Hypoallergenic, Dermatologist-Tested, Fragrance-Free: What Skincare Label Claims Have to Prove in the US vs. the EU
"Hypoallergenic" sounds like a tested guarantee, but in the United States no federal standard defines it, and a company does not have to send proof to the FDA. The EU attaches written rules to the same word. Here is what each label claim must back up.
What the FDA says about "hypoallergenic"
The FDA states that "there are no Federal standards or definitions that govern the use of the term 'hypoallergenic.'" Makers are not required to submit substantiation for the claim.
The 1975 rule that a court struck down
The FDA did try. Its final rule of June 6, 1975 defined hypoallergenic as "less likely to cause adverse reactions than some competing products" and required comparative human testing. Almay and Clinique sued; in Almay, Inc. v. Califano (D.C. Circuit, 1977, amended 1978) the court called the definition arbitrary and capricious. A survey it reviewed found only 57% of women and 45% of teenagers chose the "correct" meaning, while 65% used absolute wording such as "doesn't cause allergic reactions."
What the EU asks for instead
Under Regulation (EC) 1223/2009, claims must meet six common criteria in Regulation (EU) 655/2013, including truthfulness and evidential support. The Commission's Annex IV says "hypoallergenic" fits only a product designed to minimize allergenic potential, with known sensitizers totally avoided, and it "does not guarantee a complete absence of risk of an allergic reaction."
Dermatologist-tested and clinically tested
EU guidance reads "dermatologically tested" as human testing under a dermatologist's supervision, and rules out consumer self-perception studies as support. "Clinically tested" points to a clinical protocol overseen by a medically qualified professional. The FDA keeps no list of approved cosmetic claims, though it can act against false ones. Neither phrase tells you the sample size, skin type, or concentration tested.
"Free from" and "unscented" are looser than they sound
EU guidance bans "free from allergenic/sensitizing substances," and bans "free from formaldehyde" if the formula contains a releaser such as diazolidinyl urea. In the US, the FDA notes that some "unscented" products contain just enough fragrance to mask other smells. Read the label for "fragrance" or "parfum," plus the allergens in the EU 82-substance labeling rule.
The short version
The front of the pack is marketing; the back is data.
Reading a label with this in mind
Check the ingredient list and the opened-jar symbol in the PAO guide. Irritant and allergic reactions differ, as the contact dermatitis explainer shows. Patch-test any new product on the inner forearm first, and see a dermatologist about any reaction or skin condition; this is education, not medical advice.
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