As consumers, we are bombarded with skincare products that claim to be hypoallergenic. But what does the term actually mean, and how is it regulated in the United States?
Firstly, let's define the term hypoallergenic. It refers to a product that is less likely to cause an allergic reaction in individuals with sensitive skin. These reactions can range from mild to severe rashes (eczema) and, rarely, hives.
The term hypoallergenic, however, is not regulated by the FDA, which means that any company can use it on their product label without any scientific evidence to support the claim. In fact, manufacturers are not required to submit any substantiation of their hypoallergenicity claims to FDA. This understandably leads to confusion and skepticism among consumers, who may question the legitimacy of such claims. In fact, many studies have shown that a variety of products sold in the United States that claim to be hypoallergenic, in fact, often include ingredients that are known to be common causes of skin allergies.
Key changes to regulations
The FDA does require that companies list all the ingredients used in their skincare products on the label. This generally allows consumers to make informed decisions about which products to use based on their individual sensitivities and allergies. Fragrances are one important exception to this rule. Fragrances are made up of a unique combination of individual fragrance constituents such as linalool, geraniol, isoeugenol, etc... Fragrance formulations are considered proprietary in the US, meaning manufacturers don't have to disclose the contents of their fragrance formulations. This means that patients with specific fragrance allergies have no choice but to avoid all fragrances. Recently, the Modernization of Cosmetics Regulation Act was signed into law by President Biden and one of key changes when it is fully implemented will be required disclosure of individual fragrance components that the FDA defines as a "fragrance allergen".
At VETTED Dermlab, we've applied our lens as dermatologists and experts in skin allergies and product ingredients, and the most recent data in allergic reactions to determine what ingredients to include and exclude from our hypoallergenic products. We conduct repeat insult patch testing on all of our product lines too, and only move forward with formulations that do not elicit any irritant or allergic reactions. We are trying to set a new standard for the cosmetics industry - we believe hypoallergenic shouldn't be just a vague marketing term but a specific descriptor based on strict, scientifically determined criteria. A word you can TRUST.
Have you had an allergic reaction to a skincare product that was "hypoallergenic"? Tell us your story!
References:
Nutrition C for FS and A. “Hypoallergenic” Cosmetics. FDA [Internet]. 2022 Mar 4 [cited 2023 Apr 21]; Available from: https://www.fda.gov/cosmetics/cosmetics-labeling-claims/hypoallergenic-cosmetics
Guo L, Bai H, Botto N, Woodruff CM. Allergens and marketing claims in commercial hand sanitizers: A cross-sectional study. J Am Acad Dermatol. 2021 Nov 24;S0190-9622(21)02895-4.
Rick JW, Morgan A, De DR, Hsiao JL, Shi VY. Allergens and marketing claims of the most popular baby moisturizers: A product analysis. J Am Acad Dermatol. 2023 Jan;88(1):205–7.
Thompson AM, Kromenacker B, Loh TY, Ludwig CM, Segal R, Shi VY. Allergenic potential, marketing claims, and pricing of facial moisturizers. Dermatol Online J. 2020 Jul 15;26(7):13030/qt5vm144th.
