Cosmetic vs. Drug: Keeping Your Claims on the Safe Side of the Line

If you make beauty products, your words are as important as your formulas. A single verb on pack or a bold line on your website can flip a product from cosmetic to drug in the eyes of regulators, bringing a completely different rulebook (and risk profile).

Here's a practical guide to staying safely on the cosmetic side while still telling a compelling story.

Claims Review in Action

Why This Matters (Now More Than Ever)

MoCRA didn't turn cosmetics into drugs, but it did raise the stakes on safety substantiation, records, and accountability in the U.S. In the EU and UK, enforcement around borderline claims has sharpened, with authorities scrutinising pack copy, websites, social posts, influencer content, and retailer pages, because claims determine intended use.

Get the claims wrong and you risk misbranding, detentions, or forced relabelling, plus the reputational sting.

The Legal Bright Lines (US vs EU / UK)

United States (FD&C Act):

• Cosmetic = intended to cleanse, beautify, promote attractiveness, or alter appearance.

  
  

• Drug = intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body.

  
  

• Some categories are always drugs in the U.S. (even if they're "cosmetic" in the EU): sunscreens, antiperspirants, anti-dandruff, acne treatments (OTC monograph territory).

EU / UK (Reg. (EC) 1223 / 2009; retained law in GB):

• Cosmetics must be safe and properly labelled; claims must follow Common Criteria (Reg. (EU) No. 655 / 2013): legal compliance, truthfulness, evidential support, honesty, fairness, informed decision-making.

  
  

• Sunscreens are cosmetics in the EU / UK (SPF / UVAPF / critical wavelength rules apply), but claims must be substantiated and non-misleading.

Bottom line: intended use rules. Regulators infer intended use from words, images, and context across every channel, not just the INCI list.

Phrases That Tip You Into "Drug" Territory (US) or Outside Cosmetic Scope (EU / UK)

Steer clear of disease or therapy language, and be careful with structure / function promises:

• "Treats / cures / relieves eczema, psoriasis, rosacea, acne"

  
  

• "Anti-inflammatory therapy", "heals wounds", "regenerates cartilage / dermis", "stimulates collagen production in vivo"

  
  

• "Prevents sunburn / skin cancer" (US; drug); EU / UK: allowed as sunscreen cosmetic but must use accepted SPF / UV terms and not imply overprotection ("sunblock", "all-day protection"

  
  

• "Stops sweating" (US; antiperspirant drug)

  
  

• Scalp claims: "treats dandruff / seborrheic dermatitis" (US; drug)

  
  

• Oral care: "prevents cavities / gingivitis (US; drug)

Safer cosmetic-side alternatives (with evidence)

• "Helps reduce the appearance of redness / fine lines / dark spots"

  
  

• "Visibly brightens", "improves look of texture", "moisturises for 24 hours", "soothes feeling of tightness", "supports skin barrier (cosmetic effect)"

Tip: qualifiers like "appearance" and "look of" keep the focus on cosmetic effects rather than physiological modification, provided your substantiation matches the claim.

Substantiation that Fits the Claim

Claims must be true, supported, and proportionate to the evidence:

• Instrumental / clinical testing for performance claims (hydration over X hours, reduction in appearance of lines).

  
  

• Consumer perception studies for sensory / appearance claims (with good design and statistics).

  
  

• In vitro / ex vivo can support a mechanism narrative but rarely stands alone for bold visible-effect promises.

  
  

• Before / after visuals must be honest: same lighting, angle, duration, no filters / retouching, and disclose usage conditions.

EU Common Criteria demand evidential support and honesty; the U.S. expects adequate substantiation and will challenge exaggerated or disease-leaning statements.

Digital and Influencer Content Counts

Regulators look at everything: DTC sites, retailer PDPs, social captions, hashtags, UGC reposts, and influencer scripts. If an influencer says "this cured my eczema," and you amplify it, that's now your claim.

Build approval workflows and provide approved claim language to partners.

The Smart Play

Great marketing doesn't need to flirt with drug territory. Clear, consumer-understandable, appearance-focused claims, properly evidenced, are not only compliant, they convert.

Build a shared language with your R&D, regulatory, legal, and creative teams so everyone sells the benefit and protects the brand.

📌Need a second set of eyes on your claims?

Pharmalliance Consulting Ltd supports cosmetic brands with regulatory checks across the U.S., EU / UK and beyond. We assess, advise, and document so your teams can execute with confidence.

Reach out today to see how Pharmalliance Consulting Ltd can help you today!