US Cosmetics Brand: What Most Founders Overlook¶
The gap between making a great lipstick in your kitchen and selling it legally in the United States is wider than most founders expect. Since MoCRA was signed into law in 2022, cosmetic regulation in the US changed fundamentally — facility registration is now mandatory, product listing is mandatory, safety substantiation is mandatory, and adverse event reporting is mandatory. And if you also sell in Europe, you need a separate EU Cosmetic Product Safety Report (CPSR) before your product reaches the market.
This guide walks through launching a cosmetics brand with the regulatory steps at each stage — so you are not discovering MoCRA requirements the week your product is supposed to ship.
On the Sustalium platform, the pattern we see with cosmetics brands is consistent: the founder handles formulation, packaging, branding, and website — then discovers MoCRA product listing and safety substantiation exist when Amazon requests the documentation. The compliance obligation has been in place for two years. The brand simply did not know it applied to them.
Not sure which regulations govern your cosmetics brand? Use the Sustalium Global Compliance Map — select Cosmetics and your target market, and see every framework from FDA MoCRA to the EU CPSR and UK SCPN notification.
Step 1: Decide Whether You Are a Cosmetics Company or a Drug Company¶
The legal boundary between a cosmetic and a drug is the product's intended use. A moisturizer is a cosmetic. A moisturizer that claims to "reduce wrinkles" or "treat eczema" may be a drug. A shampoo that cleanses is a cosmetic. A shampoo that "treats dandruff" is an over-the-counter drug.
This distinction is not academic. Drugs require FDA pre-market approval or must comply with an OTC monograph. Cosmetics do not require FDA pre-market approval — but they do require MoCRA compliance. If you make a drug claim on a cosmetic label, your product is misbranded, and the FDA can take enforcement action — including requiring you to reformulate, relabel, or recall the product.
Make the classification decision before you finalize your brand positioning. It determines your entire regulatory path.
The Drug Claim Trap
Many cosmetics brands drift into drug territory unintentionally — a moisturizer described as "anti-aging" on Instagram, a shampoo called "medicated" in a product description, a serum marketed as "therapeutic." The FDA evaluates the totality of your marketing, not just the official product label. A single paid ad that makes a drug claim can render the product misbranded even if the label itself is compliant. Review every piece of marketing copy — your website, Amazon listing, social media, influencer briefs — before anything goes live.
Step 2: Find a Manufacturer, and Get Their FDA Registration in Writing¶
Most cosmetics brands use a contract manufacturer rather than operating their own facility. Under MoCRA, the manufacturing facility must be registered with the FDA — and the registration must be renewed every two years.
Before signing with a manufacturer, confirm in writing: - The facility is FDA-registered (request the registration number) - The manufacturer follows GMP (Good Manufacturing Practices) — ISO 22716 is the industry standard, and while FDA GMPs for cosmetics are not yet finalized, they are coming - The manufacturer will provide the ingredient list in INCI nomenclature, including fragrance components at the level of detail you need for your FDA product listing
What to Do If Your Manufacturer Is Overseas¶
If your contract manufacturer is located outside the US — common in the cosmetics industry, where many brands work with manufacturers in South Korea, Italy, or China — the FDA facility registration still applies. The overseas facility must be registered, and the US Responsible Person (you, as the brand owner whose name appears on the label) is responsible for ensuring the registration is current and accurate.
Additionally, CBP can detain cosmetic shipments at the port of entry if the manufacturing facility is not FDA-registered or if the product listing has not been completed. You cannot rely on your foreign manufacturer to handle FDA compliance without your direct oversight — the legal obligation under MoCRA is on the Responsible Person, not the contract manufacturer.
Step 3: Your MoCRA Obligations as the Brand¶
Even if you use a contract manufacturer, you — as the brand owner whose name appears on the label — are the Responsible Person under MoCRA. That means you must:
Register the facility (or confirm the manufacturer has registered). The FDA facility registration must be renewed every two years.
List every product. For each cosmetic SKU, submit the product name, brand name, product category, ingredient list (INCI names), and a label image to the FDA's electronic product listing portal. Existing products must be listed. New products must be listed within 120 days of first marketing.
Maintain safety substantiation. You must have documented evidence that qualified experts evaluated your product's safety under labeled conditions of use. The FDA does not pre-approve cosmetics, but it can — and increasingly does — request safety substantiation records during inspections or in response to adverse event reports.
Report serious adverse events to the FDA within 15 business days. A serious adverse event is one that results in death, life-threatening experience, hospitalization, disability, birth defect, infection, or significant disfigurement. Maintain records of all adverse events — serious and non-serious — for at least six years.
See the full guide: [FDA MoCRA: Cosmetic Compliance & Registration]
Step 4: If You Sell in Europe Too¶
The EU's cosmetic regulatory framework predates MoCRA by over a decade and is more structured. The key differences that affect you as a brand:
- Cosmetic Product Safety Report: You must commission a CPSR prepared by a qualified safety assessor (a pharmacist, toxicologist, or equivalent professional). The CPSR is a specific, structured document defined by Annex I of Regulation (EC) 1223/2009. Your MoCRA safety substantiation does not substitute for it.
- CPNP notification: Your product must be notified to the EU's Cosmetic Product Notification Portal BEFORE it is placed on the EU market — not after.
- EU Responsible Person: You must designate an entity established in the EU to act as your Responsible Person. This entity appears on your label and is the contact point for EU competent authorities.
- INCI labeling is mandatory: Unlike the US, where INCI is strongly encouraged but not mandated, the EU requires INCI nomenclature on cosmetic labels.
The underlying toxicological data — ingredient safety profiles, exposure assessments, concentration limits — supports both the MoCRA safety substantiation and the EU CPSR. Building both from the same dataset is significantly more efficient than treating them as separate compliance projects.
See the full guide: [Selling Cosmetics in the US and EU: MoCRA vs. CPSR]
Step 5: Selling on Amazon's Beauty Category¶
Amazon's beauty and personal care category has its own documentation requirements:
- Product images must show the ingredient list clearly
- Claims on the detail page must match the product label claims (a "brightening serum" on the label cannot become a "skin lightening treatment" on Amazon)
- Prop 65 warnings, if applicable, must appear on the detail page
- Amazon has begun requesting MoCRA facility registration numbers and product listing confirmations for US-listed cosmetics
If your listing is flagged and you cannot produce the requested documentation within Amazon's deadline — typically 72 hours to 7 days — the ASIN is suppressed. During the suspension, your product is invisible to customers and generates no sales. Reinstatement requires uploading the missing documents and waiting for Amazon's compliance review, which can take several business days to several weeks.
See the full guide: [Selling on Amazon: The Rules That Get You Delisted]
Step 6: Your Packaging Has Its Own Compliance Requirements¶
Cosmetics packaging is subject to the same CA TPPA heavy metal restrictions as all other consumer packaging sold in 19 states. The sum of lead, cadmium, mercury, and hexavalent chromium in your packaging — including the ink on the box, the adhesive on the label, and any foil stamping — must not exceed 100 ppm. A Declaration of Compliance from your packaging supplier certifies that the packaging meets the standard, and that declaration should be in your compliance file before your product goes to market.
Additionally, if your cosmetic product comes in a container that is also a food or beverage container — a lip balm tin, a body butter jar — the inner surface that contacts the product is functionally a food-contact surface, and the material should be FDA-cleared for that use under 21 CFR.
See the full guide: [CA TPPA: Toxics in Packaging Compliance Guide]
How Sustalium Helps You Launch a Cosmetics Brand¶
Cosmetics compliance for a new brand involves facility registration, product listing, safety substantiation, ingredient management, and — if you sell in Europe — a separate CPSR and CPNP notification. Managing this across even a five-SKU launch without a structured platform creates gaps.
Sustalium gives you a single system for cosmetics compliance:
- MoCRA registration and listing support — Structure your ingredient data and product information for FDA product listing
- Safety substantiation documentation — Link your toxicological assessments and expert reviews to each SKU
- Dual-market support — If you sell in the EU, manage your CPSR and CPNP data alongside your MoCRA documentation
- Ingredient management — Maintain your formulation data in INCI format, structured for labeling and regulatory submissions
From Formulation to Market — Without Missing MoCRA
A great formulation gets the first sale. MoCRA compliance keeps your brand on the market. Plan both from day one.
With Sustalium, build your cosmetics compliance documentation for just €10 per document.
Last updated: July 21, 2026