New FDA Regulations for “Latex-Free” Labeling

In an attempt to protect latex sensitive consumers from being misinformed and put at risk, the FDA has suggested for medical product manufacturers to cease their use of the terms “latex-free” and “does not contain latex.”


In March of 2013, the FDA announced that manufacturers who wish to market or label their products as being “latex-free” should now use the terminology “not made with natural rubber latex” instead. This product labeling suggestion also applies to FDA-approved condom manufacturers.

Up until now, “latex-free” product labeling has not been supported by any real scientific evidence. This recent re-labeling recommendation arose last year after the FDA announced that they currently have no tests which can determine whether products actually contain any latex proteins or not. These proteins are the direct cause of latex allergies.

Natural rubber latex primarily comes from the Brazilian rubber tree and is used in a slew of medical products such as: crutches, sanitary napkins, medical gloves, catheters, adhesive bandages, blood pressure monitoring cuffs and more.

Synthetic natural latex rubber derivatives, such as nitrile, are also used in a plethora of medical products. However, since nitrile is also commonly referred to and labeled as “latex,” (even though it is a synthetic derivative and contains no natural rubber latex proteins) latex sensitive consumers can easily become confused by “latex-free” labeling.

Latex allergies tend to develop over time. Repeat exposure to any products containing natural rubber latex can result in an increased sensitivity to natural rubber latex proteins, with symptoms ranging from: skin redness, rash, hives, itching, difficulty breathing and wheezing. Rarely, shock and even death can occur.

Those who have the highest risk of developing a latex allergy are those who have frequent, repetitive and long term exposures to latex, such as healthcare workers who wear disposable gloves full time. The Occupational Health and Safety Administration (OSHA) estimates that 8-12% of all healthcare workers are latex-sensitive. This is a higher percentage than the 1-6% of the general population who reports having allergic reactions to natural rubber latex.

In order to combat the development of a latex allergy over time, the Center For Disease Control (CDC) recommends using natural rubber latex products only when there is a possibility of coming into contact with a potentially bio-hazardous substance.
Source: FDA ]

About Kara

Kara is the Creative Director for the Condom Depot Learning Center, Condoms Fast Blog & the Spicy Gear Blog. She's an FSU alumni with a B.A. in Creative Writing and Studio Art & is as sex positive as they come. She be found swimming in the Gulf of Mexico, reading or playing the drums.

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