FDA Research on Allergens in Cosmetics (Five Common Allergen Categories)

FDA research on allergens in cosmetics

Cosmetics (such as soaps, lotions, facial and eye makeup, perfumes, etc.) can cause allergic reactions in certain groups of people. Many people have allergies, and anyone of any age can develop them. An allergic reaction is an overreaction of the immune system to a substance that may otherwise be harmless. Allergens trigger the immune system to release chemicals, such as antibodies that cause allergy symptoms. Many people are familiar with seasonal allergies caused by the pollen of flowering plants, or food allergies. Allergic reactions to cosmetics most often manifest as itchy, red skin rashes or contact dermatitis.

Common allergens in cosmetics

The FDA lists five common categories of allergens: natural rubber, fragrances, preservatives, dyes, and metals.

What consumers can do

Regarding possible allergens in cosmetics, the best way to prevent allergic reactions is to understand what you are sensitive to and how to avoid it. One way to achieve this is to carefully read the product ingredient list and avoid ingredients you know or believe you are allergic to. Simply checking for terms such as "hypoallergenic," "fragrance-free," or "suitable for sensitive skin" is not enough. As authorized by the Fair Packaging and Labeling Act (FPLA), the U.S. Food and Drug Administration (FDA) requires that cosmetics sold to consumers at the retail level carry an ingredient declaration.

In addition, consumers should always check the product label and follow the manufacturer''s instructions before using as directed. Reading the label on a product is especially important because, whether or not you have allergies, some products contain ingredients that may cause allergies. For example, manufacturers of some hair dyes instruct users to test a small amount of the product first to see if they are sensitive to the ingredients in the product before using it more broadly.

Symptoms of allergic reactions

Allergic reactions vary in severity and may include hives, itchy skin, rashes, skin flaking or peeling, facial swelling, irritation of the eyes, nose, and mouth, wheezing, and anaphylaxis. Severe allergic reactions can be life-threatening, with symptoms including loss of consciousness, shortness of breath, difficulty swallowing, dizziness, chest pain, a rapid or weak pulse, nausea, and vomiting. If symptoms of an allergic reaction occur, seek medical attention immediately.

In addition to allergic contact dermatitis, fragrance ingredients can also affect the respiratory system, especially in people with asthma, allergic rhinitis, and viral respiratory infections. For people sensitive to certain fragrances, inhaling them may cause shortness of breath, a feeling of suffocation, coughing, phlegm, a runny or stuffy nose, headache, chest tightness, and wheezing.

Allergen testing

Thankfully, you don''t have to wait until you have an allergic reaction to try to figure out what you are allergic to. We can be tested in advance to learn exactly which allergen is causing the reaction, so as to avoid further exposure to that substance.

Patch testing is commonly used to diagnose dermatitis or skin irritation and swelling. The test involves applying small amounts of allergens to the skin and covering the skin for 48 hours. The doctor checks the skin after 72 to 96 hours for signs of an allergic reaction, including redness, rash, or hives. Based on the symptoms present, the doctor can determine whether the patient has an allergic reaction. Patch testing requires 2 to 3 outpatient visits. For patients with very sensitive skin, patch testing may not work well and may fail to help identify allergens.

Related FDA research

To better understand allergens in cosmetics, the FDA focuses its work on three main areas:

1. Monitoring of adverse event reports

2. Scientific research on the mechanisms of allergic reactions and how allergens interact with the human immune system

3. Research on consumer behavior, the frequency of adverse reactions, and consumer awareness of allergens in cosmetics.

To this end, the FDA is collaborating with scientists at relevant research centers. Through these partnerships, it can better understand how allergic reactions are induced and identify new ingredients that can induce allergic reactions. It is working with research partners to develop animal-free testing methods to identify potential allergens, and exploring whether allergen testing data can help further identify potential allergenic ingredients in cosmetics, in order to understand quality and potential gaps.

The FDA is also involved in research specific to fragrance ingredients. The purpose of this research is to determine the likelihood of adverse reactions from using products containing fragrance ingredients. The project will help determine acceptable levels of various fragrance ingredients used in various rinse-off and leave-on cosmetics.

However, strengthening scientific research on allergens is only one area of interest to the FDA. The FDA also takes steps to learn more about consumer behavior and cosmetic use. It also conducts cooperative interviews with the cosmetics industry to understand how the manufacturing, marketing, and sale of cosmetics are affected by information on cosmetic allergic reactions. In addition, through interviews with state and local regulators, the FDA learns about their awareness of safety issues related to cosmetic ingredients (including potential allergens) and how to monitor and address these issues.