Clinical & Evidence-Based

Cosmetic vs Medical Claims: Where the Line Is Legally Drawn

Why brands can't say "treats acne" but can say "helps reduce the appearance of blemishes." Understanding the legal framework behind skincare marketing language.

January 27, 2026
12 min read
A clipboard with document about non-compliance and gavel.

The $150 Billion Question

Have you ever noticed how skincare products describe their benefits in oddly specific ways? "Helps reduce the appearance of fine lines" instead of "reduces wrinkles." "Supports skin's natural clarity" instead of "clears acne." This isn't marketing creativity—it's legal necessity.

The language on your skincare products is carefully crafted to stay on the right side of a legal line that separates cosmetics (which beautify) from drugs (which treat). Cross that line, and your moisturizer suddenly requires FDA approval, clinical trials, and a prescription.

The Fundamental Distinction

Cosmetics

Legal Definition (FDA): "Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance."

Can Claim:

  • • Moisturizes skin
  • • Improves appearance of...
  • • Cleanses, refreshes
  • • Makes skin look/feel...

Drugs

Legal Definition (FDA): "Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body."

Must Claim This:

  • • Treats acne
  • • Cures eczema
  • • Prevents skin cancer
  • • Increases collagen production

The "Magic Words" That Keep Products Legal

Skincare marketers have developed a sophisticated vocabulary to imply efficacy without making drug claims. Here are the key phrases and what they legally allow brands to avoid:

Drug Claim (NOT Allowed)

"Reduces wrinkles"

Cosmetic Claim (Allowed)

"Reduces the appearance of fine lines"

Drug Claim (NOT Allowed)

"Treats acne"

Cosmetic Claim (Allowed)

"Helps clear skin" or "For blemish-prone skin"

Drug Claim (NOT Allowed)

"Increases collagen"

Cosmetic Claim (Allowed)

"Supports skin's natural renewal process"

Drug Claim (NOT Allowed)

"Heals damaged skin"

Cosmetic Claim (Allowed)

"Helps restore skin's healthy look"

Drug Claim (NOT Allowed)

"Prevents aging"

Cosmetic Claim (Allowed)

"For a more youthful appearance"

The Key Linguistic Tricks

  • "Appearance of": Changes how skin looks, not what skin actually is
  • "Helps": Assists a natural process rather than treating a condition
  • "Supports": Works with the body rather than on the body
  • "For [skin type]": Describes who it's for, not what it does

The OTC Drug Exception

Some products straddle the line—they're called OTC (Over-the-Counter) drugs. These products CAN make drug claims because they contain FDA-approved active ingredients at specified concentrations.

Common OTC Skincare Drug Categories

Acne Treatment
  • • Benzoyl peroxide (2.5-10%)
  • • Salicylic acid (0.5-2%)
  • • Sulfur (3-10%)

CAN say "treats acne"

Sunscreen
  • • Zinc oxide
  • • Titanium dioxide
  • • Chemical UV filters

CAN say "prevents sunburn"

Anti-Dandruff
  • • Pyrithione zinc
  • • Selenium sulfide
  • • Ketoconazole (1%)

CAN say "treats dandruff"

Skin Protectant
  • • Petrolatum (30%+)
  • • Dimethicone (1-30%)
  • • Zinc oxide

CAN say "protects minor skin irritation"

What Makes a Product OTC vs Cosmetic?

Look for a "Drug Facts" panel on the packaging. This is required for all OTC drugs and lists the active ingredient(s), purpose, uses, warnings, and directions. If there's no Drug Facts panel, it's being sold as a cosmetic—regardless of what the marketing implies.

International Regulatory Differences

🇺🇸

United States (FDA)

  • • Binary system: cosmetic OR drug
  • • No pre-market approval for cosmetics
  • • Self-regulation largely relied upon
  • • OTC drug monograph system
🇪🇺

European Union

  • • Similar cosmetic/medicinal distinction
  • • Mandatory safety assessments
  • • Claims must be "truthful" and "evidence-based"
  • • Stricter ingredient restrictions
🇯🇵

Japan

  • • Three categories: cosmetics, quasi-drugs, drugs
  • • "Quasi-drugs" (medicated cosmetics) bridge the gap
  • • Pre-market approval for quasi-drugs
  • • Can make limited efficacy claims
🇰🇷

South Korea

  • • "Functional cosmetics" category
  • • Can claim whitening, wrinkle improvement, UV protection
  • • Requires safety and efficacy data
  • • More claim flexibility than US

Why This Matters for Consumers

A product sold in Korea as a "functional cosmetic" with whitening claims may be reformulated or relabeled for the US market because those same claims would make it an unapproved drug. Same brand, different product—and different regulatory oversight.

The Gray Areas: Where Claims Get Murky

1. Structure/Function Claims

Some claims describe what a product does to the skin's structure without claiming to treat a disease. These occupy a regulatory gray zone:

"Firms skin" — Does this mean it affects collagen (drug claim) or just creates a temporary tightening sensation (cosmetic claim)?

The FDA generally allows structure/function claims for cosmetics if they don't imply treating a disease or fundamentally altering skin physiology.

2. Implied Claims Through Ingredients

A product might not make explicit drug claims but heavily features ingredients known for drug-like effects:

"Contains 2% salicylic acid" (without Drug Facts panel) — The ingredient itself implies acne treatment, even if the product doesn't say so.

This is technically non-compliant but rarely enforced unless the company is explicitly marketing for acne treatment.

3. Influencer & Third-Party Claims

Brands can't make drug claims—but what about the influencers they pay?

Brand says: "For clearer-looking skin"
Paid influencer says: "This completely cleared my acne!"

The FTC holds brands responsible for claims made by paid endorsers. But enforcement is inconsistent, and the practice is widespread.

What This Means For You as a Consumer

What You CAN Trust

  • • Products with Drug Facts panels have met FDA requirements
  • • SPF claims are standardized and tested
  • • Acne drug claims (with active ingredients listed) are regulated
  • • Ingredient lists must be accurate

What to Be Skeptical Of

  • • "Anti-aging" claims without specific evidence
  • • Products implying efficacy through ingredient names
  • • "Clinically proven" without accessible studies
  • • Before/after photos (often manipulated)

Key Takeaways

Cosmetics can only claim to beautify or cleanse—not treat or cure

"Appearance of" and "helps" are legal phrases to avoid drug classification

Look for Drug Facts panels on products making treatment claims

Cosmetics don't require FDA approval before sale

International regulations vary—same brand may have different formulas

Focus on ingredients and evidence, not marketing language

Disclaimer: This article provides general information about US cosmetic and drug regulations and is not legal advice. Regulations change and vary by jurisdiction. Always consult relevant regulatory authorities or legal counsel for specific compliance questions.

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