent
Because in this market, compliance isn’t just protection—it’s positioning.