strixus:cracked:In the 1980s, a tampon manufacturer famously introduced an “improved” product design

strixus:cracked:In the 1980s, a tampon manufacturer famously introduced an “improved” product designed to be more absorbent. Unfortunately, these new tampons proved to be the ideal breeding ground for Staph bacteria, resulting in an epidemic of toxic shock syndrome, which – you guessed it – can be fatal. Of course, all the major tampon companies responded by changing their products to be safer, and the TSS epidemic ended.Oh, sorry, we were talking about Ideal World. Y'know, the place where human beings show each other empathy and people don’t die to save corporations a nickel. No, the overall composition of tampons hasn’t changed since the ‘80s – companies just slapped a warning label on their packages and called it a day. More baffling still, tampon companies are under no obligation from the FDA to list their ingredients, despite the potentially lethal consequences. That means that the average woman knows more about what’s in her made-in-China sweater from H&M than what’s in her vagina.There is a bill that’s been floating around Congress – the Robin Danielson Act, introduced by Representative Carolyn Maloney – which would establish a research program with actual scientists studying the chemicals and materials in menstrual hygiene products. The only problem is that most members of Congress have never menstruated, and further, they have the imaginations of lobotomized goldfish, so they couldn’t give less of a fuck. Maloney’s bill has been killed at least nine times.Huge Real World Consequences Of Thinking Lady Parts Are IckyI’m just going to leave a few links here. Not saying any of this article is incorrect, but it is pretty FUDish in tone.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.430https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071799.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3238331/https://books.google.com/books?id=85NKEmVnvt0C&lpg=PA7&ots=vxodJBJN_g&dq=fda%20tampons&pg=PA7#v=onepage&q&f=falsehttps://dash.harvard.edu/bitstream/handle/1/8852185/Kohen.html?sequence=2Menstrual Tampons Are Class II Medical DevicesChapter 9 of the FDCA establishes the classification of devices intended for human use. In 1980, menstrual tampons were classified as class II devices.[19] Scented or scented deodorized menstrual tampons are defined as:a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.[20]Unscented menstrual tampons are defined as:A device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.[21]Class II medical devices require more than the “general controls,” which are sufficient for class I devices, in order to ensure their safety and effectiveness.[22] Devices classified as such, like menstrual tampons, require “special controls” to provide assurance.[23] If the FDA perceives a great enough risk, it may require/perform “the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines … recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance.”[24]The Debate Over Tampon Ingredient LabelingAs early as 1982, the FDA was asked to require ingredient labeling for tampons because of consumer concerns about the safety of some ingredients, but it declined to do so.[121] Because the FDA did not have data demonstrating an association between any particular ingredient and any risk of health, including allergic reaction, sensitivity, and irritation, it did not have enough information to require ingredient labeling. The FDA noted, however, that it was reviewing the problem of adverse reactions that might be associated with tampons to determine if it should supplement current voluntary standards with regulation.[122]This refusal to require such labeling displayed a policy consideration by the FDA that inundating consumers with too much information could result in their not processing any of it, or especially, not being able to appreciate which safety information is the most meaningful or important. “Routinely, the agency has avoided requests for nonmaterial information or warning-like statements for ingredients that cause only mild or idiosyncratic responses.”[123]On August 20, 1985, after the task force tampon safety had dissolved,[124] the FDA’s Obstetrics-Gynecology Devices Panel discussed the safety of tampons. The Panel recommended the FDA consider including “content” labeling in the tampon absorbency labeling regulation, perhaps by regulating scented tampons as cosmetics.[125] The FDA declined to take up this suggestion to regulate tampons as cosmetics, since doing so would not induce ingredient labeling anyway. Under 21 C.F.R. § 701.3, which governs the labeling of ingredients in cosmetics, a fragrance may be listed on the label as “fragrance” without any further information supplementing.[126]However, concerns over tampon ingredients, particularly regarding dioxin, continued to surface in the 1980s. In 1987, an FDA scientist warned, “It is critical to an adequate risk assessment that the level of dioxins in tampons, sanitary pads, diapers, and other medical devices be measured. The capacity to measure such levels exists within FDA. Extraction data for dioxin from these products … would improve the accuracy of any risk assessment.”[127] In its Proposed Rule for absorbency labeling of September 23, 1988, the FDA invited comment on the need for ingredient labeling of scented or other tampons.In its June 12, 1989 reproposed rule for absorbency labeling,[128] the FDA reported that many consumer groups and individual consumers had commented on the need for ingredient labeling. Some argued that all materials, additives, and fragrances should be listed on the product label so that consumers may choose products on the basis of which ingredients are known to be or suspected to be hazardous, as well as which have the potential for an allergic reaction. Other comments argued against requiring ingredient labeling, maintaining that there were no data suggesting the need for ingredient labeling, or that it simply was not as important as absorbency labeling and as such might not be used by consumers. Additionally, comments noted that manufacturers had voluntarily implemented an ingredient labeling system for tampons so no required system was necessary.[129]Ultimately, the FDA felt it did not have the authority to adopt ingredient labeling requirements. “None of the comments favoring ingredient labeling cited, discussed, or submitted any data showing an association between any ingredient in any currently marketed tampon and any risk to health, including allergic reaction, sensitivity, or irritation, and FDA is unaware of any such data.”[130]Without information indicating that such labeling is necessary for the safe and effective use of tampons,  FDA is without legal authority to require such labeling.In its final rule for absorbency labeling, the FDA again responded to consumers’ and consumer groups’ requests for ingredient labeling. Once again, the FDA responded that in the absence of data showing an association between any ingredient and any risk to health, nor any legal theory under which the FDA could reside, the FDA lacked the authority to mandate ingredient labeling.[131] (emphasis added) -- source link

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