Tampons & Transparency
In November 2013, the non-profit organization Women’s Voices for Earth (WVE) issued a report titled ‘Chem Fatale‘ with a subtitle that explained the report’s contents – ‘Potential health effects of toxic chemicals in feminine care products’. By late December 2013, Salon, Jezebel, and the Daily Mail had articles online, each with headlines basically saying tampons were tubes of toxins and all citing Chem Fatale. A class of toxins that tops WVE’s list? Dioxins.
Reading about dioxins in WVE’s Chem Fatale had me* recalling a previous tampons-are-full-of-toxins time of 1998-1999. Around 1998, emails started hitting inboxes warning readers that asbestos was added to make tampon to induce bleeding and/or that tampons were teeming with dioxins. Tampon terror took-over and in July of 1999, the US Food & Drug Administration (FDA) responded with ‘Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome‘ Safety Communication.
FDA has no evidence of asbestos in tampons or any reports regarding increased menstrual bleeding following tampon use.
The Environmental Protection Agency (EPA) has worked with wood pulp producers to promote use of dioxin-free methods because dioxin is an environmental pollutant. Because of decades of pollution, dioxin can be found in the air, water and ground. Therefore, while the methods used for manufacturing tampons today are considered to be dioxin-free processes, traces of dioxin may still be present in the cotton or wood pulp raw materials used to make tampons. Thus, there may be trace amounts of dioxin present from environmental sources in cotton, rayon^, or rayon/cotton tampons.
When questions about dioxin arose a number of years ago, FDA asked tampon manufacturers to provide information about their pulp purification processes and the potential for dioxin contamination. Manufacturers of rayon tampons are also asked to routinely monitor dioxin levels in the raw material used or the finished tampons. Manufacturers have provided FDA with test results of studies conducted at independent laboratories, using the most sensitive test methods available. Dioxin monitoring is a highly technical assay performed at only a few independent expert laboratories in the U.S. The detectable limit of this assay is currently approximately 0.1 to 1 parts per trillion of dioxin.
Using these tests, dioxin levels in the rayon raw materials for tampons are reported to be at or below the detectable limit of the state-of-the-art dioxin assay, i.e., approximately 0.1 to 1 parts per trillion. FDA’s risk assessment indicates that this exposure is many times less than normally present in the body from other environmental sources, so small that any risk of adverse health effects is considered negligible. A part per trillion is about the same as one teaspoon in a lake fifteen feet deep and a mile square.
[Excerpts from FDA’s Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome]
As evidenced by WVE’s 2013 Chem Fatale, tampons and dioxins – and tampon production in general – is still a hot issue. Perhaps part of the problem is that tampon makes aren’t totally transparent with their production process and product contents. Manufacturers don’t have to reveal all. Why? As WVE notes in Chem Fatale, a tampon is classified as a Class II Medical Device. As such, the labels on tampons don’t have to list all their ingredients like a bottle of soda. That doesn’t mean a manufacture won’t list ingredients on their product boxes (see image at right). Tampons’ ‘medical device’ classification doesn’t mean there are no labeling requirements for tampons. Here’s what the FDA requires/suggests for labeling tampons and pads:
A. Tampons and Pads
User instructions for menstrual tampons and pads should familiarize users with the features of the device and how to use it in a safe and effective manner and include a description of the product and the materials it contains.
B. Tampons only
For menstrual tampons, in addition to the labeling information required by 21 CFR 801.430(d) and 21 CFR 801.430(e), user instructions should include information on:
- selection of tampon size and absorbency
- tampon insertion
- how tampon should be worn and wear-time
- tampon removal and disposal.
To avoid risk of TSS, we recommend that you include instructions that:
- limit wear-time per tampon to no more than 8 hours
- advise against the use of tampons “overnight.”
Rates of reported TSS cases associated with tampons have decreased significantly over the past 20 years (Reference 8). We believe more informative tampon labeling and educational efforts by the FDA and tampon manufacturers have played key roles in this decrease. Therefore, FDA recommends continued caution when developing tampon labeling.14
For scented or scented-deodorized tampons, we also recommend that you include a warning statement about allergic reactions and irritations, for example:
If an allergic reaction or irritation occurs from using tampons, you should discontinue use and consult a medical professional.
[Excerpt from Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s).]
Likely knowing the lack of transparency in the tampon manufacturing process helped fuel the 1998-1999 toxic tampon scare, the FDA provided some details in their July 1999 Safety Communication.
Tampons currently sold in the U.S. are made of cotton, rayon, or blends of rayon and cotton. Rayon is made from cellulose fibers derived from wood pulp. In this process the wood pulp is bleached. At one time, bleaching the wood pulp was a potential source of trace amounts of dioxin in tampons, but that bleaching method is no longer used. Rayon raw material used in U.S. tampons is now produced using elemental chlorine-free^ or totally chlorine free bleaching processes. These methods for purifying wood pulp are described below:
- Elemental chlorine-free bleaching refers to methods that do not use elemental chlorine gas to purify the wood pulp. These methods include the use of chlorine dioxide as the bleaching agent as well as totally chlorine-free processes. Some elemental chlorine-free bleaching processes can theoretically generate dioxins at extremely low levels, and dioxins are occasionally detected in trace amounts in mill effluents and pulp. In practice, however, this method is considered to be dioxin free.
- Totally chlorine-free bleaching refers to use of bleaching agents that contain no chlorine. These methods are also dioxin-free. Totally chlorine-free methods include, for example, use of hydrogen peroxide as the bleaching agent.
Today, websites of manufactures like Playtex, Tampax, Kotex, and o.b. provide variable levels of tampon transparency. In Tampax’s ‘Tampons 101‘ section, under The Benefits of Tampax Pearl Plastic Tampons and Tampax Cardboard Anti-Slip™ Applicator, it’s stated that their tampons are “…made from a combination of cotton and rayon…” Kotex says their tampons are made with cotton and their ‘Get the facts‘ Q&A “Do tampons cause cancer?” (NO!) addresses those ol’ asbestos and dioxin questions. Playtex’s website is extremely light on details, though their tampon boxes list product ingredients (see Playtex Sport image above). o.b. probably has the easiest-to-find, on-point information in their main FAQs page under What we’re made of:
Q: What are o.b. tampons made of? A: “…two types of rayon and a polyester string.”
Q: Is there chlorine bleach in o.b. tampons? A: “No.”
Q: Is there asbestos in o.b. tampons? A: “…asbestos is NOT an additive and has never been added to o.b.® tampons.”
Q: I’ve heard talk that tampons contain toxic amounts of dioxin. Is this true? A: “…dioxin levels are at or below the detectable limits, posing no risk to tampon users’ health.”
[excerpts from o.b.’s FAQs]
Neither Playtex, Tampax, Kotex, or o.b. websites address two other types of chemicals WVE’s Chem Fatale warns of – pesticides and herbicides. Here’s what the FDA tells tampon manufacturers in regards to pesticides and herbicides:
FDA recommends that tampons be free of 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)/2,3,7,8-tetrachlorofuran dioxin (TCDF) and any pesticide and herbicide residues.9
You should describe any assurances that chemical residues are not present or, if residues are present, the level present and the method used to assess it. These assurances may include, but are not limited to, test methods, tolerances, or acceptance criteria.
[footnote 9] FDA recommends that as a part of your design validation, you have in place validated test plans for monitoring dioxin and potential pesticide residues for cotton in tampon materials and final finished tampons. We recommend that you evaluate your device as described in your test plans and identify the test method and name and address of the testing laboratory in your design history file. You should also explain in your design history file whether testing was conducted on a prototype, on select or all batches, and on a fixed or “as needed” schedule.
[Excerpt from Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s).]
Are tampons “free of… any pesticide and herbicide residues”? Not according to WVE, who cites a single study of a single brand of tampons (o.b.) in Chem Fatale. This study reported to find malathion, malaoxon, dichlofluanid, and piperonyl butoxide at 1 part-per-million (ppm), methidathion and fensulfothion at 5 ppm, mecarbam at 6 ppm, procymidone at 37 ppm, and pyrethrum at 66 ppm. Of these levels, WVE says…
Granted, these levels are relatively low, and generally below the residue levels allowable in food. However, these data clearly contradict the FDA’s recommendation that tampons be “free of pesticide residue.”
[excerpt from Chem Fatale, p10]
WVE points out a weakness of this study, but seems to underline the study’s importance at the same time.
This results, despite being only one study of one brand, generate valid concern about the potential for exposure to pesticides from tampons.
[excerpt from Chem Fatale, p10]
Problem is, I’m not sure this particular study does “generate valid concern” – except for why WVE cited it. Below are the Chem Fatale endnotes for this pesticides-and-herbicides-in-o.b. study.
34 Naturally Savvy (2013). www.naturallysavvy.com
35 The study was commissioned by Naturally Savvy in preparation for their e-book Label Lessons: Your Guide to a Healthy Shopping Cart. Available at: www.naturallysavvy.com/labellessons
[excerpt from Chem Fatale, p22]
Who is Naturally Savvy?
Healthy Shopper U.S.A. Inc. (herein after referred to as “Naturally Savvy™”) is a Canadian Corporation that provides information on natural and organic products and on living a natural and healthy lifestyle through its website Naturally Savvy™.
The Naturally Savvy book mentioned in the Chem Fatale endnote #35, Label Lessons: Your Guide to a Healthy Shopping Cart, appears to be a product recommendation guide. In regards to tampons and pads, this book says popular brands (e.g. Tampax and Always) are “Bad Choices” and lists a single brand as “Naturally Savvy Approved”. That single “approved” brand is Natracare, manufacturer of “..organic cotton tampons and organic and natural pads…”. The founder and owner of Natracare is Susie Hewson. A quick search of Naturally Savvy reveals that Hewson has written for the site, in addition to being quoted and/or written about in posts on the site (here, here, and here).
I find the study produced by Naturally Savvy dubious. WVE not disclosing (or not knowing?) the connection between Naturally Savvy and Natracare is disconcerting. Natracare isn’t the only tampon and pad manufacturer connected to WVE, but not disclosed in their report Chem Fatale. In their 2012-2013 annual report, WVE lists the Seventh Generation Foundation as donor**. This is the foundation of the company Seventh Generation, maker of Organic Cotton Tampons and Chlorine-free pantiliners. This source of organizational funding is not disclosed on the WVE webpage for their ‘Chem Fatale‘ report, in the report itself, or in WVE’s press release for this report.
To me, WVE’s lack of transparency casts Chem Fatale report in an unfavorable light. This is unfortunate, because I agree*^ with WVE on the issue of tampon transparency. I think tampon manufacturers should give us a good look behind the curtain. It’s a tampon, not missile guidance system. I’m pretty sure Kotex has figured out how to make tampons and won’t be reading Tampax’s site to figure it out. The limit of tampon technology has basically been achieved, so it’s time to pack tampon manufacturer websites with information. Why?
More and more, fear of chemicals seems to be most influencing consumer and company decisions, rather than a reasoned assessment of a chemical’s safety. If we don’t have information, the empty space can easily be filled with misinformation and fear. Tampon makers should tell all, front-and-center, on their websites. List all the ingredients (not just cotton and rayon, but all chemicals), discuss product testing and results (e.g. pesticide and herbicide levels), describe the manufacturing process, etc. More information from Playtex, Tampax, Kotex, o.b., and other manufacturers may not gain them new customers, but it may help them keep some of their current ones. Especially when “toxic tampons” is the headline most associated with one’s product.
With complete transparency, we tampon buyers will know what’s in the product, how well it works for us, what it costs us each month, and then we’ll decide to buy (or not). Like we do with lots of products much less intimate than tampons.
^hyperlink was added by me and does not appear in FDA post
*In the spirit of transparency, let me disclose a bit about myself. I am an analytical chemist working on National Science Foundation funded projects at an academic institution.
**Thanks to Emily Willingham for following the money. Seventh Generation is not listed as a donor in WVE’s 2011-2012 or 2010-2011 annual reports.
*^I also agree with WVE that douching is unnecessary and with their general assertion that ladies, your vagina is just fine.
Featured image: tampon is from girlshealth.gov & the magnifying glass is clip art from PowerPoint
As the Executive Director and Director of Science & Research at Women’s Voices for the Earth, we want to thank Skepchick for writing about our new report “Chem Fatale,” and we’d like to address your concerns about our organization’s transparency.
First of all, you are right. We can do better. We believe in full transparency when it comes to companies and government policies that impact women’s health, and we strive to live by those values internally as well. As your post pointed out, we fell short this time.
WVE received funding from the Seventh Generation Foundation in 2013. The funding was a grant of $15,000 to support our engagement in the company’s online campaign pushing for federal chemical policy reform: (http://www.seventhgeneration.com/toxin-free/). We did not receive funding from the foundation for the “Chem Fatale” report, which is why they aren’t listed in it with the other funders.
Corporate funding is a new revenue stream for Women’s Voices for the Earth, and we take the implications of accepting those funds very seriously. In accordance with our Business Partner Policy (http://www.womensvoices.org/about/our-business-partners/), we only team up with companies that share our vision, and align with our mission and goals.
While WVE’s goal is not to promote “green” brands, we do recognize industry leaders who model what the new healthy economy could look like. Soon, WVE will launch our new “No Secrets” coalition for feminine care product companies. Modeled after our successful “No Secrets” coalition for cleaning product manufacturers (of which Seventh Generation is a member), this coalition will leverage the influence of forward-thinking companies to improve industry ingredient disclosure policies. So far, we haven’t asked No Secrets members to pay dues, but we will in the future because of the marketing benefits and staff time needed to maintain the advocacy coalition. WVE will be fully transparent about business partners from whom we have received funds. Not partnering with companies who do the right thing isn’t really an option for us. After all, we fulfill our mission by holding corporations accountable for the products women use every day. By showing industry examples of companies that choose to manufacturer healthy products for consumers and the planet, we hope to create a new norm based on ingredient transparency and accountability for toxic chemicals that harm women’s health.
We also appreciate SkepChick’s critique of the Naturally Savvy pesticide testing study. While you found the study less than compelling, it’s important to recognize that this study represents the only publicly-available data on pesticide residues found in tampons. It is just one small study, but we wanted to demonstrate the validity of the health concern by citing the study, in hopes of inspiring more research and testing that could further confirm (or contradict) the results.
Thank you again for taking the time to read our report and write about it. We were not aware of SkepChick before, and we really like the premise of your blog and hope our paths cross again in the future.
Erin Switalski and Alex Scranton
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