Toxic Condoms: Researchers unwrap the truth inside popular condom brands and the chemicals that may be harmful to your health.

 

It has come out in the news recently that some condom brands as well as lubricants made for sexual pleasure, may contain harmful chemicals that could cause the development of cancer cells. According to a recent study by Mamavation, a women's advocacy group, some major condom brands contain toxic chemicals called PFAS that are linked to cancer. The UK's Daily Mail was the first to break this information to the general public.  PFAS or per- and polyfluoroalkyl substances are microscopic substances that are called "forever chemicals". They are called "forever chemicals" because they take an extremely long period of time to break down in the natural environment. And yes, they can be absorbed into the human body. Several research cite evidence that these PFAS compounds can be found, at varying levels, in almost every human who walks the face of this earth. [1]

It was reported that Trojan condoms and K-Y Jelly lube and gel have detectable levels of this chemical which is cause for concern. Since these substances can be absorbed, the genitals would unfortunately be an effective means of transport into the blood stream to multiple organ tissues, because of the penis' and vagina's sensitive skin and abundant blood vessels. Additionally, PFAS could potentially do damage to the genitals causing sexual malfunction or cancer. 

According to Daily Mail, Mamavision tested twenty-nine (29) sexual/reproductive health products of which six (6) were found to contain the compounds at unsafe levels. Among the lubricants, K-Y Jelly Classic Water-Based Personal Lubricant and Lola Tingling Mint Pleasure Gel for Spot-On Arousal were found to have the highest levels, and the levels in Trojan condoms were also a major cause for concern. The researchers found PFAS at 13 parts per million in the Trojan Ultra Thin Condoms for Ultra Sensitivity, more than the 10ppm danger level. [2] 

Crazy uh?

But this is not the first study that found that some condoms had toxic levels of harmful chemicals and could be dangerous to humans.

Toxic condoms

A study done in 2004 by the Chemical and Veterinary Investigation Institute in Stuttgart, Germany had found N-Nitrosamine, a carcinogen, in 29 of 32 condom brands currently on the market. 

The scientists tested the condoms by placing them in a solution containing artificial sweat, and it was found that the condoms secreted large amounts of N-Nitrosamine at levels way above the prescribed limits for other rubber products such as baby pacifiers. [3]

But what are N-Nitrosamines and what makes them dangerous?

N-Nitrosamine is a type of substance that belongs to a class of organic compounds that are classified as a carcinogen.  Not only is N-Nitrosamine found in some types of synthetic material such as rubber and plastics. N-Nitrosamine is also in processed foods such as cured meat products, processed fish, chocolate flavored beverages, beer and other alcoholic drinks. [4] In the case of industrial products, the chemical is used in agricultural chemicals, detergents, leather products, textiles and even cosmetics. [5]  Levels of the chemical have also been found in some pharmaceutical products. [6] 

N-Nitrosamine is considered a deadly carcinogen that can produce cancer cells that affect the liver, lungs, kidneys, bladder, stomach, esophagus and sinus cells. [7]

Why is N-Nitrosamine in condoms in the first place?

Nitrosamines are formed when nitrites or nitrates react with certain amines. It is possible when the condoms were manufactured it was added in or it came about as a by-product of the manufacturing process. [8] The researchers believed it was used to improve the elasticity of the condoms to prevent breakage. [9]

Unfortunately though, when the condoms come into contact with human bodily fluids such as sweat or semen, N-Nitrosamine is released. [10]

Local government authorities while taking note of the findings, are encouraging condoms users to continue using them, as they believe the levels secreted do not pose an immediate health risk. The Baden-Wurtemmburg Social Ministry said it didn't think "it posed a risk". They have also taken steps to bar the release of the names of the condom brands affected. 

Sounds like a cover up! 

The speculation on the ground is that the authorities fear lawsuits from the condom manufacturers.  

Use alternatives

"We believe that it's up to the manufacturers to use other production processes so that no N-Nitrosamine is formed in condoms," said Werner Altkofer, head of the Chemical and Veterinary Investigation Institute, the research facility that did the study. He also noted that this was more than possible because other condom brands, namely three (3) of the 32 tested did not contain traces of the substance.

The Federal Institute of Risk Assessment in agreeing with Altkofer also called for the use of alternatives to protect the safety and health of users citing that daily condom use exposed consumers to N-Nitrosamine levels up to "three times higher than levels naturally present in food". 

Taking Precautions 

Subsequent to the release of the findings, Beate Uhse, Germany's biggest erotica company pulled chocolate flavored condoms from shelves and completely banned the condom type from its range of products, because the study showed convincingly that chocolate flavored condoms contained "overwhelmingly high levels of N-Nitrosamine". [11]

What do the condom makers have to say?

Durex, one of the most popular condom brands, in responding to the study by the Stuttgart based research facility had this to say in a press release: 

"This is completely unsupported by medical and scientific evidence and no regulatory body has ever called for limits to be set on levels of nitrosamine in condoms."

A further rebuttal of the research was sent to television company ZDF by the country’s ’condom research council’ Deutsche Latex Forschungsgemeinschaft Kondome, of which Durex is a member. The letter says: 

"The European standards authority has quite consciously omitted setting limits for nitrosamines or nitrosable substances [in condoms], because it considers there to be no question of risk ... By contrast, nitrosamine limits have been set on latex products likely to come into contact with very young children and relatively large volumes of saliva, such as dummies and plastic teats on bottles. It would be impermissible and unjustifiable to compare condoms and bottle teats or dummies, either with regard to the mode of use or to the duration of use." [12]

 Both Durex and Deutsche Latex Forschungsgemeinschaft Kondome cite a toxicological study of nitrosamines in condoms carried out by Ehrhardt Proksch at the University of Kiel, Germany, which concluded that "epidemiological studies do not support a role for condoms in the induction of cancer" ( Int. J. Hyg. Environ. Health, 2001, 204, 103). 

However, Werner Altkofer said their research findings needed to be reviewed and updated.  Accusing the company and other manufacturers of knowing there was a problem with N-Nitrosamine exposure for decades, but did nothing about it, Altkofer said, "They have known the nitrosamine problem for many years and have not performed measures to minimise it." [13] 

Is he accusing the big condoms brands of negligence? 

Regulations and Monitoring

Considered "probable human carcinogens" [14] , the European Medicines Agency (EMA) has since set up a Nitrosamine Implementation Oversight Group (NIOG) to oversee a regulatory framework that will ensure the proper monitoring of Nitrosamine levels in medicine. The regulatory network under the guidance of a 2021 implementation plan reports on progress to the EMAs Management Board and Heads of Medicines Agencies. There are also several other stakeholders involved in the process: the CHMP, CMDh, the EDQM, and other parties. [15] There has not however been a ban on products that may contain the substance since regulatory agencies agree this could lead to a shortage of pharmaceuticals deemed as "essential medicines". [16]

As for condoms?

There is no word on whether condom manufacturers are currently monitoring their products for traces of Nitrosamines/N-Nitrosamines. But a research study done in 2018 did find that some condom brands (names not revealed) had some traces of nitrosamine, though a small amount. [17]

Updated August 2, 2024, 6:28 p.m.

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References:

1. Brooks, Bob. "'Materials of concern' and the rapidly changing environmental and sustainability regulatory environment", BioPhorum, pub. 25/05/2023, https://www.biophorum.com/news/materials-of-concern-and-the-rapidly-changing-environmental-and-sustainability-regulatory-environment/
2. Boyd, Connor. "Top selling condomand lube brands contain cancer-causing PFAS 'forever chemicals', researchers warn", Daily Mail UK,  pub. 29/07/2024, https://www.dailymail.co.uk/health/article-13684935/Top-selling-condom-lube-brands-contain-cancer-causing-PFAS-forever-chemicals-researchers-warn.html
3. Deutsche Welle. "German study says condoms contain cancer-causing chemical", pub. 29/05/2004, https://www.dw.com/en/german-study-says-condoms-contain-cancer-causing-chemical/a-1220847
4. European Food Safety Authority. "Nitrosamines in food raise a health concern", updated 28/11/2023, https://www.efsa.europa.eu/en/news/nitrosamines-food-raise-health-concern#:~:text=Nitrosamines%20have%20been%20found%20in,is%20meat%20and%20meat%20products.
5. Hakkaraju, Harshita et al. "A comprehensive review of sources of nitrosamine contaminationof pharmaceutical substances and products", Regulatory Toxicology and Pharmacology, 2023, Abstract retrieved from  Science Direct, https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/nitrosamine#:~:text=Nitrosamines%20are%20considered%20to%20be,%2C%20esophagus%2C%20and%20nasal%20sinus.
6. Robles, Heriberto. "Nitrosamines", Encyclopedia of Toxicology (Fourth Edition), 2024, Abstract retrieved from Science Direct, https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/nitrosamine#:~:text=Nitrosamines%20are%20considered%20to%20be,%2C%20esophagus%2C%20and%20nasal%20sinus. 
7. Robles, Heriberto. "Nitrosamines", Encyclopedia of Toxicology (Fourth Edition), 2024, Abstract retrieved from Science Direct, https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/nitrosamine#:~:text=Nitrosamines%20are%20considered%20to%20be,%2C%20esophagus%2C%20and%20nasal%20sinus.
8. Deutsche Welle. "German study says condoms contain cancer-causing chemical", pub. 29/05/2004, https://www.dw.com/en/german-study-says-condoms-contain-cancer-causing-chemical/a-1220847
9. Deutsche Welle. "German study says condoms contain cancer-causing chemical", pub. 29/05/2004, https://www.dw.com/en/german-study-says-condoms-contain-cancer-causing-chemical/a-1220847
10. Deutsche Welle. "German study says condoms contain cancer-causing chemical", pub. 29/05/2004, https://www.dw.com/en/german-study-says-condoms-contain-cancer-causing-chemical/a-1220847
11. Deutsche Welle. "German study says condoms contain cancer-causing chemical", pub. 29/05/2004, https://www.dw.com/en/german-study-says-condoms-contain-cancer-causing-chemical/a-1220847
12. Perks, Bea. "We're no dummies, say condom manufacturers", Chemistry World, pub. 30/06/2004, https://www.chemistryworld.com/news/were-no-dummies-say-condom-manufacturers/3004296.article
13. Perks, Bea. "We're no dummies, say condom manufacturers", Chemistry World, pub. 30/06/2004, https://www.chemistryworld.com/news/were-no-dummies-say-condom-manufacturers/3004296.article
14. European Medicines Agency. Nitrosamine Impurities, https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities#:~:text=Nitrosamines%20are%20chemical%20compounds%20classified,the%20basis%20of%20animal%20studies.
15. European Medicines Agency. Nitrosamine Impurities, https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities#:~:text=Nitrosamines%20are%20chemical%20compounds%20classified,the%20basis%20of%20animal%20studies.
16. Hakkaraju, Harshita et al. "A comprehensive review of sources of nitrosamine contaminationof pharmaceutical substances and products", Regulatory Toxicology and Pharmacology, 2023, Abstract retrieved from  Science Direct, https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/nitrosamine#:~:text=Nitrosamines%20are%20considered%20to%20be,%2C%20esophagus%2C%20and%20nasal%20sinus.
17. Na Young Park et al. "Analysis of Nitrosamines concentration in condom by using LC-MS/MS", Journal of Korean Chemical Society, Vol. 62, pp. 181-186, pub. 2018. Retrieved from Kyung Hee University website, https://khu.elsevierpure.com/en/publications/analysis-of-nitrosamines-concentration-in-condom-by-using-lc-msms