Quality and Regulatory Compliance
A cosmetic can be well made and still be illegal to sell. MakeMine manages GMP at the facility, label compliance, and the testing and documentation your safety substantiation rests on — so the product that ships is one you can actually sell.
Book an Intro CallNobody tells you the rules changed
Personal care founders learn compliance from other founders, and the information circulating is out of date. The line most people still repeat — that the FDA doesn't regulate cosmetics — has not been true since MoCRA passed in 2022. Facility registration, product listing, a named Responsible Person, safety substantiation, and adverse event reporting are all obligations now.
The second gap is classification. A founder building a moisturizer adds SPF because retailers ask for it, and without noticing has converted a cosmetic into an OTC drug — a different facility, a different GMP standard, a Drug Facts panel, and an NDC number.
Compliance failures don't surface at the factory. They surface at the retailer, at customs, or in a claim.
What quality and compliance covers
Facility GMP
Manufacturing at FDA-registered facilities running GMP-aligned processes, with controls and parameters governing every run.
Facility registration
The manufacturing site holds and renews its own FDA registration. Product listing sits with the Responsible Person.
Responsible Person
The entity named on your label — which is your brand, not MakeMine. MakeMine supplies the manufacturing and testing records the role depends on.
Safety substantiation
Stability, preservative efficacy, and micro results supplied for the safety file the Responsible Person maintains.
Label review
Identity, net contents, Responsible Person, INCI declaration, and warnings checked against the regulation.
Micro and finished goods testing
Per lot, against specification.
Batch documentation and retains
Batch records, COAs, and retain samples held per lot.
Where quality happens
| Stage | What is checked |
|---|---|
| Facility qualification | GMP standard, audit history, category capability, capacity |
| Raw material release | COAs verified, materials identity-checked and released before use |
| In-process checks | pH, viscosity, appearance, temperature against the batch record |
| Bulk release | Full specification testing before filling begins |
| Micro testing | Enumeration and specified organisms on the finished product |
| Fill checks | Fill weight or volume sampled throughout the run |
| Finished goods QC | Cosmetic defects, decoration, closure torque, carton accuracy |
| Lot documentation | Batch record completed, COA issued, retains pulled and stored |
MoCRA requirements for cosmetic brands
The Modernization of Cosmetics Regulation Act took effect from 2023 and is the most significant change to US cosmetic regulation in over eighty years.
| Requirement | What it means | Who it applies to |
|---|---|---|
| Facility registration | Manufacturing and processing facilities register with FDA and renew biennially | Facilities — MakeMine's partners, not the brand directly |
| Product listing | Each cosmetic product listed with FDA, including ingredients, and updated annually | The Responsible Person |
| Responsible Person | A named person or company on the product label who carries the regulatory obligations | Every cosmetic product |
| Safety substantiation | Adequate evidence supporting the product's safety, with records maintained | Every cosmetic product |
| Adverse event reporting | Serious adverse events reported to FDA within 15 business days; records held 6 years | The Responsible Person |
| Records access | FDA may access safety substantiation and adverse event records | The Responsible Person |
| Good Manufacturing Practice | FDA is directed to establish binding cosmetic GMP regulations | Facilities |
| Fragrance allergen labeling | FDA is directed to require disclosure of specified fragrance allergens | Labels |
| Talc testing | Standardized testing methods for asbestos in talc-containing products | Talc products |
Small businesses — those averaging under $1 million in annual US cosmetic sales across the previous three years, adjusted for inflation — are exempt from facility registration, product listing, and GMP requirements. The exemption does not extend to products that regularly contact the mucous membrane of the eye, are injected, are intended for internal use, or alter appearance for more than 24 hours without consumer removal. The GMP, fragrance allergen, and talc rules remain in rulemaking.
What US law requires on a cosmetic label
| Element | Requirement |
|---|---|
| Identity statement | What the product is, on the principal display panel |
| Net quantity of contents | Weight or volume, in both US customary and metric |
| Responsible Person | Name and place of business of the manufacturer, packer, or distributor |
| Ingredient declaration | INCI names in descending order of predominance; ingredients at or below 1% may appear in any order after those above 1%; color additives listed last |
| Warnings | Required for products that may be hazardous if misused |
| Country of origin | Required for imported products |
| Drug Facts panel | Required only where the product is an OTC drug — not a cosmetic |
GMP standards by product classification
| Standard | Applies to | Nature |
|---|---|---|
| ISO 22716 | Cosmetics | International GMP guideline for cosmetic manufacturing |
| 21 CFR Parts 210 and 211 | OTC drug products | Binding US drug GMP regulation |
| MoCRA GMP regulation | Cosmetics | Mandated by MoCRA; FDA rulemaking not yet final |
An OTC drug product cannot be made at a cosmetics-only facility. This is the most expensive mistake available in this category, and it is made at the brief stage.
What MakeMine won't do on compliance
- We don't place an OTC drug product at a cosmetics-only facility, regardless of the quote.
- We don't ship product that hasn't passed micro testing.
- We tell you when your claim converts your cosmetic into a drug, even when it costs you the claim you wanted.
- Facility audit status and GMP documentation are shared with you, not held as leverage.
- We don't hold the Responsible Person role for you. It belongs to whoever is named on the label, and that is your brand.
- We don't offer legal advice. On how the regulation applies to your specific product and claims, use regulatory counsel.
Related stages
All personal care manufacturing →Personal care production and filling
Batching, filling, decoration, and pack-out, with minimums and lead times.
Sampling and stability testing
Accelerated stability, preservative efficacy, and packaging compatibility.
Cosmetic ingredient sourcing
Actives and base materials with COAs, use levels, and supply lead times.
Cosmetic packaging and componentry
Primary containers, closures, decoration, and the tooling timeline behind them.
Frequently asked questions
What is MoCRA and does it apply to my brand?
MoCRA is the Modernization of Cosmetics Regulation Act, the 2022 law that substantially expanded FDA authority over cosmetics. It applies to essentially every cosmetic sold in the US and requires facility registration, product listing, a named Responsible Person, adequate safety substantiation, and adverse event reporting. Some small businesses are exempt from parts of it.
Do cosmetics need FDA approval before being sold?
No. Cosmetics require no pre-market FDA approval. They do require MoCRA compliance — registration, listing, safety substantiation, and a named Responsible Person. Color additives are the exception: they require FDA approval and, for many, batch certification. Approval and compliance are separate obligations.
Who is the Responsible Person under MoCRA?
The Responsible Person is the entity named on the product label — typically the brand — who carries the obligations for product listing, safety substantiation records, and adverse event reporting. It is a defined regulatory role, not a courtesy line on the back panel, and it should be settled before packaging artwork is finalized.
What is ISO 22716?
ISO 22716 is the international good manufacturing practice guideline for cosmetics, covering personnel, premises, equipment, raw materials, production, finished product, quality control, and documentation. It is the standard most cosmetic contract manufacturers operate to and the one to ask about when qualifying a facility.
When does my product become an OTC drug instead of a cosmetic?
When it makes a therapeutic claim — sun protection, acne treatment, antiperspirant action, dandruff control, or similar. Intended use decides classification, and claims establish intended use. An OTC drug requires monograph compliance, a Drug Facts panel, an NDC number, and manufacturing under 21 CFR Parts 210 and 211.
What does safety substantiation actually require?
MoCRA requires adequate evidence that the product is safe under customary use, but does not prescribe a fixed protocol. In practice it is assembled from ingredient safety data and use-level review, stability and preservative efficacy results, micro testing, and where warranted, a toxicological safety assessment. The records must be maintained and made available to FDA.
Do I need to comply with California's cosmetic laws separately?
Yes, if you sell into California. Proposition 65 warning obligations, the California Safe Cosmetics Program reporting requirement, and the state's restricted-ingredient legislation all apply independently of federal law and in some cases restrict ingredients that remain federally permitted. The restricted list has expanded more than once, so check it against your formula rather than against what applied at your last launch.
Compliant before it's manufactured, not after.
GMP, MoCRA, and labeling handled as part of production. Book a call to review your product's requirements.