Latex is a milky fluid that comes from the tropical rubber tree. Hundreds of everyday products contain latex. Repeated exposure to a protein in natural latex can make you more likely to develop a latex allergy. If your immune system detects the protein, a reaction can start in minutes. You could get a rash or asthma. In rare cases you could have a severe reaction called anaphylaxis.

Your doctor may use a physical exam and skin and blood tests to diagnose it. There are medicines to treat a reaction, but it is best to try to avoid latex. Common latex products include

• Gloves
• Condoms
• Balloons
• Rubber bands
• Shoe soles
• Pacifiers

You can find latex-free versions of these products.

Latex allergy is a reaction to certain proteins in latex rubber. It usually begins within minutes of exposure but can sometimes occur hours later. It produces varied symptoms, which commonly include runny nose, sneezing, itchy eyes, scratchy throat, hives, and itchy burning sensations. However, it can involve more severe symptoms, such as asthma, marked by difficult breathing, coughing spells, and wheezing; cardiovascular and gastrointestinal ailments; and in rare cases, anaphylaxis and death.

Contact dermatitis can develop from frequent and repeated use of hand hygiene products, exposure to chemicals, and glove use. Contact dermatitis is classified as either irritant or allergic. Irritant contact dermatitis is common, nonallergic, and develops as dry, itchy, irritated areas on the skin around the area of contact. Allergic contact dermatitis can result from exposure to accelerators and other chemicals used to manufacture rubber gloves or from exposure to other chemicals found in the dental practice setting. Allergic contact dermatitis often causes a rash beginning hours after contact and, like irritant dermatitis, is usually confined to the areas of contact.

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% 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. 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.

If you’re allergic to natural rubber latex, FDA has good news for you: in the future, you are less likely to be misinformed about the absence of this allergen in such products as medical devices. To avoid false assurances about this hazard to your health, FDA is recommending to manufacturers to stop using the labels “latex-free” or “does not contain latex”.

The reason for this recommendation is that the agency is not aware of any tests that can show a product contains no natural rubber latex proteins that can cause allergic reactions. Without a way to verify that a product is completely free of these proteins, a claim that it is "latex free" is scientifically inaccurate and may be misleading.

FDA’s final guidance document, issued on December 2, 2014, advises firms who want to indicate that natural rubber latex was not used in the manufacturing of their product, to state on the label that it was "not made with natural rubber latex."

Natural rubber latex is made from plant sources such as the sap of the Brazilian rubber tree. It is used in numerous medical products, including adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches and blood-pressure monitoring cuffs. Exposure can result in sensitivity to natural rubber latex proteins, with symptoms ranging from skin redness, rash, hives or itching to difficulty breathing and wheezing. Rarely, shock and even death can occur.

It is not possible to predict in advance just how much exposure to natural rubber latex might cause reaction in any specific person.

Who is at Risk?

Since sensitivity is more likely to build up over time, health care workers and others who frequently wear latex gloves are at highest risk.

The Occupational Safety and Health Administration (OSHA) estimates that 8 to 12 percent of health care workers are latex-sensitive. Workers in plants that produce natural rubber latex or that manufacture products containing natural rubber latex might also be at greater risk. FDA estimates that 1 to 6 percent of the general population may also be sensitive to natural rubber latex.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention and OSHA recommend anyone with ongoing exposure to natural rubber latex to take the following steps for protection from allergic reactions:

• Use nonlatex gloves for activities that involve contact with biological materials including blood and bodily fluids whenever possible.
• In addition, use nonlatex gloves for activities that are not likely to involve contact with blood and bodily fluids, such as house cleaning, yard work, wall painting, etc.
• If you choose latex gloves for appropriate barrier protection, use powder-free gloves labeled as having reduced protein content. Natural rubber latex proteins can become attached to powder used to lubricate gloves and when the gloves are removed, the particles become airborne and can be inhaled, which is another form of exposure. Also when wearing gloves, do not use oil-based lotions since they can cause the gloves to deteriorate.
• After use, wash your hands with a mild soap and dry them thoroughly.
• If you have a natural rubber latex allergy, tell your physician, dentist, nurses and employer, and avoid contact with gloves and products made with natural rubber latex.

The Danger of Inaccurate Labeling

FDA’s medical device regulations require certain labeling statements on medical devices if the device or device packaging is made of natural rubber latex. At this time, there are no regulations requiring a company to make any labeling statements when natural rubber latex is not used as a material in the manufacturing of a medical product. However, some manufacturers have included such labeling statements as “latex free” or “does not contain latex” in their labeling. FDA believes that these labeling statements are not sufficiently specific, not necessarily scientifically accurate and may be misunderstood or applied too widely. Therefore, it is inappropriate to include such statements in medical product labeling.

Statements such as "latex free" are not specific about the type of latex involved and can cause confusion. Not all types of latex are from natural rubber and contain the proteins responsible for natural rubber latex allergy. For example, products containing nitrile and polyvinyl chloride are made of synthetic latex that does not contain those proteins and will not cause a latex allergy. Further, these statements do not account for the potential for accidental contamination of the medical product with natural rubber latex allergens during manufacturing or packaging.

March 24, 2015

Latex gloves have proved effective in preventing transmission of many infectious diseases to health care workers. But for some workers, exposures to latex may result in allergic reactions. Reports of such reactions have increased in recent years–especially among health care workers.

What is latex?

In this article, the term “latex” refers to natural rubber latex, the product manufactured from a milky fluid derived from the rubber tree, Hevea brasiliensis. Several types of synthetic rubber are also referred to as “latex,” but these do not release the proteins that cause allergic reactions.

What is latex allergy?

Latex allergy is a reaction to certain proteins in latex rubber. The amount of latex exposure needed to produce sensitization or an allergic reaction is unknown. Increasing the exposure to latex proteins increases the risk of developing allergic symptoms. In sensitized persons, symptoms usually begin within minutes of exposure; but they can occur hours later and can be quite varied. Mild reactions to latex involve skin redness, rash, hives, or itching. More severe reactions may involve respiratory symptoms such as runny nose, sneezing, itchy eyes, scratchy throat, and asthma (difficult breathing, coughing spells, and wheezing). Rarely, shock may occur; however, a life-threatening reaction is seldom the first sign of latex allergy.

Who is at risk of developing latex allergy?

Health care workers are at risk of developing latex allergy because they use latex gloves frequently. Workers with less glove use (such as housekeepers, hairdressers, and workers in industries that manufacture latex products) are also at risk.

Is skin contact the only type of latex exposure?

No. Latex proteins become fastened to the lubricant powder used in some gloves. When workers change gloves, the protein/powder particles become airborne and can be inhaled.

How is latex allergy treated?

Detecting symptoms early, reducing exposure to latex, and obtaining medical advice are important to prevent long-term health effects. Once a worker becomes allergic to latex, special precautions are needed to prevent exposures. Certain medications may reduce the allergy symptoms; but complete latex avoidance, though quite difficult, is the most effective approach.

Are there other types of reactions to latex besides latex allergy?

Yes. The most common reaction to latex products is irritant contact dermatitis– the development of dry, itchy, irritated areas on the skin, usually the hands. This reaction is caused by irritation from wearing gloves and by exposure to the powders added to them. Irritant contact dermatitis is not a true allergy. Allergic contact dermatitis (sometimes called chemical sensitivity dermatitis) results from the chemicals added to latex during harvesting, processing, or manufacturing. These chemicals can cause a skin rash similar to that of poison ivy.

How can I protect myself from latex allergy?

Take the following steps to protect yourself from latex exposure and allergy in the workplace:

1. Use nonlatex gloves for activities that are not likely to involve contact with infectious materials (food preparation, routine housekeeping, general maintenance, etc.).
2. Appropriate barrier protection is necessary when handling infectious materials. If you choose latex gloves, use powder-free gloves with reduced protein content.
   • Such gloves reduce exposures to latex protein and thus reduce the risk of latex allergy.
   • So-called hypoallergenic latex gloves do not reduce the risk of latex allergy. However, they may reduce reactions to chemical additives in the latex (allergic contact dermatitis).
3. Use appropriate work practices to reduce the chance of reactions to latex.
   • When wearing latex gloves, do not use oil-based hand creams or lotions (which can cause glove deterioration).
   • After removing latex gloves, wash hands with a mild soap and dry thoroughly.
   • Practice good housekeeping: frequently clean areas and equipment contaminated with latex-containing dust.
4. Take advantage of all latex allergy education and training provided by your employer and become familiar with procedures for preventing latex allergy.
5. Learn to recognize the symptoms of latex allergy: skin rash; hives; flushing; itching; nasal, eye, or sinus symptoms; asthma; and (rarely) shock.

What if I think I have latex allergy?

If you develop symptoms of latex allergy, avoid direct contact with latex gloves and other latex-containing products until you can see a physician experienced in treating latex allergy.

If you have latex allergy, consult your physician regarding the following precautions:

• Avoid contact with latex gloves and products.
• Avoid areas where you might inhale the powder from latex gloves worn by other workers.
• Tell your employer and health care providers (physicians, nurses, dentists, etc.) that you have latex allergy.
• Wear a medical alert bracelet.