The short answer
Hair loss products fall into different legal categories, and a Cosmetic Product Safety Report only covers one of them. A product claiming to regrow hair, stop hair loss or stimulate follicles is a medicine by presentation and needs a marketing authorisation from the MHRA, not a CPSR. A cosmetic scalp or hair product can be assessed by CPSR and may claim to cleanse, condition, support scalp condition and improve the appearance of fullness or density, but nothing about growth. Comparing hair loss products therefore means comparing categories before comparing evidence.
Key takeaways
- The categories come first: licensed medicines, cosmetics, food supplements and devices each have different evidence requirements and different regulators.
- A claim to regrow hair or stop hair loss makes a product a medicine by presentation, whatever its ingredients.
- Licensed medicines for hair loss have been through clinical trials and regulatory review; cosmetics have not, and cannot claim as if they had.
- Cosmetic scalp products can legitimately claim conditioning, scalp comfort and the appearance of fuller hair, with appropriate evidence.
- Botanical hair growth claims, including rosemary oil, are medicinal claims when they assert growth, and an assessor will refuse them.
- A Cosmetic Product Safety Report cannot be written for a product presented as a medicine, so the classification decides everything that follows.
Hair loss is the category where consumer confusion and regulatory boundaries collide most sharply. A shopper comparing options sees a licensed pharmacy medicine, a salon scalp serum, a supplement, a laser comb and a bottle of rosemary oil on the same search results page, all suggesting the same outcome, and reasonably assumes they are variations of one thing supported by different amounts of evidence. They are not. They sit in different legal categories under different regimes, and the first question is not how good the evidence is but which regime the product is in. Regulation (EC) No 1223/2009 and the UK regulation enforced through the Cosmetic Products Enforcement Regulations 2013 govern cosmetics; the Human Medicines Regulations 2012 and the MHRA govern medicines
This article is written for brands developing scalp and hair products and useful to anyone trying to compare what is on the market. It explains the four categories and how to tell them apart, the presentation and function tests that make a product a medicine, what a cosmetic hair product may and may not claim, how the evidence levels actually compare, the botanical claims that get brands into difficulty, what a Cosmetic Product Safety Report can and cannot do here, a worked example of a scalp serum brought back inside the cosmetic boundary, and how to develop in this category without ending up with an unlicensed medicine.
The four categories, and how to tell them apart
| Category |
Examples |
Regulator and requirement |
Evidence behind it |
| Licensed medicine |
Products containing authorised active substances for androgenetic alopecia |
MHRA marketing authorisation |
Clinical trials reviewed by a regulator before sale |
| Cosmetic |
Shampoos, conditioners, scalp serums, oils and styling products presented cosmetically |
Cosmetic Product Safety Report, PIF, Responsible Person, notification |
Safety assessment; efficacy claims need their own studies |
| Food supplement |
Oral vitamin and mineral products marketed for hair |
Food law, with permitted health claims only |
Authorised health claims where they exist |
| Medical device |
Some scalp devices and light based products |
Conformity assessment and UKCA or CE marking |
Technical file and clinical evaluation appropriate to the class |
Ask yourself
If your scalp product's claims were read aloud to a pharmacist, would they sound like a cosmetic or like something that should be behind the counter? That instinct is very close to the presentation test.
What the CPSR can and cannot do here
It can assess a cosmetic scalp or hair product thoroughly: exposure to the scalp, which is living skin with its own absorption characteristics, sensitisation from essential oils and other ingredients, the conditions attaching to any restricted actives, preservation for a product used on a warm moist scalp, and the claims consistency review. It can support the cosmetic claims listed above where evidence exists. It cannot make a growth claim lawful, cannot substitute for a marketing authorisation, and cannot be written at all for a product presented as a medicine. This applies just as much to products pitched at thinning hair or general hair health as to those explicitly marketed as hair loss treatments. A brand that arrives with a finished product and artwork promising regrowth is usually facing a rewrite rather than a reassessment, and the sooner that conversation happens the cheaper it is. This is also why classification belongs at the start of development rather than at artwork stage.
What about supplements, devices and combination offers?
Brands in this category increasingly sell a system: a serum, a supplement and sometimes a device, bundled as a programme. Each component keeps its own regulatory status, which is the point most often missed. The serum is a cosmetic needing a Cosmetic Product Safety Report, a Product Information File, a Responsible Person and a notification. The supplement is a food, subject to food law, permitted to make only authorised health claims, and there are very few authorised claims relevant to hair beyond the maintenance of normal hair associated with certain nutrients. The device, if it makes a medical claim or works by a physical mechanism for a medical purpose, is a medical device needing conformity assessment and a UKCA or CE mark. A red light therapy cap or comb is a common example in this space, and whether it is treated as a cosmetic accessory or a medical device depends entirely on the claims made for it rather than on the underlying light therapy technology itself. Bundling them does not merge the regimes, and it creates a new risk: the marketing for the bundle is read as a whole, so a programme sold on a regrowth promise turns the cosmetic component into part of a medicinal presentation. Assess each component separately and write the bundle copy to the strictest of the three.
A worked example: a scalp serum brought back inside the line
A brand submits a caffeine and rosemary scalp serum with artwork claiming stimulates follicles, reduces hair loss and promotes regrowth, supported by two supplier studies on the actives. The assessor's review takes a morning. All three claims fail the presentation test and are refused; the supplier studies are ingredient level in vitro work and would not have supported the claims even in a category where they were permitted. The formula itself assesses well: the actives are unrestricted at the levels used, the essential oil is capped by its sensitising constituent, and the preservative system passes. The brand rewrites the pack as a lightweight scalp serum with caffeine and rosemary that conditions the scalp and leaves hair looking fuller, commissions a small instrumental study on hair diameter and a perception study on fullness for the following season, and keeps the ingredient stories in body copy where they describe the ingredients rather than promise an outcome. A claim framed around improved hair density, if genuinely measured, is a very different proposition from one implying a reduction in hair loss or a reversal of hair follicle miniaturisation, which strays straight back into medicinal territory. The product launches three weeks later than planned and is lawful, which is three weeks better than a suspension.
Why enforcement in this category is increasing
Hair loss marketing has attracted attention from several directions at once, and brands should assume the level of scrutiny will rise rather than fall. The MHRA acts against products presented as medicines without authorisation, and hair growth claims are among the clearest examples, whether the product is a serum, a supplement or a device marketed around light therapy. The Advertising Standards Authority rules regularly on hair and scalp advertising, including influencer content, and its decisions are published and searchable by competitors and journalists. Online marketplaces have compliance teams that remove listings making medicinal claims, often without warning and without an appeal that arrives quickly. And the category attracts consumers in distress, who are more likely to complain when an expensive product does not deliver what the pack implied, whether their concern was framed as hair loss or thinning or simply as thinning hair they wanted to address cosmetically. The commercial consequence is that a growth claim is not a small regulatory risk taken for a large marketing gain; it is a listing suspension, a published ruling and a refund wave waiting to happen, against a benefit that careful cosmetic wording can largely capture anyway.
- Developing in this category without ending up with a medicine
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Decide the category before the formula is finalised.
Write the claims you want, and test them against the presentation test first.
- Avoid every growth, loss, follicle and alopecia word on packs, pages and social media.
- Build claims around breakage, fibre strength, scalp comfort and appearance of ullness.
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Commission finished product studies for the claims you intend to keep.
Brief influencers with approved wording, because their posts are your claims.
- Treat customer testimonials about regrowth as claims you have adopted if you repost them.
- Get the assessor's view on the artwork before the plates are made.
Find out which side of the line your product is on
Spectra's assessors classify scalp and hair products before assessment, prepare the Cosmetic Product Safety Report for those that are cosmetics, and tell you plainly which claims cannot be made. Certified assessors, 3 to 5 day standard turnaround, Complete Compliance Pack at £295.
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Myths we hear
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If the ingredient has published research, we can claim it. Published research does not change the category of the claim.
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Natural products can make growth claims because they are gentle. The presentation test does not care about origin.
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Everyone in the category says regrowth. Many of them are trading unlawfully, and enforcement is increasing.
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A disclaimer protects us. Disclaimers do not undo the overall impression a pack gives.
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A CPSR legitimises the product. A CPSR cannot be written for a product presented as a medicine.
What to do this week
- Read every scalp and hair product page for growth, loss and follicle language.
- Remove it, including from social posts and influencer briefs.
- Reframe around breakage, strength, scalp comfort and appearance.
- Check whether any active in your range is pharmacologically active at the level used.
- Ask your assessor to classify anything you are unsure about.
This is a category where the honest cosmetic claims are genuinely useful and the unlawful ones are genuinely risky. That applies as much to products addressing hair thinning as to those marketed more broadly around hair loss and thinning. Get the classification right and there is a good product to sell; get it wrong and there is an unlicensed medicine on a shelf.
Related reading on the Spectra blog
• Clinically proven and dermatologist tested: the evidence a CPSR files
• Can a Cosmetic Product Safety Report back up hair care claims?
• When can a Cosmetic Product Safety Report support a hypoallergenic claim?
• All Spectra articles
Spectra services mentioned in this article
• The Complete Compliance Pack: CPSR, PIF, SDS and SCPN or CPNP (£295)
• CPSR services by product type
• PIF services
• CPSR for Perfumes and Fragrances (from £84)
• UK and EU Responsible Person
• Contact Spectra
Official sources and legislation
• Human Medicines Regulations 2012
• Medicines and Healthcare products Regulatory Agency
• Regulation (EU) No 655/2013 on cosmetic claims
• Regulation (EC) No 1223/2009 on cosmetic products
• OPSS guidance on cosmetic products regulations
About the author
Spectra Cosmetic Compliance is a UK based cosmetic regulatory consultancy (Spectra Private Limited, Chadwell Heath, Essex) whose certified safety assessors and toxicologists prepare Cosmetic Product Safety Reports, Product Information Files, Safety Data Sheets and SCPN and CPNP notifications, and provide UK and EU Responsible Person cover, for brands selling in the UK, EU, USA, Middle East and Asia. Standard turnaround is 3 to 5 days with a Regulator-Ready Guarantee. Talk to the team on WhatsApp at +44 7468 895676 or at info@spectracomply.com.
Disclaimer: This article is general information, not legal advice. Regulations change and product decisions depend on your exact formulation, claims and market. Have your product assessed by a qualified professional before sale.
