Safety
The Center for Baby and Adult Hygiene Products is the only U.S.-based organization dedicated to advancing the personal absorbent hygiene products industry in North America
FDA Regulation of
Tampons and Pads
The U.S. Food and Drug Administration (FDA) classifies menstrual tampons as Class II medical devices and pads as Class I medical devices. This means tampon manufacturers are required to submit to the FDA a detailed risk assessment of the device components, the design, and test results before they are approved and able to be sold. For pads, this information must be available upon request from the FDA. If questions are raised about safety at any time, manufacturers are required to provide additional information to the FDA.
For tampons, the FDA data submission process includes:
Detailed description of the products including its composition.
Detailed risk assessments.
Assessments of human safety, such as irritation and allergy, in accordance with internationally-recognized consensus standards.
Confirmation of the microbiological safety of tampons.
Evaluation of the intended labeling to assure women have access to the proper usage and safety information.
Cotton and Rayon
Many feminine care products use a blend of materials to increase and achieve the optimal level of absorbency. These materials have a long history of safe use in feminine hygiene and other products. Cotton has been used in the manufacturing of tampons since the 1930s, and rayon has been used at least since the 1970s.
Manufacturers take intentional steps to assure the high quality of all materials, including cotton and rayon, used in pads and liners and tampons. Also, cotton and rayon go through a rigorous purification process. Before being used in feminine care products, cotton is rigorously cleaned through a scrubbing process that removes any pesticides used in farming and then purified. Rayon, which is created from cellulose (typically from wood pulp), is similarly purified.
Current practices for purification or bleaching utilize the Elemental Chlorine Free or Totally Chlorine Free processes that the U.S. Food and Drug Administration (FDA) considers dioxin-free. For tampons, manufacturing practices to purify and monitor cotton and rayon are in line with FDA recommendation that products be free of dioxins, furans, and pesticide and herbicide residues.
Some people wonder if cotton and rayon are both safe for use, especially in tampons. In fact, scientific evidence has repeatedly shown that the cotton and rayon materials used today are equally safe for use in tampons. These components have a long history of safe use, and in 2005, the FDA published guidance for consumers that confirmed that tampons, whether made with rayon, cotton, or a blend of rayon and cotton, have equivalent, low risk of Toxic Shock Syndrome (TSS).
Fragrance
Fragrances have been enjoyed for thousands of years and contribute to people’s individuality, self-esteem and personal hygiene. Millions of fragrances are used every year in consumer and personal care products sold in countries all over the world.
Many women prefer feminine care products with fragrance. Some pads and liners and tampons include fragrance to add a pleasant scent to a product or to mask unwanted smells.
Scented pads and liners and tampons are routinely assessed to assure that they have a low likelihood of irritating or causing allergic reactions. The fragrances used in scented feminine products comply with the International Fragrance Association (IFRA) safety standards for usage limits of these specific product types. IFRA bases these standards on risk assessments by expert panels of the Research Institute for Fragrance Materials (RIFM). In scented tampons and pads and liners, all components of the perfume adhere to the IFRA Code of Practice. For more information on the IFRA Code of Practice, click here.
Manufacturers monitor actions by IFRA and RIFM, scientific literature, and relevant legislation to assure the continued safety of all fragrance materials used in their feminine hygiene products. Scented products are labeled clearly so that consumers can make decisions based on their needs and preferences.
Adhesives
Feminine hygiene products may use adhesives to construct the product, or on the outer surface of the pad or liner to enable it to be adhered to a panty. Pads and liners are also designed in a way that limits direct skin contact with adhesives. The adhesives used in feminine care products, like all used materials, must have a favorable safety profile, demonstrate skin tolerance in the rare chance there is skin contact, and be safe for your body over long-term use.
Non-Woven Materials
Pads and liners and tampons usually have components made of non-woven materials. Designed to wick moisture these materials are made of high molecular weight polymers, which means they cannot be absorbed by the body and are inert. They have a very safe use history in consumer and personal care products as well as in food packaging and medical devices.
Colors
The colorants used in pads and liners and tampons are similar to those used in baby diapers and many other commonly used household items. Inks and pigments help to identify various parts of the product for use and make them more enjoyable to use.
Most importantly, these colors must have been proven to be safe in order for them to be used in products.
Super Absorbent Polymers: In Pads and Liners Only
Inside the core of some pads and liners are super absorbent polymers (SAP), highly absorbent materials that lock away liquid. SAPs go through extensive safety testing, and SAPs have low toxicity and do not cause skin irritation or sensitization. For more than five decades, SAPs have been widely used in consumer products and remains a trusted ingredient across the personal care and food industries.
Women can be confident the pads and liners and tampons that they depend on are safe. Because the FDA regulates all menstrual products as medical devices, there are specific guidelines for safety assessment and manufacturing obligations that the menstrual products sold in the United States must follow.
Toxic Shock Syndrome (TSS)
Toxic Shock Syndrome (TSS) is a rare, serious but treatable disease associated with tampon use. TSS occurs in men, children, and non-menstruating women as well. All tampons on the U.S. market today are associated with an equally low risk of TSS.
The U.S. Centers for Disease Control and Prevention (CDC) reports, for the United States, a menstrual TSS case incidence rate of 1/100,000 in women of menstruating age per year and an overall TSS case incidence rate of 0.53/100,000 people per year. Epidemiological evidence shows that the incidence has remained essentially unchanged since the 1980s. For more information, click here.
Every woman who purchases tampons in the United States and Canada today receives important safety information in the packaging about TSS, ways to minimize her risk of TSS, and advice on what to do if she experiences the signs and symptoms of TSS. For more information on TSS, click here.
Identification of TSS
TSS was first described in 1978 by Dr. James Todd, based on cases in seven children, three of whom were boys. The illness is caused by toxins produced by specific strains of the bacteria Staphylococcus aureus. Most people have antibodies in their bloodstream to protect them from the toxin, if it is produced.
TSS is characterized by symptoms such as fever, headache, vomiting, low blood pressure, diarrhea, difficulty breathing, and rash. If TSS is diagnosed and treated quickly, most women who contract TSS will recover after treatment. Therefore, if you are using a tampon and start to feel sick, remove your tampon, see a doctor immediately, and tell them you think you might have TSS.
Risk Factors
TSS studies show several possible risk factors for menstrual TSS, including:
tampon usage
young user age
continuous use of tampons
absorbency of tampons
This is why it is important for women to interrupt their tampon usage with pads from time to time during their period, and to use the lowest absorbency tampon for their flow.
Nighttime tampon use will not increase your risk for TSS if proper safety tips are followed, including changing your tampon before you go to sleep and not wearing it for more than 8 hours. For more information, click here.
Despite tampon use as a risk factor, tampons are neither a source of S. aureus (the bacteria that causes TSS), nor do they increase the likelihood of the organism being present in a woman’s vagina, nor do they increase the numbers of the organism present in the vagina.
For more information, look at the product insert found in all boxes of tampons, or read more here.
Research Relating to Cotton and Rayon Fibers
Numerous studies have demonstrated the safety of tampons made with cotton and/or rayon fibers. Extensive research has repeatedly disproven the belief that TSS risk increases because of the presence of rayon fiber in tampons:
Four separate, independent studies failed to reproduce an earlier report asserting that rayon was associated with a higher risk of TSS.
Epidemiological studies conducted in the 1980s confirmed that tampons made with cotton and/or rayon fibers had the lowest relative risk of TSS vs. tampons made with other compositions.
Microbiological and laboratory studies confirmed that cotton and rayon fibers did not differ in their propensity to increase risk of TSS.
FDA guidance states that “Tampons made with rayon do not appear to have a higher risk of TSS than cotton tampons of similar absorbency.”