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What Does Hypoallergenic Mean Anyway?

The word “hypoallergenic” is a term that probably most of us have run across during our lifetime. It is used in advertising and placed on product labels of shampoo, moisturizer, make-up, and even jewelry. Most people think it means that a product that is hypoallergenic won’t react with their allergies — but is that the true definition?

Greek Origin of the Word

Cosmetic advertisers first used the word hypoallergenic in the 1960s. The word comes from the Greek prefix “hypo,” which translates to below, or less. So the word itself translates to “less allergens.” Since its inception, it has been widely adopted and used by advertisers, manufacturers, and marketers to sell products that claim to be gentler on the skin than other similar products. 

American Food and Drug Administration’s Statement

The American Food and Drug Administration has stated, 

“Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with “normal” skin, may be led to believe that these products will be gentler to their skin than non-hypoallergenic cosmetics. 

There are no Federal standards or definitions that govern the use of the term “hypoallergenic.” The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA. The term “hypoallergenic” may have considerable market value in promoting cosmetic products to consumers on a retail basis, but dermatologists say it has very little meaning.”

History of FDA Hypoallergenic Regulation

The FDA attempted to put regulation on products that claimed to be hypoallergenic in 1974. These regulations stated that a product could be labeled as hypoallergenic only if studies were conducted on human subjects and showed a significantly lower reaction to allergies than products not making the claim. 

They went on to say that companies had to conduct these tests on their own and (most importantly) at their own expense. This caused problems and complications across the board with companies immediately targeting lawsuits against the decision, claiming that the tests, “would pose an undue economic burden on them.”

Continued Attempts at Regulations

The FDA tried again to regulate the use of the word on June 6, 1975 by requiring companies to do scientific studies, but the procedures for the tests were changed to reduce the cost to the manufacturers. This still didn’t sit well with the companies who apparently wanted no regulations on what they were producing. 

Cosmetic companies challenged the FDA decision in the U.S. Court of Appeals, which ruled that the regulation was invalid. The court said the FDA’s definition of “hypoallergenic” was unfair because of a lack of evidence that consumers perceived the term in the way it is described by the organization. 

The result? Manufacturers can continue to advertise and label their products “hypoallergenic” without any kind of regulation or standard set forth by the government. Consumers have no assurance that a product labeled “hypoallergenic” is any less reactive than any other product. Theoretically, a company could put out a product that is “hypoallergenic” that is full of toxins and allergens.

Current Regulations for Hypoallergenic Products

The one small victory that the FDA seems to have had is that at least now manufacturers are now required to put the ingredients on the labels of the products so that consumers can avoid substances that they know they are allergic to or have had problems with in the past. 

As consumers, we must be aware of ingredients in the products we use because apparently the companies who make them aren’t very concerned about our health over their profit margins. There is no doubt that some products out there that claim to be hypoallergenic actually are, but if you are a smart consumer and concerned for you and your family’s health, you’ll do the research yourself and not rely on these companies’ claims. 

Hypoallergenic? More like hypohonest.


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Dr. Athré is one of the few cosmetic and reconstructive surgeons in Houston who is a double board-certified Facial Plastic Surgeon, certified in Otolaryngology, Head/Neck Surgery, and Facial Plastic Surgery.

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