Two FDA Rules Your Hair Care Manufacturer Is Watching
Two FDA cosmetics proposed rules carry a November 2026 target date, and the first is about hair. FDA’s rule to prohibit formaldehyde and formaldehyde-releasing chemicals in heated hair smoothing and straightening products has been under White House review since August 6, 2026. A second rule requiring fragrance allergen disclosure on cosmetic labels carries the same target. Neither is law yet. Both decide what a hair care brand can put in a bottle and what must appear on the label — a conversation to have with your hair care manufacturer before a formula is locked.
What the formaldehyde rule actually covers
The rule is RIN 0910-AI83, and its stated scope is narrow enough to read literally: it would prohibit formaldehyde and formaldehyde-releasing chemicals such as methylene glycol as an ingredient in hair smoothing or straightening products applied to the hair and heated under their conditions of use. It is written against 21 CFR 700 and carries no legal deadline.
Two details matter. It is not a ban on formaldehyde releasers across all cosmetics, so a preservative in a conditioner is outside the stated scope. And the rule has been pending review at the Office of Management and Budget since August 6, 2026, with November 2026 listed as the target for the proposal, not an effective date. A proposal must publish, take comment and be finalized before anything binds. FDA has moved this date more than once.
The fragrance allergen rule lands on labels
The second rule, RIN 0910-AI90, would identify certain substances as fragrance allergens and require them disclosed on cosmetic labels. It comes from section 609(b) of the Federal Food, Drug, and Cosmetic Act, added by the Modernization of Cosmetics Regulation Act of 2022. The statutory deadline for the proposal was June 29, 2024; it still has not published.
For a hair line this is a packaging problem more than a formulation one. Shampoo, conditioner and styling products are among the most heavily fragranced things a brand sells, and the ingredient list is printed. The label you print in volume may not be the one you print next year.
Where hair care quietly becomes a drug
This one predates the new rules and catches first-time brands anyway. A product’s category is set by its intended use. A cleansing shampoo is a cosmetic. An anti-dandruff shampoo, in FDA’s own words, is both cosmetic and drug: intended to cleanse the hair and to treat dandruff. Same for a scalp product aimed at seborrheic dermatitis or psoriasis.
Such a product must fit an over-the-counter monograph or hold an approved application. The monograph, 21 CFR 358 subpart H, is specific: pyrithione zinc at 0.3 to 2 percent when washed off after brief exposure, salicylic acid at 1.8 to 3 percent, selenium sulfide at 1 percent, coal tar at 0.5 to 5 percent, sulfur at 2 to 5 percent. Labeling is prescribed too, and a combination drug-cosmetic product needs Drug Facts labeling with actives listed separately from cosmetic ingredients. A one-word change from “scalp care” to “dandruff” moves the product between regimes — a cheap conversation before tooling, an expensive one after.
Hair dye has a carve-out, and it is conditional
Most hair dyes are what FDA calls coal-tar hair dyes, and under FD&C Act section 601(e) they sit outside the general requirement for color additives to be cleared before use. The exemption is not free. Per FDA’s hair dye page, the agency is limited on a poisonous or deleterious ingredient claim only while the label carries the section 601(a) caution statement and adequate skin-test directions. Miss either and the protection is gone. It does not extend to eyebrow or eyelash dyes, and the color additive listing for lead acetate in scalp hair dyes was terminated effective January 6, 2022.
- Ask your manufacturer in writing whether any formaldehyde releaser appears in a heated smoothing or straightening formula, and what the replacement route is.
- Treat the November 2026 dates as targets. Plan the reformulation path, not a compliance date that does not exist.
- Decide early whether a scalp product is a cosmetic or an OTC drug; that drives the label format, not just the copy.
- If you sell dye, verify the caution statement and skin-test directions are on the artwork you print.
- Order fragranced-product packaging in quantities you can afford to reprint once a disclosure list lands.
- Under MoCRA the responsible person named on the label carries safety substantiation and adverse event duties — usually the brand, not the factory.
What this means when choosing a factory
No hair care manufacturer can tell you what the final rules will say. What one can do is tell you what is in your formula today, flag ingredients inside a proposed scope, and keep documentation that survives a label change. Reasonable to ask during supplier selection; hard to retrofit later.
Moe’s Group is an FDA registered contract manufacturer in Chatsworth, California, formulating, filling and labeling skin care, hair care and body care in one facility, under ISO 22716 cosmetic GMP certification whose scope covers hair care. Ready-made formulas start at a 200-unit minimum order; custom formulation starts at 1,000 units; facility capacity runs up to one million units per month, which is capacity rather than a lead-time commitment. Certificates are downloadable at moesgroup.com/certifications.
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