Solid Shampoo and Conditioner

Top 10 FDA Compliance Questions to Ask Your Hair Care Contract Manufacturer

Written by

Creighton Thomas

Published on

June 1, 2026

Picking a partner to make your shampoo bars or solid conditioners is one of the bigger commitments an indie brand will sign for. The formulation, the bar weight, the bath bar fragrance, the box, and the launch date all run through one factory. And as of 2026, the regulatory side of that decision carries more weight than it used to.

The Modernization of Cosmetics Regulation Act, better known as MoCRA, has been rolling out in pieces since 2022. It is the most significant expansion of the FDA’s authority over cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938. Manufacturers and processors must register their facilities with the FDA and renew their registration every two years. Each cosmetic product must also be listed using Form FDA 5067, with annual updates to confirm formulation accuracy and facility linkage.

Translation: the factory you choose is now part of your compliance footprint. If they get something wrong, your brand wears the consequences. So before you send a deposit, here are the ten things to press them on.

1. Are You Registered With the FDA Under MoCRA, and Can You Share Your FEI Number?

This is the first filter. Without an active FDA Establishment Identifier, a facility cannot legally process cosmetics for the U.S. market. The FEI is a non-negotiable prerequisite for facility registration, and procurement teams should verify that any potential contract manufacturer already holds an active FEI number.

Ask for the number itself. A serious operator will hand it over without flinching. If the response is vague, that is your answer.

2. How Do You Handle Cosmetic Product Listing on Our Behalf?

Facility registration is one thing. Product listing is another. Brands sometimes assume their factory handles both; in reality, it depends on who serves as the Responsible Person.

The regulatory burden falls primarily on the Responsible Person, the entity named on the product label, including making sure the listing is filed and the facility where it is manufactured is registered. Most often, that is the brand owner or the U.S. importer. A good partner will walk you through how listings get filed, who provides which inputs, and how often the listings are renewed.

3. Which GMP Standards Do You Follow Day to Day?

The FDA is finalizing formal Good Manufacturing Practice rules for cosmetics, but most reputable factories already operate in accordance with ISO 22716 or the FDA’s draft cGMP guidance.

You want to know:

Whether the GMP framework is documented or just claimed
How batch records are stored and for how long
How the facility handles deviations and out-of-spec results
Who is responsible for internal quality audits
Whether third parties have ever audited the site

This is also where you can ask about water systems, ingredient receiving, and equipment cleaning between runs. Generic answers here are a yellow flag.

4. What Is Your Process for Ingredient Vetting and Restricted Substance Screening?

MoCRA gave the agency greater power over specific substances, and several rules are set to take effect soon. FDA’s plan continues to show a December 2025 NPRM to prohibit formaldehyde and formaldehyde-releasing chemicals in hair-smoothing and straightening products, a May 2026 NPRM for fragrance-allergen labeling, and a March 2026 final rule establishing standardized asbestos testing for talc-containing cosmetics.

State-level rules add another layer. By late 2025, nearly 20 states will have enacted or proposed legislation restricting PFAS, formaldehyde, lead, and other substances in cosmetics.

Your partner should already be screening incoming raw materials against this moving target. Ask them to walk you through how they vet a new fragrance or a new surfactant before it ever touches a press.

5. How Do You Distinguish Cosmetic Claims From Drug Claims on the Bars You Make for Us?

This trips up new brands constantly. A “clarifying” shampoo bar is fine. A bar that claims to “treat dandruff” is a different beast. According to the FDA, cosmetic and OTC overlap occurs when a product makes a therapeutic claim; for example, a leave-in hair product that claims to treat dandruff is considered both a cosmetic and an OTC drug.

OTC means active ingredient monographs, drug GMPs, and a different labeling regime entirely. A capable partner will flag risky language on your draft packaging before it goes to print, not after.

6. What Does Your Cosmetic Labeling Review Process Look Like?

Even purely cosmetic labels have to comply with the FD&C Act, the Fair Packaging and Labeling Act, and 21 CFR 701. INCI names, net contents, principal display panel rules, distributor statements, country of origin: every line on that wrapper has a rule behind it.

A solid factory will at minimum review your artwork against U.S. labeling regulations and call out anything that looks off. Some go further and offer ingredient declaration drafts straight from the master formula. Ask which they do.

7. What Product Testing Do You Run Before a Batch Ships?

Without rigorous quality control, you are guessing. Standard pre-shipment checks for hair bars usually include:

pH measurement on a freshwater test
Weight and dimensional checks per bar
Visual and surface defect inspection
Microbial testing where the formula or the water activity warrants it
Fragrance and color verification against a master sample
Stability check-ins on retained samples

For a solid format like a syndet bar, microbial risk is lower than a liquid, but it is not zero, and a good partner will explain why their testing protocol fits the format. Quality control should not be a black box.

8. How Do You Track and Report Adverse Events?

This one is genuinely new. Under MoCRA, the Responsible Person must report serious adverse events to the FDA within 15 business days of learning of them. If the agency reasonably believes that a fragrance or flavor ingredient contributed to a reported serious adverse event, it may request a written list of ingredients or ingredient categories in the fragrance or flavor of concern, and the responsible person must convey this information within 30 days of the request.

Your factory may not be the legal Responsible Person, but they hold the formulation data you need to comply. Ask how they will support an adverse event investigation, how fast they can produce ingredient breakdowns, and how long they retain batch records.

9. How Do You Protect Our Formula and What Happens If We Leave?

It is uncomfortable to ask. It is also the conversation that prevents the worst kind of breakup. Who owns the master formula? Who owns the raw material relationships? If the contract ends, do you walk away with a portable formulation document, or do you start from zero somewhere else?

This is where contract language matters as much as factory floor capability. Clarify it in writing before the first production run, not during a dispute.

10. Can You Walk Us Through a Recent Compliance Update You Made?

This last one is a posture check. The cosmetics rulebook will keep moving. Brands that wait for final rules will find themselves unable to reprint or relabel fast enough to meet new requirements.

A factory that can describe a specific change it made in the last twelve months, whether tightening allergen documentation, updating SDS handling, or revising label review procedures, is a factory paying attention. One that cannot is coasting.

At-a-Glance Checklist for Vetting a Hair Care Production Partner

Area	What to Ask	What a Strong Answer Sounds Like
Facility registration	Active FEI and MoCRA registration status	Verifiable FEI number, biennial renewal in place
Product listing	Who files Form FDA 5067 and how often	Clear handoff between brand and factory, annual updates
Manufacturing standards	GMP framework and audit history	Documented procedures, third-party or internal audit cadence
Ingredient screening	Restricted substance and state-level monitoring	Active vetting against MoCRA, FDA, and state rules
Claim review	Cosmetic vs. drug claim handling	Pre-print review of marketing copy on packaging
Batch testing	Pre-shipment QC protocol	Format-appropriate physical, microbial, and sensory checks
Adverse event support	Data access and turnaround	Defined records retention, fast ingredient disclosure
Formula ownership	IP terms and exit options	Written contract with clear ownership and transition terms

A Few Practical Notes Before You Sign

A few smaller things tend to surface late in vendor conversations and are worth raising early.

Production volume sets a floor. At our shop, solid shampoo bar manufacturing starts at a minimum order of 5,000 bars, with a weekly capacity of around 35,000 bars. Other partners run different numbers, and that math affects launch planning more than people expect.

Format matters too. Pressed bars and poured bars have different timelines, different surface finishes, and different fragrance load tolerances. If your factory cannot explain why one process suits your formula better, push harder. The Society of Cosmetic Chemists and the Personal Care Products Council both publish resources that help, but the partner you hire should already be fluent in this.

And document everything. The brands that ride out a regulatory change cleanly are the ones with paper trails. Boring, but true.

Frequently Asked Questions

What are some questions to ask a manufacturer before signing a production agreement?

Start with regulatory standing: facility registration, GMP framework, and audit history. Then move to operational fit: minimum order volumes, lead times, capacity headroom, and which inputs they source versus which they expect from you. Finally, cover the legal layer, including formula ownership, exclusivity provisions, exit terms, and dispute resolution. Brands sometimes skip the legal layer because the conversation feels uncomfortable, but it is usually where partnerships succeed or fail.

What are the most asked questions on skincare and hair care formulation?

Common ones include shelf life, preservative selection, fragrance allergens, scalability from pilot to full production, and how a formula will perform across different water hardnesses. For solid formats specifically, brands also ask about lather, transfer to the hair, dissolve rate, and how the bar holds up in shower environments. A capable partner answers these from formulation experience rather than reading from a generic spec sheet, and they should be willing to run small pilot batches before committing to a full run.

What are the 5 main categories of cosmetic products?

Most industry classifications group personal care into five buckets: hair (shampoos, conditioners, styling products); skincare (cleansers, moisturizers, serums); color cosmetics (foundation, lipstick, mascara); fragrance (perfumes, body sprays, scented mists); and personal hygiene (bath and cleansing items). Solid formats now span several of those buckets, especially hair and personal hygiene, which is a meaningful change from a decade ago. Regulatory classification can sometimes shift a familiar item into a different bucket depending on the marketing claims attached to it.

Ready to Vet a Solid Bar Production Partner?

If you are weighing options for shampoo bars, conditioner bars, or guest amenity formats, we are happy to walk through how our shop handles every item on this list. No script, no pressure. Get in touch via our contact page or browse our private-label conditioner bar program to see how we run things.