Most people use cosmetic products containing latex without adverse effects. However, some people may have had allergic reactions to latex-containing products. Because of this the FDA is concerned that consumers might not be aware that some cosmetic products contain natural rubber latex.

What We Know about Latex Allergy

Roughly 1-6% ^[1] of the general population is allergic to natural rubber latex. Natural rubber latex is a milky fluid that contains extremely small particles of rubber that comes from plants, principally from the H. brasiliensis rubber tree. Natural rubber latex also contains a variety of naturally occurring substances, including the polymer cis-1,4-polyisoprene and various plant proteins, including what are called antigenic proteins that may trigger an immune response. Some of these antigenic proteins may also be allergenic: that is, they can cause a latex-sensitive person to have an allergic reaction. Sensitivity to latex may develop over time, especially for people who are often exposed to it.

From January 2015 to September 2017, the FDA received 30 reports of allergic reactions involving cosmetic products that typically contain natural rubber latex, including hair bonding adhesives, face and body paints, eyeliner, and eyelash adhesives. Allergic reactions can range from skin irritations or rashes to respiratory problems and even to a more severe reaction called anaphylactic shock. Four of these reports appeared to be of anaphylactic reactions. Because reporting is not required, the actual number of cases is likely to be higher than what is reported to the FDA. The only way that the FDA learns about incidents like these is when consumers, physicians or companies voluntarily report them. The current laws regulating cosmetics do not require companies to submit reports about cosmetic-related adverse events to the FDA.

How to Know if a Cosmetic Contains Natural Rubber Latex

Read the label

Although cosmetic products are not required to include a latex allergy warning, the FDA does require that the labels of cosmetics include a list of ingredients, in order of decreasing amount ^[2]. Consumers should review labeling information prior to purchase. Usually the ingredient list is on the package, where the consumer can easily find it. If the product is sold by mail order, including online, the list may be on the package directly or consumers may be directed to a product catalog or a website, or there may be specific information about how to request a copy of the ingredient list. FDA regulations requires that mail-order distributors respond promptly to your request.

Here are some ingredient names to watch for, all of which indicate the presence of latex:

• Natural Rubber Latex
• Natural Latex Rubber
• Rubber Latex
• Natural Latex
• Latex Rubber
• Natural Centrifuged Latex
• Natural Liquid Latex
• Aqueous Latex Adhesive
• Latex

Manufacturers can change their products' ingredients at any time, so it's a good idea to check the ingredient list every time you buy the product - even if you have used it before.

Consumers who are concerned about natural rubber latex allergy may want to take more precautions, such as:

• Avoiding all products that commonly contain natural rubber latex ingredients (body paints, theatrical cosmetics, hair bonding adhesives, and eyelash adhesives), even if latex isn't listed as an ingredient, or
• Contacting the manufacturer to learn more about the ingredients in the product.
• Speaking with your healthcare professional or dermatologist about your concerns.
• Telling your salon professional if you have or suspect that you have a latex allergy, to avoid possible exposure.

Products marketed only to professionals may not have a list of ingredients. That's because the Fair Packaging and Labeling Act doesn't apply to those cosmetic products sold for professional use. Salon professionals may need to contact the manufacturer to find out what's in these products.

What should I do if I think that I may have a problem with latex?

If you are allergic to natural rubber latex and you have reaction to a cosmetic product, stop using the product and contact your healthcare professional. Please inform the FDA by using our adverse events reporting tools (see below how to report a problem).

How to Report a Problem

If you are a consumer, health professional, attorney, or member of the cosmetics industry who wants to report a complaint or an adverse event (such as an allergic reaction) related to a cosmetic, you have three choices:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

When you report a reaction, be sure to include as much information as possible. It is helpful for FDA to know the precise product name, place, and time of purchase, lot number, labeling, and ingredients, especially if you believe you have experienced a reaction to latex. It is also important to let us know if you have a latex allergy or sensitivity.

The law does not require cosmetic companies to report problems to the FDA. Therefore, your report is very important in order to help the FDA monitor the cosmetics market.

Related Resources:
Consumer Update: Don't be Misled by "Latex Free" Claims

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¹https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm342641.htm

² Under the Fair Packaging and Labeling Act, the FDA requires cosmetics to list their ingredients, in order of decreasing amount, up to greater than 1%, if the cosmetics are marketed to consumers on a retail basis, such as in stores, online, or person to person (see also 21 CFR 701.3).