Hypoallergenic Has No Legal Definition - Anyone Can Claim It
The word 'hypoallergenic' sounds like a safety guarantee but requires no testing, meets no standards, and means nothing legally. Here's the truth.
“Hypoallergenic” sounds like a safety guarantee. It appears on products marketed to babies, people with sensitive skin, and anyone worried about reactions. The word implies testing, standards, and verification.
None of this is required.
What “Hypoallergenic” Actually Means
Legally, in most jurisdictions including the UK, EU, and US: nothing.
There is no regulatory definition of “hypoallergenic.” There are no required tests. There are no standards to meet. Any brand can put “hypoallergenic” on any product without proving anything.
The word literally means “less likely to cause allergic reactions” — but there’s no baseline, no comparison, and no verification.
The Regulatory History
In the 1970s, the US FDA attempted to establish regulations for “hypoallergenic” claims. The proposed rules would have required:
- Comparative testing against competitor products
- Evidence that the product caused fewer reactions
The cosmetics industry challenged these regulations in court — and won. The courts ruled the FDA hadn’t adequately justified the requirements.
The result: no regulations were implemented. “Hypoallergenic” has remained an unregulated marketing term ever since.
In the EU and UK, similar situations exist. While cosmetic regulations require products to be safe, the specific claim “hypoallergenic” carries no defined meaning.
What Brands Can (and Do) Claim
Without regulatory standards, “hypoallergenic” is interpreted freely:
Minimal Interpretation
Some brands use “hypoallergenic” simply to mean “we’ve excluded some common allergens” — maybe no fragrance, maybe no common sensitisers.
This is something, but it’s not standardised. What one brand excludes may differ entirely from another.
Self-Certified Claims
Some brands conduct their own testing — patch testing on a small panel of volunteers, monitoring for adverse reactions in a limited trial.
This is better than nothing, but:
- Sample sizes are often small
- Testing conditions may not reflect real-world use
- Results are interpreted by the brand, not independent authorities
Pure Marketing
Some brands simply add “hypoallergenic” because it sounds reassuring and there’s no penalty for doing so. No testing required, no verification needed.
The Problem for Consumers
False Reassurance
People with sensitive skin or allergy concerns specifically seek “hypoallergenic” products, believing they’re safer. This belief may be misplaced.
A product labelled “hypoallergenic” might contain:
- Common irritants
- Allergens for specific individuals
- The same ingredients as non-hypoallergenic products
The label provides reassurance without guaranteeing anything.
No Recourse
If you react to a “hypoallergenic” product, there’s little recourse. The claim isn’t a guarantee — it’s not even a promise. It’s a marketing term with no legally binding meaning.
Variable Standards
Without consistent definitions, comparing “hypoallergenic” products is meaningless. One brand’s hypoallergenic cream might be genuinely carefully formulated; another’s might be identical to their regular range but with different labelling.
What “Hypoallergenic” Products Often Have (and Lack)
Common features of products marketed as hypoallergenic:
Often include:
- Fragrance-free formulation (though not always)
- Simpler ingredient lists (sometimes)
- Exclusion of some common sensitisers
Often lack:
- Independent verification
- Comparative testing data
- Consistent standards across products in the range
May still include:
- Preservatives (necessary for safety)
- Emulsifiers and stabilisers
- Various plant extracts (which can cause reactions)
- Ingredients that sensitised individuals react to
Better Alternatives to the Hypoallergenic Label
Instead of relying on “hypoallergenic,” more reliable approaches include:
Read the Ingredient List
If you know your allergens or sensitivities, check the INCI list directly. This is more reliable than any front-of-pack claim.
Look for Specific Claims
“Fragrance-free” has more consistent meaning than “hypoallergenic.” Similarly:
- “Preservative-free” (when appropriate for the product type)
- “No [specific ingredient]” claims
These specific exclusions are verifiable.
Seek Dermatologist-Tested Products
“Dermatologically tested” means the product has been tested on human skin under dermatological supervision. This doesn’t guarantee you won’t react, but it indicates some level of human testing.
Note: “Dermatologist recommended” is less meaningful — it just means a dermatologist somewhere said something positive about it, possibly for payment.
Patch Test Yourself
Regardless of claims, patch testing is the most reliable way to predict how your skin will respond to a product.
Apply a small amount to a test area (inner forearm or behind ear), wait 24-48 hours, and monitor for reaction before applying to face.
Look for Dedicated Sensitive Skin Lines
Brands specialising in sensitive skin often have more rigorous internal standards than mass-market brands adding “hypoallergenic” to existing products.
This isn’t guaranteed, but dedicated formulation tends to be more thoughtful than marketing-driven label additions.
The Broader Problem
“Hypoallergenic” exemplifies a larger issue in cosmetic marketing: terms that sound meaningful but aren’t regulated.
Other examples:
- “Natural” (no legal definition in cosmetics)
- “Clean” (marketing term with no standards)
- “Gentle” (subjective and unverified)
- “Non-comedogenic” (no required testing in most jurisdictions)
- “Clinically tested” (tested how? by whom? with what results?)
Consumers assume these terms mean something specific. They don’t.
What Should Happen
In an ideal regulatory environment:
- “Hypoallergenic” would have a defined meaning
- Products would require specific testing protocols
- Claims would be verified before marketing
- Consumers could trust the label
This doesn’t exist. Regulatory agencies lack resources or authority to enforce meaningful standards for such claims.
The Practical Takeaway
Don’t trust “hypoallergenic” as a safety indicator. It doesn’t guarantee anything.
Read ingredient lists. This is the only reliable way to know what’s in a product.
Know your allergens. If you’ve had reactions, identify the specific ingredients and avoid them directly.
Patch test new products. Your own skin is the most accurate test for how you’ll respond.
Expect nothing from the label. Treat marketing claims as signals of positioning, not facts about formulation.
The Bottom Line
“Hypoallergenic” is marketing, not medicine. It sounds reassuring because it’s meant to sound reassuring — that’s the entire purpose.
The word has no standardised meaning, requires no testing, and provides no guarantee. Anyone can use it. Many do.
If you have sensitive or allergy-prone skin, you need to do your own due diligence. Check ingredients, patch test, and don’t assume a marketing term protects you.
The term “hypoallergenic” should mean something. Regulatory failure means it doesn’t. Until that changes, trust ingredient lists, not front-of-pack claims.