What MoCRA asks of a small balm brand once the label is right

Facility registration, product listing, safety substantiation files and adverse event records under MoCRA, with the small business exemption tested on real numbers.

Getting a US cosmetic label right is a job you finish. MoCRA's other duties are not: they are a registration you renew, a listing you update annually, a safety file you keep current for every formula, and a complaint log you start on the day of your first sale. This page is about those, for a maker turning over well under a million dollars, and about which of them the small business exemption leaves untouched.

• Threshold: 1,000,000 dollars, 3 year average
• Exempt from 2 duties, not 8
• Serious event report: 15 business days
• Records: 6 years, 3 if exempt

The eleven sections, and which of them can reach you

The Modernization of Cosmetics Regulation Act of 2022 was signed on 29 December 2022 and works by inserting new sections 604 to 614 into the Federal Food, Drug, and Cosmetic Act. It applies to cosmetic products distributed in the United States, whoever makes them and wherever they are made, so a UK or EU maker shipping to American customers is inside it. FDA cites these by their FD&C Act section number; the codified citations run from 21 U.S.C. 364 in step, so adverse events at section 605 is 21 U.S.C. 364a and the small business provision at section 612 is 21 U.S.C. 364h.

Nine of the eleven bind you whatever your size. That is the single most useful thing to know, because the phrase "small business exemption" is routinely read as though it meant exemption from MoCRA, and it means exemption from two sections of it.

Testing the threshold on real numbers

Section 612 defines a small business as a responsible person or facility owner whose average gross annual sales in the United States of cosmetic products for the previous three-year period is less than 1,000,000 dollars, adjusted for inflation. Four words in that sentence do the work.

• Gross sales, not profit and not margin. A maker with 900,000 dollars of turnover and 40,000 dollars of net profit is measured on the 900,000.
• Of cosmetic products. If you also sell candles, soap that is genuinely soap, or workshops, that revenue sits outside the count.
• In the United States. A British maker counts American sales only.
• Average, previous three years. One good year does not remove the exemption on its own.

Two practical points. The first case shows why the arithmetic is worth doing in the accounts every year rather than when someone asks: the year you cross is not the year your average crosses, and you get roughly a year of warning if you are looking. The second shows that a single large wholesale account can end the exemption for a business that still feels small, which is a good reason to have the registration path understood before you need it. The cost side of that decision belongs with costing and pricing.

The products that lose the exemption whatever you turn over

Section 612 removes the exemption entirely for four kinds of product. A cosmetic that regularly comes into contact with the mucous membrane of the eye under customary conditions of use; one that is injected; one intended for internal use; and one intended to alter appearance for more than 24 hours where removing it is not part of customary use. Make any of those and you register and list regardless of revenue.

Run a normal balm range past that test and almost everything survives. Lip balm is external even though some of it is swallowed, and it does not touch the eye. A tinted lip balm wears off through the day, so it is not a long-wear appearance product. Body balms, salves, hand and foot balms, beard balm and cuticle balm are nowhere near any of the four limbs.

Three products in this trade do need a decision. An eye makeup remover balm is sold to be used on the eye area and worked over the lash line, which is the clearest case of regular mucous membrane contact you are likely to formulate. A cleansing balm marketed as removing all makeup including mascara is arguably in the same position, and the marketing copy is what puts it there. An under-eye balm is a genuine grey area, and the words to argue over are "regularly" and "mucous membrane": applying to the orbital bone is not the same as applying to the lash line, but your own instructions may say otherwise. Long-wear lip stains and semi-permanent colour are caught by the fourth limb. In each case the intended use you publish decides it, which is the same principle that governs the line between a cosmetic and a drug on cosmetic versus drug claims.

Registration and listing, if you have to do it

If the exemption does not apply, section 607 splits the work in two. Every facility that manufactures or processes cosmetics for US distribution registers, renewing every two years and updating within 60 days of a change. Every product is listed by the responsible person, meaning whoever is named on the label, within 120 days of going to market and then updated annually.

Both go through Cosmetics Direct, FDA's free electronic portal, which is built on the same structured submission framework as drug listings. In practice that means creating an FDA account first, obtaining a facility identifier for the registration, and then working through a form rather than uploading a document. Paper alternatives exist, forms FDA 5066 for registration and 5067 for listing, and are slower in every respect. Submissions are free at every stage.

Three details save real time. You must choose a product category from FDA's list, which derives from the old Voluntary Cosmetic Registration Program taxonomy, and the category follows intended use rather than the word on your tin: a balm for lips is a lip product, a balm for hands is a skin care preparation. FDA returns a listing number for each submission, which you quote on every later update, so keep those numbers with your formula records rather than in an inbox. And products with identical formulations that differ only in colour, fragrance, flavour or fill weight can go on a single listing, which collapses a range of six flavours of one lip balm base into one submission instead of six.

If a contract manufacturer makes your product, they register the facility and you do the listing, but your listing has to carry their facility registration number. Ask for it in writing at the point you agree terms, alongside the specifications discussed under sourcing ingredients, because chasing it later is a slow conversation.

Adequate substantiation, as a file rather than a certificate

Section 608 requires the responsible person to keep records supporting adequate substantiation of safety, defined as evidence sufficient to support a reasonable certainty that the product is safe. There is no filing, no approval and no fee. There is also, unlike the EU and UK position, no requirement that a qualified assessor signs it: a balm sold in the United States needs no equivalent of the safety report described on safety assessment and the CPSR. That makes the American duty cheaper and, for a careful maker, more demanding, because nobody hands you a template.

A workable file per formula, kept as a folder with a version number and a date, holds these things.

1. The formula in weight percent, totalling 100, with the INCI name of every input and the batch size it is made at.
2. A supplier specification and certificate of analysis for each raw material, plus the safety data sheet. This is the layer that fails most often, because it depends on suppliers rather than on you.
3. A safety basis per ingredient. For most balm materials that means the relevant Cosmetic Ingredient Review conclusion, with a Scientific Committee on Consumer Safety opinion or a long record of documented safe use where CIR is silent.
4. Reasoning on the exposure. Site of application, quantity per use, frequency, and whether it is a leave-on product, which every balm is.
5. The microbiological argument. For an anhydrous product this is a water activity argument rather than a challenge test, set out on do balms need preservatives, and it needs the moisture controls that back it up.
6. Stability and a dated best before, from real time observation or the protocols on shelf life testing, with the packaging it was tested in.
7. The finished artwork as sold, and a dated, signed conclusion by a named person.

Two things that are not in that list but are often assumed to be: a laboratory report, and insurance. Neither substantiates safety. Product liability cover pays for the consequences of a problem and is worth having for other reasons set out under insurance and liability, but it is not evidence.

Adverse events: what gets logged and what gets reported

Section 605 draws a line that people miss. Every adverse event, meaning any adverse health-related event associated with use of the product, goes in your records. Only a serious adverse event is reported to FDA, and the statutory list is specific: death, a life-threatening experience, inpatient hospitalisation, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement, which the Act expands to include serious and persistent rashes, second or third degree burns, and significant hair loss or persistent alteration of appearance. An event requiring medical or surgical intervention to prevent one of those counts too.

That disfigurement limb is the one that catches this trade. A customer reporting a mild sting from a peppermint lip balm is an adverse event to be logged and investigated. A customer reporting a rash across the lips and chin that has persisted for three weeks is a serious adverse event, and the 15 business day clock starts on the day you first learn of it, not the day you finish deciding whose fault it is.

The report goes to FDA with a copy of the label on or inside the retail packaging, using the MedWatch route. If material new medical information reaches you within a year of that report, you have a further 15 business days to submit it. Reporting is not an admission that your product caused anything, which the statute says explicitly.

Two neighbouring powers explain why the log matters more than its length suggests. Section 610 lets FDA access and copy safety records where it has a reasonable belief a product is adulterated and presents a threat of serious adverse health consequences, though it expressly cannot take your recipes, financial data, pricing, personnel or non-safety research. Section 611 lets FDA order a recall after offering you the chance to recall voluntarily. Both work from records that either exist or do not.

The rules still coming, and the two ingredient questions

Section 609(b) requires FDA to identify fragrance allergens that must be declared on the label, by regulation, and directs it to consider the approach taken elsewhere, which in practice means the European list. The proposed rule was due 18 months after enactment, that is 29 June 2024, and nothing had been published as at 6 September 2026. This is the one outstanding item with real consequences for balm labels, because a maker using lavender, citrus or mint will almost certainly have declarable allergens once it lands. Working to the EU thresholds now costs nothing and is the sensible hedge: the numbers are on fragrance allergen labelling and the substances themselves on fragrance allergens.

Two ingredient provisions sit outside the numbered sections, as freestanding parts of the Act. MoCRA told FDA to set standardised methods for detecting and identifying asbestos in talc-containing cosmetic products; a proposed rule appeared and was then withdrawn on 28 November 2025, so no federal test method stands. If you use talc, and some mineral-containing balms and pressed products do, the practical answer is a supplier declaration and asbestos testing to a recognised method, held in the safety file. Related powders are discussed under kaolin and cosmetic clays. MoCRA also required an assessment of per- and polyfluoroalkyl substances in cosmetics; FDA reported in December 2025 and found PFAS in a small fraction of listed products, with a majority of the most common substances lacking the toxicological data to assess. There is still no federal PFAS rule, but several states have their own, and section 614 preserves state authority to restrict ingredients even though it preempts state rules on registration, listing, records, recalls, reporting and substantiation.

What the year actually looks like

For an exempt maker that is four recurring items, none of which costs money, and one of which is arithmetic you were doing anyway. The workload argument against MoCRA compliance is weaker than the workload argument for keeping decent records, which you need for workshop hygiene and complaint handling regardless.

What this page cannot settle for you

Three things, and they are the three that matter most.

It cannot confirm your exemption status. That depends on your own sales figures, on which of your revenue is cosmetic, and on a threshold FDA has not yet restated for inflation. Nobody outside your business can do that calculation, and no one inside FDA will validate it in advance.

It cannot file anything on your behalf, and neither can a page of instructions. Registration and listing are account-based submissions tied to your business identity, and the responsible person named on the label is the party FDA holds to them.

And it is not legal advice. MoCRA is still being implemented, two of the rulemakings Congress ordered are overdue, enforcement positions shift without any change in the statute, and state ingredient law runs alongside all of it. The scope of what this site can and cannot tell you is set out on the safety disclaimer. What is durable is the shape of the obligation: keep a safety file per formula, keep a complaint log from your first sale, keep the label compliant as covered on labelling cosmetics in the US, and recalculate your average every year so that the day you stop being a small business is a day you saw coming.

Reviewed and updated 6 September 2026. Spotted an error? Tell us and we will fix and log it.