MoCRA for Soap Makers: What the New Cosmetics Law Means for You
In 2022, Congress passed the first major overhaul of US cosmetics law since 1938. If you make and sell soap, lotion, bath bombs, or anything that goes on skin, it probably affects you — but there’s a good chance the biggest requirements don’t apply to your business at all. Here’s the plain-English version.
Not a lawyer, not legal advice. This is a plain-English summary of publicly available FDA guidance for small makers. If you’re unsure about your specific products, talk to a regulatory consultant or attorney.
What is MoCRA?
MoCRA — the Modernization of Cosmetics Regulation Act — was signed on December 29, 2022. Before it, the FDA had surprisingly little authority over cosmetics: companies didn’t have to register, list their products, or even prove they were safe. MoCRA changed that. Key deadlines have been rolling out since late 2023:
- Facility registration & product listing: due December 2023 (enforcement delayed to July 2024)
- Safety substantiation & serious adverse-event reporting: December 2023
- Adverse-event contact info on labels: December 2024
Two big pieces are still pending: a fragrance-allergen labeling rule (expected late 2026) and final manufacturing-practice rules (the legal deadline passed with no rule issued yet). More on those below.
The question that matters most: is your product even a “cosmetic”?
Here’s the part most small makers miss. MoCRA only covers cosmetics. And under FDA rules, true soap isn’t a cosmetic at all — it’s outside MoCRA entirely.
Your bar counts as true soap (and skips MoCRA) only if all three of these are true:
- The bulk of it is alkali salts of fatty acids — in plain terms, saponified oils (what you get from a real lye-based recipe).
- Its cleaning action comes from those saponified oils.
- It’s labeled and sold only as soap — no other claims.
The claims test: the moment your label or listing says “moisturizing,” “exfoliating,” or “deodorizing,” the FDA treats it as a cosmetic. Say “treats eczema,” “kills bacteria,” or make an SPF claim, and it’s a drug — a whole stricter category. Melt-and-pour bases, syndet (synthetic detergent) bars, shampoo bars, shave bars, and bath bombs generally don’t qualify as true soap.
If you make only true soap with no cosmetic or drug claims, MoCRA doesn’t apply to you. (Your soap falls under general consumer-product labeling instead: product identity, net weight, and your business name and address — no ingredient list required, though most makers include one anyway.)
If your products ARE cosmetics: the small-business exemption
This is the second piece of good news. As of 2026, makers with under $1 million in average annual US cosmetic sales (averaged over the prior three years) are exempt from facility registration, product listing, and manufacturing-practice requirements.
But “exempt” doesn’t mean “off the hook.” Small businesses must still:
- Substantiate product safety — keep documented evidence your products are safe (supplier safety data sheets, stability testing, preservative challenge testing for water-based products).
- Label properly — full ingredient declaration using standard (INCI) names, plus a domestic address, phone number, or electronic contact where consumers can report problems (required since December 2024).
- Report serious adverse events to the FDA within 15 business days, and keep all adverse-event records for 3 years (larger companies keep them 6).
The exemption disappears if you make products that contact the eye mucosa, are injectable, are for internal use, or alter appearance for more than 24 hours. Those products face the full requirements regardless of your size.
What full compliance looks like (for larger makers)
If you’re over the $1M threshold — or just want to know what the big players deal with — here’s the complete picture:
| Requirement | What it means | Cost |
|---|---|---|
| Facility registration | Register each manufacturing facility with the FDA via the free Cosmetics Direct portal (new facilities: within 60 days; renew every 2 years) | Free |
| Product listing | List every cosmetic product with its full INCI ingredient list, renewed annually (new products: within 120 days of marketing) | Free |
| Safety substantiation | Documented evidence each product is safe under normal use | Varies |
| Labeling | INCI ingredients + adverse-event contact info | Label redesign |
| Adverse events | Report serious events within 15 business days; keep records 6 years | Recordkeeping |
Enforcement is real: the FDA has issued warning letters citing MoCRA violations, unregistered products can be treated as misbranded, and marketplaces like Amazon increasingly ask for proof of registration.
Your practical checklist
- Classify every product. Run each SKU through the true-soap test above. Be honest about your label claims — “moisturizing” counts.
- Strip drug claims. “Heals,” “treats,” “antibacterial,” SPF — remove them unless you’re prepared for drug regulation.
- Check your small-business status. Under $1M in cosmetic sales? You skip registration and listing — but do everything below.
- Fix your labels. Full INCI ingredient lists and a way for customers to contact you about problems (address, phone, or email/website).
- Build a safety file. One folder per product: supplier data sheets, your formula, any stability or preservative testing.
- Set up adverse-event logging. A simple log (date, product, what happened) plus a plan to report serious events to the FDA within 15 business days.
- Use batch/lot codes. If you ever need to trace a problem, you’ll be glad you did.
- Watch the pending rules. The fragrance-allergen labeling proposal (expected late 2026) could force label redesigns — don’t print a five-year supply of labels until it lands.
What’s still coming
- Fragrance allergen labeling — the FDA is expected to propose requiring specific fragrance allergens to be named on labels (the EU already does this). Expected late 2026.
- Manufacturing practice (GMP) rules — the law required final rules by December 2025; none have been issued. Small businesses are currently exempt anyway.
Summary based on FDA guidance and regulatory analyses current as of October 2026. MoCRA implementation is ongoing — check the FDA’s cosmetics page for the latest before making big compliance decisions.
