Labeling Handmade Cosmetics: What FDA and MoCRA Texts Say

Three questions decide most of what a handmade honeysuckle product owes the government, and they come in a fixed order: what you claim for it, how big your cosmetic business is, and what the label must say. This guide reports what the primary texts say, with the dates on the pages we read, because several of these rules have moved since MoCRA became law in December 2022 and some are still moving. It is not legal advice. For a product you sell, a regulatory consultant or an attorney who handles FDA cosmetics should make the final call, and an insurer should be asked what it requires.

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Question 1: is it soap, a cosmetic or a drug?

FDA says classification follows intended use. Its soap FAQ (content current as of 20 August 2024) says a product is regulated as soap only if all three conditions of 21 CFR 701.20 are met: it is composed mainly of alkali salts of fatty acids, those salts are the only material that results in the cleaning action, and it is labeled and marketed only for use as soap. Moisturizing, making the user smell nice or deodorizing makes it a cosmetic; claims about killing germs or about skin conditions make it a drug; a product can be both. The regulation itself adds that body cleansers which are not soap are cosmetics and that a bar-form one must carry a weight statement in avoirdupois pounds and ounces.

If your product is soap by that definition, the Consumer Product Safety Commission, not FDA, has jurisdiction. CPSC's soap page says it has no specific requirements for soaps; they generally fall under the Federal Hazardous Substances Act and the Consumer Product Safety Act, and soaps intended mainly for children 12 and under are children's products needing a permanent tracking label, third-party lead testing and a Children's Product Certificate. A bar sold on its honeysuckle fragrance sits near FDA's "smell nice" line. Whether your wording crosses it is exactly the judgment to put to a professional. Everything below assumes a cosmetic, which is what lotion, body butter, scrub and a detergent-containing bar are.

Question 2: does the small business exemption cover you?

The FDA's MoCRA page (content current as of 10 August 2026) says MoCRA exempts certain small businesses from good manufacturing practice, facility registration and product listing requirements. The statute is 21 U.S.C. 364h: the exemption reaches responsible persons and facility owners whose average gross annual U.S. cosmetic sales over the previous three years are below one million dollars, adjusted for inflation. We could not find the current inflation-adjusted figure on the pages we read; check it.

The exemption has exclusions that apply whatever your sales. It does not apply to anyone manufacturing or processing products that regularly contact the mucous membrane of the eye under customary use, injected products, products intended for internal use, or products intended to alter appearance for more than 24 hours where removal is not part of customary use. A body butter or lotion is none of those, but an eye-area product might fall under the first exclusion. What the exemption does not say matters too. The FDA page lists the serious adverse event requirement separately: responsible persons must report a serious adverse event to FDA within 15 business days, with a copy of the label. Neither the page nor the exemption text we read says that duty falls away for a small business, so ask counsel before assuming it does. The same page says no law or regulation requires specific tests to show product safety, but responsible persons must keep records supporting safety substantiation.

Reasoning from the statute text: the exemption names sections 364b and 364c, while the label contact requirement sits in 364e. That suggests the exemption does not remove the label requirement, but we are not lawyers; confirm.

Question 3: what does the label carry?

ElementWhat the text saysSource
Statement of identityOn the principal display panel, in bold type, by common name, descriptive name or an illustration of the use21 CFR 701.11
Net quantitySolids by weight, liquids by fluid volume, on the principal display panel, within its bottom 30 percent, in avoirdupois ounces (with pounds if 1 lb or more)21 CFR 701.13
Name and place of businessName, city, state, ZIP; "Manufactured for" or "Distributed by" if you are not the maker; street address may be left off if listed in a current directory21 CFR 701.12
IngredientsEach ingredient in descending order of predominance; those at 1 percent or less may be grouped in any order (701.3(f)); colors last; "fragrance" permitted as a term21 CFR 701.3
Contact for adverse eventsA domestic address, domestic phone number or electronic contact (a website may do); effective 29 December 202421 U.S.C. 364e(a)

The "1 percent" rule is where a honeysuckle product's arithmetic meets the label. Our absolute is used at 0.5% to 2% in skin products, so in a lotion at 0.5% it would fall in the any-order group and at 2% in the descending group; the lotion arithmetic is in the lotion article. Section 701.3 also says a fragrance blend can be declared as "fragrance" only if the ingredient fits the common consumer meaning of that term, so whether a single absolute is declared by name or as fragrance is another question for your consultant. The principal-display-panel and 30 percent placement rules have exceptions for tiny panels and boudoir-type containers.

The allergen rule that has not arrived

Section 609(b) of the Act, codified at 21 U.S.C. 364e(b), requires fragrance allergens to be listed on the label and told FDA to propose which substances count by 29 June 2024. The Unified Agenda entry for the rule, "Disclosure of Fragrance Allergens in Cosmetic Labeling" (RIN 0910-AI90, the 2026 agenda), shows it still at the proposed rule stage, with the proposal listed for November 2026 and that June 2024 date recorded as the legal deadline. We read no proposed text, so no allergen list or threshold exists to quote. Dates in an agenda are targets and can slip.

What this means for a maker using our absolute: our published COA shows density, refractive index, optical rotation, appearance and smell for one batch, and we publish no IFRA certificate, allergen declaration or SDS. If the rule is finalized, you may need constituent data our COA does not contain. If you sell finished products, ask for any such document in writing before you order, and do not assume one exists; see the COA reading guide and the IFRA article.

What to do before the first sale

  1. Write down what each product is for in plain words and check it against the soap and cosmetic definitions above.
  2. Check your trailing three-year average U.S. cosmetic sales against the current inflation-adjusted threshold, and check the four excluded product types.
  3. Draft the label against the table and have a regulatory consultant or attorney review it.
  4. Decide who receives adverse event reports and how, and keep the label with each report.
  5. Look for new rules before each print run; the pages cited here carry dates for a reason. The soap and body care guide places these steps in the wider decision order.

We sell the absolute only, so the label, the legal review and the insurance sit with you and your advisers.

Honeysuckle Absolute bottle

Honeysuckle Absolute

Honeysuckle Absolute from our own shop, in sizes from 0.5 oz to bulk.

From $13.99

Shop Now →

Sources & Further Reading