Petition to FDA Commissioner Robert M. Califf M.D.
Petition started on the 23rd June 2023 by Deon Black
- Each year, 100,000 premature deaths in the USA are attributed to phthalates. In a 2023 study, phthalates were present in all tested sex toys at levels exceeding hazard warnings – even in those labeled as “phthalate-free”. [4][6]
- Recent studies show that rubbing sex toys against your skin releases Microplastic and Nanoplastic into your bloodstream (through dermal exposure), potentially penetrating the intestinal barrier, the blood–air barrier, the blood–brain barrier, and placental barrier. Nanoplastics carry phthalates and other plastic additives around your body through your blood. [5][6]
- Vibrator and dildo injuries treated at US emergency departments have increased by 1000% from 2000 to 2019 [2]
- “Retained sex toy” accidents have increased by 164% in men, and 200% in women over the past 10 years [1].
- The highest phthalate concentration allowed in a child’s toy, as outlined by the FDA, is 0.1%. In 2023, most sex toys have a phthalates concentration between 24% – 60%. [6][12]
My Story
“Ouch!” I dropped the clitoral vibrator on the floor.
A few weeks ago, I was about to test a clitoral vibrator with my girlfriend when it suddenly became very, very hot. I scalded my index finger, middle finger, and thumb. I was lucky and my accident was minor, and I was thankful that the burn was on my fingers rather than on anybody’s genitals.
But what would happen if this vibrator was in a vagina, and how many people would be embarrassed to report a sex toy accident?
I was very angry. After years of testing sex toys for work, I began to question the very industry I was a part of.
This marked the beginning of my research, diving deep down into the rabbit hole I discovered the ugly truth of Microplastics, Nanoplastics, Phthalates contained in “Phthalates-free” toys, and the popular “novelty” scam.
Key Takeaways
- Sex toys are killing you: They can cause cancer, birth defects, infertility, cell damage, and more. [6]
- Sex toy companies dodge the FDA (and scam users), by labeling their products as novelty items. This does not reflect consumer use patterns and has little legal meaning. [6]
- We aim to collect 10,000 signatures to bring this problem to the attention of the FDA commissioner, Robert M. Califf M.D., MACC, requesting that sex toys be classified as Class II devices, and require 510(k) clearance.
Documented Sex Toys Health Risks
- Reproductive, developmental, and carcinogenic effects targeting: liver, testes, uterus, ovaries, thyroid, and developing fetuses [6]
- Loss of fertility [6]
- Birth defects [7]
- Breast cancer [8]
- Developmental delays [9]
- Electrical shock [10]
- Adverse skin reactions [10]
- Burns [10]
- Peritonitis [1]
- Long-term damage to vaginal mucosa [1]
- Long-term damage to anal mucosa [1]
- Cell damage [11]
- Inflammation, organ damage, and fibrosis [11]
- Systemic immunological and metabolic conditions [11]
Sex Toys Cybersecurity Risks
The advance of AI technologies, apps, Teledildonics, and remote controlled sex toys gave rise to new unmitigated risks:
The Wild West Of Unregulated Sex Toys
Through the Consumer Product Safety Improvement Act (CPSIA) of 2008, the FDA established that children’s toys cannot have more than 0.1% phthalates due to the risks involved [12]. For instance, when children put toys in their mouths and the toy comes into contact with their mucosa.
Recent research [6] shows that most sex toys have phthalate concentrations ranging between 24% and 60% by weight. Sex toys make contact with vaginal and anal mucosa.
The same study revealed that sex toys claiming to be phthalate free and/or body safe, as printed on the packaging, were in fact not phthalate free. [6]
Sex toy companies are exploiting people’s ignorance and governmental laissez-faire, and will keep doing so as long as people are unaware of the dangers posed by unregulated sex toys.
Deon Black
Who Is Impacted?
The sex toy market is booming. [17] It is estimated that over 80% of American women own a sex toy [18][19]. As consumer access to and interest in sex toys continues to grow, alongside the ever increasing selection of sex toys available on the market, it is expected that the exposure of consumers to unregulated risks will continue to rise in the future.
What Is At Stake?
Death, cancer, infertility, birth defects, and pain. Sex toy companies won’t move a muscle until they’re either forced by the government, or until people, like you reading this, spread the message and make others aware. Now is the time to put an end to this mayhem.
Why Is Now The Time To Act?
The sex toy landscape is only becoming increasingly intricate due to the convergence of artificial intelligence, advanced materials, robotics, and even the emergence of sex robot brothels. Poor quality sex toy shops are proliferating to try and take a piece of the sex toy market pie. This puts unaware consumers at risk of hurting themselves. The government should step in and protect their citizens.
An Interesting Precedent
In 2015, a company labeled a vibrator as being “for premature ejaculation” before submitting it to the FDA for approval [10]. The device worked similarly to any other male vibrators and required no penetration (it’s applied to the top of the penis). We can safely assume the same risks, if not much worse, apply to penetrative vibrators.
The FDA identified the following risks:
- Pain or discomfort due to misuse of device
- Burns
- Electrical shock
- Adverse skin reactions
- Patient injury due to device breakage or failure
- Interference with other devices/electrical equipment
The FDA requested the following mitigation measures:
- Labeling
- Electrical and thermal safety testing
- Electrical safety testing
- Biocompatibility testing
- Mechanical safety testing
- Electromagnetic compatibility testing
We believe that these tests should be required for all motorized sex toys!
The Well-Ignored ISO Standard 3533:2021
A smaller step towards regulation would be for sex toy manufacturers to start adopting the new ISO Standard 3533:2021 [13], which was published in September 2021 and has been completely ignored by all so far.
Sex toy manufacturers will not do anything unless consumers are made aware of the ISO 3533, and therefore seek its mark of approval in every sex toy prior to purchasing it.
Please sign this petition and spread the word.
It Will Be Better For Manufacturers, Too!
One common argument against this petition is that it will be expensive for sex toy manufacturers to complete all required testing to ensure that the sex toy is safe. Besides the obvious reasons of health over profits, I believe that this will actually be a competitive advantage for the few, serious sex toy companies who choose to undergo testing and therefore differentiate themselves from the thousands who don’t. [16]
References
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318238/
[2] https://www.tandfonline.com/doi/abs/10.1080/0092623X.2021.1938319
[3] https://www.researchgate.net/publication/6112898_Vibrator-induced_fatal_rectal_perforation
[4] https://www.sciencedirect.com/science/article/abs/pii/S0269749121016031
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9026096/
[6] https://microplastics.springeropen.com/articles/10.1186/s43591-023-00054-6
[7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3385442/
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5581466/
[9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218126/
[10] https://www.federalregister.gov/documents/2015/05/28/2015-12852/medical-devices-gastroenterology-urology-devices-classification-of-the-vibrator-for-climax-control
[11] https://portlandpress.com/emergtoplifesci/article-abstract/6/4/411/232185/Micro-and-nano-plastics-a-threat-to-human-health
[12] https://www.cpsc.gov/content/CPSC-Prohibits-Certain-Phthalates-in-Children%E2%80%99s-Toys-and-Child-Care-Products
[13] https://www.iso.org/standard/79631.html
[14] https://www.vice.com/en/article/m7apnn/your-cock-is-mine-now-hacker-locks-internet-connected-chastity-cage-demands-ransom
[15] https://www.npr.org/sections/thetwo-way/2017/03/14/520123490/vibrator-maker-to-pay-millions-over-claims-it-secretly-tracked-use
[16] https://www.accessdata.fda.gov/cdrh_docs/pdf/K955648.pdf
[17] https://www.prnewswire.com/news-releases/global-sex-toys-market-trajectory–analytics-2022-2026—development-of-technologically-sophisticated-sex-toys-and-continuous-innovation-bodes-well-for-growth-301462591.html
[18] https://www.statista.com/forecasts/744538/sex-toy-ownership-of-female-consumers-in-the-us-by-type
[19] https://letstalksex.net/sex-toys-statistics/