End False Allergen-Free Labeling


Target: Margaret A. Hamburg, Commissioner at the U.S. Food and Drug Administration

Goal: Require products claiming to be hypoallergenic to provide proof.

Companies are misusing the term “hypoallergenic” to convince consumers that their products are safe when they may still contain allergens, according to the U.S. Food and Drug Administration (FDA). In fact, the regulation which put the onus of proof of the manufacturer was struck down in 1978 by the federal courts. Since that time, consumers have unwittingly purchased countless products containing ingredients that may cause harm based on a label with no official definition. Demand an end to misleading labeling.

The FDA’s website specifically states that “hypoallergenic” is not a term with any official definition and can mean whatever the company using it chooses. Since the ingredients are listed on the bottle, says the web page, the consumer can still make an educated decision, despite the misleading label. While that sentiment may hold some water, not every consumer is a dermatologist and companies have a responsibility to their customers to provide accurate information about their product and its effects. Without proof that a product’s ingredients reduce the risk of causing an allergic reaction, such claims are unequivocally misleading.

According to an article from the American Chemical Society’s news magazine, Chemical and Engineering News (C&EN), a recent study tested 187 children’s personal care products labeled” hypoallergenic,” “paraben-free” and “dermatologist recommended/tested” to see if these claims had any bearing on the ingredients. According to C&EN, what was found was that 89 percent contained at least one known chemical skin allergen, 11 percent contained five or more allergens and 11 percent contained a preservative called methylisothiazolinone, deemed the contact allergen of the year by a dermatologist society in 2013.

Many companies claim to self-regulate to reduce the risk of causing allergic reactions among consumers, but their methods are varied and often involve trading one evil for another. Without regulation from the FDA, personal care products may continue to spout false claims, harming unwitting consumers. Demand claims of hypoallergenic products be substantiated or that the label be removed entirely.


Dear Ms. Hamburg,

As the FDA is aware, terms like “hypoallergenic” and “dermatologist recommended” are claims providers of personal care products can make without proof. In fact, the FDA website clearly states that each company may decide what the label means for that product.

While a large portion of responsibility is on the consumer to decide based on the ingredients which products are best for them, unsubstantiated claims that certain products will cause fewer allergies is clearly false advertising.

I urge you to define the term “hypoallergenic” or remove it from personal care product labeling entirely.


[Your Name Here]

Photo credit: Maegan Tintari via Flickr

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