The U.S. beauty industry is entering a new regulatory era in 2025. Whether you're a salon owner, skincare startup, contract manufacturer, or an international exporter, the changes brought by the Modernization of Cosmetics Regulation Act (MoCRA) and new state-level chemical bans are reshaping how beauty businesses operate and compete.

In this post, we’ll break down what’s changing at the federal and state levels, how it affects your business, and what you can do now to stay ahead of the curve. This is not another templated “compliance checklist.” Instead, we’re here to help you understand real implications and offer grounded strategies tailored for B2B operators.

🇺🇸 Section 1: MoCRA – A Regulatory Revolution, Not Just a Reform

The Modernization of Cosmetics Regulation Act (MoCRA) is far more than a policy update—it's a foundational shift in how cosmetics are regulated in the United States. Enacted in 2022 but phased in gradually, 2025 is the critical year when many of its major enforcement elements take effect. For any business operating in the U.S. beauty market—manufacturer, brand owner, distributor, or importer—MoCRA compliance is now legally mandatory.

1.1 Facility and Product Registration: No More Voluntary Listings

Before MoCRA, cosmetic facility and product listings with the FDA were voluntary and largely symbolic. That era is over.

As of July 1, 2024, all manufacturing and processing facilities—whether domestic or foreign—must register with the FDA. In addition, each cosmetic product must be individually listed with details about:

 · Product name and category

 · Ingredient list (INCI name)

 · Facility location and contact

 · U.S. agent (for foreign firms)

By early 2025, over 9,500 facilities and nearly 590,000 products had already been registered with the FDA’s Cosmetics Direct portal—a huge leap in transparency.

Pro Tip for B2B Sellers: If you contract out production to a third-party manufacturer, you must confirm they are registered or you risk liability as the “responsible person.”

1.2 Safety Substantiation Requirement: No Evidence, No Market

Under MoCRA, every product sold in the U.S. must have “adequate substantiation of safety”—a legal standard requiring:

 · Toxicological risk assessments

 · Ingredient safety data from reputable sources (e.g., CIR, SCCS, EPA)

 · Human and clinical safety testing (when applicable)

This documentation must be readily available and provided to the FDA upon request.

Why it’s critical: If your product is found to lack safety substantiation—especially if linked to adverse effects—the FDA can mandate a recall or seize inventory. Lack of documentation is not just risky—it's now illegal.

Reality for Small Brands: Many indie brands have relied on supplier spec sheets or anecdotal testing. That’s no longer enough. If your ingredient supplier can’t produce toxicological evidence or SDS (Safety Data Sheet), you may need to re-source or reformulate.

1.3 Adverse Event Reporting and Record-Keeping

Another game-changing requirement: the “responsible person” (brand owner or label holder) must report serious adverse events to the FDA within 15 business days.

A "serious" event includes:

 · Hospitalization

 · Infection

 · Permanent damage

 · Death

Companies must also keep 6 years’ worth of complaint records—even if the incident occurred after purchase or via a third-party retailer.

 Practical Tip: Your complaint form and customer service process should now include:

 · Lot number/batch ID tracking

 · Standardized report forms

 · Escalation flow to the compliance team

Ignoring a complaint could now result in federal scrutiny.

Section 2: State-Level Chemical Bans – The Rise of “Toxic-Free” Mandates

While MoCRA sets the federal baseline, several U.S. states are introducing far stricter cosmetic safety standards—focusing especially on endocrine disruptors, allergens, and persistent pollutants.

2.1 Washington State Toxic-Free Cosmetics Act (Effective Jan 1, 2025)

Washington is now the most aggressive U.S. state in banning “chemicals of concern” from personal care products. Under its new law, manufacturers must not sell cosmetics containing:

 · Formaldehyde and formaldehyde-releasing preservatives (e.g., DMDM hydantoin, quaternium-15)

 · Lead, mercury, and other heavy metals

 · PFAS chemicals (used for waterproofing, stain resistance)

 · Phthalates (e.g., DEP, DEHP – plasticizers used in fragrance)

 · Triclosan, a known antimicrobial with hormone-disrupting effects

The law applies to products sold within Washington, regardless of manufacturing origin. Noncompliant products will be pulled from shelves and barred from e-commerce platforms shipping into the state.

🎯 Full List of Banned Chemicals – WA Dept. of Ecology

2.2 California, Colorado, and New York: Following Suit

California already prohibits 24 cosmetic ingredients banned in the EU, and is phasing out PFAS in cosmetics by 2025. Colorado has introduced similar PFAS bans, and New York is moving toward more stringent disclosure laws.

For national brands, this means:

 · You must track state-by-state compliance.

 · In many cases, you'll need to reformulate to the strictest standard and apply nationwide—especially if you sell online.

Challenge for Manufacturers: Raw materials (like mica, talc, or botanical extracts) may have trace contaminants that push a product over legal thresholds—even without being intentionally added.

Compliance Tip: Request batch-specific COAs (Certificates of Analysis) from ingredient suppliers and test final formulations for trace PFAS or metals where required.

Section 3: The End of Import Exemptions – FDA to Screen All Shipments

Starting July 2025, the FDA will begin inspecting all cosmetics imports, including those valued under $800.

Previously, under the de minimis rule, products shipped via courier (FedEx, DHL, USPS, etc.) below this value were exempt from inspection—allowing many gray market or non-compliant brands to fly under the radar.

Not anymore.

3.1 Why It Matters

The FDA’s updated screening will:

 · Block non-registered products from clearing customs

 · Delay shipments with incomplete documentation

 · Penalize foreign sellers using U.S. fulfillment centers without proper FDA facility listing

For many Amazon, Shopify, or TikTok Shop sellers importing products directly from overseas, this means:

 · You need FDA-registered production partners

 · Your packaging and labeling must meet U.S. standards

 · Each SKU must be matched with a registered listing

3.2 U.S. Agent Requirement for Foreign Brands

Foreign manufacturers must appoint a U.S.-based agent responsible for:

 · Communication with the FDA

 · Receiving legal documents

 · Assisting in inspection coordination

Failing to designate a U.S. agent will result in automatic import denial.

Pro Tip: Use experienced U.S. compliance firms or regulatory agents who understand MoCRA, not just general freight brokers.

The Good News – Long-Term Benefits for Compliant Brands

While these new regulations might seem overwhelming, they offer significant advantages to brands that are ready to adapt:

- Consumer Trust: Safer, well-documented products boost your credibility.

- Competitive Advantage: Small and unregulated players will likely exit, leaving more room for serious businesses.

- Global Alignment: MoCRA brings the U.S. closer to EU-level compliance, helping international expansion.

⚠️ Key Challenges Facing the Industry

2025 may feel like a turbulent year for the U.S. beauty industry, but businesses that embrace compliance will come out stronger. With growing consumer demand for transparency, clean beauty, and ingredient safety, aligning your practices with the new law isn't just mandatory—it's smart strategy.

By approaching MoCRA and state laws not as barriers but as blueprints for building trust and expanding globally, you can turn regulation into a market advantage.

FAQ

Q1: What is MoCRA and why does it matter for beauty brands?

A: MoCRA is the Modernization of Cosmetics Regulation Act, which updates how the FDA regulates cosmetics. It introduces mandatory product registration, safety substantiation, and serious adverse event reporting. It impacts all cosmetic brands selling in the U.S.

Q1: Are small beauty brands exempt from MoCRA?

A: No. All brands—regardless of size—must register products and facilities. However, the FDA may allow certain flexibilities for small businesses under 500 employees.

Q2: What ingredients are banned under the 2025 state laws?

A: Washington bans formaldehyde, phthalates, mercury, lead, PFAS, triclosan, and others. California and Colorado have similar bans. Brands must audit formulations to avoid restricted substances.

Q3: What happens if I don’t register my cosmetics with the FDA?

A: Your products can be blocked at the border, pulled from shelves, or subject to mandatory recall. Noncompliance also affects partnerships with retailers and platforms like Amazon.

Q4: How can international beauty brands comply with U.S. regulations?

A: They must appoint a U.S.-based agent, register their facilities and products, and ensure labeling and ingredients comply with both federal and state rules.