QuestionShould the Food and Drug Administration regulate lube?
Hopes&Fears answers questions with the help of people who know what they're talking about. Today we look at the legal, financial and ethical arguments relating to regulating personal lubricants.
All sex should aspire to be safe, or at least safer, so it seems like FDA regulation of personal lubricant and sex toys should be a no-brainer. We want scientists poking, prodding and testing the goop that’s going to be all up on our junk to make sure it’s not, like, poisonous... right?
At the moment, it’s the law. All products that make medical claims (e.g., Take this magic pill, it’ll make you hard for days!) require something called FDA 510(k) approval. In layman’s speak, that means your product has passed the necessary tests to convince the medical folks and lawyer folks at the FDA that your product is safe enough to be sold in the US of A.
But just because it’s the law, doesn’t mean businesses or consumers have to like it. And many don’t. In light of the FDA’s alleged recent intensification of lubricant scrutiny, reportedly seizing shipments of non-approved slippery stuff across the country, we decided to ask some people in the know – is FDA regulation of lube a good thing?
Sex Educator at Smitten Kitten, a non-toxic sex toy retailer based in Minneapolis
I think FDA approval for lubricant could be a great thing. As it is right now, it is extremely expensive and really difficult for smaller lubricant manufacturers to achieve. It requires animal testing. A lot of organic lubes say they don’t do animal testing on the packaging, as a point of pride, so that’s frustrating. But the regulations are also inadequate. They’ve been proven inadequate by scientific study.
When you classify something as a medical device, say a lubricant puts on its packaging that it relieves vaginal dryness, that is technically a medical claim and now that lubricant has to be regulated as a medical device. But because it’s regulated as a medical device, it no longer has to list its ingredients on the package. So there are a lot of things about the way that the regulations are enforced that are frustrating.
If look at it from a financial standpoint it’s also kind of bullshit. These companies that make products that are known to be irritating, known to cause yeast infections, known to make the body more susceptible to STIs, have medical device approval on their products already because they can afford to pay for that testing very quickly. That testing is minimally $20,000, if not over $300,000 dollars. It’s a lot of money.
It’s still the same testing that allowed nonoxynol-9 go on to human bodies. Like, it’s not good at predicting what’s going to happen or actually determining the safety of the use of these products on genitals. So I have mixed feelings. I think if the actual testing processes were refined, and the patternization of medical devices not having to list their ingredients was altered, I think it would be a great thing. But as it is now, I don’t think it’s really helping anybody. Except the FDA.
— Used to reduce friction and increase pleasure during intercourse, lubricants are about a $219 million market in the U.S. alone, according to the Chicago-based market research firm SymphonyIRI Group.
— Questions about lubricant safety arose nearly a decade ago when microbicide developers were testing whether the detergent nonoxynol-9 could block HIV transmission. Manufacturers had been incorporating the compound into spermicidal lubricants for years because of its ability to punch holes in the cell membranes of sperm.
In 2002, however, a Phase II/III clinical trial of a nonoxynol-9 vaginal gel failed to protect women from HIV infection. Not only that, but the detergent actually increased the risk of HIV infection in the sex workers tested—women living in countries such as South Africa and Thailand who used the product three or four times per day (Lancet, DOI: 10.1016/s0140-6736(02)11079-8).
Food and Drug Administration spokesperson
The mission of the FDA is to protect the public health. The FDA regulation helps ensure the medical devices on the market perform according to their indicated use and that they are safe and effective. The FDA has the responsibility of protecting consumers against the health hazards associated with medical products. The agency relies on consumers, physicians and industry professionals to provide feedback on products and on any perceived regulatory impediments that may be deterring new safe and effective products from entering the marketplace.
The mission of the FDA is to protect the consumer and we know that some of the non-FDA approved lubricants on the market have some pretty frightening ingredients. A lubricant can stay inside the body for days or be swallowed unintentionally during the heat of the moment. Consumers should know that it’s OK to use a lubricant anywhere and everywhere and FDA approval tells the buyer they have nothing to fear. Even suntan lotions are FDA regulated as a drug and they don’t end up in inside the body like lubricants.
CEO of Simply Slick, the 95% organic personal lubricant
What we’re talking about is the health and safety of the people we are supposed to care for most. This isn’t just a non-starter. It’s not a non-issue. We know that current lubricants’ chemical construction increases the likelihood of sexually transmitted diseases. So tell me this shouldn’t be regulated and tested. Unless you think herpes, genital warts, AIDS, syphilis is all ok. [Other lubricant companies] want to tell you that this isn’t true or that they’ve done this for 50 years. Well, we’ve done a lot of things wrong for 50 years.
It doesn’t matter if it’s [financially] manageable. If I make an unhealthy product, if you get genital warts or breast cancer, is the fact that I didn’t want to spend $40K ok with you? If you don’t understand from a chemistry standpoint how your product interacts with human beings, if you do damage in that process, is that ok with you? So if you’re in the business to make a lubricant, $40K is the cost of business.
The tests that they have picked, honest to god, are good tests. They’re tests that I would have used, in part. We did additional testing because I want to know first and foremost that this is not going to hurt my wife or my daughter or my mother, or anybody else that chooses to use it. So I have to have an understanding of what’s happening. I do believe that there are additional tests that should be used. Did you know that there is no lubrication test that the FDA requires for you to make a personal lubricant? If you and I took water and cactus juice and we threw cellulose in it to make it thick and we added propylene glycol to preserve it, we could get approved as a lube because it would pass all their tests. But when you go to use it, it wouldn’t lubricate anything…
The problem is, everyone thinks they can make a lubricant. But the truth is, you need to have chemists, you need to have biologists and you need to have people that understand the FDA process. This isn’t like making a cherry pie for your aunt. Unprofessional people need to get out or they need to make themselves professional.
World Health Organization study (2012):
This study rocked the lube industry because it details specific problems with existing lubes.
The issue of 'osmolality' is a buzz issue in the lube world right now. a snippet from the WHO study:
— Try and limit osmolality to less than 1200 mOsm/kg (total glycol content below ca 8.3% mass fraction (w/w)).
— Avoid lubricant formulations containing polyquaternium 15 specifically, and perhaps polyquaternary compounds in general.
— If the primary intended target population use is vaginal use then a pH of 4.5 is preferable.
— If the primary intended users are MSM or cannot be determined, then a pH in the range 5.5–7 would be more
Moreover, additional lubricants are also frequently used by men who have sex with men (MSM) and sex workers. In a survey of Latino MSM in New York City, 93% used additional lubricants (59% always and 74% in at least 80% of sexual encounters) regardless of condom use (1). In a survey of MSM in San Francisco 89% reported always using a lubricant (2). Female sex workers also report high rates of additional lubricant use with condoms. Sex workers in brothels in the American state of Nevada used additional water-based lubricant with condoms 89% of the time (3). These women most frequently apply the additional lubricant to the outside of the condom or the surfaces of the vagina.
Director of Scientific Affairs at Doc Johnson, manufactured innovative adult products since 1976
The regulation of personal lubricants and materials are a welcome relief to us. Doc Johnson has always striven to do the right thing, removing phthalates, parabens and other questionable materials as quickly as possible. Doc Johnson has been trying to bring order to the industry and these regulations will knock-out those fly-by-night companies that profit at the potential cost of the public’s health.
The only downside we see is the potential for required animal testing, when Doc Johnson has gone to great lengths to be cruelty-free. Even though most of the big players in the cosmetic world are backing the pending regulations, animal testing in this way does not strike us as ethical nor necessary. This is an uphill battle for the little guy entrepreneurs. If Doc Johnson can’t provide body-safe products in a category, we will not be in that category.
Earlier this year, a class action lawsuit was brought against a 50 Shades of Grey-branded lube made by UK sex toy/lube manufacturing giant Lovehoney for falsely marketing beneficial, aphrodisiac and orgasm-enhancing properties and latex compatibility, as well as failure to register Fifty Shades of Grey Come Alive Pleasure Gel as a Class I Medical Device or a Class II Medical Device with the FDA.
Source: Truth In Advertising (pdf)