According to the FDA, products labeled as hypoallergenic are “products that manufacturers claim produce fewer allergic reactions than other cosmetic products.”1 You have probably seen this claim advertised with various skincare products, including those used to treat acne.
Many people with sensitive skin might expect hypoallergenic products to be certain not to irritate their skin. But this may not be the case because hypoallergenic claims are not necessarily supported by any testing, standards, or regulations.
Hypoallergenic Is Not Nonallergenic
It is important to know that hypoallergenic is not the same as nonallergenic, which means that a product is allergy-free.1 According to the FDA:
"Consumers concerned about allergic reactions from cosmetics should understand one basic fact: there is no such thing as a ‘nonallergenic’ cosmetic, that is, a cosmetic that can be guaranteed never to produce an allergic reaction."1
There are three main reasons that hypoallergenic products may still cause skin irritations.
1. Lack of Regulation
First, the term hypoallergenic itself is not regulated in any way. Despite the FDA’s definition of the term, there are no requirements that a product must meet to be considered hypoallergenic. Some manufacturers may define it differently than others, and there is no guarantee that hypoallergenic products are any safer for people with sensitive skin. As stated by the FDA:
"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."1
Since 1974, the FDA has sought to prohibit manufacturers from making hypoallergenic claims about their products unless scientific studies backed up those claims. But their efforts were legally blocked by the U.S. Court of Appeals for the District of Columbia. This may change at some point in the future if the FDA decides to pursue it. However, the FDA has been successful in requiring products marketed in the U.S. to carry a list of ingredients. This enables consumers to avoid products that contain substances that they are allergic to. Checking the ingredients list on products is the best way to avoid allergies if you know that you are allergic to a particular ingredient.1,2
2. People Are Genetically Different
We are all genetically different, so our skin is different too. What causes an allergy in one person may not cause an allergy in another.
3. Products Contain Many Ingredients
A product can contain dozens of ingredients. While ingredients that are known to commonly cause allergic reactions are no longer used in cosmetics in most countries, there is a chance that a small percentage of the population may still experience allergic reactions to some ingredients, particularly those that have been recently introduced into products. Consequently, there is no way to be sure that at least some people will not experience an allergy to some products.1,2
Signs of an Allergic Reaction
There are several indications that a specific ingredient or combination of ingredients in a skincare product may be the cause of an allergy. Irritations and other possible allergic reactions that you should be aware of include the following:
- Most common with skincare products: Delayed itchiness, redness, flaky skin, or tiny bumps (allergic contact dermatitis, or type IV hypersensitivity) – usually on the on face and neck
- Immediate itching, burning, or stinging (irritant contact dermatitis)
- Redness and skin irritation (contact urticaria)
- Bumps on the skin (folliculitis)
- Sudden onset of acne-like lesions on the skin (acneiform eruptions)
- Sensitivity to the sun (photosensitization, photoirritation, or phototoxic dermatitis)
- Dark marks (hyperpigmentation, hypopigmentation, and other pigmentary disorders)
- Worsening of a previously established skin disorder 2,3
Identifying the Ingredient(s) That Cause Allergies
If a person has an allergic reaction to a skincare product and seeks medical attention, doctors can use a standard test to figure out exactly which ingredient in the product is the irritant. This process for diagnosing allergies is called patch testing, and it has been in use since the 1800s.1,4
Performing a Patch Test
When performing a patch test, a doctor gently pricks the skin—normally the forearm—with a set of known allergens and then evaluates how the skin reacts to each of those allergens after waiting for a certain period of time. Doctors also take into consideration the patient’s clinical history.
The FDA-approved patch test kit that most doctors in the U.S. use is called the thin-layer rapid-use epicutaneous – or TRUE – test. It now includes 35 different allergens that patients can be tested for, as selected by the North American Contact Dermatitis Group and European Community Cosmetics Directive.4 Fragrances and preservatives are the most common ingredients in cosmetics that people are allergic to.4
How Often Do Allergic Reactions Occur?
Irritations that fall under the category of allergic contact dermatitis (ACD) are most likely to happen with skincare products. Fortunately, adverse reactions such as these are not common—regardless of whether a product is labeled “hypoallergenic” or not4—because new ingredients usually undergo extensive safety testing before hitting the market.3 According to a 2013 report in the scientific journal Dermatitis:
"Modern cosmetics are safe for most users, and adverse reactions are very rare because the manufacturers invest heavily in safety, quality control, and product testing before releasing the product to the market."4
But despite safety testing, allergic reactions do happen. Several studies have tried to estimate how often they occur based on patch testing results.6–8
A 2004 study in the American Journal of Clinical Dermatology found that 23% of women and 13.8% of men had an adverse reaction to a personal care product over a one-year period.6
A 2011 report in the journal Skin Therapy Letter compiled a set of seven studies that included 30,207 participants from the U.S. and the U.K. and found that 9.8% of the people studied tested positive for a skin allergy.7
As noted, there is a variety of allergic reactions that can occur, and some are more severe than others. It can be difficult for researchers to estimate how often the less severe reactions occur. For instance, authors of various studies report ACD, or type IV hypersensitivity, occurs in less than 1% of the population.9–13
But according to a 2014 study in the journal Dermatologic Clinics, this estimate is probably low because not all patients who experience a skin allergy seek medical attention. Many simply stop using the product, and never report the allergy.3
Product Safety Testing
The process for testing the safety of new skincare products usually begins with testing on animals. After individual ingredients are tested on animals and appear to be safe, the final product is then sometimes tested on humans in early trials. Many companies skip this testing process because it is expensive and can take a long time to complete. Manufacturers can advertise their products as hypoallergenic, regardless of how much product testing they perform, and results from animals or small groups of people cannot represent how all people will respond. Also, if a new ingredient is causing allergies, it may be sold in products for quite some time before dermatologists can identify it as part of a trend.2,4
Any manufacturer can claim a product is hypoallergenic. Since all skincare products must include an ingredients list, consumers should refer to this list and avoid products that contain ingredients that they are allergic to.