Personal lubricant products-referred to as lubricants-are medical products designed to facilitate vaginal or anal sexual intercourse and masturbation with others or sexual toys by reducing friction and reducing trauma to delicate tissues.
Personal lubricants are also commonly used to treat symptoms of menopause vaginal dryness and vulvar vaginal atrophy, especially for women who use estrogen
Cream is disabled.
Lubricants also play an important role in promoting health.
Water recommended by CDCor silicone-
As a preventive strategy to prevent HIV transmission, it is based on the use of lubes with condoms to prevent breakage.
According to the World Health Organization, for men who have sex with men, the rate of condom breakage without lubricants is 21.
4%, but only 3% when using individual lubricant products.
Acceptance of sex anal use lubricants resulted in testing of products containing antiretroviral drugs to prevent HIV infection.
In the American dialect. S.
The Food and Drug Administration classifies lube as Class II medical devices in the same category as electric wheelchairs and some pregnancy test kits.
This complex reasoning boils down to 1)
Original development of patient lubricant for gynecological examination and 2)
Original packaging of a condom with a lubricant and/or a detergent (
Condoms are also secondary medical devices).
The official definition of the FDA is: until recently, the lubricant has not explicitly required a mammal safety test.
But the FDA's equipment and Radiation Health Center (CDRH)
Last year, informed individual lubricant industry stakeholders said that by December 31, 2015, 100% of the products will need to be submitted for pre-market notifications, including irritating and allergic safety tests for rabbits and guinea pigs.
In response, the regulatory authority for Ethical Treatment of Animals (PETA)
Product manufacturers objected to the FDA, saying that less expensive testing methods with cultured human cells can predict or predict human safety better than animal testing.
These critics point out that CDRH clearly promises to minimize the use of animals.
But Wendy Steger, CEO and founder of Good Clean Love, told me that the agency accepted only one of the four alternative test models they proposed.
FDA marketing approval (PDF)
The request for CRDH was confirmed for clean love.
An FDA spokesperson responded to my email comment request and wrote "CDRH was tested in vitro to assess the potential for cellular and acute systemic toxicity of individual lubricants.
Regarding vaginal stimulation and sensitivity, at this time, we do not know any validated in vitro models of these tests.
"Why does the FDA not require a human safety test? This 510(k)
Notice-named after the portion of the food, drug and Cosmetic acts governing medical devices-if manufacturers can demonstrate that their products are "substantially equivalent" to products already in the market in terms of safety and effectiveness, human clinical trials are not required (
A "called product ")
Or have been commercially distributed before 1976.
Human testing is also more expensive than animal research. "Iso-
Osmolar "lubricating oil is the first article written by safestI in an article published in" Chemical and Engineering News "on December 2012 about lubricating oil safety (C&EN)
Some studies have revealed that certain types of lubricants can cause cell damage and destroy the protective lactic acid bacteria that are prevalent in the vagina.
C & EN article by Lauren K
Dr. Wolf, assistant editor-in-chief of Science and Technology at the American Society of Chemistry weekly, pays special attention to the chemical properties of a lubricant called penetration. (
Disclosure: I am a paid contributor to the magazine and its former Blog Network Central Science. )
Penetration is a chemical term that describes the number of particles dissolved in a certain volume of liquid.
When the penetration of the lubricant exceeds the epithelial cells of normal vaginal secretions and vaginal lining, water flows out of the cells, causing the cells to shrink or even die.
The importance of this quality was tested in 2012 by a team led by Dr. Charlene Dezzutti of Magee
The Women's Institute at the University of Pittsburgh, published in the journal Public Library of Science.
Dezzutti and his colleagues tested the toxicity of 14 commercial personal lubricants to human cervical or rectal epithelial cells, three lactic acid bacteria that maintain the pH of vaginal acidity, and the susceptibility of cells to HIV infection.
The products that cause the least damage are those that penetrate within twice as much from normal vaginal secretions or semen. (
None of these lubricants increased HIV infection in the culture, and some did not even resistHIV activity. )
The best of these iso-
Penetration lubricant is a clean love.
Dezzutti's team also found that silicone-
Basic lubricants such as female condom 2 lubricants and Wet Platinum are also the safest in vitro tests.
But she warned in an interview with Wolf, "it's just a model in a test tube and it's hard to equate it with reallife activity.
"What works," Reallife" tests?
Dezzutti's warning is at the heart of PETA's beef with the FDA.
Jeffrey Brown, a scientist at PETA's regualogic testing department, provided me with a letter from the organization to Jeffrey schuren, director of Jeffrey h center, jd md, noting that the producers of good and clean Love did provide the agency with equivalent data for in vitro and animal testing.
People may be surprised to learn about the work of PETA in human tissue research.
Eric Boodman of STAT News wrote last week that investments in scientific research by PETA and support for research methods by external scientists will help the use of laboratory animals.
One of the animal-friendly organizations
The supported test is a derivative of two MIT bioengineering professors-the 3D human vaginal epithelial model soldby MatTek.
The cell biology company has produced a series of test systems designed to summarize the histological tissues and different cell types of specific human tissues.
Researchers at the University of Utah used a prevaginal analysis system to verify the safety of the vaginal inner ring designed to release the HIV reverse transcription inhibitor dapivirine.
Strgar of Good Clean Love believes that these complex multi-cell analysis systems from human donor tissues are more relevant than injecting lubricating oil into the rabbit vagina and killing them to check their histology.
"In this kingdom, no other animal has the same vagina as humans," Strgar said . ".
In fact, the rabbit vagina contains fewer specialized cells than the human vagina, and their increased sensitivity to stimulation is the reason why it was originally used as a toxicology model.
In a conference call with the agency on June 2015, discuss the tests required for 510 (k)
She was shocked at the fact that CDRH was reluctant to undergo cell testing and the possibility that the objections were not entirely scientific.
"One thing that keeps coming up throughout the negotiations is, 'Oh, you don't want to include PETA --
This will put you against the FDA, "Strgar said.
"If you want to get 510, you can't even mention that you're working with Peta (k).
"Strgar's Good Clean Love is licensed for EU medical devices and costs less than $10,000 for in vitro testing.
She said additional animal tests required by CDRH would cost at least $50,000.
The company finally received their £ 510 (k)
Authorized on November 19, 2015 (PDF).
Strgar said that as an established company, she was not very concerned about the money she spent.
Strgar said, "I never wanted to test on animals and I was angry that I was forced to do so.
In the end, the animal test did not even tell us the toxicity.
"It's the stupidest and miserable part of the whole thing.